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Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin GI (IgGl) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa.
BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use.
Each BIMZELX prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1.
BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis.
BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis.
The recommended dosage of BIMZELX is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dosage of 320 mg every 4 weeks after Week 16 [see CLINICAL PHARMACOLOGY].
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.
For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing regimen for adult patients with plaque psoriasis [see Recommended Dosage For Plaque Psoriasis].
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The recommended dosage is 160 mg by subcutaneous injection every 4 weeks.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Injection: 160 mg/mL clear to slightly opalescent, and colorless to pale brownish-yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution. Each prefilled autoinjector or prefilled syringe contains 1 mL of a 160mg/mL solution. BIMZELX is supplied as:
BIMZELX autoinjector:
BIMZELX prefilled syringe:
Store cartons with BIMZELX refrigerated between 2°C to 8°C (36°F to 46°F). Keep the product in the original carton to protect it from light until the time of use. Do not freeze. Do not shake. Do not use beyond expiration date. BIMZELX does not contain a preservative; discard any unused portion. Not made with natural rubber latex.
When necessary, BIMZELX prefilled syringes or autoinjectors may be stored at room temperature up to 25°C (77°F) in the original carton for a single period of up to 30 days. Once BIMZELX prefilled syringes or autoinjectors have been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and discard if not used within a 30-day period.
Manufactured by: UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080. Revised: Sep 2024.
The following adverse reactions have been observed with BIMZELX and are discussed in greater detail in other sections of the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, a total of 1789 subjects with plaque psoriasis were treated with BIMZELX. Of these, 1073 subjects were exposed to BIMZELX for at least one year.
The safety of BIMZELX was evaluated in two placebo-controlled trials (Ps-1 and Ps-2), an active-controlled trial (Ps-3), and an open-label extension trial. Data from Trials Ps-1 and Ps-2 in 839 subjects (mean age 45 years, 72% male, 84% white) were pooled to evaluate the safety of BIMZELX in comparison to placebo up to 16 weeks after treatment initiation. A total of 670 subjects were treated during this initial period with BIMZELX 320 mg at Weeks 0, 4, 8, 12, and 16. Table 1 summarizes the adverse reactions that occurred at a rate of 1% or greater and at a higher rate in the BIMZELX group than the placebo group.
Table 1: Adverse Reactions Occurring in ≥1% of Subjects with Plaque Psoriasis in the BIMZELX Group and More Frequently than in the Placebo Group in Trials Ps-1 and Ps-2
| BIMZELX N=670 n (%) |
Placebo N=169 n (%) |
|
| URIa | 102 (15) | 24 (14) |
| Oral Candidiasisb | 61 (9) | 0 (0) |
| Headache | 22 (3) | 0 (0) |
| Injection Site Reactionsc | 19 (3) | 2 (1) |
| Tinea Infectionsd | 18 (3) | 1 (1) |
| Gastroenteritise | 12 (2) | 0 (0) |
| Herpes Simplex Infectionsf | 9 (1) | 0 (0) |
| Acne | 8 (1) | 0 (0) |
| Folliculitis | 8 (1) | 0 (0) |
| Other Candida Infectionsg | 7 (1) | 1 (1) |
| Fatigue | 7 (1) | 0 (0) |
| a Upper Respiratory Infections include nasopharyngitis, upper respiratory tract infection, pharyngitis, rhinitis, viral upper respiratory tract infection, tonsillitis, sinusitis, pharyngitis streptococcal, pharyngitis bacterial, peritonsillar abscess, viral rhinitis, and influenza b Oral Candidiasis includes oral candidiasis, oropharyngeal candidiasis, oral fungal infection, fungal pharyngitis, and oropharyngitis fungal c Injection Site Reactions include injection site reaction, injection site erythema, injection site pain, injection site edema, injection site bruising, and injection site swelling d Tinea Infections include tinea pedis, fungal skin infection, tinea versicolor, tinea cruris, tinea infection, body tinea, and onychomycosis e Gastroenteritis includes Enterovirus infection, gastroenteritis, gastroenteritis bacterial, and gastroenteritis viral f Herpes Simplex Infections include herpes simplex and oral herpes g Other Candida Infections include vulvovaginal candidiasis, vulvovaginal mycotic infection, skin candida, and genital candidiasis. |
||
Adverse reactions that occurred in < 1% but > 0.1% of subjects in the BIMZELX group and at a higher rate than in the placebo group through Week 16 were neutropenia, eczema, otitis externa, otitis media, and pyrexia.
The safety of BIMZELX was evaluated in another active-controlled trial (Ps-4) in 743 adult subjects who received BIMZELX 320 mg every 4 weeks or every 8 weeks through Week 48.
The study populations of Trial Ps-1, Trial Ps-2, Trial Ps-3 and Trial Ps-4 excluded subjects with active suicidal ideation, suicidal ideation within the month prior to screening, a history of suicide attempt within the past 5 years prior to screening, or moderately severe to severe major depression (i.e., score of ≥15 on the screening Patient Health Questionnaire-9 (PHQ-9)).
Based on a pooled analysis of the first 16 weeks of the placebo controlled clinical trials, 12 of the 670 subjects in the BIMZELX group (1.8%) reported passive suicidal ideation on the C-SSRS compared to 1 of 169 subjects in the placebo group (0.6%).
During the course of the clinical trials for plaque psoriasis, there was 1 completed suicide in the open label extension trial after 718 days of treatment (1/2480; 0.01/100 subject-years). The completed suicide was reported in a subject without a past reported psychiatric history. There were also 3 suicide attempts (3/2480; 0.04/100 subject-years); 2 of these subjects had a history of prior suicide attempts.
During the placebo-controlled period of Trials Ps-1 and Ps-2, infections were reported in 36% of subjects (141.7 per 100 patient-years) treated with BIMZELX compared with 23% of subjects (84.6 per 100 patient-years) treated with placebo. Serious infections occurred in 0.3% of subjects (1.0 per 100 patient-years) treated with BIMZELX and 0% treated with placebo.
The most common infections were upper respiratory tract infections and Candida infections, including oral candidiasis (oral candidiasis, oropharyngeal candidiasis, oral fungal infection, fungal pharyngitis, and oropharyngitis fungal) occurring in 9% (30.6 per 100 patient-years) of subjects treated with BIMZELX and other Candida infections (vulvovaginal candidiasis, vulvovaginal mycotic infection, skin candida, and genital candidiasis) in 1% (3.4 per 100 patient-years) of subjects treated with BIMZELX compared to 0% and 1%, respectively, of subjects treated with placebo.
During the combined initial, maintenance, and open-label extension treatment periods of trials Ps-1, Ps-2, Ps-3, and the open-label extension trial, infections were reported in 63% of subjects treated with BIMZELX (120.4 per 100 patient-years). Serious infections were reported in 1.5% of subjects treated with BIMZELX (1.6 per 100 patient-years).
