Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn's disease and ulcerative colitis included in randomised controlled trials.

While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, comparative data specific to subcutaneous (SC) IFX (i.e., CT-P13 SC) versus VDZ are limited. Pooled analysis of randomised studies to compare efficacy and safety with IFX SC and VDZ in moderate-to-severe inflammatory bowel disease. Parallel-group, randomised studies evaluating IFX SC and VDZ in patients with moderate-to-severe CD or UC were identified. Eligible studies reported ≥ 1 prespecified outcome of interest at Week 6 (reflecting treatment during the induction phase) and/or at 1 year (Weeks 50-54; reflecting treatment during the maintenance phase). Prespecified efficacy and safety outcomes considered in this pooled analysis included the proportions of patients achieving disease-specific clinical responses, clinical remission, or discontinuing due to lack of efficacy, and the proportions of patients experiencing adverse events (AEs), serious AEs, infections, serious infections, or discontinuing due to AEs. Data from multiple studies or study arms were extracted and pooled using a random-effect model; comparative analyses were performed separately for patients with CD and UC. We identified three eligible CD trials and four eligible UC trials that assigned over 1200 participants per disease cohort to either IFX SC or VDZ. In patients with CD, intravenous induction therapy with IFX demonstrated better efficacy (non-overlapping 95% confidence intervals [CIs]) compared with VDZ; during the maintenance phase, IFX SC showed numerically better efficacy (overlapping 95% CIs) than VDZ. A lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In patients with UC, efficacy profiles were similar with IFX SC and VDZ during the induction and maintenance phases, and a lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In both cohorts, safety profiles for IFX SC and VDZ were generally comparable during 1 year. IFX SC demonstrated better efficacy than VDZ in patients with CD, and similar efficacy to VDZ in patients with UC; 1-year safety was comparable with IFX SC and VDZ.

Peyrin-Biroulet L ，Arkkila P ，Armuzzi A ，Danese S ，Ferrante M ，Jordi Guardiola ，Jahnsen J ，Louis E ，Lukáš M ，Reinisch W ，Roblin X ，Smith PJ ，Kwon T ，Kim J ，Yoon S ，Kim DH ，Atreya R ... -  《BMC GASTROENTEROLOGY》

Azathioprine and 6-mercaptopurine for maintenance of surgically-induced remission in Crohn's disease.

Gordon M ，Taylor K ，Akobeng AK ，Thomas AG ... -  《Cochrane Database of Systematic Reviews》

Etrolizumab for induction of remission in ulcerative colitis.

Rosenfeld G ，Parker CE ，MacDonald JK ，Bressler B ... -  《Cochrane Database of Systematic Reviews》

Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study).

ReFLECT was a French, prospective, multicenter, observational cohort study evaluating the effectiveness and safety of the infliximab (IFX) biosimilar CT-P13 in a real-world setting. Here, we describe the results for adults with inflammatory bowel disease (IBD). Eligible patients with IBD were recruited and received intravenous CT-P13 induction and/or maintenance therapy; patients were either naive to IFX (IFX-naive) or previously treated with IFX originator or another IFX biosimilar (IFX-switched). The primary objective was CT-P13 persistence, which was measured as a time-dependent variable during a two-year follow-up period with four prespecified visits. Safety was assessed. The adult IBD population comprised 530 patients with Crohn's disease (CD), including 327 categorized as IFX-naive, 188 as IFX-switched, 11 as other (i.e., previously received IFX but received another treatment before switching to CT-P13), and 4 with missing data; and 221 patients with ulcerative colitis (UC), including 152 categorized as IFX-naive, 59 as IFX-switched, 8 as other, and 2 with missing data. After two years of follow-up, the rates of CT-P13 persistence were 71.7 % (95 % CI: 66.7, 77.0) and 63.7 % (55.3, 73.3) in patients with CD and UC, respectively. CT-P13 persistence was greater for IFX-switched patients than for IFX-naive patients (CD: 83.7 % [95 % CI: 78.0, 89.9] vs 65.7 % [58.6, 73.7]; UC: 91.2 % [81.7, 100.0] vs 53.4 % [43.0, 66.2]). The main reason for CT-P13 discontinuation was loss of response (CD/UC) in both IFX-naive (14.7 %/21.7 %) and IFX-switched (7.4 %/5.1 %) groups. Among patients (CD and UC, respectively), 51.3 % and 45.2 % reported ≥1 adverse event (AE), and 13.2 % and 12.7 % reported serious AEs, respectively. After two years of follow-up, the effectiveness of intravenous CT-P13 was maintained in >80 % of IFX-switched patients. CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile. ClinicalTrials.gov identifier: NCT02925338.

Laharie D ，Bouhnik Y ，Vuitton L ，Biron A ，Pierron G ，Brault Y ，Assing M ，Bouzidi A ，Amiot A ，Nancey S ... -  《-》

Transition to Subcutaneous Infliximab vs Vedolizumab in Inflammatory Bowel Disease: A Prospective Multicenter Study.

Transition from intravenous (IV) to subcutaneous (SC) administration is an option in inflammatory bowel disease (IBD) with Infliximab (IFX) or Vedolizumab (VDZ). The aim was to compare the adherence, the persistence in therapy, and quality of life (QoL) at baseline, at 6, at 12 months of SC IFX versus SC VDZ. This was a prospective, observational, multicenter study on patients with IBD in treatment with IV IFX or VDZ who switched to SC. All patients investigated the QoL by the short IBD Questionnaire (sIBDQ) and the concerns and expectations by a 6-item survey. Any adverse events, local and systemic, were reported. Safety, concerns, and satisfaction were evaluated. One hundred and eight out of 93 patients were replaced, 51 to SC IFX and 42 to SC VDZ. The majority accepted the SC route. Persistence in therapy was similar between the two groups. The QoL improved after 6 months (p = 0.004), but at T12 both groups show a significant decline in QoL. SC administration has not caused any concern for patients. As safety, both groups reported a similar number of local reactions (IFX 19.60% vs VDZ 19.04%). In the IFX group were reported more systemic reactions (IFX 11.6% vs VDZ 7.14%) without the need for hospitalization. The transition from IV to SC administration is an appropriate and safe option for treatment with IFX or VDZ. It is very important to consider the patient's choice and preference. The SC administration led to a significant benefit in QoL, especially in the first 6 months of therapy.

Principi M ，Brescia IV ，Stasi E ，Mazzuoli S ，D'Uggento AM ，Equatore E ，Lacavalla I ，Di Leo A ... -  《-》