Objective: The aim of this study was to assess the risk of active tuberculosis (TB) in patients with immune-mediated inflammatory diseases treated with biologics and tofacitinib in randomized controlled trials (RCTs) and long-term extension (LTE) studies.
Methods: A systematic review of the English-language literature by was performed by searching the Medline, Embase, Cochrane and Web of Knowledge databases. The search strategy focused on synonyms of diseases, biologics and tofacitinib. Data from RCTs were combined to assess the rate of TB using a random effects model. The incidence rate (IR) of TB and its association with disease, location and treatment were assessed in LTE studies.
Results: The search captured 11 130 articles and abstracts. One-hundred RCTs (75 000 patients) and 63 LTE studies (80 774.45 patient-years) met the inclusion criteria. There were 31 TB cases with TNF inhibitors, 1 with abatacept and none with rituximab, tocilizumab, ustekinumab or tofacitinib. The odds ratio for TNF inhibitors was 1.92 (95% CI 0.91, 4.03, P = 0.085). In LTE studies, the IR of TB was >40/100 000 with tofacitinib and all biologics except rituximab. IR was higher in RA patients with anti-TNF monoclonal antibodies [307.71 (95% CI 184.79, 454.93)] than in those with rituximab [20.0 (95% CI 0.10, 60)] and etanercept [67.58 (95% CI 12.1, 163.94)] or AS, PsA and psoriasis with etanercept [60.01 (95% CI 3.6, 184.79)]. The IR of TB was higher in high-background TB areas.
Conclusion: RCTs are not sensitive enough to assess the risk of reactivation of latent TB infection (LTBI). Disease, treatment and background TB rate are associated with different frequencies of active TB. The benefit/risk balance of preventing reactivation of LTBI in different backgrounds should be considered in clinical practice.
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http://dx.doi.org/10.1093/rheumatology/keu172 | DOI Listing |
Orbit
December 2024
Faculty of Medicine, Univerza v Ljubljani, Ljubljana, Slovenia.
We present a patient with isolated autoimmune anterior scleritis and a patient with nonspecific orbital inflammation (NSOI). Both patients were treated with systemic corticosteroids during multiple recurrences, with the addition of various disease-modifying antirheumatic drugs (DMARDs), including biologics, in the case of scleritis, resulting in complications and local adverse events. Both patients were subsequently effectively managed using Janus kinase inhibitors (JAK-i), specifically baricitinib and tofacitinib without relapses of inflammation during the follow-up of more than one year.
View Article and Find Full Text PDFDig Dis Sci
December 2024
Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Small molecule Janus kinase (JAK) inhibitors have revolutionized the management of ulcerative colitis (UC) and Crohn's disease (CD) through their low immunogenicity, safety, and consistent pharmacologic response that are superior to existing therapeutic options. In this perspective, we highlight existing evidence supporting the use of currently approved JAK inhibitors (upadacitinib, tofacitinib, and filgotinib) for UC or CD, additionally emphasizing the evidence for their use in related autoimmune conditions such as rheumatoid arthritis and spondyloarthropathies. Our perspective concludes with a review of the existing comparative effectiveness literature, which positions JAK inhibitors, particularly upadacitinib, favorably compared with other biologic therapies.
View Article and Find Full Text PDFImmunotherapy
December 2024
Department of Clinical Immunology and Allergy, Flinders Medical Centre, Bedford Park, South Australia.
Relapsing polychondritis is rare and affects non-synovial fibrocartilage. Currently, there is a paucity of treatment algorithms, especially for those with refractory disease. A middle-aged man presented with polychondritis affecting the nose, ears, joints, and larynx.
View Article and Find Full Text PDFIntest Res
January 2025
Office of the Chief Medical Officer, Johnson & Johnson, Raritan, NJ, USA.
Background/aims: There are few studies that comprehensively report real-world persistence for first-line advanced therapies used to treat inflammatory bowel disease. We aimed to describe persistence of first-line advanced therapies among incident biologic or Janus kinase inhibitor users with inflammatory bowel disease.
Methods: Retrospective cohort study using the Japan Medical Data Center database from January 1, 2010, until September 30, 2022.
Adv Rheumatol
December 2024
Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Objectives: Describe tofacitinib safety from an integrated analysis of randomized controlled trials (RCTs) in patients with ankylosing spondylitis (AS).
Method: Pooled data from Phase 2 (NCT01786668; 04/2013-03/2015)/Phase 3 (NCT03502616; 06/2018-08/2020) RCTs in AS patients were analyzed (3 overlapping cohorts): 16-week placebo-controlled (tofacitinib 5 mg twice daily [BID] [n = 185]; placebo [n = 187]); 48-week only-tofacitinib 5 mg BID (n = 316); 48-week all-tofacitinib (≥ 1 dose of tofacitinib 2, 5, or 10 mg BID; n = 420). Baseline 10-year atherosclerotic cardiovascular disease (ASCVD) risk was determined in patients without history of ASCVD (48-week cohorts).
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