In clinical trials in subjects with plaque psoriasis, subjects with active inflammatory bowel disease were excluded. In these trials, which included 2480 subjects exposed to BIMZELX accounting for 5830 patient-years, adjudicated cases of new onset of inflammatory bowel disease (including ulcerative colitis (UC), Crohn’s disease (CD) and IBD-undetermined) occurred in seven subjects (0.12 per 100 patient-years); the majority of these cases were serious and resulted in discontinuation of therapy.
During the placebo-controlled period of Trials Ps-1 and Ps-2, liver serum transaminase elevations (> 3 times the upper limit of normal [ULN]) occurred in 1.0% of subjects treated with BIMZELX versus 0.6% of subjects treated with placebo. Elevated liver serum transaminases resolved during continued treatment or after discontinuation of BIMZELX.
During the maintenance period (Week 16 through Week 52 of Trial Ps-1 and Week 56 of Trial Ps-2), adverse reactions were consistent with those observed during the initial 16 weeks of treatment with BIMZELX. During the maintenance treatment periods of Trial Ps-2 and Trial Ps-3, the rates of adverse reactions were similar between subjects treated with BIMZELX 320 mg every four week and every eight weeks, after the initial 16 weeks of treatment.
During the open-label extension trial, including data from Week 56 through Week 128, new adverse reactions of suicide attempt and a completed suicide occurred [described above].
In an active-controlled clinical trial (Trial Ps-4), 691 subjects with plaque psoriasis were treated with BIMZELX for up to 144 weeks. Adverse reactions were consistent with those observed during the initial 16 weeks of treatment and with the overall safety profile of BIMZELX.
The safety of BIMZELX was evaluated in two placebo-controlled trials (PsA-1 and PsA-2). Data from Trials PsA-1 and PsA-2 in 1,111 subjects (mean age 49 years, 47% male, 96% white) were pooled to evaluate the safety of BIMZELX in comparison to placebo up to 16 weeks after treatment initiation. A total of 698 subjects were treated during this initial period with BIMZELX 160 mg at Weeks 0, 4, 8, 12, and 16. Table 2 summarizes the adverse reactions that occurred at a rate of 2% or greater and at a higher rate in the BIMZELX group than the placebo group.
Table 2: Adverse Reactions Occurring in ≥ 2% of Subjects with Psoriatic Arthritis in the BIMZELX Group and More Frequently than in the Placebo Group in Trials PsA-1 and PsA-2
| BIMZELX N=698 n (%) |
Placebo N=413 n (%) |
|
| URIa | 99 (14) | 41 (10) |
| Headache | 25 (4) | 7 (2) |
| Diarrhea | 19 (3) | 8 (2) |
| Urinary Tract Infection | 14 (2) | 7 (2) |
| Oral Candidiasis | 16 (2) | 0 |
| a Upper Respiratory Tract Infections (URI) includes: nasopharyngitis, upper respiratory tract infection, pharyngitis, sinusitis, and rhinitis. | ||
Adverse reactions that occurred in < 2% but > 1% of subjects in the BIMZELX group and at a higher rate than in the placebo group through Week 16 included neutropenia (placebo: n=0; BIMZLEX: n=8 (1.1%)), stomatitis (placebo: n=0; BIMZELX: n=8 (1.1%)), bronchitis (placebo: n=1 (0.2%); BIMZLEX: n=11 (1.6%)), and oropharyngeal pain (placebo: n=0; BIMZELX: n=9 (1.3%)).
The neuropsychiatric inclusion/exclusion criteria in PsA trials were the same as in PSO.
Based on a pooled analysis of the first 16 weeks of the placebo controlled clinical trials, 2 of the 698 subjects in the BIMZELX group (0.3%) reported passive suicidal ideation on the C-SSRS compared to 3 of 413 subjects in the placebo group (0.7%).
During the entire clinical trial program for PsA (2,664 patient-years), there were 2 cases of suicidal ideation (2/1413; 0.08/100 patient-years) and 1 suicide attempt (1/1413; 0.04/100 patient-years); all reported in BIMZELX-treated subjects with pre-existing psychiatric conditions. There were no completed suicides.
During the placebo-controlled period of Trials PsA-1 and PsA-2, infections were reported in 27% of subjects (100.7 per 100 patient-years) treated with BIMZELX compared with 18% of subjects (62.8 per 100 patient-years) treated with placebo. Serious infections occurred in 0.4% of subjects (1.4 per 100 patient-years) treated with BIMZELX and 0% treated with placebo.
The most common infections were upper respiratory tract infections, nasopharyngitis, urinary tract infection and Candida infections, including oral candidiasis (oral candidiasis, oral fungal infection, and tongue fungal infection), occurring in 3.2% (10.2 per 100 patient-years) of subjects treated with BIMZELX and other Candida infections (skin candida, vulvovaginal candidiasis, and vulvovaginal mycotic infection) in 0.6% (1.8 per 100 patient-years) of subjects treated with BIMZELX compared to 0% and 1%, respectively, of subjects treated with placebo.
During the combined placebo-controlled, maintenance and open-label extension treatment periods of Trials PsA-1 and PsA-2, infections were reported in 58% of subjects treated with BIMZELX (58.5 per 100 patients-years). Serious infections were reported in 2% of subjects treated with BIMZELX (1.3 per 100 patient-years).
In clinical trials in subjects with psoriatic arthritis, subjects with active inflammatory bowel disease were excluded. In these trials, which included 1,413 subjects exposed to BIMZELX accounting for 2,664 patient-years, adjudicated cases of new onset of inflammatory bowel disease (including ulcerative colitis (UC) and IBD) occurred in 2 subjects (0.08 per 100 patient-years); one of these cases was serious and none resulted in discontinuation of therapy.
During the placebo-controlled period of Trials PsA-1 and PsA-2, liver serum transaminase elevations (> 3 times the upper limit of normal [ULN]) occurred in 1.3% of subjects treated with BIMZELX versus 0% of subjects treated with placebo. Elevated liver serum transaminases resolved during continued treatment or after discontinuation of BIMZELX.
During the maintenance period (Week 16 through Week 52 of Trial PsA-1), adverse reactions were consistent with those observed during the initial 16 weeks of treatment, and with the overall safety profile of BIMZELX.
BIMZELX was evaluated in a placebo-controlled trial (Trial nr-axSpA-1) in subjects with non-radiographic axial spondyloarthritis (128 subjects on BIMZELX and 126 subjects on placebo). The safety profile observed in subjects with non-radiographic axial spondyloarthritis treated with BIMZELX was overall similar to the safety profile seen in subjects with psoriatic arthritis, except for cough, musculoskeletal pain, myalgia, tonsilitis, transaminase increase (placebo: n=0; BIMZELX: n=3 (2.3%) for each), and fatigue (placebo: n=1 (0.8%); BIMZELX: n=3 (2.3%)).
The neuropsychiatric inclusion/exclusion criteria were the same in non-radiographic axial spondyloarthritis trials as in PSO.
