Escalation to weekly dosing recaptures response in adalimumab‐treated patients with moderately to severely active ulcerative colitis. Issue 5 (15th July 2014)

• Record Type: Journal Article
• Authors: Wolf, D.; D'Haens, G.; Sandborn, W. J.; Colombel, J.‐F.; Van Assche, G.; Robinson, A. M.; Lazar, A.; Zhou, Q.; Petersson, J.; Thakkar, R. B.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 40:Issue 5(2014)
• Page Start: 486
• Page End: 497
• Publication Date: 2014-07-15
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12863
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12863-abs-0001"> <title>Summary</title> <sec id="apt12863-sec-0001" sec-type="section"> <title>Background</title> <p>Patients with moderately to severely active ulcerative colitis occasionally do not respond to or lose initial response to maintenance dosing of anti‐TNF therapy.</p> </sec> <sec id="apt12863-sec-0002" sec-type="section"> <title>Aim</title> <p>To report the efficacy of escalation from every other week (EOW) to weekly adalimumab dosing in patients from the clinical trial ULTRA 2 (NCT00408629), by week 8 response (i.e. response after adalimumab induction therapy).</p> </sec> <sec id="apt12863-sec-0003" sec-type="section"> <title>Methods</title> <p>Week 52 remission, response, and mucosal healing rates were assessed in ULTRA 2 adalimumab‐randomised patients who escalated to weekly dosing. Patients were stratified by week 8 response per partial Mayo score. Kaplan–Meier and logistic regression analyses estimated time to weekly dosing and defined predictors of escalation to weekly dosing, respectively. Adverse events were reported for patients receiving open‐label adalimumab.</p> </sec> <sec id="apt12863-sec-0004" sec-type="section"> <title>Results</title> <p>The rate of escalation to weekly dosing was 16.3% (20/123) for week 8 responders and 38.4% (48/125) for week 8 nonresponders. Week 52 remission, response and mucosal healing rates with weekly dosing were 20%, 45%, and 45% for week 8 responders and 2.1%, 25% and 29.2% for nonresponders, respectively (NRI). The median time to weekly dosing was 288 days for week 8 nonresponders and not estimable for responders. Prior anti‐TNF use was a significant predictor of escalation to weekly dosing. Treatment‐emergent adverse event rates were similar for patients receiving open‐label EOW or weekly adalimumab.</p> </sec> <sec id="apt12863-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Escalation to weekly adalimumab dosing demonstrated clinical benefits for patients who lost response to therapy and may be beneficial for patients not initially responding to induction therapy. No new safety risks were identified with weekly dosing.</p> </sec> </abstract>