Faculty Opinions recommendation of Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis.

Author(s):  
Elizabeth Mellins
2003 ◽  
Vol 2 (1) ◽  
pp. 25-26
Author(s):  
M Suleman ◽  
◽  
MB Chaudri ◽  
C Deighton ◽  
RB Hubbard ◽  
...  

Low dose methotrexate has been used successfully to treat patients with refractory rheumatoid arthritis.1 Methotrexate-induced pneumonitis occurs in about 1 to 5% of patients, although opportunistic infections have also been reported.1 We report a case of fatal pneumocystis carinii pneumonia (PCP) in an otherwise healthy female patient treated with methotrexate for rheumatoid arthritis and review the literature.


2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Teresa A. Simon ◽  
Maarten Boers ◽  
Marc Hochberg ◽  
Nicole Baker ◽  
Mary L. Skovron ◽  
...  

Abstract Background Patients with rheumatoid arthritis (RA) are at an increased risk of developing certain cancers and infections compared with the general population. Biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) are effective treatment options for RA, but limited evidence is available on the comparative risks among b/tsDMARDs. We assessed the risk of malignancies and infections in patients with RA who initiated abatacept versus other b/tsDMARDs in a real-world setting. Methods This retrospective, observational study used administrative data from three large US healthcare databases (MarketScan, PharMetrics, and Optum) to identify patients treated with abatacept or other b/tsDMARDs. In both groups, age-stratified incidence rates (IRs) with 95% confidence intervals (CIs) were calculated for total malignancy and hospitalized infections; propensity score matching and Cox proportional hazards regression models were used to estimate hazard ratios (HRs) with 95% CIs for total malignancy, lung cancer, lymphoma, breast cancer, non-melanoma skin cancer (NMSC), hospitalized infections, opportunistic infections, and tuberculosis (TB), both within individual databases and in meta-analyses across the three databases. Results A rounded total of 19.2, 13.6, and 4.2 thousand patients initiating abatacept and 55.3, 40.8, and 13.8 thousand initiating other b/tsDMARDs were identified in the MarketScan, PharMetrics, and Optum databases, respectively. The IRs for total malignancy and hospitalized infections were similar between the two groups in each age stratum. In meta-analyses, total malignancy risk (HR [95% CI] 1.09 [1.02–1.16]) of abatacept versus other b/tsDMARDs was slightly but statistically significantly increased; small, but not statistically significant, increases were seen for lung cancer (1.10 [0.62–1.96]), lymphoma (1.27 [0.94–1.72]), breast cancer (1.15 [0.92–1.45]), and NMSC (1.10 [0.93–1.30]). No significant increase in hospitalized infections (0.96 [0.84–1.09]) or opportunistic infections (1.06 [0.96–1.17]) was seen. For TB, low event counts precluded meta-analysis. Conclusions In this real-world multi-database study, the risks for specific cancers and infections did not differ significantly between patients in the abatacept and other b/tsDMARDs groups. The slight increase in total malignancy risk associated with abatacept needs further investigation. These results are consistent with the established safety profile of abatacept.


2019 ◽  
Vol 8 (3) ◽  
pp. 387 ◽  
Author(s):  
Eleftherios Pelechas ◽  
Paraskevi Voulgari ◽  
Alexandros Drosos

Since the advent of infliximab for the treatment of rheumatoid arthritis (RA), new genetically-engineered molecules have appeared. This review aims to present the current data and body of evidence for golimumab (GLM). Safety, efficacy, tolerability and immunogenicity are all being investigated, not only through phase III trials (GO-BEFORE, GO-FORWARD, GO-AFTER, GO-MORE, GO-FURTHER, GO-NICE), but also through studies of real-world data. It seems that GLM in the subcutaneous form is an efficacious molecule with a good safety profile at the standard dosage scheme, but a 100 mg subcutaneous dose is associated with a higher risk of opportunistic infections, lymphoma and demyelination. Furthermore, when compared to other tumor necrosis factor-α molecules, it is non-inferior, and, at some points, such as when it comes to immunogenicity and persistence of the drug, it has a better profile. In summary, GLM is an effective, well-tolerated option for the treatment of RA, for both the clinician and patients who are seeking a convenient dosage scheme.


2017 ◽  
Vol 45 (2) ◽  
pp. 170-176 ◽  
Author(s):  
Arthur N. Lau ◽  
Matthew Wong-Pack ◽  
Rod Rodjanapiches ◽  
George Ioannidis ◽  
Sally Wade ◽  
...  