During the first 16 weeks of the placebo controlled clinical trial Trial nr-axSpA-1, no subjects in the BIMZELX or placebo group reported suicidal ideation on the C-SSRS. During the entire clinical trial program for nr-axSpA (398 patient-years), there were no cases of suicidal ideations. One suicide attempt (1/244; 0.25/100 subject-years) was reported in a BIMZELX-treated patient with pre-existing psychiatric conditions and recent life stressors. There were no completed suicides.
During the placebo-controlled period of Trial nr-axSpA-1, infections were reported in 36% of subjects (144.8 per 100 patient-years) treated with BIMZELX compared with 25% of subjects (94.4 per 100 patient-years) treated with placebo. There were no reports of serious infections reported during the placebo-controlled period of the trial.
During the combined 52 week treatment period of Trial nr-axSpA-1, and subsequent open-label treatment, infections were reported in 68% of subjects treated with BIMZELX (78.0 per 100 patient-years). Serious infections were reported in 1.6% of subjects treated with BIMZELX (1.0 per 100 patient-years).
In the clinical trial in subjects with non-radiographic axial spondyloarthritis, subjects with active inflammatory bowel disease were excluded. In placebo-controlled, maintenance, and open label treatment periods of this trial, which included 244 subjects exposed to BIMZELX accounting for 397 patient-years, adjudicated cases of new onset of inflammatory bowel disease occurred in 1 subject (Ulcerative Colitis; 0.26 per 100 patient-years); this case of ulcerative colitis was nonserious and did not result in discontinuation of therapy.
During the placebo-controlled period of Trials nr-axSpA-1, liver serum transaminase elevations (> 3 times the upper limit of normal [ULN]) occurred in 1.6% of subjects treated with BIMZELX versus 0.8% of subjects treated with placebo. Elevated liver serum transaminases resolved during continued treatment or after discontinuation of BIMZELX.
During the maintenance period (Week 16 through Week 52 of Trial nr-axSpA-1), adverse reactions were consistent with those observed during the initial 16 weeks of treatment, and with the overall safety profile of BIMZELX.
BIMZELX was evaluated in a placebo-controlled trial (Trial AS-1) in subjects with ankylosing spondylitis (221 subjects on BIMZELX and 111 subjects on placebo) The safety profile observed in subjects with ankylosing spondylitis treated with BIMZELX was overall similar to the safety profile seen in subjects with psoriatic arthritis, except for injection site pain, rash (placebo: n=1 (0.9%); BIMZELX: n=6 (2.7%), for each) and vulvovaginal mycotic infection (placebo: n=0; BIMZELX: n=5 (2.3%)).
The neuropsychiatric inclusion/exclusion criteria were the same in AS trials as in PSO.
During the first 16 weeks of the placebo controlled clinical Trial AS-1, no subjects in the BIMZELX or placebo group reported suicidal ideation on the C-SSRS. During the entire clinical trial program for AS (1,844 patient-years), there was 1 case of suicidal ideation (1/684; 0.05/100 subject-years) reported in a subject with pre-existing psychiatric conditions. There were no completed suicides or suicide attempts.
During the placebo-controlled period of Trial AS-1, infections were reported in 28% of subjects (110.3 per 100 patient-years) treated with BIMZELX compared with 23% of subjects (83.7 per 100 patient-years) treated with placebo. Serious infections occurred in 1 (0.5%) subject (1.5 per 100 patient-years) treated with BIMZELX and 1 (0.9%) subject (2.9 per 100 patient-years) treated with placebo.
During the combined 52 week treatment period of Trial AS-1, and subsequent open-label treatment, infections were reported in 62% of subjects treated with BIMZELX (58.8 per 100 patient-years). Serious infections were reported in 2.7% of subjects treated with BIMZELX (1.5 per 100 patient-years).
In clinical trials in subjects with AS, subjects with active inflammatory bowel disease were excluded In these phase 2/3 trials, which included 593 subjects exposed to BIMZELX accounting for 1,599 patient-years, adjudicated cases of new onset of inflammatory bowel disease (including ulcerative colitis (UC), Crohn’s disease (CD) and IBD-undetermined) occurred in 6 subjects (0.38 per 100 patient-years); 4 cases were serious, and 3 cases resulted in discontinuation of therapy.
During the placebo-controlled period of Trial AS-1, liver serum transaminase elevations (> 3 times the upper limit of normal [ULN]) occurred in 1.4% of subjects treated with BIMZELX versus 1.8% of subjects treated with placebo. Elevated liver serum transaminases resolved during continued treatment or after discontinuation of BIMZELX.
During the maintenance period (Week 16 through Week 52 of Trial AS-1), adverse reactions were consistent with those observed during the initial 16 weeks of treatment, and with the overall safety profile of BIMZELX.
The following adverse reactions have been reported during post-approval use of BIMZELX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections:conjunctivitis, esophageal candidiasis
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with BIMZELX may modulate serum levels of some cytokines.
Therefore, upon initiation or discontinuation of BIMZELX in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.
Population pharmacokinetic (PK) data analyses indicated that the clearance of BIMZELX was not impacted by concomitant administration of cDMARDs including methotrexate, or by prior exposure to biologics.
Included as part of the PRECAUTIONS section.
During the 16-week, placebo-controlled period of Trials Ps-1 and Ps-2, higher rates of suicidal ideation were reported in BIMZELX-treated subjects than in placebo-treated subjects.
Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials of psoriasis. The C-SSRS is an interview-based instrument used to monitor for the presence and severity of suicidal ideation (ranging from “none” to “active suicidal ideation with specific plan and intent”) and behaviors (rating the injury and potential lethality of self-injury, if present). Pooled analysis of C-SSRS data from two 16-week, placebo-controlled clinical trials indicated that 12/670 (1.8%) BIMZELX-treated subjects and 1/169 (0.6%) placebo-treated subjects reported passive suicidal ideation with an estimated relative risk of 3.0 (95% confidence interval: 0.39, 22.74). Subjects without a prior history of SI/B treated with BIMZELX also reported a higher rate of new-onset suicidal ideation on the C-SSRS than subjects treated with placebo (1.3% vs. 0.6%). During the open-label extension trial, one completed suicide was reported in a BIMZELX-treated subject. [see ADVERSE REACTIONS]. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been established.
Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or suicidal ideation or behavior. Advise patients, their caregivers, and families to monitor for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise them to promptly seek medical attention or call the National Suicide and Crisis Lifeline at 988 [see Patient Counseling Information]. BIMZELX-treated patients with new or worsening symptoms of depression or suicidal ideation and/or behavior should be referred to a mental health professional, as appropriate. Prescribers should also re-evaluate the risks and benefits of continuing treatment with BIMZELX if such events occur.
BIMZELX may increase the risk of infections. In clinical trials in subjects with plaque psoriasis, infections occurred in 36% of the BIMZELX group compared to 23% of the placebo group through 16 weeks of treatment. Upper respiratory tract infections, Candida infections, tinea infections, gastroenteritis, and Herpes Simplex infections occurred more frequently in the BIMZELX group than in the placebo group [see ADVERSE REACTIONS].
