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Sotatercept: Changing How PAH is Managed, Experience from First Four Patients in India

Mar 4, 2026 | Blog

2025 marks a transformative year in the field of pulmonary arterial hypertension (PAH) treatment in India. For those living with this debilitating condition, hope has always been a distant dream. However, the availability of sotatercept—a groundbreaking biologic therapy—has breathed new life into the PAH field. As one of the first institutions to introduce sotatercept for PAH patients in India, we’ve witnessed some of the most remarkable clinical improvements that highlight not just the potential of the drug, but also the resilience and courage of the patients and caregivers who inspire us every day.

Dr. Prashant Bobhate, a highly experienced pulmonary hypertension specialist in Mumbai, India, has been at the forefront of this clinical innovation. Sotatercept, which has already shown significant promise in global clinical trials, is now delivering real-world results that are hard to ignore. This blog outlines the early experience of sotatercept use for the first four PAH patients in India, and the profound impact it has had on their quality of life.

The Indian PAH Context: Why This Matters

  • Younger Patients: The average age of diagnosis is about a decade earlier than in Europe.
  • Higher CTD-PAH Rates: More patients have PAH related to connective tissue diseases like systemic sclerosis.
  • Delayed Diagnosis: Many patients are diagnosed at later stages (WHO Functional Class III or IV).
    • Limited Access to Therapy: Parenteral prostanoids, key for high-risk cases, are not widely available in India.
    • Financial and Logistical Barriers: Long-term treatments like subcutaneous or intravenous therapy are difficult for many patients outside major cities

    Given these challenges, sotatercept’s subcutaneous dosing every three weeks offers a practical advantage, making it easier for patients to manage their treatment while potentially reducing the need for more intensive therapies. Dr. Prashant Bobhate, Pediatric Cardiologist in Mumbai, emphasizes the need for accessible treatment options, particularly in underserved areas, where patients face greater hurdles in managing their condition.

    Patient Profiles: The First Four Cases

    In this section, we highlight the first four cases of Pulmonary Arterial Hypertension (PAH) treated with sotatercept (brand name Winrevair) at Kokilaben Dhirubhai Ambani Hospital, Mumbai. These patients under the care of Dr Prashant Bobhate were suffering from severe PAH. Importantly, three of the patients were totally dependent on their wheelchairs at the time of the first visit. After continuing the treatment for over six months, the patients exhibited remarkable improvement that was comparable to the outcomes of the global STELLAR trial. This local experience highlights the high efficacy of sotatercept in bringing a positive change to the lives of patients with advanced PAH.

    Patient 1: Idiopathic PAH, WHO FC III, 34-Year-Old Female

    A young woman with a two-year history of idiopathic PAH (IPAH), on dual therapy (ambrisentan + tadalafil), with persistently poor functional status (6MWD: 265 m) and elevated NT-proBNP. Sotatercept was initiated at 0.3 mg/kg, with planned escalation to 0.7 mg/kg.

    Clinical Outcomes:

    • 6MWD improvement: +47 meters.
    • NT-proBNP decline: 38%.
    • Symptom improvement: Reported meaningful reduction in dyspnoea on exertion.
    • Tolerability: Escalated to target dose with no significant adverse events, only mild transient erythema at the injection site after the first dose.

    Patient 2: Systemic Sclerosis-Associated PAH, WHO FC III, 52-Year-Old Female

    A patient with limited cutaneous systemic sclerosis and PAH on triple oral therapy (ambrisentan + tadalafil + selexipag), with persistently intermediate-high risk hemodynamics. Given the disease progression and desire to avoid parenteral escalation, sotatercept was added.

    Clinical Outcomes:

    • Reduction in PVR: 28% at 16 weeks (RHC repeat).
    • WHO functional class improvement: From FC III to FC II.
    • Safety: Mild thrombocytopenia (platelet count nadir: 118 x 10^9/L), requiring a brief dose delay but no discontinuation.

    Patient 3: PAH Associated with Repaired Congenital Heart Disease, WHO FC II, 29-Year-Old Male

    A young male with repaired ventricular septal defect and residual PAH, on dual therapy, with an intermediate-risk profile based on the REVEAL Lite 2 score. Sotatercept was initiated due to persistent hemodynamic evidence of active vascular disease despite vasodilator therapy.

    Clinical Outcomes:

    • Improvement in exercise capacity: Notable improvement after 12 weeks.
    • Echocardiogram results: Reduction in estimated right ventricular systolic pressure.
    • Tolerability: The patient tolerated therapy without incident.This case highlights the potential role of sotatercept in PAH associated with congenital heart disease, a group not well-represented in pivotal trials.

