Adalimumab Maintenance Treatment in Ulcerative Colitis: Outcomes by Prior Anti-TNF Use and Efficacy of Dose Escalation
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The impact of prior anti-TNF use on “real-life” outcomes of adalimumab therapy in ulcerative colitis (UC) is not well known.
To compare the influence of prior anti-TNF use on the outcomes of adalimumab maintenance treatment in UC patients. We also assessed the effectiveness of adalimumab dose escalation.
This retrospective multicenter cohort study included consecutive UC who advanced to an adalimumab maintenance regimen. Patients in whom adalimumab was discontinued prior to week eight of treatment were excluded. The co-primary efficacy endpoints were the cumulative probabilities of adalimumab failure-free survival and colectomy-free survival. We also assessed the need for and the effectiveness of adalimumab dose escalation.
Of 184 UC on maintenance treatment with adalimumab, 116 (63%) had previous anti-TNF use. After a median follow-up of 23 months (interquartile range 13–49), 112 patients (60%) maintained corticosteroid-free clinical response. Sixty-nine patients (37%) had adalimumab failure, and 22 (12%) needed colectomy. Anti-TNF-naïve patients had significantly lower adjusted rates of adalimumab failure (hazard ratio [HR] 0.65; p < 0.001), adalimumab dose escalation (HR 0.35; p = 0.002), and need for colectomy (HR 0.26; p < 0.004). Seventy-six patients (41%) needed dose escalation after secondary loss of response, and 47% of these regained response after escalation. Short-term response after escalation was identified as a significant predictor of colectomy avoidance (HR 0.53; p = 0.007).
In this “real-life” cohort of UC patients on maintenance treatment with adalimumab, anti-TNF-naïve patients had significantly better long-term outcomes. Adalimumab dose escalation enabled recovery of response in nearly half of patients.
KeywordsUlcerative colitis Adalimumab Infliximab Secondary loss of response Dose escalation Colectomy
The authors would like to thank Dr. C. Fernandez for her assistance in the statistical analysis and Dr. G. Morley for writing support and for reviewing the English manuscript.
Compliance with ethical standards
Conflict of interest
CT, MB, AR, JLP, AP, FB, and IF have served as a speaker and/or consultant for or have received research funding from MSD and AbbVie. FM, MC, XC, JPG, and MCH have served as a speaker and/or consultant for or have received research funding from MSD, AbbVie, and Takeda. CdeC have served as a speaker and/or consultant for AbbVie. The remaining authors declare that they have nothing to disclose.
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