AbbVie announced that a Phase III study of Rinvoq (upadacitinib) in adults with moderate-to-severe ulcerative colitis and a late-stage trial in adults with moderate-to-severe atopic dermatitis met their primary endpoints, as well as all ranked secondary goals. The company noted that the U-ACHIEVE trial is the first of two late-stage studies to evaluate the oral JAK inhibitor in ulcerative colitis.
The trial, which is designed to evaluate the efficacy and safety of Rinvoq for induction and maintenance therapy, included 473 patients with moderate-to-severe ulcerative colitis. The study's primary endpoint is achievement of clinical remission, per Adapted Mayo Score, at week eight, while ranked secondary goals included clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement at week eight.
For the main endpoint, AbbVie said that 26% of patients administered Rinvoq achieved clinical remission at week eight, compared to 5% of those given placebo (see table below for further results). The company indicated that the safety profile of Rinvoq was "consistent" findings from previous studies across indications, with no new safety risks observed. According to AbbVie, full results from the trial will be presented at an upcoming medical meeting and submitted for publication in a peer-reviewed journal.
Meanwhile, the Phase IIIb Heads Up study randomised 692 adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapyto receive upadacitinib or Sanofi and Regeneron Pharmaceuticals' Dupixent (dupilumab) for 24 weeks. The trial's primary endpoint was the proportion of patients achieving at least a 75% improvement in the Eczema Area Severity Index (EASI 75) at week 16, while secondary goals included EASI 75 at week two, percent change from baseline in Worst Pruritus numerical rating scale (NRS) at week one and week 16, EASI 90 at week 16, EASI 100 at week 16 and improvement in Worst Pruritus NRS of at least four at week 16.
Results showed that 71% of patients given Rinvoq achieved EASI 75 at week 16, compared to 61% in the Dupixent arm. AbbVie noted that Rinvoq also showed superiority compared to Dupixent for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction (see table below for further results).
"As we enter a new era of advanced therapies in atopic dermatitis, head-to-head studies like this will be important to help healthcare providers understand differences in therapies," remarked Michael Severino, president of AbbVie. The company noted that the safety profile of Rinvoq in the Head Up trial was "consistent" with what was observed in the Phase III Measure Up 1, Measure Up 2 and AD Up studies.
Rinvoq, which generated sales of $215 million in the third quarter, received approval in the US and Europe last year for adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Meanwhile, applications seeking clearance for the treatment of adults and adolescents with moderate-to-severe atopic dermatitis were also submitted in both markets.
To read more Top Story articles, click here.