Assessment of Long-Term Efficacy and Safety of Adalimumab in Patients with Ulcerative Colitis: Results from a 6-Year Real-World Clinical Practice

Abstract

Background: Although evidence for the short- to medium-term efficacy of adalimumab in ulcerative colitis (UC) patients is emerging, there are a limited number of reports on the long-term efficacy of adalimumab. This study was to understand baseline demographic features, which potentially could be risk factors for relapse or colectomy following induction of remission by adalimumab in UC patients. Additionally, factors affecting long-term outcomes were to be identified. Methods: Twenty-one patients with UC who had been treated with adalimumab were reviewed retrospectively. Comparative analyses were undertaken by factoring steroid withdrawal versus non-withdrawal, long-term remission versus relapse following remission, and requiring surgical intervention for UC versus surgery-free. Results: Adalimumab treatment was associated with steroid tapering in steroid-dependent cases in the long term. Of the 14 patients in whom clinical remission was achieved, the cumulative nonrelapse survival rate at 350 weeks was 43.8% and the cumulative nonoperative survival rate was 85.7%. Risk factors for surgery included intolerance to salicylates (p = 0.005) and past treatment with tacrolimus (p = 0.023). Conclusions: Adalimumab treatment was associated with long-term efficacy in patients with mild UC – patients achieved a high cumulative nonoperative survival rate over a long period of time, beyond 6 years.

Systematic Review and Meta-analysis: Loss of Response and Need for Dose Escalation of Infliximab and Adalimumab in Ulcerative Colitis

“…Two studies were included for the meta-analysis ( Figures 2 and 3 ). 57 , 58 The random-effects summary showed an annual LOR of 11.7% (95% CI, 5.5-25.1; I 2 = 82.1%).…”

“… 12 , 23–39 , 49–52 , 56 , 57 , 59–66 , 69 , 70 Outcomes for ADA were described in 23 studies. 11 , 24 , 25 , 28 , 31 , 33 , 37 , 40–48 , 53–55 , 57 , 58 , 67 , 68 Forty-one were retrospective cohort studies, and 9 were prospective cohort studies. Characteristics of all included studies are provided in Tables 1 and 2 .…”

“…A total of 21 studies included 1128 UC patients with primary response to ADA that were treated for 2219 patient-years of follow-up. 11 , 24 , 25 , 28 , 31 , 33 , 37 , 40–48 , 53–55 , 57 , 58 Follow-up ranged from 40 weeks to 350 weeks. Seven studies included >50% of patients with prior anti-TNF exposure.…”

Clinical, Laboratory, and Endoscopic Efficacy of Adalimumab and Infliximab in Inflammatory Bowel Disease

“…Studies have shown that not only the decrease in CDAI score but also the decrease in CRP values is significant in terms of remission follow-up. 16 Sugimoto et al 17 in their study on UC patients, showed that CRP levels started to decrease and Hb increased in the fourth week of ADA treatment. In our study, in line with the literature, it was found that disease activation scores and CRP levels decreased and Hb values increased.…”