Escalation to weekly dosing recaptures response in adalimumab-treated patients
with moderately to severely active ulcerative colitis.
Author(s): Wolf D(1), D'Haens G, Sandborn WJ, Colombel JF, Van Assche G, Robinson AM, Lazar
A, Zhou Q, Petersson J, Thakkar RB.
Affiliation(s): Author information:
(1)Atlanta Gastroenterology Associates, Atlanta, GA, USA.
Publication date & source: 2014, Aliment Pharmacol Ther. , 40(5):486-97
BACKGROUND: Patients with moderately to severely active ulcerative colitis
occasionally do not respond to or lose initial response to maintenance dosing of
anti-TNF therapy.
AIM: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
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