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Meta-Analysis
. 2022 Jun 8;22(1):291.
doi: 10.1186/s12876-022-02347-1.

Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis

Laurent Peyrin-Biroulet  1 , Perttu Arkkila  2 , Alessandro Armuzzi  3 , Silvio Danese  4 , Jordi Guardiola  5 , Jørgen Jahnsen  6 , Charles Lees  7 , Edouard Louis  8 , Milan Lukáš  9 , Walter Reinisch  10 , Xavier Roblin  11 , Minyoung Jang  12 , Han Geul Byun  12 , Dong-Hyeon Kim  12 , Sung Jeong Lee  12 , Raja Atreya  13
Affiliations
Meta-Analysis

Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis

Laurent Peyrin-Biroulet et al. BMC Gastroenterol. .

Abstract

Background and aims: There are limited comparative data for infliximab and vedolizumab in inflammatory bowel disease patients.

Methods: We conducted a systematic review and meta-analysis to compare the efficacy and safety of infliximab and vedolizumab in adult patients with moderate-to-severe Crohn's disease or ulcerative colitis.

Results: We identified six eligible Crohn's disease and seven eligible ulcerative colitis trials that randomised over 1900 participants per disease cohort to infliximab or vedolizumab. In the Crohn's disease and ulcerative colitis cohorts, infliximab yielded better efficacy than vedolizumab for all analysed outcomes (CDAI-70, CDAI-100 responses, and clinical remission for Crohn's disease and clinical response and clinical remission for ulcerative colitis) during the induction phase, with non-overlapping 95% confidence intervals. In the maintenance phase, similar proportions of infliximab- or vedolizumab-treated patients achieved clinical response, clinical remission, or mucosal healing in both Crohn's disease and ulcerative colitis. For the safety outcomes, rates of adverse events, serious adverse events, and discontinuations due to adverse events were similar in infliximab- and vedolizumab-treated patients in both diseases. The infection rate was higher in infliximab for Crohn's disease and higher in vedolizumab when treating patients with ulcerative colitis. There was no difference between the treatments in the proportions of patients who reported serious infections in both indications.

Conclusions: Indirect comparison of infliximab and vedolizumab trials in adult patients with moderate-to severe Crohn's disease or ulcerative colitis demonstrated that infliximab has better efficacy in the induction phase and comparable efficacy during the maintenance phase and overall safety profile compared to vedolizumab.

Keywords: Antibodies; Biological therapy; Crohn’s disease; IBD; Monoclonal; Tumor Necrosis Factor-alpha; Ulcerative colitis.

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Conflict of interest statement

LP received personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Boerhinger-Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergan, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, Theravance. PA has been an advisory board member of Janssen. AA has been a consultant for AbbVie, Allergan, Amgen, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Ferring, Gilead, Janssen, Lilly, MSD, Mylan, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda; SD has received consultancy fees from AbbVie, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer-Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB Inc., Vifor, and lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, and Takeda. Jordi Guardiola: Roche, MSD, Abbvie, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Chiesi, GE Healthcare; JJ has been a speaker, consultant or advisory board member (ABM) for AbbVie, Astro Pharma, Boerhinger-Ingelheim, BMS, Celltrion, Ferring, Giliad, Hikma, Janssen, Meda, MSD, Napp Pharma, Novartis, Orion Pharma, Pfizer, Pharmacosmos, Roche, Takeda, Tillotts, Sandoz, Unimedic Pharma. CL has received research support from Abbvie, Gilead, and Trellus Health; acted as a consultant to Abbvie, Janssen, Takeda, Pfizer, Celltrion, Galapagos, GSK, Gilead, Vifor Pharma, Dr Falk, and Iterative Scopes; he has received speaking fees and travel support from Pfizer, Janssen, Abbvie, Celltion, Galapagos, Takeda, Shire, Ferring and Dr Falk. EL has received research grants from Takeda, Pfizer, Janssen, educational grants from Abbvie, Takeda, Janssen, has received speaker fees from Abbvie, Ferring, MSD, Falk, Takeda, Janssen, Pfizer, Celgene, has been an ABM of Abbvie, Ferring, MSD, Takeda, Celgene, Janssen, Gilead-Galapagos, Arena, Pfizer, Eli Lilly, and a consultant of Abbvie. ML has received financial supports for research and educational activities from Takeda, Janssen, Pfizer, has been an ABM of Janssen, Takeda, Egis. WR has been a speaker for Abbott Laboratories, Abbvie, Aesca, Aptalis, Astellas, Centocor, Celltrion, Danone Austria, Elan, Falk, Ferring, Immundiagnostik, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor, Yakult, a consultant for Abbott Laboratories, Abbvie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Arena Pharmaceuticals, Astellas, Astra Zeneca, Avaxia, Roland Berger GmBH, Bioclinica, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernest & Young, Falk, Ferring, Galapagos, Gatehouse Bio Inc., Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, J&J, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, LivaNova, Mallinckrodt, Medahead, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Periconsulting, Pharmacosmos, Philip Morris Institute, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Sandoz, Schering-Plough, Second Genome, Seres Therapeutics, Setpointmedical, Sigmoid, Sublimity, Takeda, Therakos, Theravance, Tigenix, UCB, Vifor, Zealand, Zyngenia, 4SC, an ABM for Abbott Laboratories, Abbvie, Aesca, Amgen, AM Pharma, Astellas, Astra Zeneca, Avaxia, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, J&J, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpointmedical, Takeda, Therakos, Tigenix, UCB, Zealand, Zyngenia, 4SC, has received research funding from Abbott Laboratories, Abbvie, Aesca, Centocor, Falk, Immundiagnostik, Janssen, MSD, Sandoz, Takeda. XR Celltrion, MSD, Janssen, Takeda, Pfizer, Amgen, Gilead, Tillots. MJ, HGB and D-HK are employees of Celltrion Healthcare. SJL is an employee of Celltrion, Inc. RA declares the following paid or unpaid consultancies, or sources of honoraria payments, which could potentially be viewed as a conflict of interest: AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion Healthcare, DrFalk Pharma, Ferring, Fresenius Kabi, Galapagos, Gilead, GlaxoSmithKline, InDex Pharmaceuticals, Janssen-Cilag, Kliniksa Pharmaceuticals, MSD Sharp & Dohme, Novartis, Pandion Therapeutics, Pfizer, Roche Pharma, Samsung Bioepsis, Stelic Institute, Sterna Biologicals, Takeda Pharma, Tillotts Pharma AG, Viatris.

