Patients with moderately to severely active ulcerative colitis occasionally do not respond to or lose initial response to maintenance dosing of anti-TNF therapy.
Dr Wolf and colleagues from Atlanta, USA reported the efficacy of escalation from every other week (EOW) to weekly adalimumab dosing in patients from the clinical trial ULTRA 2, by week 8 response.
Week 52 remission, response, and mucosal healing rates were assessed in ULTRA 2 adalimumab-randomized 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.
|Response rates with weekly dosing were 45% for week 8 responders|
|Alimentary Pharmacology & Therapeutics|
The research team reported adverse events for patients receiving open-label adalimumab.
The rate of escalation to weekly dosing was 16% for week 8 responders, and 38% 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%, 25% and 29% for nonresponders, respectively (NRI).
The team noted the median time to weekly dosing was 288 days for week 8 nonresponders, and not estimable for responders.
The researchers observed that 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.
Dr Wolf's team concludes, "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."