PMID- 33305638 OWN - NLM STAT- MEDLINE DCOM- 20211216 LR - 20211216 IS - 1744-8409 (Electronic) IS - 1744-666X (Linking) VI - 17 IP - 1 DP - 2021 Jan TI - Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis. PG - 85-99 LID - 10.1080/1744666X.2020.1858803 [doi] AB - OBJECTIVES: There are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA). METHODS: Historical data for reference product/biosimilar intravenous infliximab, or adalimumab and etanercept, were pooled and compared with phase 3 study results for a subcutaneous (SC) formulation of the infliximab biosimilar CT-P13, in a systematic review and meta-analysis (PROSPERO: CRD42019149621). RESULTS: The authors identified 13 eligible controlled trials that randomized over 5400 participants to prespecified treatments of interest. Comparison with pooled historical data suggested a numerical advantage for CT-P13 SC over intravenous infliximab for almost every prespecified efficacy outcome evaluated, including Disease Activity Score in 28 joints (C-reactive protein/erythrocyte sedimentation rate), Clinical/Simplified Disease Activity Index scores, American College of Rheumatology responses, and multiple measures of disease remission and low disease activity; for the majority of outcomes, there was no overlap in 95% confidence intervals between groups. A numerical advantage for CT-P13 SC was also observed for safety outcomes (adverse events, infections, and discontinuations). Similar, but less marked, trends were observed for comparison with historical efficacy and safety data for adalimumab/etanercept. CONCLUSION: CT-P13 SC offers an improved or similar benefit-to-harm ratio compared with infliximab (intravenous) and adalimumab/etanercept, for the treatment of moderate-to-severe RA. FAU - Caporali, Roberto AU - Caporali R AUID- ORCID: 0000-0001-9300-6169 AD - Department of Clinical Sciences and Community Health, Research Centre for Adult and Pediatric Rheumatic Diseases, University of Milan, ASST Pini-CTO, Milan, Italy. FAU - Allanore, Yannick AU - Allanore Y AD - Rheumatology Department, Hopital Cochin, Paris Descartes University, Paris, France. FAU - Alten, Rieke AU - Alten R AUID- ORCID: 0000-0002-3395-4412 AD - Department of Internal Medicine and Rheumatology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany. FAU - Combe, Bernard AU - Combe B AUID- ORCID: 0000-0003-4002-1861 AD - Department of Rheumatology, CHU, CHU Montpellier, Montpellier University, Montpellier, France. FAU - Durez, Patrick AU - Durez P AD - Rheumatology, Cliniques Universitaires Saint-Luc - Universite Catholique De Louvain - Institut De Recherche Experimentale Et Clinique (IREC), Brussels, Belgium. FAU - Iannone, Florenzo AU - Iannone F AD - Rheumatology Unit, Department of Emergency and Organ Transplantation, Universita Degli Studi Di Bari Aldo Moro, Bari, Italy. FAU - Nurmohamed, Mike T AU - Nurmohamed MT AD - Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, The Netherlands. AD - Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands. FAU - Lee, Sang Joon AU - Lee SJ AD - Celltrion, Inc. Incheon, Republic of Korea. FAU - Kwon, Taek Sang AU - Kwon TS AD - Celltrion Healthcare, Incheon, Republic of Korea. FAU - Choi, Jean Soo AU - Choi JS AD - Celltrion Healthcare, Incheon, Republic of Korea. FAU - Park, Gahee AU - Park G AD - Celltrion, Inc. Incheon, Republic of Korea. FAU - Yoo, Dae Hyun AU - Yoo DH AUID- ORCID: 0000-0002-0643-4008 AD - Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea. LA - eng SI - figshare/10.6084/m9.figshare.13490888.v1 PT - Comparative Study PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Systematic Review DEP - 20201228 PL - England TA - Expert Rev Clin Immunol JT - Expert review of clinical immunology JID - 101271248 RN - 0 (Antirheumatic Agents) RN - 0 (Biosimilar Pharmaceuticals) RN - B72HH48FLU (Infliximab) RN - FYS6T7F842 (Adalimumab) RN - OP401G7OJC (Etanercept) SB - IM MH - *Adalimumab/adverse effects/therapeutic use MH - Administration, Cutaneous MH - Administration, Intravenous MH - *Antirheumatic Agents/administration & dosage/adverse effects/therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - *Biosimilar Pharmaceuticals/administration & dosage/adverse effects/therapeutic use MH - *Etanercept/adverse effects/therapeutic use MH - Humans MH - Infliximab/administration & dosage/*adverse effects/*therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - Adalimumab OT - CT-P13 OT - biosimilar OT - etanercept OT - infliximab OT - rheumatoid arthritis EDAT- 2020/12/12 06:00 MHDA- 2021/12/17 06:00 CRDT- 2020/12/11 08:37 PHST- 2020/12/12 06:00 [pubmed] PHST- 2021/12/17 06:00 [medline] PHST- 2020/12/11 08:37 [entrez] AID - 10.1080/1744666X.2020.1858803 [doi] PST - ppublish SO - Expert Rev Clin Immunol. 2021 Jan;17(1):85-99. doi: 10.1080/1744666X.2020.1858803. Epub 2020 Dec 28.