Quarter in review – Clinical Science

Ritasman Baisya DM
Assistant Professor, Dept of Clinical Immunology and Rheumatology, Nizam’s Institute of Medical Sciences, Hyderabad

Study in focus 1: Sotatercept may be a promising drug for the treatment of pulmonary artery hypertension.

Stellar trial is a Phase 3, randomized, double-blind study where Sotatercept, a fusion protein restoring the balance between BMPR signaling pathways, was used in 163 patients of pulmonary arterial hypertension (PAH) with concomitant background therapy. Sotatercept improved 6MWD (+40.8 m, 95% CI, 27.5 to 54.1; p<0.001) and delivered broad clinical benefits across multiple domains including hemodynamics, WHO functional class, disease biomarkers, risk scores, and patient-reported outcomes. Though the majority was idiopathic or hereditary PAH, CTD-PAH comprised 48 patients with 29 patients getting sotatercept. Thrombocytopenia and increased hemoglobin were major adverse events. In this trial, change in the cardio-pulmonary symptoms domain score of the PAH-SYMPACT questionnaire, a new disease-specific patient-reported outcome instrument, was used as a secondary end-point which showed greater improvement in cardio-pulmonary symptoms but not in cognitive/emotional impacts domain score. Optimal therapy for CTD-PAH is still a challenge in rheumatology practice predominantly in scleroderma with severe PAH who are often refractory to dual endothelin antagonists and PDE inhibitors. Sotatercept might have a promising future in such patients to achieve target pulmonary arterial pressure, decrease admission rate and improve quality of life.

Study in focus 2: Secukinumab improves outcome in Psoariatic arthritis with sustained remission or low disease activity.

A significant result came from the 2-year phase 3 FUTURE 5 study which in sights into the long-term achievement (at 2 years) of LDA (low disease activity) or REM (Remission) in psoriatic arthritis (PsA) patients treated with secukinumab. The result suggests that secukinumab use is associated with better long-term function and patient-reported outcome benefits. It also highlights that a high proportion of secukinumab-treated patients were non-structural progressors at 2 years irrespective of achieving sustained LDA/REM. This study also showed a higher rate of sustained DAPSA (disease activity in PSA) -LDA+REM (73%–81%) compared to more stringent composite measures of MDA (minimal disease activity) or VLDA (very low disease activity). Younger age, lower body mass index at baseline, reduced tender joint count and PsA pain at week 16 were key predictors of sustained LDA in secukinumab-treated patients. Recent treat to target strategy in psoriatic arthritis is focused to address all the disease domains and achieve remission or minimal disease activity. Secukinumab, an IL-17A inhibitor, is shown to have a promising outcome in different domains of PsA including radiographic progression with long-term improved quality of life.


  1. Hoeper MM, et al. STELLAR Trial Investigators. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023;388(16):1478-1490.
  2. Coates LC, et al. Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study. RMD Open 2023;9: e002939.