Serious infections occurred in 0.3% of subjects treated with BIMZELX and 0% treated with placebo.
Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and discontinue BIMZELX until the infection resolves.
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients treated with BIMZELX for signs and symptoms of active TB during and after treatment.
Treatment with BIMZELX was associated with increased incidence of liver enzyme elevations compared to treatment with placebo in randomized clinical trials. Liver serum transaminase elevations > 3 times the upper limit of normal were reported in subjects treated with BIMZELX [see ADVERSE REACTIONS]. Elevated liver serum transaminases resolved after discontinuation of BIMZELX. The time to onset of these adverse reactions varied between 28 and 198 days after starting BIMZELX treatment.
Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, intemipt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Patients with acute liver disease or cirrhosis may be at increased risk for severe hepatic injury; avoid use of BIMZELX in these patients.
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX [see ADVERSE REACTIONS]. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Limited data are available regarding coadministration of BIMZELX with non-live vaccines [see CLINICAL PHARMACOLOGY].
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Instruct patients or caregivers to perform the first self-injection under the supervision and guidance of a qualified healthcare professional for proper training in subcutaneous injection technique [see DOSAGE AND ADMINISTRATION, Instructions for Use].
Instruct patients or caregivers to administer two 160 mg single-dose syringes or two 160 mg single-dose autoinjectors to achieve the 320 mg dose of BIMZELX [see DOSAGE AND ADMINISTRATION].
Instruct patients or caregivers in the technique of needle and syringe disposal [see Instructions For Use].
Advise patients if they forget to take their dose of BIMZELX to inject their dose as soon as they remember. Instruct patients to then take their next dose at the appropriate scheduled time [see DOSAGE AND ADMINISTRATION].
Instruct patients and their caregivers to monitor for the emergence of suicidal ideation and behavior and promptly seek medical attention if the patient experiences suicidal ideation or behavior; or new onset or worsening depression, anxiety, or other mood changes. Instruct patients to call the National Suicide and Crisis Lifeline at 988 if they experience suicidal ideation or behavior. [see WARNINGS AND PRECAUTIONS].
Inform patients that BIMZELX may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see WARNINGS AND PRECAUTIONS].
Inform patients that BIMZELX may increase the risk of elevated liver enzymes. Acute liver disease or cirrhosis may increase this risk. Advise patients that laboratory evaluation is needed prior to and periodically during treatment. Advise patients to hold the next dose of BIMZELX and call their healthcare provider right away, if signs or symptoms of liver dysfunction occur. [see WARNINGS AND PRECAUTIONS].
Instruct patients to seek medical advice if they develop signs and symptoms of Crohn’s disease or ulcerative colitis [see WARNINGS AND PRECAUTIONS].
Advise patients that vaccination with live vaccines is not recommended during BIMZELX treatment. Instruct patients to inform their healthcare practitioner that they are taking BIMZELX prior to a potential vaccination [see WARNINGS AND PRECAUTIONS].
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to BIMZELX during pregnancy [see Use In Specific Populations].
Carcinogenicity and mutagenicity studies have not been conducted with bimekizumab-bkzx.
No effects on fertility parameters such as effects on reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were subcutaneously administered 200 mg/kg/week bimekizumab-bkzx (150 times the MRHD, based on mg/kg comparison) for 26 weeks. The monkeys were not mated to evaluate fertility.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BIMZELX during pregnancy. For more information, healthcare providers or patients can contact the Organization of Teratology Information Specialists (OTIS) Autolmmune Diseases Study at 1-877-311- 8972 or visit https://mothertobaby.org/pregnancy-studies/.
Available data from case reports on BIMZELX use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, BIMZELX may be transmitted from the mother to the developing fetus (see Clinical Considerations). In an enhanced pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of bimekizumab-bkzx during the period of organogenesis through parturition at doses up to 38 times the maximum recommended human dose (MRHD) (see Data).
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Fetal/Neonatal Adverse Reactions
Because bimekizumab-bkzx may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to BIMZELX in utero. There are no data regarding infant serum levels of bimekizumab-bkzx at birth and the duration of persistence of bimekizumab-bkzx in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 4 months after birth may be considered because of the half-life of the product.
Animal Data
An enhanced pre- and postnatal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered subcutaneous doses of bimekizumab-bkzx of 20 or 50 mg/kg/week from gestation day 20 to parturition and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study. There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology or neurobehavioral development. The no observed adverse effect level (NOAEL) for both maternal and developmental toxicity was identified as 50 mg/kg/week (38 times the MRHD, based on mg/kg comparison of 1.33 mg/kg/week administered as a 320 mg dose to a 60 kg individual once every 4 weeks).
There are no data on the presence of bimekizumab-bkzx in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Endogenous IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to bimekizumab-bkzx are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BIMZELX and any potential adverse effects on the breastfed infant from BIMZELX or from the underlying maternal condition.
The safety and effectiveness of BIMZELX in pediatric patients have not been established.
Of the 1789 subjects with plaque psoriasis that were exposed to BIMZELX, a total of 153 subjects were 65 years of age or older, and 18 subjects were 75 years of age or older. Although no differences in safety or effectiveness were observed between subjects 65 years of age or older and younger adult subjects, the number of subjects aged 65 years and over is not sufficient to determine whether they respond differently from younger adult subjects.
No Information provided
None.
Bimekizumab-bkzx is a humanized immunoglobulin IgG1/ κ monoclonal antibody with two identical antigen binding regions that selectively bind to human interleukin 17A (IL-17A), interleukin 17F (IL-17F), and interleukin 17-AF cytokines, and inhibits their interaction with the IL-17 receptor complex. IL-17A and IL-17F are naturally occurring cytokines that are involved in normal inflammatory and immune responses. Bimekizumab-bkzx inhibits the release of proinflammatory cytokines and chemokines.
Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin. Bimekizumab-bkzx exposure-response relationships to serum biomarkers, including IL-17A and IL-17F, and the time course of such pharmacodynamic responses are unknown.
Healthy individuals who received a single 320 mg dose of BIMZELX two weeks prior to vaccination with an inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive BIMZELX prior to vaccination. The effectiveness of inactivated seasonal influenza vaccines and other inactivated and non-live vaccines has not been evaluated in patients treated with BIMZELX.
Bimekizumab-bkzx pharmacokinetics are comparable in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.
The median peak plasma concentration of bimekizumab-bkzx was 25 (range: 12-50) μg/mL and was reached in 3-4 days. Bimekizumab-bkzx exhibited dose-proportional pharmacokinetics in patients with plaque psoriasis over a dose range of 64 mg to 480 mg (0.2 to 1.5 times the approved recommended dosage) following subcutaneous administration.
The absolute bioavailability of bimekizumab-bkzx was 70% in healthy subjects.
