Riociguat (Adempas) stimulates an enzyme called soluble guanylate cyclase (sGC) and is available in the U.S. for pulmonary hypertension treatment. The enzyme regulates several processes, including the formation of connective tissue. For scleroderma patients, riociguat may decrease abnormal growth of fibrous connective tissue and improve the symptoms of the disease.
The most common adverse effects in people who use riociguat for pulmonary hypertension are headache, gastritis, dizziness and nausea, hypotension, and gastrointestinal disorders.
Two Phase 2 riociguat studies are currently recruiting participants to assess the effectiveness and safety of the therapy in scleroderma. RESCUE (NCT02915835) is studying the therapy in people with scleroderma-associated digital ulcers. The other study (NCT02283762) aims to evaluate riociguat in people with diffuse cutaneous systemic sclerosis.
The primary objective in RESCUE is to measure digital ulcer net burden in patients using riociguat: the number of new or active digital ulcers at assessment, plus the number of indeterminate ulcers that had previously been classified as either active or new at any earlier study assessment. The second study will report changes in the extent and severity of skin thickening in patients, per the modified Rodnan skin score, during 52 weeks of treatment with riociguat.
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- http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2014/09/WC500171964.pdf
- http://www.scleroderma.org/site/DocServer/Bayer_Adempas_FDA_Approval_Press_Release_10_8_13.pdf?docID=6981
- https://www.drugs.com/adempas.html