The market already had a strong efficacy baseline, so durability was the real test. ONWARD1/2 had established roughly 65% PASI 90 and above 40% PASI 100 at Week 24, with no obvious plateau in clearance; the standing assumption was therefore that longer treatment should preserve or improve those results rather than reveal rapid erosion.
| Measure | Earlier benchmark | 48-week result |
|---|---|---|
| PASI 90 | 62.1%-68.0% at Week 24 (ONWARD1/2) | 66% integrated analysis (Integrated ONWARD1/2/3) |
| PASI 100 | 39.5%-41.0% at Week 24 (ONWARD1/2) | 47% integrated analysis; 54% in the continuous-treatment LTE subset (Integrated ONWARD1/2/3; ONWARD3 LTE) |
| ONWARD3 rollover | Not previously available | 1,509 patients; above 85% rollover (ONWARD3 LTE) |
The actual read is sustained-to-improving efficacy, not merely maintenance. In the 773-patient continuous-treatment LTE analysis, PASI 100 reached 54% at Week 48, while the broader 890-patient integrated analysis—which included patients who did not enter ONWARD3—showed 66% PASI 90 and 47% PASI 100 (ONWARD3 LTE; Integrated ONWARD1/2/3). That is directionally better than the roughly 40% Week 24 PASI 100 benchmark and supports the commercial claim that complete clearance continues to build over time.
The positive signal is meaningful but not a clean upside surprise. The filing provides topline data without detailed confidence intervals, discontinuation breakdowns, or a full adverse-event table; “consistent safety profile” is reassuring but less informative than the earlier detailed safety disclosure. It also does not provide a randomized comparator at Week 48, so the “highest reported” cross-trial positioning remains company-framed rather than a controlled head-to-head result. Still, the large rollover, rising PASI 100 response, and unchanged plan to submit an NDA in the fourth quarter of 2026 modestly improve the picture versus the prior expectation of simple durability, while leaving regulatory and lupus-readout risk unchanged (ONWARD3 LTE; Forward-Looking Statements).
Read the original 8-K on SEC EDGAR ↗