Long-term safety and efficacy of olokizumab in patients with rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitor therapy in phase II studies

Genovese, Mark C.; Durez, Patrick; Fleischmann, Roy; Tanaka, Yoshiya; Fürst, Daniel E.; Yamanaka, Hisashi; Korneva, Elena; Vasyutin, Igor; Takeuchi, Tsutomu

doi:10.5152/eurjrheum.2021.19207

Cited by 6 publications

(3 citation statements)

References 34 publications

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“…From a total of 2961 references (after de-duplication), 226 were selected for a full-text review and 59 observational studies fulfilled the inclusion criteria 16–74. In addition, 2 RCTs with a primary safety outcome,2 3 and 28 RCTs/LTEs from the efficacy SLR,75–102 were included (flow chart in online supplemental figure S1). Studies were heterogeneous, precluding data pooling, and results are presented descriptively.…”

Section: Resultsmentioning

confidence: 99%

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Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

et al. 2022

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ObjectivesTo perform a systematic literature review (SLR) concerning the safety of synthetic(s) and biological (b) disease-modifying antirheumatic drugs (DMARDs) to inform the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis (RA).MethodsSLR of observational studies comparing safety outcomes of any DMARD with another intervention in RA. A comparator group was required for inclusion. For treatments yet without, or limited, registry data, randomised controlled trials (RCTs) were used.ResultsFifty-nine observational studies addressed the safety of DMARDs. Two studies (unclear risk of bias (RoB)) showed an increased risk of serious infections with bDMARDs compared with conventional synthetic (cs)DMARDs. Herpes zoster infections occurred more with JAKi than csDMARDs (adjusted HR (aHR): 3.66) and bDMARDs (aHR: 1.9–2.3) (four studies, two low RoB). The risk of malignancies was similar across bDMARDs (five studies) and with tofacitinib compared with bDMARDs (one study, low RoB). The risk of major adverse cardiovascular events (MACE) was similar with bDMARDs and tofacitinib (two studies, one low RoB). Thirty studies reported safety from RCTs, with one, designed to evaluate safety, showing that malignancies (HR (95% CI): 1.48 (1.04 to 2.09)) and MACE (HR (95% CI): 1.33 (0.91 to 1.94)) occurred numerically more frequently with tofacitinib (5 mg and 10 mg doses combined) than with TNFi in patients with cardiovascular risk factors. In this study, the risk of venous thromboembolism (VTE) was higher with tofacitinib 10 mg than with TNFi.ConclusionThe safety profile of bDMARDs was further demonstrated. Whether the difference in incidence of malignancies, MACE and VTE between tofacitinib and TNFi applies to other JAKi needs further evaluation.

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Section: Resultsmentioning

confidence: 99%

“…Eleven studies evaluating bDMARDs,2 75 76 78 79 84 87 90 92 96 100 and 19 evaluating tsDMARDs were included (online supplemental tables S138–152). 3 77 80–83 85 86 88 89 91 93–95 97–99 101 102 Most RCTs were not designed, and therefore, not powered, to evaluate safety outcomes.…”

Section: Resultsmentioning

confidence: 99%

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

et al. 2022

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“…Особый интерес представляют результаты успешных испытаний препарата Олокизумаб (фармацевтическая компания Р-ФАРМ), представляющего собой мАТ к ИЛ-6 и являющегося первым препаратом класса ингибиторов ИЛ-6, блокирующим не ИЛ-6 рецептор, а саму молекулу это важного провоспалительного цитокина [129]. В настоящее время завершилась серия крупных международных рандоминизрованных плацебо-контролируемых исследований (РПКИ) (CREDO-1, CREDO-2, CREDO-3), результаты которых опубликованы в ведущих зарубежных журналах [130][131][132][133] и в течение 2022 года будут широко представлены на станицах журнала «Научнопрактическая ревматология».…”

Section: российские биоаналоги и оригинальные гибп участие в междунар...unclassified

Advances in rheumatology at the beginning of the 21st century

Насонов

Лила

Дубинина³

et al. 2022

Naučno-praktičeskaâ revmatologiâ

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Olokizumab's Effectiveness and Safety in Patients with Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Mahmoud

2023

Journal of Clinical Densitometry

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Long-term safety and efficacy of olokizumab in patients with rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitor therapy in phase II studies

Cited by 6 publications

References 34 publications

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

Advances in rheumatology at the beginning of the 21st century

Olokizumab's Effectiveness and Safety in Patients with Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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