Correspondence to: Iain B. McInnes, Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, 120 University Place, Glasgow G12 8TA, UK.
Safety profiles of these JAK inhibitors in randomized controlled trials and their long-term extension studies have been demonstrated; however, real world evidence remains to be established to bridge the gap between randomized controlled trials and rheumatology clinics.
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During the placebo-controlled period (baseline to week 24) of a merged dataset including three phase II and three phase III studies, 23 patients (2.3%) in the baricitinib 4-mg group (Risks of DVT/PE in patients treated with tofacitinib were analysed using the data from phase II and phase III randomized clinical studies for RA, psoriasis, psoriatic arthritis (PsA) and ulcerative colitis [Because the observation period of the placebo group was relatively short because of the nature of RCTs, the risk of DVT/PE should be interpreted in the context of the risk in the general population and patients with RA in general. However, there are data from animal models and In animal arthritis models, JAKinibs have been found to inhibit, dependent on the cytokine environment, the expression of Th17-related cytokines (IL-17A, IL-17F, IL-22), thereby blocking the IL-23/-17 axis [A recent clinical research programme led to the Food and Drug Administration approving tofacitinib for PsA.
None developed TB among 286 patients who were reported to have untreated latent TB infection upon screening and were treated with tofacitinib and isoniazide concomitantly, and none developed clinically significant hepatitis by isoniazid [Of 5671 patients enroled in phase II, phase III and LTE studies of tofacitinib, 34 non-TB opportunistic infections developed, including oesophageal candidiasis (Previous studies demonstrated that the risk of overall malignancy in patients with RA is moderately increased compared with that in the general population. In the recent EULAR recommendations for the management of RA, JAK inhibitors are recommended in patients failing initial treatment with MTX or other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs… Occupational silica exposure in an Australian systemic sclerosis cohort E-mail:
Data for baricitinib were from reference [NMSC: non-melanoma skin cancer; MACE: major adverse cardiovascular event; DVT: deep vein thrombosis; PE: pulmonary embolism; PBO: placebo; GI: gastrointestinal; JAK: Janus kinase.Incidence rates of serious adverse events in patients with RAIncidence rates per 100 patient-years and 95% CIs of infection requiring hospitalization (for registries) or serious infection (for tofacitinib and baricitinib) (Incidence rates of serious adverse events in patients with RAIncidence rates per 100 patient-years and 95% CIs of infection requiring hospitalization (for registries) or serious infection (for tofacitinib and baricitinib) (In patients with RA, the risk of HZ is elevated by 2- to 3-fold [In patients who received baricitinib in phase I, phase II, phase III and LTE studies (Patients with RA are more susceptible to tuberculosis (TB) than non-RA individuals [Of 5671 patients enroled in phase II, phase III and LTE studies of tofacitinib, 26 cases of TB were reported only in the tofacitinib-treated patients of phase III and LTE studies, and the crude IR (95% CI) was 0.21 per 100 PY (0.14–0.30).
Long-term efficacy of adding intravenous immunoglobulins as treatment of refractory dysphagia related to myositis: a retrospective analysis As described in another article from this issue, Janus kinase (JAK) inhibitors with a different specificity to JAK family kinases have been launched into the market or under clinical development for RA.