Yufeng Yin1, Mengru Liu2, Erye Zhou1, Xin Chang1, Michun He1, Mingjun Wang1, Jian Wu3. 1. Department of Rheumatology, The First Affiliated Hospital of Soochow University, No. 188 Shizi St, Suzhou, 215006, Jiangsu, China. 2. Department of Rheumatology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. 3. Department of Rheumatology, The First Affiliated Hospital of Soochow University, No. 188 Shizi St, Suzhou, 215006, Jiangsu, China. njwujian@163.com.
Abstract
OBJECTIVES: To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). METHODS: A systematic search was conducted in PubMed, Embase, and the Cochrane Library. Randomized placebo-controlled trials (RCTs) of jakinibs in RA patients were eligible. The effective outcome was RA improvement to reach an American College of Rheumatology 20%/50%/70% (ACR20/50/70) response rate at weeks 12 and 24 after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to adverse events, infections, and serious infections. RESULTS: Twenty-eight randomized, double-blind, controlled trials including 14,500 patients were included. At both weeks 12 and 24, the pooled analysis suggested effective treatment with jakinibs, represented as an increased clinical response of ACR20, ACR50, and ACR70. Subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12. Jakinibs were associated with an increased incidence of infections at week 12 and TEAEs and infections at week 24. No increase in the risk of SAEs, discontinuations due to adverse events, or serious infections was observed in comparisons between treatment with jakinibs and treatment with placebo in these patients. CONCLUSIONS: Jakinibs are efficacious and well tolerated in RA patients up to 24 weeks, although they are associated with an increased risk of infectious complications. Key Points • ACR20/50/70 in patients treated with jakinibs was significantly higher than those in patients treated with placebo. • No difference in ACR50/70 was observed in patients with RA treated with peficitinib and placebo. • Jakinibs are beneficial and well tolerated in RA treatment.
OBJECTIVES: To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). METHODS: A systematic search was conducted in PubMed, Embase, and the Cochrane Library. Randomized placebo-controlled trials (RCTs) of jakinibs in RApatients were eligible. The effective outcome was RA improvement to reach an American College of Rheumatology 20%/50%/70% (ACR20/50/70) response rate at weeks 12 and 24 after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to adverse events, infections, and serious infections. RESULTS: Twenty-eight randomized, double-blind, controlled trials including 14,500 patients were included. At both weeks 12 and 24, the pooled analysis suggested effective treatment with jakinibs, represented as an increased clinical response of ACR20, ACR50, and ACR70. Subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12. Jakinibs were associated with an increased incidence of infections at week 12 and TEAEs and infections at week 24. No increase in the risk of SAEs, discontinuations due to adverse events, or serious infections was observed in comparisons between treatment with jakinibs and treatment with placebo in these patients. CONCLUSIONS:Jakinibs are efficacious and well tolerated in RApatients up to 24 weeks, although they are associated with an increased risk of infectious complications. Key Points • ACR20/50/70 in patients treated with jakinibs was significantly higher than those in patients treated with placebo. • No difference in ACR50/70 was observed in patients with RA treated with peficitinib and placebo. • Jakinibs are beneficial and well tolerated in RA treatment.
Authors: Josef S Smolen; Robert Landewé; Johannes Bijlsma; Gerd Burmester; Katerina Chatzidionysiou; Maxime Dougados; Jackie Nam; Sofia Ramiro; Marieke Voshaar; Ronald van Vollenhoven; Daniel Aletaha; Martin Aringer; Maarten Boers; Chris D Buckley; Frank Buttgereit; Vivian Bykerk; Mario Cardiel; Bernard Combe; Maurizio Cutolo; Yvonne van Eijk-Hustings; Paul Emery; Axel Finckh; Cem Gabay; Juan Gomez-Reino; Laure Gossec; Jacques-Eric Gottenberg; Johanna M W Hazes; Tom Huizinga; Meghna Jani; Dmitry Karateev; Marios Kouloumas; Tore Kvien; Zhanguo Li; Xavier Mariette; Iain McInnes; Eduardo Mysler; Peter Nash; Karel Pavelka; Gyula Poór; Christophe Richez; Piet van Riel; Andrea Rubbert-Roth; Kenneth Saag; Jose da Silva; Tanja Stamm; Tsutomu Takeuchi; René Westhovens; Maarten de Wit; Désirée van der Heijde Journal: Ann Rheum Dis Date: 2017-03-06 Impact factor: 19.103