February 2024

Long term safety of ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: A post hoc analysis of final safety data from 25 randomized clinical trials

Arthritis Res Ther 2024;26(1):49 doi: 10.1186/s13075-023-03257-7

Incident rates of TEAEs were comparable for patients with PsO, PsA, and axSpA and did not increase with prolonged ixekizumab (IXE) treatment. Deodhar, et al. presented the final update on the long-term safety of IXE up to 6 years in PsO patients and up to 3 years in PsA and axSpA patients. Exposure-adjusted incident rates were calculated using patient data (TEAEs, SAEs, selected AEs) from 25 clinical trials.

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Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years

Rheumatol Ther 2024;11(1):157–175 doi 10.1007/s40744-023-00624-3

Charles-Schoeman, et al. carried out a descriptive integrated analysis on patients with RA that were treated in the SELECT programme, with up to 6.5 years of exposure. They concluded that upadacitinib 15 mg QD had an acceptable safety profile, but long-term upadacitinib treatment was associated with dose-dependent laboratory abnormalities.

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January 2024

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: efficacy and safety results from an open-label, Phase 3 trial

J Dermatol 2024;00:1–15. doi: 10.1111/1346-8138.17074

Week 16 coprimary endpoints of PASI 75 response and sPGA score improved in the majority of patients and was overall maintained through week 52. Deucravacitinib therapy was also associated with a low AE rate. This study presented results from the POETYK PSO-4 trial on the safety and efficacy of deucravacitinib 6mg QD in Japanese patients with psoriasis.

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December 2023

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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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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Deucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two Phase 3 randomized trials in plaque psoriasis

Am Acad Dermatol 2023. doi: 10.1016/j.jaad.2023.11.060

This pooled analysis of the Phase 3 PSO-1 and PSO-2 trials shows that deucravacitinib has greater efficacy in treating scalp PsO than placebo and apremilast. At week 16, response rates were greater with deucravacitinib versus placebo or apremilast for scalp-specific Physician Global Assessment 0/1 and Psoriasis Scalp Severity Index. Efficacy was maintained through 52 weeks in patients who received continuous deucravacitinib treatment.

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September 2023

Efficacy and Safety of Upadacitinib in Patients with Ankylosing Spondylitis Refractory to Biologic Therapy: 1-year Results From the Open-label Extension of a Phase III Study

Arthritis Res Ther 2023; 2023;18;25(1):172 doi 10.1186/s13075-023-03128-1

The efficacy and safety of updacitinib in bDMARD-IR patients with AS were sustained through to one year in an open-label extension of the SELECT-AXIS 2 study.

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July 2023

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 3-year Results from the Open-Label Extension of the Randomised Controlled Phase 3 SELECT-PsA 2 Study

Clin Exp Rheumatol. 2023;41(11):2286–2297 doi: 10.55563/clinexprheumatol/8l7bbk.

Data from this open-label extension showed the efficacy of upadacitinib observed at 56 weeks was maintained through to 152 weeks in the treatment of patients with PsA. No cumulative adverse effects were observed, and no new safety signals were identified.

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June 2023

Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme

Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.

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Effect of Upadacitinib on Disease Activity, Pain, Fatigue, Function, Health-Related Quality of Life and Work Productivity for Biologic Refractory Ankylosing Spondylitis

Rheumatol Ther 2023; 10:679–91 doi 10.1007/s40744-023-00536-2

Upadacitinib significantly improved patient-reported outcomes in AxSpA patients with bDMARD-IR after 14 Weeks of treatment. There were notable improvements in disease activity, pain, fatigue, function, HRQoL, and work productivity.

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