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Risk of Infection with Methotrexate Therapy in Inflammatory Diseases: A Systematic Review and Meta-Analysis
Ammar Ibrahim1, Mohammed Ahmed2, Richard Conway3
1Department of Medicine, National University of Ireland Galway, Galway, Ireland. ammar.ibrahim@nuigalway.ie.
Abstract:
The aim of this study was to determine the risk of infection in adults with inflammatory rheumatic diseases (IRDs) treated with methotrexate. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) assessing methotrexate versus placebo in adults using MEDLINE, EMBASE, and CENTRAL databases from 1980 to August 2017. The primary outcome was the risk of infection associated with methotrexate therapy. We chose a random effect model to summarize adverse event outcomes as risk ratios (RRs) and related 95% confidence intervals (95% CI). Twelve RCTs (total patients 1146) met the inclusion criteria for our main analysis, and ten for risk of serious infection (total patients 906). Overall, methotrexate was associated with increased risk of infection in rheumatoid arthritis (RA) (RR: 1.25; 95% CI, 1.01⁻1.56; p = 0.04; I² = 0%), but not in other non-RA IRD populations. There was no increased risk of total infections (RR: 1.14; 95% CI, 0.98⁻1.34; p = 0.10; I² = 0%) or serious infections (RR: 0.76; 95% CI, 0.11⁻5.15; p = 0.78; I² = 0%) in all included IRDs. Conclusively, methotrexate use in IRDs is associated with a higher risk of all infections in RA, but not in other non-RA (IRD) populations. There is no increased risk of serious infections.
Insights
Methotrexate increases infection risk in rheumatoid arthritis patients, but not in other inflammatory rheumatic diseases. Serious infection risk remains unchanged across all studied groups.
Area of Science:
- Rheumatology and Immunology
- Infectious Diseases
- Pharmacology
Background:
- Methotrexate is a common disease-modifying antirheumatic drug (DMARD) used for inflammatory rheumatic diseases (IRDs).
- Concerns exist regarding the potential for increased infection risk with methotrexate therapy in immunocompromised patients.
Purpose of the Study:
- To systematically evaluate the risk of infection in adult patients with IRDs treated with methotrexate.
- To differentiate infection risk between rheumatoid arthritis (RA) and other non-RA IRD populations.
Main Methods:
- A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted.
- Searches were performed in MEDLINE, EMBASE, and CENTRAL databases (1980–August 2017).
- Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random-effects model.
Main Results:
- Twelve RCTs (1146 patients) were included for overall infection risk.
- Methotrexate showed a statistically significant increased risk of infection in rheumatoid arthritis (RR: 1.25; 95% CI, 1.01–1.56).
- No significant increase in total or serious infections was observed in other IRD populations or across all IRDs combined.
Conclusions:
- Methotrexate use is associated with a higher risk of all infections specifically in rheumatoid arthritis patients.
- The risk of serious infections did not increase with methotrexate therapy in the examined IRD populations.
- Clinicians should consider the specific risk of infection in RA patients initiating methotrexate therapy.
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