Golimumab Compliance In Long-Term Arthritis Treatment
STUDY BACKGROUND
Biological and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs) are the cornerstones in treating inflammatory arthritides such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (SpA). Tumor necrosis factor-alpha (TNFα) inhibitors, including adalimumab, infliximab and golimumab are the most commonly prescribed bDMARDs. Each bDMARD works in unique ways to suppress pathways in the inflammatory cascade.
Long-term medication adherence is important for controlling chronic inflammation. However, it has been reported that due to inefficacy of the drug, adverse events, and personal preference, up to 50% of patients discontinue treatment after the first or second line of therapy.
Golimumab (GLM) is a TNFα-specific human IgG1κ monoclonal antibody approved for the treatment of inflammatory arthritides. Phase III trials showed that subcutaneous administration of golimumab every 4 weeks improved the signs and symptoms of RA, axial SpA, and PsA in adults. Furthermore, it had a 5-year retention rate of about 70% when used as first-line biological therapy. In RA patients treated with golimumab as second-line therapy, however, the 5-year retention rate was only 40%. Golimumab has a high probability of persistence in patients with rheumatic diseases, with a 7-year retention rate of 39.5%, according to recent studies. However, the sample size in these studies was small.
The objective of this study is to assess the golimumab retention rate in a large cohort and any associated factors after up to 8 years of follow-up.
Methods
This retrospective study involved database analysis of BIOBADASER, the Spanish registry of patients with rheumatic diseases. BIOBADASER involves investigators from 28 university hospitals representing the Spanish healthcare system. Patients are enrolled when they begin a biologic therapy or targeted-synthetic DMARD and are prospectively monitored until treatment discontinuation.
Inclusion Criteria
this study included adults who had ever received golimumab for RA, SpA, or PsA and initiated it > 6 months before the analysis date. Data were extracted in November 2021.
Exclusion Criteria
Patients who were prescribed golimumab for conditions not listed on the label or who began golimumab before reaching adulthood.
Outcome Variables
The main goal of this study was to determine the probability of golimumab retention rate up to 8 years after treatment initiation. The two outcome variables were the treatment start date (the first time golimumab was administered after a prescription) and the end date (the date golimumab was definitely stopped). Patients who discontinued golimumab permanently or temporarily for more than 90 days were considered permanent discontinuations.
Secondary goals of this study included determining the likelihood of golimumab retention by disease type (RA, axial SpA, or PsA) and line of biological therapy (first, second, third, or later), as well as investigating potential retention factors (including demographic and disease-related variables).
Statistical Analysis
Kaplan-Meier survival analysis was used to assess the probability of golimumab’s retention rate. Patients were right-censored if they were still on treatment at the time of data analysis. Kaplan–Meier analyses were performed for each disease (RA, axial SpA, and PsA) and line of golimumab therapy (first, second, third, or later line of therapy). A Cox regression analysis was done to identify factors associated with golimumab discontinuation. P-values less than 0.05 were considered statistically significant.
RESULTS
- At the time of data extraction, 885 patients (412 men and 473 women) fulfilled the inclusion criteria. The indication for golimumab was RA for 267 patients, axial SpA for 370 patients, and PsA for 248 patients.
- The mean age and median duration of disease at the onset of golimumab treatment were 51.5 and 7.6 (R = 2.8–15.0) years, respectively.
- Golimumab was the first biological drug in 33.2% (n = 313) of patients, the second in 32.2% (n = 303), and the third or later biological drug in 34.8% (n = 328).
- Across the three indications, concomitant medications at golimumab initiation were methotrexate (32.3%), steroids (28.7%), leflunomide (13.4%), and sulfasalazine (5.7%).
- The overall probability of golimumab retention since treatment initiation was 71.1% (95% CI 68-73.9%) at year 1, 60.2% (56.9-63.6%) at year 2, 54.3% (50.8-57.6%) at year 3, 48% (44.5-51.4%) at year 4, 43.9% (40.2-47.6%) at year 5, 41% (3701-44.9%) at year 6, and 37.7% (33.3-42.1%) at years 7 and 8.
- Retention of golimumab was more or less similar for patients with axial SpA and PsA. For RA, it was much lower—the probability of retention was 58.6% (year 1) and 24.6% (year 8). For patients with axial SpA, the probability of retention was 77.2% in year 1 and 45.8% in year 8, whereas it was 75.4% in year 1 and 39.9% in year 8 for PsA patients.
- Women, patients over 65 years old, patients who used steroids at initiation, and patients with advanced disease at baseline had lower rates of retention with golimumab therapy.
- The Cox regression analysis revealed that patients who received golimumab as first-line therapy had higher long-term retention than those who received it as second or third-line therapy. Those who needed concomitant steroids at the start had a lower probability.
DISCUSSION
This retrospective registry analysis found that the overall probability of retention of golimumab treatment for patients with RA, axial SpA, or PsA was high—about 71% after one year, as well as in the long term, with an overall retention rate of up to 37.7% after 8 years of treatment initiation.
Previous analyses have shown high retention with golimumab therapy, although they were limited by a shorter follow-up period or analyzed by one specific immune-mediated rheumatic disease. The current study is the first in Spain to have an 8-year follow-up period and larger sample size. In this study, golimumab retention at 5 years was 43.9%, compared with 45.1% and 57.1% in the earlier analyses by Hernandez et al. and Pombo-Suarez et al. Pombo‐Suarez et al. reported a 39.5% retention at 7 years; the current study reported a 37.7% retention at years 7 and 8.
Surprisingly, real-world retrospective studies complement the findings of clinical trials. Golimumab’s 5-year retention rate was about 70% when used as first-line biological DMARD therapy in patients with RA, axial SpA, or PsA. The results of this study appear to be consistent with previous findings. When golimumab was used as first-line therapy, the probability of retention at 1 year was 81.7%, compared to 69.9% when it was used as second-line therapy. At year 7, retention rates for first-line and second-line therapy were 49.9% and 35.0%, respectively. The authors also discovered that patients with axial SpA or PsA had higher golimumab retention rates than those with RA. This is consistent with the data reported by Egeberg et al.
In this study, regression analysis confirmed that patients receiving methotrexate concurrently had better golimumab retention. Finally, golimumab retention was lower in patients receiving concomitant steroids, which is consistent with previous studies suggesting the effect of steroids on treatment failure. In the Cox regression model, smoking habit, body mass index (BMI), and diagnosis were not associated with golimumab retention rate.
This study has several limitations. It lacks information on golimumab use, dose escalation or tapering strategies, and concomitant medications at the time of golimumab initiation. Also, data on other confounding factors that may affect treatment adherence are incomplete.
CONCLUSION
In conclusion, almost 37.7% of the participants continued golimumab therapy for 8 years. Retention was higher in axial SpA and PsA indications, especially when golimumab was used as the first biological drug.
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