Selexipag Therapy Effective For Pulmonary Hypertension Patients

Pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD) presents a significant clinical challenge, with affected patients often experiencing worse outcomes than those with idiopathic pulmonary arterial hypertension (IPAH). Although earlier short-term studies suggested a limited response to PAH-specific therapies in PAH-CTD patients, recent long-term research has shown consistent positive effects across both PAH-CTD and IPAH populations. This research summary examines the characteristics, treatment patterns, tolerability, and outcomes of PAH-CTD patients treated with selexipag in clinical practice, drawing on data from the Exploratory Observational Study of Uptravi in Real-life (EXPOSURE) study.

 

THE STUDY BACKGROUND

The care of patients with pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD) is particularly challenging, as these patients generally have a worse prognosis compared to those with idiopathic pulmonary arterial hypertension (IPAH) [1]. PAH-CTD patients are a significant subset of the broader PAH population and have been routinely included in randomized controlled trials (RCTs) evaluating PAH therapies. Historically, short-term RCTs focused on exercise capacity indicated that PAH-CTD patients responded less to PAH-specific treatments [2]. However, the more recent shift in understanding, brought about by longer follow-up studies, has shown that both PAH-CTD and IPAH/heritable PAH patients benefit from PAH therapies, particularly in terms of reducing morbidity and mortality [3]. This shift in understanding is a significant development in the field of PAH-CTD treatment.

Among the studies that have contributed to this shift in understanding is the GRIPHON (Prostacyclin (PGI2) Receptor Inhibitor for Pulmonary Arterial Hypertension) trial, the largest RCT in PAH. GRIPHON enrolled 334 PAH-CTD patients and demonstrated that treatment with the oral prostacyclin receptor agonist selexipag significantly reduced the risk of disease progression by 41%, a result that was consistent with the 39% reduction observed in IPAH/heritable PAH patients [4]. This evidence has led to the inclusion of selexipag in treatment guidelines, particularly for PAH-CTD patients who are at intermediate-low to high risk and for whom parenteral prostacyclin therapies may not be feasible [5].

As of November 30, 2023, it is estimated that approximately 46,452 PAH patients worldwide have been treated with commercial selexipag [6]. Given that the PAH-CTD population represents an estimated 14% to 39% of the overall PAH population, 6,503 and 18,116 PAH-CTD patients have likely been exposed to selexipag during this period [7]. It underscores the importance of understanding the real-world characteristics, treatment patterns, tolerability, and outcomes associated with selexipag in PAH-CTD patients.

The current analysis aims to fill this gap by utilizing data from the Exploratory Observational Study of Uptravi in Real-life (EXPOSURE) study. This analysis will provide crucial insights into how PAH-CTD patients respond to selexipag in clinical practice, with IPAH patients included as a comparative context. Such information is vital for optimizing treatment strategies and improving outcomes for this vulnerable patient population.

 

THE STUDY METHOD

The Exploratory Observational Study of Uptravi in Real-life (EXPOSURE) is an ongoing multicenter, prospective, observational study initiated in 2017 across Europe and Canada. The study focuses on PAH patients aged 18 and older who are initiating a new PAH-specific therapy, excluding calcium channel blockers, either within one month of enrollment or at the time of enrollment. Patients must have been previously treated with a different drug to be eligible. This study does not mandate specific patient visits, allowing follow-up to occur according to standard clinical practice.

This particular analysis within the EXPOSURE study examined PAH-CTD patients who began treatment with selexipag between September 17, 2017, and November 30, 2022, with follow-up data available. IPAH patients who met the same criteria were also included for comparative context. The PAH-CTD group consisted of patients with PAH associated with various connective tissue diseases, including systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren’s syndrome, mixed connective tissue disease, and undifferentiated connective tissue disease.

 

ANALYSIS

In the EXPOSURE study, patients were monitored from the initiation of selexipag treatment until the last available data, discontinuation of selexipag, or death, whichever occurred first. The analysis primarily involved descriptive methods without formal statistical comparisons. The risk of 1-year mortality was assessed using a minimum of two baseline parameters, including brain natriuretic peptide (BNP) or N-terminal proBNP, and either World Health Organization functional class (WHO FC) or 6-minute walk distance (6MWD). Selexipag titration and individualized dosing were determined based on clinical practice, with dose groups categorized as low, medium, or high based on the final dose after titration.

Treatment patterns were classified as monotherapy when selexipag was used alone or as combination therapy when used alongside one or more other PAH-specific therapies. Incidence rates for all-cause and PAH-related hospitalizations and mortality were calculated per 100 person-years, with rates also expressed during the observation period, regardless of selexipag continuation. Kaplan-Meier estimates were used to analyze the time to first hospitalization or death during the selexipag exposure period.

Adverse reactions commonly associated with prostacyclin pathway drugs were only reported as adverse events if they met specific criteria, such as seriousness, leading to discontinuation or dose reduction, or requiring symptomatic treatment. The study adhered to ethical guidelines, with approvals obtained from relevant Institutional Review Boards, and written informed consent was collected from all participants.

 

RESULTS

The results of this study provide crucial insights into the outcomes of PAH-CTD patients treated with Selexipag. They focus on mortality, treatment discontinuation, adverse events, and a comparison with IPAH patients. These findings are important for understanding Selexipag’s real-world effectiveness and safety in managing PAH-CTD.

1. Mortality Among PAH-CTD Patients

• Total Deaths: A total of 29 patients (16%) with PAH-CTD died during the median follow-up period of 8.6 months.
• PAH-Related Deaths: Out of these, 83% were judged by physicians to be related to PAH.
• Mortality Rate: The mortality rate during selexipag exposure was calculated at 15.5 deaths per 100 person-years, with a 95% confidence interval (CI) of 10.4−22.2.
• Survival Estimates: Kaplan-Meier survival estimates indicated that 85% of patients survived at least one year, and 71% survived at least two years.
• Primary Cause of Death: The most frequently cited cause of death was disease progression or worsening of PAH, as determined by the treating physicians.

