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A new oral drug for psoriatic arthritis keeps working — and tolerating well. Phase 3 trial data show deucravacitinib (Sotyktu) outperformed placebo at 16 weeks and maintained those gains through 52 weeks in adults with active psoriatic arthritis. The results helped secure FDA approval for the drug, introducing a novel mechanism of action to the PsA treatment landscape.
A phase 3 trial has confirmed that deucravacitinib (Sotyktu, Bristol Myers Squibb) — an oral, selective tyrosine kinase 2 (TYK2) inhibitor — offers sustained efficacy and a favorable safety profile for adults with active psoriatic arthritis (PsA) over a full year. The POETYK PsA-2 trial enrolled 729 patients across 124 sites in 18 countries, with most participants being biologic-naïve and having inadequate responses to conventional therapies.
At 16 weeks, significantly more patients on deucravacitinib hit the primary endpoint of ACR20 response compared to placebo. Those gains held — and even improved — through week 52. The drug also outperformed apremilast (Otezla) on tolerability, with fewer reports of nausea, diarrhea, and headache. No deaths occurred during the study.
Why it matters: These results, combined with the POETYK PsA-1 trial, supported FDA approval of deucravacitinib for PsA — bringing a first-in-class TYK2 inhibitor mechanism targeting IL-23, IL-12, and interferon to rheumatology practice, giving clinicians a new oral option for patients who've struggled with existing therapies.