Objective.Previous studies combining biologic disease-modifying antirheumatic drugs (bDMARD) to treat rheumatoid arthritis (RA) have shown an increased risk of infection. However, the risk of infection with concurrent use of denosumab, a biologic agent for the treatment of osteoporosis, and a bDMARD remains unclear. Here, we evaluated the incidence of serious and opportunistic infections in patients treated concurrently with denosumab and a bDMARD and patients treated with a bDMARD alone.Methods.A chart review of patients with RA from 2 Canadian rheumatology practices between July 1, 2010, and July 31, 2014, identified 2 groups of patients: those taking denosumab and a bDMARD concurrently (concurrent group) and those taking only a bDMARD (biologic-alone group). Patients were followed from the time of initiation of denosumab, or a matched index date for the biologic-alone group, to the end of the study or loss to followup. Instances of serious or opportunistic infections were recorded.Results.A total of 308 patients (n = 102 for the concurrent group and n = 206 for the biologic-alone group) were evaluated. Within the concurrent group, 3 serious infection events occurred. Within the biologic-alone group, 4 serious infection events and 1 opportunistic infection event occurred. In both groups, all patients with serious or opportunistic infection recovered, and there were no instances of death during the study period.Conclusion.This study demonstrated a low occurrence of serious and opportunistic infections in patients with RA taking bDMARD, including patients with concurrent denosumab use.


2020 ◽  
Vol 79 (10) ◽  
pp. 1290-1297 ◽  
Author(s):  
Kevin L Winthrop ◽  
Masayoshi Harigai ◽  
Mark C Genovese ◽  
Stephen Lindsey ◽  
Tsutomu Takeuchi ◽  
...  

ObjectivesTo evaluate the incidence of infection in patients with active rheumatoid arthritis (RA) treated with baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor.MethodsInfections are summarised from an integrated database (8 phase 3/2/1b clinical trials and 1 long-term extension (LTE)) with data to 1 April 2017. The ‘all-bari-RA’ analysis set included patients who received any baricitinib dose. Placebo comparison was based on six studies with 4 mg and placebo to week 24, including four trials with 2 mg (placebo-controlled set). Dose–response assessment was based on four studies with 2 mg and 4 mg, including LTE data (2–4 mg extended set).ResultsThere were 3492 patients who received baricitinib for 7860 patient-years (PY) of exposure (median 2.6 years, maximum 6.1 years). Treatment-emergent infections were higher for baricitinib versus placebo (exposure-adjusted incidence rate (IR)/100 PY: placebo 75.9, 2 mg 84.0 (p not significant), 4 mg 88.4 (p≤0.001)). The IR of serious infection was similar for baricitinib versus placebo and stable over time (all-bari-RA IR 3.0/100 PY). There were 11 cases of tuberculosis (all-bari-RA IR 0.1/100 PY); all occurred with 4 mg in endemic regions. Herpes zoster (HZ) IR/100 PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3). Opportunistic infections, including multidermatomal HZ, were infrequent in the baricitinib programme (all-bari-RA IR 0.5/100 PY).ConclusionsIncreased rates of treatment-emergent infections including HZ were observed in patients with RA treated with baricitinib, consistent with baricitinib’s immunomodulatory mode of action.


Author(s):  
Katherine Macdonald ◽  
Jennifer Hannah ◽  
James Galloway

Rheumatoid arthritis (RA) is a systemic disease that while primarily affecting joints, can also involve multiple organs of body including the lungs, heart, and blood vessels, bone, muscle, skin, central, and peripheral nervous system, and bone marrow. In addition, RA impacts upon mental health and mood. The process by which extra-articular organs are involved is less well understood than the articular manifestations, but most effects are thought to be driven by similar immune disturbances that drive the disease of the synovium. The 10-year cumulative incidence of any non-articular manifestation is approximately 50%, although severe manifestations are less than 10%. The non-articular manifestations of RA remain a common complication of the disease that account for substantial morbidity and mortality. Annual review of cardiovascular risk factors, bone health, and mental health is important to prevent future morbidity. It is vital to remain vigilant to the development of pulmonary, ocular, infectious, dermatological, or malignant complications. Controlling RA disease burden is the mainstay of management of most extra-articular manifestations, but immunomodulatory therapies come with additional specific risks which include opportunistic infections, malignancies, liver, and haematological abnormalities. Working in close partnership with other specialties is valuable when looking after these complex patients.


2014 ◽  
Vol 58 (12) ◽  
pp. 1649-1657 ◽  
Author(s):  
Irene S. Kourbeti ◽  
Panayiotis D. Ziakas ◽  
Eleftherios Mylonakis

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