The median volume of distribution at steady state was 11.2 L.
The median (coefficient of variation %) clearance (CL/F) of bimekizumab-bkzx was 0.337 L/day (32.7%). The mean terminal elimination half-life was 23 days, with clearance independent of dose.
Metabolism
Bimekizumab-bkzx is expected to be degraded into small peptides by catabolic pathways.
No significant differences in the pharmacokinetics of bimekizumab-bkzx were observed based on age (≥18 years).
The average plasma concentration in adult subjects weighing ≥120 kg was predicted to be at least 30% lower than those weighing < 120 kg (median of 87 kg) [see DOSAGE AND ADMINISTRATION Section].
The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of BIMZELX or of other bimekizumab products.
Across the pivotal trials in all indications, there was no identified clinically significant effect of anti-bimekizumab-bkzx antibodies, including neutralizing anti-drug antibodies, on safety or effectiveness of BIMZELX.
During the 52–56-week treatment period in Trial-Ps-1, Trial-Ps-2, and Trial-Ps-3 [see Clinical Studies], 116/257 (45%) of BIMZELX-treated subjects (at the recommended dosage) developed anti-bimekizumab-bkzx antibodies (also referred to as ADA). Of the BIMZELX-treated subjects who developed ADA in these trials, approximately 16% had neutralizing antibodies.
During the 52-week treatment period in Trial PsA-1 (see Clinical Studies, 201/431 (47%) of subjects treated with BIMZELX had ADA, and 18% had neutralizing ADA.
During the 52-week treatment period in Trial-nr-axSpA [see Clinical Studies], 68/119 (57%) of BIMZELX-treated subjects had anti-bimekizumab-bkzx as ADA, and approximately 25% had neutralizing ADA.
During the 52-week treatment period in Trial AS-1 [see Clinical Studies], 86/194 (44%) of BIMZELX-treated subjects had anti-bimekizumab-bkzx ADA, and approximately 20% had neutralizing ADA.
Three multicenter, randomized, double-blind trials [Trial-Ps-1 (NCT03370133), Trial-Ps-2 (NCT03410992), and Trial-Ps-3 (NCT03412747)] enrolled a total of 1480 subjects 18 years of age and older with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, an Investigator’s Global Assessment (IGA) score of ≥3 (“moderate”) in the overall assessment of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score ≥12.
In Trial-Ps-1, 567 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks, ustekinumab (for subjects weighing ≤100kg, 45 mg initially and 4 weeks later, then every 12 weeks; for subjects weighing >100kg, 90 mg initially and 4 weeks later, then every 12 weeks), or placebo through Week 52. At Week 16, subjects originally randomized to placebo received BIMZELX 320 mg every 4 weeks through Week 52.
In Trial-Ps-2, 435 subjects were randomized to either BIMZELX 320 mg by subcutaneous injection every 4 weeks or placebo. At Week 16, subjects who achieved a PASI 90 response continued into a 40-week randomized withdrawal period. Subjects originally randomized to BIMZELX 320 mg every 4 weeks were re-randomized to either BIMZELX 320 mg every 4 weeks or BIMZELX 320 mg every 8 weeks or placebo. Subjects originally randomized to placebo continued to receive placebo if they were PASI 90 responders. Subjects who did not achieve a PASI 90 response at week 16 entered an open-label escape arm and received BIMZELX 320 mg every 4 weeks for 12 weeks. Subjects who relapsed, defined as having a less than PASI 75 response compared to baseline, during the randomized withdrawal period also entered the 12-week escape arm.
In Trial-Ps-3, 478 subjects were randomized to receive either BIMZELX 320 mg by subcutaneous injection every 4 weeks through week 56, BIMZELX 320 mg every 4 weeks through week 16 followed by BIMZELX every 8 weeks through week 56, or adalimumab (80 mg as an initial dose followed by 40 mg every other week starting 1 week after initial dose through Week 24) followed by BIMZELX 320 mg every 4 weeks through Week 56.
In Trial-Ps1, Trial-Ps-2, and Trial-Ps-3, 71% of the subjects were male and 84% of the subjects were White, with a mean age of 45 years and a mean weight of 89 kg. At baseline, subjects had a median baseline PASI score of 18, median baseline for BSA of 20%, and baseline IGA score of 4 (“severe”) in 33% of subjects. A total of 93% subjects had psoriasis of the scalp (Scalp IGA score of ≥1) and a total of 26% of subjects had a history of psoriatic arthritis. Additionally, 38% had received prior biologic therapy.
Trial-Ps-1 and Trial-Ps-2 responses at Week 16 compared to placebo for the two co-primary endpoints:
Secondary endpoints included the proportion of subjects who achieved PASI 100, IGA 0, and Scalp IGA response (defined as Scalp IGA score of 0 [clear] or 1 [almost clear] with at least 2-grade of improvement from baseline) at Week 16, and PASI 75 at Week 4. In addition, secondary endpoints included assessment of psoriasis symptoms (itching, pain, and scaling) measured by the Patient Symptom Diary (PSD) at Week 16.
The proportion of subjects who achieved IGA 0 or 1, PASI 90, IGA 0, and PASI 100 response at Week 16 are presented in Table 3.
Table 3: Efficacy Results at Week 16 in BIMZELX- or Placebo-Treated Adults with Plaque Psoriasis in Trial-Ps-1 and Trial-Ps-2
| Trial-Ps-1 | Trial-Ps-2 | |||
| BIMZELX 320 mg every 4 weeks (N=321) n (%) |
Placebo (N=83) n (%) |
BIMZELX 320 mg every 4 weeks (N=349) n (%) |
Placebo (N=86) n (%) |
|
| IGA 0 or 1 (“clear” or “almost clear”) a | 270 (84%) | 4 (5%) | 323 (93%) | 1 (1%) |
| Difference (95% CI) | 79% (73%, 85%) | 91% (88%, 95%) | ||
| PASI 90a | 273 (85%) | 4 (5%) | 317 (91%) | 1 (1%) |
| Difference (95% CI) | 80% (74%, 86%) | 90% (86%, 93%) | ||
| IGA 0 (“clear”) | 188 (59%) | 0 (0%) | 243 (70%) | 1 (1%) |
| Difference (95% CI) | 59% (53%, 64%) | 69% (64%, 74%) | ||
| PASI 100 | 188 (59%) | 0 (0%) | 238 (68%) | 1 (1%) |
| Difference (95% CI) | 59% (53%, 64%) | 67% (62%, 73%) | ||
| a Co-primary endpoints | ||||
Examination of age, gender, race, baseline IGA score and previous treatment with systemic or biologic agents did not identify differences in response to BIMZELX among these subgroups at Week 16.
A greater proportion of subjects randomized to BIMZELX achieved PASI 75 at Week 4 in both trials compared to placebo. In Trial-Ps-1, 77% of subjects treated with BIMZELX achieved PASI 75 compared to 2% treated with placebo. In Trial-Ps-2, 76% of subjects treated with BIMZELX achieved PASI 75 compared to 1% treated with placebo.
