BACKGROUND: Optimal treatment for rheumatoid arthritis (RA) after inadequate response (IR) to tumour necrosis factor α inhibitors (TNFi) remains uncertain. OBJECTIVE: To compare the efficacy and safety of biological agents after TNFi-IR. METHODS: A systematic literature search was carried out using Medline and Cochrane databases, as well as http://www.clinicaltrials.gov, and bibliographies of the retrieved literature were searched by hand. Randomised, placebo-controlled trials that enrolled patients with RA with TNFi-IR were included and American College of Rheumatology (ACR) response as primary efficacy outcome and adverse events (AEs), serious adverse events (SAEs) and serious infections (SIs) as safety measures were extracted. An indirect meta-analysis with pairwise comparisons of efficacy and safety data was then carried out using ORs or risk differences (RDs) in a random effects model. RESULTS: In four randomised controlled trials with 24 weeks' follow-up, direct comparisons of abatacept, golimumab, rituximab and tocilizumab versus placebo showed statistically significant mean ORs of 3.3-8.9 for ACR20, 5.5-10.2 for ACR50 and 4.1-13.5 for ACR70. Risks of AEs, SAEs and SIs versus placebo were non-significant. Indirect pairwise comparisons of the four biological agents showed no significant differences in ACR50 and ACR70. Golimumab had a significantly lower OR (0.56-0.59) for ACR20 but significantly fewer AEs (RD 0.13-0.18). Efficacy after one versus multiple TNFi failures did not differ significantly between the different biological agents. CONCLUSION: In patients refractory to one or more TNFi, new biological agents provide significant improvement with good safety. Lacking head-to-head trials, indirect meta-analysis enables a comparison of effectiveness and safety of biological agents with each other and shows that all biological agents have similar effects.
BACKGROUND: Optimal treatment for rheumatoid arthritis (RA) after inadequate response (IR) to tumour necrosis factor α inhibitors (TNFi) remains uncertain. OBJECTIVE: To compare the efficacy and safety of biological agents after TNFi-IR. METHODS: A systematic literature search was carried out using Medline and Cochrane databases, as well as http://www.clinicaltrials.gov, and bibliographies of the retrieved literature were searched by hand. Randomised, placebo-controlled trials that enrolled patients with RA with TNFi-IR were included and American College of Rheumatology (ACR) response as primary efficacy outcome and adverse events (AEs), serious adverse events (SAEs) and serious infections (SIs) as safety measures were extracted. An indirect meta-analysis with pairwise comparisons of efficacy and safety data was then carried out using ORs or risk differences (RDs) in a random effects model. RESULTS: In four randomised controlled trials with 24 weeks' follow-up, direct comparisons of abatacept, golimumab, rituximab and tocilizumab versus placebo showed statistically significant mean ORs of 3.3-8.9 for ACR20, 5.5-10.2 for ACR50 and 4.1-13.5 for ACR70. Risks of AEs, SAEs and SIs versus placebo were non-significant. Indirect pairwise comparisons of the four biological agents showed no significant differences in ACR50 and ACR70. Golimumab had a significantly lower OR (0.56-0.59) for ACR20 but significantly fewer AEs (RD 0.13-0.18). Efficacy after one versus multiple TNFi failures did not differ significantly between the different biological agents. CONCLUSION: In patients refractory to one or more TNFi, new biological agents provide significant improvement with good safety. Lacking head-to-head trials, indirect meta-analysis enables a comparison of effectiveness and safety of biological agents with each other and shows that all biological agents have similar effects.
Authors: M Cárdenas; S de la Fuente; P Font; M C Castro-Villegas; M Romero-Gómez; D Ruiz-Vílchez; J Calvo-Gutiérez; A Escudero-Contreras; M A Casado; J R Del Prado; E Collantes-Estévez Journal: Rheumatol Int Date: 2016-02 Impact factor: 2.631
Authors: Monika M Schoels; Désirée van der Heijde; Ferdinand C Breedveld; Gerd R Burmester; Maxime Dougados; Paul Emery; Gianfranco Ferraccioli; Cem Gabay; Allan Gibofsky; Juan Jesus Gomez-Reino; Graeme Jones; Tore K Kvien; Miho Murakami; Miho M Murikama; Norihiro Nishimoto; Josef S Smolen Journal: Ann Rheum Dis Date: 2012-11-10 Impact factor: 19.103
Authors: Maike H M Wientjes; Sadaf Atiqi; Gerrit Jan Wolbink; Michael T Nurmohamed; Maarten Boers; Theo Rispens; Annick de Vries; Ronald F van Vollenhoven; Bart J F van den Bemt; Alfons A den Broeder Journal: Trials Date: 2021-06-19 Impact factor: 2.279
Authors: Josef S Smolen; Monika M Schoels; Norihiro Nishimoto; Ferdinand C Breedveld; Gerd R Burmester; Maxime Dougados; Paul Emery; Gianfranco Ferraccioli; Cem Gabay; Allan Gibofsky; Juan Jesus Gomez-Reino; Graeme Jones; Tore K Kvien; Miho Murakami; Neil Betteridge; Clifton O Bingham; Vivian Bykerk; Ernest H Choy; Bernard Combe; Maurizio Cutolo; Winfried Graninger; Angel Lanas; Emilio Martin-Mola; Carlomaurizio Montecucco; Mikkel Ostergaard; Karel Pavelka; Andrea Rubbert-Roth; Naveed Sattar; Marieke Scholte-Voshaar; Yoshiya Tanaka; Michael Trauner; Gabriele Valentini; Kevin L Winthrop; Maarten de Wit; Désirée van der Heijde Journal: Ann Rheum Dis Date: 2012-11-21 Impact factor: 19.103