Rheumatoid arthritis oral abstractsO01. Efficacy and Safety of Baricitinib Versus Placebo and Adalimumab in Patients with Moderately to Severely Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Summary Results from the 52-Week Phase 3 RA-Beam Study

Taylor, Peter; Krogulec, Marek; Dudek, Anna; Drescher, Edit; Cseuz, Regina; Kausiene, R.; Andersone, Daina; Unikienė, Dalia; Burson, Juan Sanchez; Alonso, Ricardo Blanco; Dvořák, Zdeněk; Ghizdavescu, A; Irtó, I; Larsson, Esbjörn; Bello, Natalia; Barry, Jane; Durand, Frédérick; Holzkämper, Thorsten; Otawa, S.; Bono, Stephanie de; Keystone, Edward; Rubbert-Roth, Andrea; Combe, Bernard; Torre, Inmaculada de la

doi:10.1093/rheumatology/kex061

Cited by 2 publications

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“…In addition, the risk of infection by HZ with JAKi was reported in three head-to-head trials. In two studies, the risk was low and comparable between tofacitinib (1%–2%) or baricitinib (2%) and adalimumab (2%) 93 94. The risk was somewhat higher in another study comparing baricitinib (2%–3%) with methotrexate (1%) 95.…”

Section: Resultsmentioning

confidence: 96%

“…The risk of VTE/PE with JAKi was reported in three placebo-controlled trials and in two head-to-head trials (all at low RoB) (table 4). Although the number of events was low, in three of these trials, VTE occurred only in patients receiving tsDMARDs (in total six events, five were PE, one fatal) 92 94 96…”

Section: Resultsmentioning

confidence: 99%

“…In total, 21 studies evaluating bsDMARDs,52–72 18 studies evaluating boDMARDs73–90 and 21 studies evaluating tsDMARDs91–111 were included (online supplementary table S104). Overall, the incidence of major adverse events was low in all RCTs with mostly no differences between the active treatment and placebo or active comparator.…”

Section: Resultsmentioning

confidence: 99%

“…History of diverticulitis was an exclusion criteria in only one study,73 and no association with other known risk factors, for example, treatment with glucocorticoids or NSAIDs, has been reported in any study. The risk of LIP was assessed in nine RCTs/LTEs in patients on tsDMARDs and all report no cases 91 92 94 97 98 102 108 110 111…”

Section: Resultsmentioning

confidence: 99%

“…Even if most RCTs are not powered to detect differences in adverse events between treatment groups, and LTEs have no comparator allowing a proper risk assessment, early safety signals can be detected and inform future research. Two examples are the assessment of VTE/PE with JAKi and the imbalance in mortality for sirukumab 86 88 92 94 96…”

Section: Discussionmentioning

confidence: 99%

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Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis

et al. 2020

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ObjectivesTo perform a systematic literature review (SLR) concerning the safety of synthetic (s) and biological (b) disease-modifying anti rheumatic dugs (DMARDs) to inform the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis (RA).MethodsAn SLR of observational studies comparing safety outcomes of any DMARD with another intervention for the management of RA. A comparator group was required for inclusion. For treatments still without registry data (eg, sarilumab and the Janus kinase (JAK) inhibitors baricitinib, upadacitinib), randomised controlled trials (RCTs) and long-term extensions (LTEs) were used. Risk of bias (RoB) was assessed according to standard procedures.ResultsForty-two observational studies fulfilled the inclusion criteria, addressing safety outcomes with bDMARDs and sDMARDs. Nine studies showed no difference in the risk of serious infections across bDMARDs and two studies (high RoB) showed an increased risk with bDMARDs compared with conventional synthetic (cs) DMARDs (adjusted incidence rate ratio 3.1–3.9). The risk of Herpes zoster infection was similar across bDMARDs, but one study showed an increased risk with tofacitinib compared with abatacept (adjusted HR (aHR) 2.0). Five studies showed no increased risk of cancer for bDMARDs compared with csDMARDs. An increased risk of lower intestinal perforation was found for tocilizumab compared with csDMARDs (aHR 4.5) and tumour necrosis factor inhibitor (TNFi) (aHR 2.6–4.0). Sixty manuscripts reported safety data from RCTs/LTEs. Overall, no unexpected safety outcomes were found, except for the possibly increased risk of venous thromboembolism (VTE) with JAK inhibitors.ConclusionData obtained by this SLR confirm the known safety profile of bDMARDs. The risk of VTE in RA, especially in patients on JAK inhibitors, needs further evaluation.

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Section: Resultsmentioning

confidence: 96%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis

et al. 2020

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Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study

2020

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Objective The primary objectives of two phase II studies of fostamatinib were to evaluate efficacy (OSKIRA-Asia-1: NCT01569074) and long-term safety/tolerability (OSKIRA-Asia-1X: NCT01640054) in patients from Asia with active RA despite MTX treatment. Methods OSKIRA-Asia-1 was a 12-week, multicentre, double-blind, placebo-controlled, parallel-group study. Patients were randomized to receive one of four fostamatinib doses (groups A–D; n = 31, 33, 33, 33) or placebo (group E; n = 33). OSKIRA-Asia-1X was a long-term extension study (100 mg fostamatinib qd) of patients who completed OSKIRA-Asia-1. RA signs and symptoms were measured by ACR response criteria and DAS based on a 28-joint count. Physical function status was assessed with the HAQ–Disability Index. Safety findings were monitored. Results In OSKIRA-Asia-1, fostamatinib revealed numerical improvements in ACR 20% response (ACR20) at week 12 in group A (100 mg bid) and group B (100 mg bid, then 150 mg qd) vs placebo. Statistically significant improvements in ACR20 and ACR50 at week 8 and in ACR70 at week 12, and statistically significant achievement in low disease activity (defined as DAS based on a 28-joint count ≤3.2 based on C-reactive protein) occurred in groups A and B. Improvement in physical function was numerically higher in group A. The most common adverse events were hypertension, diarrhoea and neutropenia. In OSKIRA-Asia-1X, the most common adverse events were nasopharyngitis, hypertension, RA and neutropenia. Conclusion Fostamatinib achieved both statistically and clinically significant improvements in RA signs and symptoms. The safety and tolerability of fostamatinib (plus MTX) were consistent with previous studies. Trial registration OSKIRA-Asia-1 trial registration: https://clinicaltrials.gov, NCT01569074; OSKIRA-Asia-1X trial registration: https://clinicaltrials.gov, NCT01640054.

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Rheumatoid arthritis oral abstractsO01. Efficacy and Safety of Baricitinib Versus Placebo and Adalimumab in Patients with Moderately to Severely Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Summary Results from the 52-Week Phase 3 RA-Beam Study

Cited by 2 publications

References 0 publications

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis

Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study

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