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Showing 311 results for “Safety”.

January 2024

Cardiovascular Safety of Janus Kinase Inhibitor Therapy in a Multi-ethnic Population

Musculoskeletal Care 2023 doi 10.1002/msc.1853 Epub ahead of print

This study by Sunmboye, et al. investigated the relationship between CV event incidence and age in a multi-ethnic population that received JAK inhibitor therapy. They concluded that JAK inhibitor therapy was generally safe in a multi-ethnic population with a large age range, but they did find a statistically significant but numerically small positive correlation between age and CV incidence

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Efficacy of Pharmacological Interventions: A Systematic Review Informing the 2023 EULAR Recommendations for the Management of Fatigue in People with Inflammatory Rheumatic and Musculoskeletal Diseases

RMD Open 2023;9(4):e003349 doi 10.1136/rmdopen-2023-003349

Adalimumab demonstrated superiority over placebo in reducing fatigue in RA at 12 and 52 weeks. Other interventions, which included golimumab, baricitinib, sarilumab, tocilizumab, and tofacitinib, also proved effective in reducing fatigue in patients with RA. Secukinumab also reduced fatigue by Week 52 in patients with SpA.

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Implementation of Regulatory Guidance for JAK Inhibitors Use in Patients with Immune-Mediated Inflammatory Diseases: An International Appropriateness Study

Autoimmun Rev. 2023;23(3):103504 doi: 10.1016/j.autrev.2023.103504 Epub ahead of print

In this two-round modified RAM study by Solitano, et al., the authors found that experts preferred to assess JAK inhibitor risk on a case-by-case basis across all specialties. Uncertainty remained on several clinical scenarios regarding the appropriate use of JAK inhibitors, however they remain an important therapy option for the treatment of IMIDs  and were deemed appropriate for patients with moderate risk profiles.

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Drug Survival, Effectiveness and Safety of Ixekizumab for Moderate-to-severe Psoriasis up to 5 Years

J Eur Acad Dermatol Venereol 2023 doi 10.1111/jdv.19682 Epub ahead of print

This monocentric, retrospective clinical study by Mastorino, et al. found that ixekizumab demonstrated efficacy an safety in patients with PsA and PsO for up to five years. Being a super-responder was significantly associated with a lower rate of discontinuation, while high BMI was associated with a lower achievement of more than one PSAI measure up to Week 104.

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December 2023

Comparative Efficacy and Safety of Bimekizumab in Axial Spondyloarthritis: A Systematic Literature Review and Network Meta-analysis

Rheumatology (Oxford). 2023 doi: 10.1093/rheumatology/kead598 Epub ahead of print

This systematic literature review and network meta-analysis provides evidence for bimekizumab being an efficacious option in the management of both b/tsDMARD-naïve and experienced patients across the axSpA spectrum, with similar safety and tolerability to existing treatments.

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Real-world Comparative Study of the Efficacy of Janus Kinase Inhibitors in Patients with Rheumatoid Arthritis: The ANSWER Cohort Study

Rheumatology 2023 doi 10.1093/rheumatology/kead543

This multicentre, retrospective study by Hayashi, et al. found no significant differences in efficacy and safety between tofacitinib, baricitinib, peficitinib and upadacitinib in patients with RA. Predictive factors for resistance to LDA achievement included baseline CRP and CDAI for tofacitinib and baseline glucocorticoid dose, baseline CDAI and number of previous b/tsDMARDs for baricitinib.

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MACE and VTE across Upadacitinib Clinical Trial Programmes in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

RMD Open 2023; 9(4):e003392 doi 10.1136/rmdopen-2023-003392

Rates of MACE and VTE events in patients with RA or PsA treated are consistent across 15 mg and 30 mg doses of upadacitinib, and comparable with active comparators adalimumab and MTX. Several risk factors were also identified for MACE and VTE events in patients with RA.

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Sex-related Differences in Patient Characteristics, and Efficacy and Safety of Advanced Therapies in Randomised Clinical Trials in Psoriatic Arthritis: A Systematic Literature Review and Meta-analysis

Lancet Rheumatol 2023;5:e716–27

In this study, Eder, et al. performed a systematic literature review and meta-analysis of RCTs to assess information on participants’ characteristics and rates of American College of Rheumatology response and minimal disease activity by sex. The authors found that the biological sex of patients with PsA influences their response to advanced therapies, but the effect varies by drug class.

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November 2023

Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

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Bimekizumab Treatment in Patients With Active Axial Spondyloarthritis: 52-week Efficacy and Safety from the Randomised Parallel Phase 3 BE MOBILE 1 and BE MOBILE 2 Studies

Ann Rheum Dis. 2023;83(2):199–213 doi 10.1136/ard-2023-224803

Baraliakos, et al. present data from two Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, that investigated the clinical efficacy and safety of bimekizumab in axSpA patients. They found that bimekizumab had sustained and consistent efficacy in patients with nr-axSpA and r-axSpA.

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