    Patient 4: CTD-PAH (MCTD), WHO FC II-III, 44-Year-Old Female

    A patient with mixed connective tissue disease (MCTD) and PAH, on dual therapy, who had remained stable but not improved over 18 months. Sotatercept was added to target residual disease activity and vascular remodeling.

    Clinical Outcomes:

    • 6MWD improvement: +34 meters at 16 weeks.
    • NT-proBNP: Showed a downward trend.
    • Quality of life improvement: Patient reported improved daily function.
    • Hemoglobin: Rose from 11.8 g/dL to 13.4 g/dL, an expected effect of ActRIIA inhibition, no intervention needed.

    Expanding Beyond Treatment: Impactful Research and Collaboration

    At Kokilaben Dhirubhai Ambani Hospital, our journey with sotatercept is just one part of a larger commitment to improving outcomes for PAH patients in India. Led by Dr. Prashant Bobhate, a renowned Pediatric Cardiologist in Mumbai, we are pushing the boundaries of PAH research and collaboration:

    • Digital Stethoscope and AI-based Early Detection: We are developing innovative tools for early diagnosis of CHD and PAH using advanced digital stethoscopes and AI technologies to detect cardiovascular anomalies at the earliest stages, leading to better outcomes.

    • Multicenter Yoga Study: Initiated with 35 patients, this study focuses on the potential of yoga as an adjunct to traditional PAH treatments, helping patients improve functional capacity and quality of life.

    • ICMR-Recognized Centre of Excellence for PAH: Our institution is actively participating in three national clinical studies to further understand PAH and its treatment in the Indian context.

      These initiatives, combined with the positive clinical outcomes from sotatercept therapy, underscore the transformative changes happening in PAH care in India. We are not only providing better treatments but also striving to make early detection and holistic care a reality for all patients.

      Conclusion: A Pivotal Moment for Indian PAH Care

      Sotatercept is redefining the treatment of Pulmonary Arterial Hypertension (PAH) in India. Early experiences, including four patients at Kokilaben Dhirubhai Ambani Hospital, show significant improvements in functional capacity, haemodynamics, and disease risk profile, aligning with global trial results.

      For Indian clinicians, sotatercept represents a shift from vasodilatory management to disease modification, especially for patients with CTD-PAH and limited access to parenteral alternatives. As access expands and more real-world data is collected, larger registries will help assess its performance in India’s unique patient population.

      2025 marks a hopeful year for PAH care in India, with sotatercept leading the way in changing the treatment landscape and improving patient outcomes across the country.

      FAQs

      How is sotatercept different from other PAH drugs?
      Other than medications that dilate blood vessels, sotatercept works differently as it focuses on vascular remodeling by blocking activin signaling, thus hitting the root cause of PAH.
      Can sotatercept be used alone as a first, line treatment?
      In general, sotatercept is designed to be used with other PAH medications, and it is an add, on therapy rather than a solo treatment option.
      How is sotatercept given, and can I self, inject?
      Sotatercept is administered to patients via a subcutaneous injection every 21 days, and if properly trained, patients can perform the injections themselves at home.
      What monitoring is needed while on sotatercept?
      Monitoring will often include blood tests (hemoglobin, platelets), echocardiograms, 6, minute walk test, and NT, proBNP levels. Right heart catheterization might be planned at 6, 12 months.
      Are there any PAH subtypes that must not be treated with sotatercept?
      Sotatercept is not indicated for PAH Groups 2, 5 and in cases of severe thrombocytopenia, pericardial effusion, or pregnancy, caution should be exercised.
      What are the usual side effects in India?
      Increasing hemoglobin, decreasing platelet count, reactions at the injection site, headache, diarrhea, and skin changes (e.g. telangiectasias) are among the possibilities. Blood tests are done to keep these under control.
      Is sotatercept commercially available in India?

      Sotatercept has received FDA approval in the US, but there are still some issues with its availability in India. It is advisable to contact your medical professional or local healthcare provider for the most recent information on how to get it.

      How quickly will I be able to tell that sotatercept is working?
      One can usually observe better walking distance and functional status within 12, 24 weeks and changes in haemodynamics by 6 months.

      References:

      • Hoeper MM, et a1. STELLAR Trial. NEJM, 2023.
      • Rajagopal S, et a1. PULSAR Trial. NEJM Evidence, 2021.
      • HYPERION Trial. New England Journal ofMedicine, September 2025.
      • Mantoo MR, Majeed MW, Roy A. Efficacy and safety of sotatercept in pulmonary arterial hypertension: a systematic review and meta-analysis. Indian Heart Journal, January 2026.
      • Gomez Rojas O, et a1. Real-world performance of sotatercept in PAH with cardiopulmonary comorbidities. Pulmonary Circulation, 2025.