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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

  • decodeMR Team
  • 2 days ago
  • 1 min read

06/03/2026




























The US FDA approved deucravacitinib for the treatment of patients with active PsA (Ref)


BMS announced that the US FDA had approved Sotyktu® (deucravacitinib; TYK2 inhibitor) for the treatment of adult patients with active psoriatic arthritis (PsA)


  • The approval was based on positive results from the pivotal POETYK PsA-1/ NCT04908202 and POETYK PsA-2/ NCT04908189 trials, which evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active PsA


  • In both trials, treatment with Sotyktu resulted in significant improvements in disease activity, as measured by ACR 20 and MDA response


  • The overall safety profile was generally consistent with the safety profile observed in those with plaque psoriasis



























Aisa Pharma announced the results from its Phase 2 trial of AISA-021 in patients with SSc RP (Ref)


Aisa Pharma announced results from its Phase 2, RECONNOITER-1/ ACTRN12621000459820 trial of cilnidipine (AISA-021; calcium channel blocker) for the treatment of patients with systemic sclerosis-associated Raynaud’s phenomenon (SSc RP)


  • The study demonstrated a significant improvement in the number of attack-free days and a reduction in median weekly Raynaud’s attack frequency


  • The analysis showed that more than twice as many patients who received AISA‑021 achieved a ≥70% reduction in attack frequency


  • The company stated that it intended to meet with the US FDA and other regulators to determine the Phase 3 study design and potential registration pathway


  • AISA-021 was generally well-tolerated with a safety profile comparable to placebo




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