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Showing 243 results for “Safety”.

March 2023

Safety Profile of Upadacitinib over 15 000 Patient-years Across Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Atopic Dermatitis

RMD Open. 2023;9(1):e002735 doi: 10.1136/rmdopen-2022-002735

Integrated analysis of the safety profile of upadacitinib demonstrates that it was generally well-tolerated in RA, PsA, AS and AD, with no new safety risks identified, compared with previous reports.

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Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications

Adv Ther. 2023:1–17 doi: 10.1007/s12325-023-02445-w Epub ahead of print

Analysis of pooled data from the baricitinib clinical development programmes finds a low incidence rate of MACE, myocardial infarction, lung cancer, VTE, and overall mortality in patients <65 years without risk factors.

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Safety of Biological and Targeted Synthetic Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis as used in Clinical Practice: Results from the ARTIS Programme

Ann Rheum Dis. 2023 doi: 10.1136/ard-2022-223762 Epub ahead of print

Nationwide register-based cohort study corroborates and extends previous evidence that the currently available biologic/targeted synthetic DMARDs have an acceptable and, on the whole, similar safety profile.

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February 2023

Herpes zoster in Patients with Inflammatory Arthritides or Ulcerative Colitis Treated with Tofacitinib, Baricitinib or Upadacitinib: A Systematic Review of Clinical Trials and Real-world Studies

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

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Safety of Guselkumab with and without Prior TNF-α Inhibitor Treatment: Pooled Results Across Four Studies in Patients with Psoriatic Arthritis

J Rheumatol. 2023 jrheum

These results demonstrate that guselkumab was well tolerated in studies continuing for 1 to 2 years among patients with moderate-to-severe PsA regardless of TNFi experience and concomitant MTX use. The objective of this study was to assess pooled safety results from Phase 2/3 studies of guselkumab in TNFi-naïve and experienced PsA patients.

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Selective Inhibition of the MK2 Pathway: Data From a Phase IIa Randomized Clinical Trial in Rheumatoid Arthritis

ACR Open Rheumatol. 2023. doi: 10.1002/acr2.11517 Epub ahead of print

Data show that the first-in-class MK2 pathway inhibitor ATI-450 was well tolerated and induced sustained anti-inflammatory efficacy over 12 weeks in patients with moderate-to-severe RA.

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Impact of Cardiovascular Risk Enrichment on Incidence of Major Adverse Cardiovascular Events in the Tofacitinib Rheumatoid Arthritis Clinical Programme

Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-223406 Epub ahead of print

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

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January 2023

Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study

Arthritis Rheumatol. 2022;74:1943–58

In this open-label extension study of BE AGILE, the safety profile of bimekizumab was found to be consistent with previously demonstrated findings, and no new safety signals were identified. The objective was to assess the long-term safety, tolerability, and efficacy of bimekizumab in patients with active AS.

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