Among subjects with Scalp IGA score of at least 2 at baseline, a greater proportion of subjects randomized to BIMZELX achieved Scalp IGA response at Week 16 in both trials compared to placebo. In Trial-Ps-1, 84% (240/285) of subjects treated with BIMZELX achieved Scalp IGA response compared to 15% (11/72) of placebo treated subjects. In Trial-Ps-2, 92% (286/310) of subjects treated with BIMZELX achieved Scalp IGA response compared to 7% (5/74) of placebo treated subjects.
In Trial-Ps-2, subjects randomized to BIMZELX every 4 weeks at Week 0 and who were PASI 90 responders at Week 16 were re-randomized to either continue treatment with BIMZELX every 4 weeks, switched to BIMZELX every 8 weeks, or be withdrawn from therapy (i.e., received placebo).
Figure 1 and Figure 2 present the percentage of subjects maintaining IGA score of 0 (“Clear”) or 1 (“Almost Clear”) and PASI 90, respectively, through Week 56 after re-randomization at Week 16.
Figure 1: Percentage of Subjects Maintaining IGA 0 or 1 through Week 56 after Re-Randomization at Week 16
 |
For IGA 0 or 1 responders at Week 16 who were re-randomized to treatment withdrawal (i.e., placebo), the median time to loss of IGA 0 or 1 response was approximately 24 weeks. Among these subjects with IGA score of 2 at retreatment, 58% (14/24) achieved IGA score of 0 within 12 weeks of restarting treatment with BIMZELX 320 mg every 4 weeks. Among these subjects with IGA score ≥ 3 at retreatment, 87% (34/39) regained IGA 0 or 1 response with at least 2-grade improvement from retreatment within 12 weeks of restarting treatment with BIMZELX 320 mg every 4 weeks.
Figure 2: Percentage of Subjects Maintaining PASI 90 through Week 56 after Re-Randomization at Week 16
 |
For PASI 90 responders at Week 16 who were re-randomized to treatment withdrawal (i.e., placebo), the median time to loss of PASI 90 response was approximately 24 weeks.
Greater improvements in itch, pain, and scaling at Week 16 with BIMZELX compared to placebo were observed in both trials as measured by the Patient Symptom Diary (PSD).
The safety and efficacy of BIMZELX were assessed in 1,112 subjects in two multicenter, randomized, double-blind, placebo-controlled studies [Trial PsA-1 (NCT 03895203) and Trial PsA-2 (NCT 03896581)] in subjects 18 years and older with active psoriatic arthritis (PsA).
Subjects in these studies had a diagnosis of PsA of at least 6 months based on Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of 4.6 years at baseline, and active disease with ≥3 tender joint count and ≥3 swollen joint count. Subjects with each subtype of PsA were enrolled in these studies, including polyarticular symmetric arthritis (63.5%), oligoarticular asymmetric arthritis (25.9%), distal interphalangeal joint predominant (4.4%), spondylitis predominant (4.2%), and arthritis mutilans (1.5%). At baseline, 56% of subjects had ≥3% Body Surface Area (BSA) with active plaque psoriasis. At baseline across both studies, 32% and 12% of subjects had enthesitis and dactylitis, respectively, 58% of subjects had psoriatic nail disease, and 53% of subjects were receiving concomitant methotrexate.
The PsA-1 study evaluated 852 biologic-naïve subjects, who were treated with either BIMZELX 160 mg every 4 weeks up to Week 52, adalimumab 40 mg every 2 weeks up to Week 52 (active reference arm), or placebo. Subjects receiving placebo were switched to BIMZELX every 4 weeks at Week 16 to Week 52.
In this study, 78% of subjects had received prior treatment with ≥ 1 conventional DMARDs (cDMARDs), and 22 % of subjects had no prior treatment with cDMARDs. At baseline, 58% of subjects were receiving concomitant methotrexate (MTX), 11% were receiving concomitant cDMARDs other than MTX, and 31% were receiving no cDMARDs. The PsA-2 study evaluated 400 anti-TNFα experienced subjects (inadequate response or intolerance to treatment), who were treated with BIMZELX 160 mg every 4 weeks or placebo up to Week 16. In this study, 43% of subjects were receiving concomitant MTX, 8% were receiving concomitant cDMARDs other than MTX, and 50% were receiving no cDMARDs.
For both studies, the primary endpoint was the proportion of subjects who achieved an America College of Rheumatology (ACR) 50 response at Week 16.
In both studies, treatment with BIMZELX resulted in significant improvement in disease activity, as measured by ACR, compared to placebo at Week 16 (see Table 4). Responses in Trial PsA-2 (anti-TNF experienced) were similar to Trial PsA-1.
Table 4: Clinical Responses at Week 16 in Trial PsA-1 and Trials PsA-2
| Trial PsA-1 – bDMARD naïve | Trial PsA-2 – anti-TNFα experienced | |||||
| Endpoint | BIMZELX 160 mg Q4W N=431 n(%) |
Placebo N=281 n(%) |
Difference from Placebo** (95% CI) |
BIMZELX 160 mg Q4W N=267 n(%) |
Placebo N=133 n(%) |
Difference from Placebo** (95% CI) |
| ACR 20 Response | ||||||
| Week 16 | 268 (62.2) |
67 (23.8) |
38.3 (31.6, 45.1) |
179 (67.0) |
21 (15.8) |
51.3 (42.9, 59.6) |
| ACR 50 Response | ||||||
| Week 16 | 189 (43.9)* |
28 (10.0) |
33.9 (28.0, 39.7) |
116 (43.4)* |
9 (6.8) |
36.7 (29.4, 44.0) |
| ACR 70 Response | ||||||
| Week 16 | 105 (24.4) |
12 (4.3) |
20.1 (15.4, 24.8) |
71 (26.6) |
1 (0.8) |
25.8 (15.6, 35.7)*** |
| CI= confidence interval * Multiplicity-controlled p<0.001 **95% CI based on normal approximation ***Exact 95% CI used |
||||||
The percentage of subjects achieving ACR50 responses in Trial PsA-1 by visit through Week 16 is shown in Figure 3. Similar responses were seen in Trial PsA-2 up to Week 16.
Figure 3: Percent of Subjects Achieving ACR 50 Responses in Trial PsA-1 through Week 16
 |
The results of the components of the ACR response criteria are shown in Table 5.
