Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis
Rheumatol Ther. 2023 doi: 10.1007/s40744-023-00576-8 Epub ahead of print
The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.
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.
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.
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update
Ann Rheum Dis. 2022. Epub ahead of print [05/12/2022] doi: 10.1136/ard-2022-223356
Smolen, et al. provide a 2022 update of the EULAR recommendations for the management of RA with synthetic and biological DMARDs.
Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study
Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00498-x
Post hoc analysis from the FINCH 1 study highlights filgotinib as a potential beneficial treatment option for patients with RA who have had inadequate response to MTX and have high risk of disease progression and poor prognosis.
Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update
Blocking the IL-6R is a major therapeutic advance for many diseases in adults and children. Updated consensus statement provides guidance to rheumatologists and other experts, as well as patients and administrators, on managing patients with the use of drugs blocking the IL-6 pathway.
Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure
This analysis aimed to report the safety profile of ixekizumab for the PsA SPIRIT programme. The overall safety profile and tolerability of ixekizumab are consistent with the previously known safety profile in patients with PsA.
Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials
Rheumatol Ther. 2022 doi: 10.1007/s40744-021-00410-z
Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA
Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment
Rheumatol Ther. 2021. Epub ahead of print. doi: 10.1007/s40744-021-00390-0This post hoc analysis provides the first detailed description of the management and outcomes of HZ events in tofacitinib RA and PsA clinical studies.While prior studies have characterised the increased HZ risk with JAKinibs, the clinical management of these events has not been detailed.To this end, Winthrop, et al. analysed data from 21 RA and 3 PsA clinical studies to evaluate how HZ events and their sequelae were clinically managed during the RA and PsA tofacitinib clinical development progra...
Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years
Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221051Integrated analysis evaluates the safety of filgotinib among patients with RA treated for a median of 1.6 years.Winthrop, et al. analysed data from seven trials, including long-term extension studies, and found that rates of TEAEs, grade ≥3 TEAEs, serious TEAEs and TEAEs leading to study drug discontinuation were comparable for filgotinib and placebo. In addition, analysis of AEs of special interest showed a generally similar incidence for filgotinib 200 mg and 100 mg....