J&J’s oral Icotyde shows promising PsA results, but higher dose misses statistical mark

Johnson & Johnson reported Phase 3 ICONIC-PsA 1 results for icotrokinra (ICOTYDE), its once-daily oral IL-23 receptor-targeting peptide, in adults with active psoriatic arthritis who had not previously used biologic therapies.

At Week 16, 58% of patients on the 200 mg dose achieved an ACR20 response, versus 41% on placebo. ACR50 responses were 29% versus 16%, and ACR70 responses were 13% versus 5%.

Skin outcomes also favored the 200 mg dose:
among participants with qualifying skin involvement, 57% reached clear or almost-clear skin versus 14% on placebo; PASI 90 was 37% versus 6%.

The caveat behind the headline:
the 400 mg dose had a 52% ACR20 response, but narrowly missed statistical significance versus placebo (p=0.052). Because the study required both doses to meet the primary endpoint, that miss limits formal statistical testing of secondary outcomes.

By Week 24, response rates in the 200 mg group had risen, but placebo participants crossed over at Week 16, so those later figures no longer have a concurrent placebo comparison. J&J reported no new safety signals through Week 24.

The results are investigational for psoriatic arthritis; ICOTYDE is not approved for that condition.