Table 5: Mean change from Baselin in ACR Component Scores at Week 16 in Trial PsA-1 and Trial PsA-2
| Trial PsA-1 – bDMARD naïve | Trial PsA-2 anti-TNFα experienced | |||
| Placebo (N=281) |
BIMZELX 160 mg Q4W (N=431) |
Placebo (N=133) |
BIMZELX 160 mg Q4W (N=267) |
|
| Number of swollen joints | ||||
| Baseline | 9.5 | 9.0 | 10.3 | 9.7 |
| Mean change at Week 16 | -3.0 | -6.6 | -2.0 | -7.0 |
| Number of Tender Joints | ||||
| Baseline | 17.1 | 16.8 | 19.3 | 18.4 |
| Mean change at Week 16 | -3.2 | -10.0 | -2.4 | -10.9 |
| Patient’s Assessment of Pain | ||||
| Baseline | 56.8 | 53.7 | 61.7 | 58.3 |
| Mean change at Week 16 | -6.2 | -23.6 | -4.5 | -27.7 |
| Patient’s Global Assessment | ||||
| Baseline | 58.6 | 54.4 | 63.0 | 60.5 |
| Mean change at Week 16 | -7.7 | -26.3 | -5.5 | -31.8 |
| Physician Global Assessment | ||||
| Baseline | 57.3 | 57.2 | 57.7 | 59.3 |
| Mean change at Week 16 | -12.5 | -37.4 | -6.8 | -49.4 |
| Health Assessment Questionnaire- Disability Index (HAQ-DI) | ||||
| Baseline | 0.9 | 0.8 | 1.0 | 1.0 |
| Mean Change at Week 16 | -0.1 | -0.3* | -0.1 | -0.4* |
| High sensitivity C-reactive protein (hsCRP) mg/L | ||||
| Baseline | 11.4 | 8.7 | 11.6 | 12.4 |
| Mean Change at Week 16 |
-2.4 | -4.2 | 3.6 | -7.0 |
| Multiple Imputation (MI) is used for all endpoints presented in Table 5. *p<0.001 reference-based imputation versus placebo adjusted for multiplicity. |
||||
Treatment with BIMZELX resulted in improvement in dactylitis and enthesitis in subjects with pre-existing dactylitis or enthesitis, compared to placebo.
In subjects with coexistent plaque psoriasis receiving BIMZELX, the skin lesions of psoriasis improved with treatment, relative to placebo, as measured by the Psoriasis Area Severity Index (PASI 90) at Week 16.
In Trial PsA-1, inhibition of progression of structural damage was assessed radiographically and expressed as the change from baseline in the Van der Heijde modified total Sharp Score (vdHmTSS) and its components, the Erosion Score (ES) and the Joint Space Narrowing score (JSN), at Week 16 (see Table 6).
BIMZELX significantly inhibited the rate of progression of joint damage at Week 16 in the overall population compared to placebo. The change from Baseline in erosion subscores contributed more to the change from Baseline in vdHmTSS total score than the change from Baseline in joint narrowing subscore. The percentage of subjects with no radiographic joint damage progression (defined as a change from baseline in mTSS of ≤0.0) from randomization to Week 16 was 77% for BIMZELX and 69% for placebo in the overall population. Similar responses were achieved in the population with elevated hs-CRP and/or at least 1 bone erosion (75% for BIMZELX and 67% for placebo).
Table 6: Change in vdHmTSS in PsA-1 at Week 16
| Placebo | BIMZELX 160 mg Q4W |
Difference from Placebo (95% CI)a | |
| Overall population | (N=269) | (N=420) | |
| Baseline mean (SE) | 12.34 (1.37) | 12.47 (1.46) | |
| Mean change from baseline at Week 16 (SE) | 0.32 (0.09) | 0.04 (0.04)* | -0.26 (-0.29, -0.23) |
| * p≤0.001 versus placebo. p-values are based on reference-based imputation using difference in LS Mean using an ANCOVA model with treatment, bone erosion at Baseline and region as fixed effects and Baseline score as a covariate. a) Unadjusted differences are shown |
|||
In both studies, subjects treated with BIMZELX showed statistically significant improvement from baseline in physical function compared with placebo as assessed by HAQ-DI at Week 16 (see Table 5).In both studies, a greater proportion of subjects achieved a reduction of at least 0.35 in HAQ-DI score from baseline in the BIMZELX group compared with placebo at Week 16.
Fatigue was assessed by Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue). Additionally, in both studies at Week 16, subjects treated with BIMZELX showed improvements in FACIT-Fatigue scores.
The efficacy and safety were assessed in 254 patients in one randomized, double-blind, placebo-controlled study [(Trial nr-axSpA-1 (NCT03928704)] in adult subjects 18 years of age and older with active non-radiographic axial spondyloarthritis. Subjects had to have objective signs of inflammation with elevated C-reactive protein (CRP) level and/or evidence of sacroiliitis on Magnet Resonance Imaging (MRI). Subjects met ASAS classification criteria for axial spondyloarthritis and have active disease as defined by BASDAI greater than or equal to 4, spinal pain of greater than or equal to 4 (0-10 numeric rating scale (NRS)), and no definitive radiographic evidence of structural damage in the sacroiliac joints. At baseline, 73% of subjects had enthesitis. Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 24% of subjects were on concomitant cDMARDs. Overall, 11% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents.
Subjects were randomized to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.
In Trial nr-axSpA-1 Study, treatment with BIMZELX resulted in significant improvements in the measure of disease activity compared to placebo at Week 16 (Table 7).
Table 7: Clinical Response in Trial nr-axSpA-1 at Week 16
| BIMZELX 160 mg Q4W (N=128) n (%) |
Placebo (N=126) n (%) |
Difference from placebo (95% CI)** | |
| ASAS 40 response | 61 (47.7%)* | 27 (21.4%) | 26.2 (15.0, 37.5) |
| ASAS 20 response | 88 (68.8%)* | 48 (38.1%) | 30.7 (19.0, 42.3) |
| NRI is used CI= confidence interval *Multiplicity-controlled p<0.001 **95% CI based on normal approximation |
|||
Similar responses were seen regardless of prior anti-TNF alpha therapy. Treatment with BIMZELX resulted in improvement in enthesitis in subjects with pre-existing enthesitis.
The results of the main components of the ASAS 40 response criteria and other measures of disease activity are shown in Table 8.
Table 8: Components of the ASAS40 Response Criteria and Other Measures of Disease Activity in nr-axSpA Subjects at Baseline and Week 16 in Trial nr-axSpA-1
| BIMZELX 160 mg Q4W (N= 128) |
Placebo (N=126) |
|
| ASAS Components | ||
| Patient Global Assessment (0-10) | ||
| Baseline Mean Change from Baseline |
7.1 -3.2 |
6.9 -1.4 |
| Total Spinal Pain (0-10) | ||
| Baseline Mean Change from Baseline |
7.3 -3.4 |
7.1 -1.7 |
| BASFI (0-10) | ||
| Baseline Mean Change from Baseline |
5.5 -2.5* |
5.3 -1.0 |
| Inflammation (0-10)a | ||
| Baseline Mean Change from Baseline |
7.0 -3.6 |
6.9 -1.9 |
| Other Measures of Disease Activity | ||
| BASDAI Score | ||
| Baseline Mean Change from Baseline |
6.9 -3.1* |
6.7 -1.5 |
| BASMI | ||
| Baseline Mean Change from Baseline |
2.9 -0.4 |
3.0 -0.1 |
| hsCRP (mg/L) | ||
| Baseline Mean Change from Baseline |
11.1 -6.7 |
10.2 0.0 |
| a Inflammation is the mean of patient-reported stiffness self-assessments (questions 5 and 6) in BASDAI BASFI = Bath Ankylosing Spondylitis Functional Index BASMI = Bath Ankylosing Spondylitis Metrology Index BASDAI = Bath Ankylosing Spondylitis Disease Activity Index MI is used for all endpoints presented in Table 8 * Multiplicity-controlled p<0.001 |
||
The percentage of subjects achieving ASAS40 responses in Trial nr-AxSpa-1 by visit through Week 16 is shown in Figure 4.
