Opportunistic Infections Associated with Janus Kinase Inhibitor Treatment for Rheumatoid Arthritis: A Structured Literature Review
Semin Arthritis Rheum. 2023;58:152120
Structured literature review shows a varied incidence of opportunistic infections (OIs) among RA patients exposed to JAK inhibitors.
The Incidence of Opportunistic Infections in Patients with Psoriatic Arthritis Treated with Biologic and Targeted Synthetic Agents: A Systematic Review and Meta-analysis
Front Pharmacol 2022;13:992713 doi: 10.3389/fphar.2022.992713
This is the largest meta-analysis to date, assessing the risk of OIs (Opportunistic infection) in patients with PsA. In coming to this conclusion, a systematic review and meta-analysis was undertaken to estimate the incidence of OIs following treatment with b- and tsDMARDs.
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
Immune‑related adverse events (irAEs) in ankylosing spondylitis (AS) patients treated with interleukin (IL)‑17 inhibitors: a systematic review and meta‑analysis
Inflammopharmacology. 2022, Apr;30(2):435-451. doi: 10.1007/s10787-022-00933-z
The most common immune system-related AEs in patients treated with IL-17 inhibitors are mucosal and opportunistic infections.
Interleukin (IL)-17 inhibitors are a series of biological drugs used to treat a number of conditions, including ankylosing spondylitis, a disease characterised by immune system dysregulation and joint inflammation. Azadeh, et al. aimed to assess the risk of immune system-related AEs due to targeting IL-17 or IL-17R.
Annals of the Rheumatic Diseases, May 2020Baricitinib, an oral selective JAK1 and JAK2 inhibitor,8 demonstrated significant clinical efficacy in phase 3 RA trials. Pooled data from these trials, including a long-term extension (LTE), inform the safety profile for baricitinib, mainly to evaluate the incidence of infection in patients with active rheumatoid arthritis (RA), with a focus on serious infection, tuberculosis (TB), herpes zoster (HZ) and opportunistic infection (OI). The data collected were from eight double-blind randomised tr...
Safety Profile of Baricitinib For the Treatment of Rheumatoid Arthritis Over a Median of 3 Years of Treatment: An Updated Integrated Safety Analysis
Lancet Rheumatol 2020;2:e347–57RA is a chronic, life-long disease requiring long-term treatment. As such, it is important to understand the long-term safety profile of DMARDs. In this analysis, baricitinib maintained a stable safety profile during long-term exposure. This baricitinib safety analysis included integrated data from nine Phase 3, 2, and 1b clinical trials, and one long-term extension, with data up to 360 weeks. 3700 patients were included, with maximum follow-up of almost 7 years – representing an additional 3,54...
An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis Across Phase III and Long Term Extension Studies with Comparison to Real World Observational Data
Drug Saf. 2020;43:379-392Patients with psoriatic arthritis (PsA) had similar safety profile with TOF to that of other systemic therapies in real-world settings, except for the known risk of HZ. Treatment recommendations from EULAR and GRAPPA for patients with PsA vary according to adverse prognostic risk factors, disease manifestations and responsiveness to prior treatment. Safety concerns for most PsA therapies include gastrointestinal AEs, hepatotoxicity, opportunistic infections (OIs) including TB, and SIEs. This stu...
A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis
Rheumatology (Oxford) 2019;58(10):1755–66Absolute serious infection rates were low. However, across the JAKinibs, the incidence of HZ is higher than expected for the population. While the risk was numerically greatest with BARI, indirect comparisons between the drugs did not demonstrate any significant difference in risk. How JAKinibs increase the risk of HZ reactivation is unclear, but how different JAKs interact in the immune response suggest that there may be differences in safety profiles between JAKinib drugs, underpinned by their...
Effect of Filgotinib vs Placebo on Clinical Response in Patients with Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial
JAMA 2019 322(4):315-325Among RA patients with an inadequate response or intolerance to bDMARDs, filgotinib (FIL) doses, compared to PBO resulted in significantly greater proportions achieving a clinical response at Wk12.Patients with active RA despite treatment with bDMARD therapy need treatment options. The FINCH 2 Phase 3 study compared the effects of FIL vs PBO for the treatment of RA patients with inadequate response or intolerance to ≥1 prior bDMARDs. Patients were randomized in a 1:1:1 ratio, receiving FIL 200 m...
Safety and Efficacy of Baricitinib through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis
J Rheumatol. 2018 Jan;45(1):14-21. doi: 10.3899/jrheum.161161This open-label extension (OLE) of a Phase 2b randomised controlled trial (RCT) found that safety data collected over 2 years of treatment were generally consistent with previous findings for baricitinib in RA.In the RCT, baricitinib demonstrated significant improvement in disease activity compared with placebo and an acceptable safety profile in patients with RA and an inadequate response to MTX. Patients who completed the 24-week double-blind period of the study were eligible for the OLE. Rate...