JJ (Jørgen Jahnsen) has served as a speaker, consultant or advisory board member for AbbVie, Astro Pharma, Boerhinger Ingelheim, BMS, Celltrion, Celgene, Ferring, Giliad, Hikma, Janssen, Meda, MSD, Napp Pharma, Novartis, Orion Pharma, Pfizer, Pharmacosmos, Roche, Takeda, Tillotts, Sandoz and Unimedic Pharma.

Figures

Fig. 1
Fig. 1
PRISMA flow diagrams for A Crohn’s disease and B ulcerative colitis. Abbreviation: PRISMA Preferred reporting items for systematic reviews and meta-analyses
Fig. 2
Fig. 2
Quality assessment results for studies contributing data to the analyses for A Crohn’s disease and B ulcerative colitis. Panel A: Risk of bias determined based on assessment of the following study publications: SONIC, NOR-SWITCH, GEMINI 2, GEMINI 3, CT-P13 SC trial, and PLANET CD. Abbreviation: SC, subcutaneous. Panel B: Risk of bias determined based on assessment of the following study publications: GEMINI 1, NOR- SWITCH, ACT 1, ACT 2, VISIBLE 1, VARSITY, and CT-P13 SC trial. Abbreviation: SC, subcutaneous
Fig. 3
Fig. 3
A A comparison of infliximab versus vedolizumab for key efficacy outcomes in patients with Crohn’s disease. Abbreviation: CDAI, Crohn’s Disease Activity Index; IFX, infliximab; VDZ, vedolizumab. B A comparison of infliximab versus vedolizumab for key efficacy outcomes in patients with ulcerative colitis. Abbreviation: IFX, infliximab; VDZ, vedolizumab
Fig. 4
Fig. 4
A A comparison of infliximab versus vedolizumab for key safety outcomes in patients with Crohn’s disease (≤ 1 year) Abbreviation: AE, adverse events; SAE, serious adverse events; IFX, infliximab; VDZ, vedolizumab. B. A comparison of infliximab versus vedolizumab for key safety outcomes in patients with ulcerative colitis (≤ 1 year). Abbreviation: AE, adverse events; SAE, serious adverse events; IFX, infliximab; VDZ, vedolizumab
Fig. 5
Fig. 5
Forest plots showing the proportion of patients with Crohn’s disease achieving clinical remission during A the induction phase and B the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Panel A SONIC (a): IFX IV (corticosteroid free); SONIC (b): combination therapy; PLANET CD (a): patients with CT-P13 IV only; PLANET CD (b): patients with CT-P13 IV and IFX IV; GEMINI 2 (a): VDZ before TNFi; GEMINI 2 (b): VDZ after TNFi failure; GEMINI 3 (a): VDZ IV before TNFi; GEMINI 3 (b): VDZ IV after TNFi failure. Abbreviation: CI, confidence interval; IFX, infliximab; IV, intravenous; TNFi, tumour necrosis factor-α inhibitor; VDZ, vedolizumab. Panel B SONIC (a): IFX IV (corticosteroid free); SONIC (b): combination therapy; PLANET CD (a): CT-P13 IV only; PLANET CD (b): CT-P13 IV switch to IFX IV; PLANET CD (c): IFX IV only; PLANET CD (d): IFX IV switch to CT-P13 IV; CT-P13 SC trial (a): CT-P13 SC only; CT-P13 SC trial (b): CT-P13 IV switch to CT-P13 SC; GEMINI 2 (a): VDZ before TNFi; GEMINI 2 (b): VDZ after TNFi failure. Abbreviation: CI, confidence interval; IFX, infliximab; IV, intravenous; SC, subcutaneous; TNFi, tumour necrosis factor-α inhibitor; VDZ, vedolizumab
Fig. 6
Fig. 6
Forest plots showing the proportion of patients with ulcerative colitis achieving clinical remission during A the induction phase and B the maintenance phase with infliximab (upper plot) or vedolizumab (lower plot). Panel A Abbreviation: CI, confidence interval. Panel B CT-P13 SC trial (a): CT-P13 SC only; CT-P13 SC trial (b): CT-P13 IV switch to CT-P13 SC; VISIBLE 1 (a): VDZ SC; VISIBLE 1 (b): VDZ IV Abbreviation: CI, confidence interval; IV, intravenous; SC, subcutaneous
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