Johnson & Johnson reports Phase 3 icotrokinra benefit in psoriatic arthritis

A Phase 3 psoriatic arthritis trial met its primary endpoint as Johnson & Johnson NYSEJNJ reported on Saturday that its once-daily oral icotrokinra outperformed placebo. At week 16, 58 per cent of treated patients achieved the main joint response versus 41 per cent receiving placebo.

The Nov. 7 release describes results for biologic-naive adults, meaning patients who had not previously received biologic treatment. The reported comparison used a 200-milligram dose, and J&J said safety findings through week 24 showed no new safety signals. ICONIC-PsA 1 was randomized and double-blind, with placebo control.

J&J is a large U.S. healthcare group with medicines and medical technology businesses. Icotrokinra, marketed as ICOTYDE, blocks the interleukin-23 receptor, but is not approved for active psoriatic arthritis.

Shares on NYSEJNJ closed at US$276.22, up 1.43 per cent, in New York at 4 p.m. EST on Nov. 6, according to Google Finance. That session preceded Saturday's announcement and therefore provides no measure of the market's response to these results.

The sponsor's registry record, updated Nov. 3, lists actual enrolment of 552 across two icotrokinra dose groups, placebo and an active-reference comparator.

The primary endpoint was an American College of Rheumatology 20 response, or ACR20. It requires at least a 20 per cent improvement in both tender and swollen joint counts, together with improvement in other disease assessments.

The difference between the reported treatment and placebo response rates was 17 percentage points. J&J called the primary result statistically significant, although its efficacy summary supplied no primary-endpoint p value or confidence interval.

Joint And Skin Responses Extend The Evidence

More demanding joint-response measures numerically favoured icotrokinra: ACR50 responses were 29 per cent versus 16 per cent on placebo. ACR70 responses were 13 per cent versus 5 per cent. These measures use the same framework as ACR20, with higher improvement thresholds.

Among patients with qualifying skin involvement, 37 per cent receiving icotrokinra achieved a PASI90 response, compared with 6 per cent on placebo. That measure represents at least a 90 per cent improvement in psoriasis severity; J&J reported a nominal p value below 0.001.

By week 24, the icotrokinra ACR20 response rate had reached 69 per cent. However, placebo recipients still on treatment crossed to icotrokinra at week 16, so the later result does not preserve the original placebo comparison.

"Effective management of psoriatic arthritis requires addressing both joint and skin disease, and patients continue to need treatment options that can provide meaningful improvement across both," rheumatologist Joseph F. Merola said in J&J's release.

An Oral Rival Already Has Longer Follow-Up

Bristol-Myers Squibb Company NYSEBMY reported two-year Sotyktu results on Sept. 17, describing its oral TYK2 inhibitor as approved for adults with active psoriatic arthritis. Those open-label extension results concern a different population and follow-up period, and do not establish how the medicines compare.

J&J's Nov. 7 release estimates that nearly 30 per cent of people with plaque psoriasis develop psoriatic arthritis. J&J said the results were being presented as a late-breaking poster at American College of Rheumatology Convergence 2026.

J&J's Oct. 15 program description also identifies ICONIC-PsA 2, which includes biologic-experienced and biologic-naive patients. Saturday's readout concerns ICONIC-PsA 1 and does not establish efficacy across that broader population.

Read more: Satellos changes BASECAMP trial endpoint after FDA feedback

The registry's next dated study milestone is estimated completion on Feb. 4, 2028.