A ‘real‐world’ retrospective multi‐centre cohort study comparing infliximab and adalimumab for the maintenance of remission in ulcerative colitis

Abstract

Background: Anti-tumour necrosis factor therapy is an established treatment for moderate-to-severely active ulcerative colitis (UC). Recent network meta-analyses of controlled trial data have indicated a superiority of intravenous drugs (infliximab) over subcutaneous (adalimumab). We conducted a retrospective multi-centre cohort study to determine the comparative effectiveness of these two drugs.Methods: Patients with UC administered infliximab or adalimumab as their first biologic, identified from the therapy databases of five UK hospitals, were included, if they had completed induction and were on maintenance treatment. Patients receiving infliximab as 'rescue' therapy for acute severe UC were excluded. The primary end-points for comparison were the number of patients remaining on initial therapy (infliximab or adalimumab) at 52 weeks and the number of patients in clinical remission at 52 weeks (Simple Clinical Colitis Activity [SCCAI] score ≤ 3).Results: Seventy-eight infliximab and 63 adalimumab patients were analysed. At 52 weeks, 83% of infliximab patients and 59% of adalimumab patients remained on therapy (P = 0.001). At 52 weeks, 62% of the infliximab group were in clinical remission compared to 32% of the adalimumab group (P = 0.0004). Primary nonresponse was reported in 24% of adalimumab patients and 5% of infliximab patients (P = 0.001). There were no significant differences in colectomy rates or hospital admission for acute flares at 52 weeks. Conclusions:Our real-world results affirm the findings of network meta-analyses of clinical trials, suggesting that infliximab is superior to adalimumab in the maintenance of remission in UC up to 52 weeks. How to cite this article: Kronsten VT, Colwill MJ, Nayeemuddin S, et al. A 'real-world' retrospective multi-centre cohort study comparing infliximab and adalimumab for the maintenance of remission in ulcerative colitis. GastroHep.

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

“…Sixteen studies were included in the meta-analysis ( Figures 2 and 3 ). 11 , 24 , 25 , 28 , 31 , 33 , 37 , 40–48 The random-effects summary showed an annual LOR of 10.7% (95% CI, 6.1-18.9; I 2 = 84.8%). Subgroup analysis showed a random-effect summary of 18.8% annual LOR (95% CI, 13.2-26.9; I 2 = 43.6%) for studies with a follow-up ≤65 weeks ( n = 10), and 5.0% annual LOR (95% CI, 1.6-15.5; I 2 = 92.7%) for studies with a follow-up >65 weeks ( n = 6).…”

“…Finally, we included 50 unique observational cohort studies and no randomized controlled trials on adult UC patients treated with either IFX, and/or ADA. These studies provided data on LOR incidence (n = 38), 11 , 23–59 and/or dose escalation incidence (n = 31), 11 , 24 , 26–28 , 31 , 33 , 37–41 , 47–50 , 53–57 , 59–68 and/or dose escalation outcomes (n = 15). 11 , 12 , 27 , 31 , 39 , 50 , 53–56 , 59 , 62 , 66 , 69 , 70 Outcomes for IFX were described in 34 studies.…”

“…These studies provided data on LOR incidence (n = 38), 11 , 23–59 and/or dose escalation incidence (n = 31), 11 , 24 , 26–28 , 31 , 33 , 37–41 , 47–50 , 53–57 , 59–68 and/or dose escalation outcomes (n = 15). 11 , 12 , 27 , 31 , 39 , 50 , 53–56 , 59 , 62 , 66 , 69 , 70 Outcomes for IFX were described in 34 studies. 12 , 23–39 , 49–52 , 56 , 57 , 59–66 , 69 , 70 Outcomes for ADA were described in 23 studies.…”

“… 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.…”