Deucravacitinib - Effective in Systemic Lupus Erythematosus Save

A Phase II, multicenter study has demonstrated the efficacy and safety of deucravacitinib, an oral, selective, allosteric inhibitor of TYK2, in  adults with active systemic lupus erythematosus (SLE).

A total of 363 SLE patients were randomized 1:1:1:1 to receive deucravacitinib 3 mg twice daily, 6 mg twice daily, 12 mg once daily, or placebo. The primary end point of the study was the SLE Responder Index 4 (SRI-4) response at week 32.

The week 32 SRI-4 responses were: 

• PBO 34%
• DEUCRA 3 mg bid 58% (P < 0.001 versus placebo)
• DEUCRA 6 mg bid 50% (P = 0.02 versus placebo)
• DEUCRA 12 mg qd 45% (P = 0.08 versus placebo).

Secondary outcomes also favored deucravacitinib treatment for BICLA, CLASI-50, LLDAS, and joint counts compared to placebo. Comparisons of DEUCRA vs PBO favored the former for:

• LLDAS 36.3% versus 13.3%; (P < 0.001 versus placebo)
• CLASI-50 response  69.6% versus 16.7% (P < 0.001 versus placebo)
• Active joint count change, –8.9 versus –7.6, (P = 0.001 versus placebo)

Rates of adverse events were similar across groups, except higher rates of infections and cutaneous events, including rash and acne, with deucravacitinib treatment.

Rates of serious adverse events were low and comparable. There were very few serious infections, with no deaths, opportunistic infections, tuberculosis infections, major adverse cardiovascular events, or thrombotic events reported.

This phase II trial is encouraging as deucravacitinib was safe and significantly more effective compared with placebo adult SLE patients.