2. Selexipag Discontinuation

• • Total Discontinuations: 79 patients (44%) discontinued using selexipag during the study.

• Reasons for Discontinuation:

• • Tolerability of Adverse Events: 36 patients (20%) stopped selexipag due to issues with tolerability or adverse events.
  • Death: 29 patients (16%) discontinued due to death.
  • PAH Disease Progression: 8 patients (4%) discontinued selexipag due to the progression of PAH.

3. Adverse Events

• Most Frequent Adverse Events: Diarrhea and headache were the most commonly reported adverse events. These side effects were consistent with Selexipag’s known mode of action, which targets the prostacyclin pathway.

4. Hospitalization and Survival Data for IPAH Patients

• Comparison: Hospitalization and survival data for IPAH patients were also collected and presented, providing context and comparison to the PAH-CTD group. The specifics of this data were detailed in corresponding tables and figures but were not the primary focus of this summary.
• Selexipag Discontinuation and Safety: Detailed data on selexipag discontinuation and safety for the IPAH cohort were also provided, emphasizing the overall treatment experience and outcomes across different PAH subgroups.

 

DISCUSSION

Patients with pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD) represent a significant subset of the PAH population, comprising 14%–39% in recent European registries [14–18]. The management of PAH-CTD is complex due to the interplay of underlying connective tissue diseases (CTD) and associated comorbidities. Despite these complexities, treatment guidelines for PAH-CTD align with those for idiopathic PAH (IPAH). This study followed 178 PAH-CTD patients who began selexipag treatment, providing important insights into dosing patterns, treatment management, and long-term outcomes.

Selexipag, a prostacyclin analogue, requires careful titration, starting at 200 µg twice daily and adjusting based on individual tolerability. The GRIPHON trial established a 12-week titration phase with weekly dose increases [27]. The study found that selexipag dosing in clinical practice often deviated from the trial’s protocol, with 30% of PAH-CTD patients on low doses, 41% on medium doses, and 23% on high doses. This deviation suggests a more cautious dosing approach in real-world settings, with a median of 6 weeks to reach individualized doses [6].

The safety profile of selexipag in this study was consistent with previous findings. Discontinuation rates due to adverse events were similar to those observed in the GRIPHON trial (20% vs. 19%) [6]. Common adverse events, such as diarrhoea and headache, were in line with known side effects [10]. Most patients were treated with a triple oral therapy regimen, including selexipag, an endothelin receptor antagonist (ERA), and a phosphodiesterase-5 inhibitor (PDE5i), reflecting the aggressive management required for this population [17].

Survival data indicated a 1-year survival rate of 85% and a 2-year survival rate of 71% for PAH-CTD patients, which is higher than some contemporary registry estimates [17, 20]. However, these figures should be interpreted cautiously as the data were collected during treatment escalation. The GRIPHON trial showed better outcomes when selexipag was added within 6 months of diagnosis [10, 30], suggesting that earlier initiation of triple oral therapy could enhance long-term outcomes for PAH-CTD patients.

Hospitalization rates for PAH-CTD patients were higher compared to IPAH patients, likely due to the additional burden of CTD-related complications [33, 34]. Despite higher overall hospitalization rates, PAH-related hospitalizations were similar between PAH-CTD and IPAH patients, indicating that comorbidities and patient age may contribute to increased hospitalization rates in PAH-CTD. These findings highlight the need for tailored management strategies to address both PAH and CTD-related health issues.

 

STUDY LIMITATIONS

1. Patient Enrollment Timing

• The study cohort was enrolled during treatment escalation, which may affect the interpretation of survival data.
• The reported survival rates (85% at 1 year and 71% at 2 years) are based on patients who were already on advanced treatment regimens, potentially skewing results compared to broader PAH-CTD populations.

2. Single CTD Type Dominance

• Most patients had systemic sclerosis (SSc), which limits the generalizability of findings to other connective tissue diseases.
• The diversity of CTD subtypes in the study was less than in other trials, such as GRIPHON, which included a wider range of CTD types.

3. Dosing Protocol Variability

• There was a deviation from the GRIPHON trial dosing protocol, with clinical practice showing more conservative dosing approaches.
• The study observed a shift towards lower doses of selexipag compared to the trial, which could influence treatment efficacy and patient outcomes.

4. Hospitalization Data Context

• Higher hospitalization rates in PAH-CTD patients compared to IPAH patients may be influenced by comorbidities and age rather than PAH severity alone.
• The study’s hospitalization data could have differentiated better between PAH-related and other causes of hospitalization, complicating the assessment of treatment impact on PAH-specific hospitalizations.

5. Generalizability of Results

• The findings from this study may not fully reflect the experiences of all PAH-CTD patients, especially those with less severe forms or those not yet on triple therapy.
• The results are context-specific and may not translate directly to other clinical settings or patient populations.

 

CONCLUSION

This analysis underscores the critical importance of combination therapy for managing pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD), especially in patients with comorbidities. Most PAH-CTD patients began treatment with selexipag as part of a triple therapy regimen, regardless of their 1-year mortality risk category. The safety and tolerability of selexipag in this cohort mirrored that seen in idiopathic PAH (IPAH) patients. The study suggests that earlier treatment escalation—rather than waiting for clinical deterioration—could significantly enhance outcomes for PAH-CTD patients. This proactive approach may help address disease progression and improve long-term patient prognosis.

 

Reference

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