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