Figure 4: Percent of Subjects Achieving ASAS40 Responses in Trial nr-axSpA-1 Week 16
 |
BIMZELX treated subjects showed significantly greater improvement compared to placebo-treated patients at Week 16 in health-related quality of life as measured by the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score.
The efficacy and safety were assessed in 332 patients in one randomized, double-blind, placebo-controlled study [Trial AS-1 (NCT03928743)] in adult subjects 18 years of age and older with active ankylosing spondylitis. Subjects had to have documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS. Subjects had active disease as defined by BASDAI ≥4 and spinal pain ≥4 on a 0 to 10 numeric rating scale (NRS)(from BASDAI Item 2). Subjects also had a history of inadequate response to 2 different non-steroidal anti-inflammatory drugs (NSAIDs), or intolerance or contraindication to NSAIDs. Approximately 20% of subjects were on concomitant cDMARDs. Overall, 16% of subjects had received previous treatment (failed or were intolerant to) with anti-TNF alpha agents.
Subjects were randomized 2:1 to receive BIMZELX 160 mg or placebo every 4 weeks up to the completion of Week 16 assessments. Starting at Week 16, all subjects received BIMZELX every 4 weeks up to Week 52. The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS 40) at Week 16.
In Trial AS-1, treatment with BIMZELX resulted in significant improvements in the measure of disease activity compared to placebo at Week 16 (Table 9).
Table 9: Clinical Response in Trial AS-1 at Week 16
| BIMZELX 160 mg Q4W (N=221) n (%) |
Placebo (N=111) n (%) |
Difference from placebo (95% CI)** | |
| ASAS 40 response | 99 (44.8%)* | 25 (22.5%) | 22.3 (12.1, 32.4) |
| ASAS 20 response | 146 (66.1%)* | 48 (43.2%) | 22.8 (11.7, 34.0) |
| NRI is used CI= confidence interval * Multiplicity-controlled p<0.001 **95% CI based on normal approximation |
|||
Similar responses were seen regardless of prior anti-TNF alpha therapy. Treatment with BIMZELX resulted in improvement in enthesitis in subjects with pre-existing enthesitis.
The results of the main components of the ASAS 40 response criteria and other measures of disease activity are shown in Table 10.
Table 10: Components of the ASAS40 Response Criteria and Other Measures of Disease Activity in Ankylosing Spondylitis Subjects at Baseline and Week 16 in Trial AS-1
| BIMZELX 160 mg Q4W (N= 221) |
Placebo (N=111) |
|
| ASAS Components | ||
| Patient Global Assessment (0-10) | ||
| Baseline Mean Change from Baseline |
6.6 -2.7 |
6.7 -1.6 |
| Total Spinal Pain (0-10) | ||
| Baseline Mean Change from Baseline |
7.1 -3.3 |
7.2 -1.9 |
| BASFI (0-10) | ||
| Baseline Mean Change from Baseline* |
5.3 -2.2* |
5.2 -1.1 |
| Inflammation (0-10)a | ||
| Baseline Mean Change from Baseline |
6.7 -3.2 |
6.8 -2.1 |
| Other Measures of Disease Activity | ||
| BASDAI Score | ||
| Baseline Mean Change from Baseline |
6.4 -2.9* |
6.5 -1.9 |
| BASMI | ||
| Baseline Mean Change from Baseline |
3.9 -0.5** |
3.8 -0.2 |
| hsCRP (mg/L) | ||
| Baseline Mean Change from Baseline |
14.7 -8.6 |
13.6 -2.2 |
| a Inflammation is the mean of patient-reported stiffness self-assessments (questions 5 and 6) in BASDAI.; BASFI = Bath Ankylosing Spondylitis Functional Index BASMI = Bath Ankylosing Spondylitis Metrology Index BASDAI = Bath Ankylosing Spondylitis Disease Activity Index MI is used for all endpoints presented in Table 10 *Multiplicity-controlled p<0.001 **Multiplicity-controlled p<0.006 |
||
The percentage of subjects achieving ASAS40 responses in Trial AS-1 by visit through Week 16 is shown in Figure 5.
Figure 5: Percent of Subjects Achieving ASAS40 Responses in Trial AS-1 Through Week 16
 |
BIMZELX treated subjects showed significantly greater improvement compared to placebo-treated subjects at Week 16 in health-related quality of life as measured by the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score.
BIMZELX®
(bim zel’ex)
(bimekizumab-bkzx) injection, for subcutaneous use
What is the most important information I should know about BIMZELX?
BIMZELX is a medicine that affects your immune system. BIMZELX may increase your risk of having serious side effects, including:
Before starting BIMZELX, tell your healthcare provider if you:
After starting BIMZELX, call your healthcare provider right away if you have any of the signs of infection listed above. Do not use BIMZELX if you have any signs of infection unless you are instructed to by your healthcare provider.
See “What are the possible side effects of BIMZELX?” for more information about side effects.
What is BIMZELX?
BIMZELX is a prescription medicine used to treat:
It is not known if BIMZELX is safe and effective in children.
Before using BIMZELX, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins and herbal supplements.
How should I use BIMZELX?
See the detailed “Instructions for Use” that comes with your BIMZELX for information on how to prepare and inject a dose of BIMZELX, and how to properly throw away (dispose of) used BIMZELX autoinjectors and prefilled syringes.
What are the possible side effects of BIMZELX?
BIMZELX may cause serious side effects, including:
The most common side effects of BIMZELX in people treated for Psoriasis include:
The most common side effects of BIMZELX in people treated for psoriatic arthritis include:
The most common side effects of BIMZELX in people treated for non-radiographic axial spondyloarthritis include:
The most common side effects of BIMZELX in people treated for ankylosing spondylitis include:
These are not all of the possible side effects of BIMZELX.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store BIMZELX?
Keep BIMZELX and all medicines out of the reach of children.
General information about the safe and effective use of BIMZELX.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BIMZELX for a condition for which it was not prescribed. Do not give BIMZELX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BIMZELX that is written for health professionals.
What are the ingredients in BIMZELX?
Active ingredient: bimekizumab-bkzx
Inactive ingredients: glacial acetic acid, glycine, polysorbate 80, sodium acetate and Water for Injection, USP.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
