Comparison of Infliximab and Adalimumab in Biologic-Naive Patients With Ulcerative Colitis: A Nationwide Danish Cohort Study

Abstract

Background & Aims We compared the effectiveness and safety of infliximab and adalimumab in biologic-naïve patients with ulcerative colitis (UC), in a nationwide register-based propensity score-matched study of patients in Denmark. Methods We collected data from 1719 adults with UC, 15–75 years old, in Denmark who were treated with either infliximab or adalimumab as their first biologic agent. We compared rates of all-cause hospitalization, UC-related hospitalization, major abdominal surgery, and serious infections after a variable 2:1 propensity score matching, accounting for baseline clinical characteristics, disease severity, healthcare use, and use of UC-related medications. Results Compared to patients treated with infliximab, patients treated with adalimumab had a higher risk for all-cause hospitalization (hazard ratio [HR], 1.84; 95% CI, 1.18–2.85), with a trend towards higher risk of UC-related hospitalization (HR, 1.71; 95% CI, 0.95–3.07)—particularly for patients on concomitant immune modulator therapy. However, risk of abdominal surgery (HR, 1.35; 95% CI, 0.62–2.94) did not differ between patients given adalimumab vs infliximab. Risk of serious infection requiring hospitalization was significantly higher among patients treated with adalimumab (HR, 5.11; 95% CI, 1.20–21.80). Conclusion In a nationwide propensity score matched-cohort study of biologic-naïve adults with UC in Denmark, use of adalimumab as first-line biologic vs infliximab was associated with higher risk of hospitalization and serious infections, though risk of surgery was not different. In the absence of trials to directly compare these drugs, these findings could assist patients, healthcare providers, purchasers, and policy makers in making decisions that might improve care for patients with UC.

The effectiveness and safety of infliximab compared with biosimilar CT‐P13, in 3112 patients with ulcerative colitis

“…All‐cause and UC‐related hospitalisation rates were 38.1/100 PY and 21.4/100 PY, respectively. These rates are similar to those reported in a real‐life Danish study (all‐cause: 37.4/100 PY; UC‐related: 19.3/100 PY) . Combination therapy with a thiopurine, with or without previous exposure to thiopurines, was associated with better outcomes.…”

“…The incidence of serious infection was lower in the CT-P13 group (HR 0.65; 95%CI: 0.48-0.88), but there was no significant difference in the incidence of solid or hematologic malignancies was observed between the two groups.All-cause and UC-related hospitalisation rates were 38.1/100 PY and 21.4/100 PY, respectively. These rates are similar to those reported in a real-life Danish study (all-cause: 37.4/100 PY; UCrelated: 19.3/100 PY) 33. Combination therapy with a thiopurine, with or without previous exposure to thiopurines, was associated with better outcomes.…”

“…To our knowledge, only one real‐life effectiveness study has been conducted in UC. It used Danish National Patient Registry data for 1719 anti‐TNF‐naive UC patients and showed that the use of adalimumab as first‐line biologic over infliximab was associated with a higher risk of hospitalisation and serious infections …”

“…It used Danish National Patient Registry data for 1719 anti-TNF-naive UC patients and showed that the use of adalimumab as first-line biologic over infliximab was associated with a higher risk of hospitalisation and serious infections. 33 We have previously conducted a study on the SNDS database in infliximab-naïve patients with Crohn's disease, treated with either the RP or CT-P13. In this previous study, the effectiveness of CT-P13 was equivalent to that of RP and no difference was observed for safety outcomes.…”

Systematic review with network meta‐analysis: first‐ and second‐line pharmacotherapy for moderate‐severe ulcerative colitis

“…Our findings on comparative efficacy of first‐line pharmacotherapy in moderate‐severe ulcerative colitis builds on previous network meta‐analyses, and population‐based cohort studies which have suggested superiority of infliximab over adalimumab for inducing clinical response and decreasing the risk of hospitalisation . This may be related to difference in pharmacokinetics and bioavailability with different dosing schema (weight‐based vs fixed dose), adequacy of dose finding studies to fully explore dose response, and route of administration.…”