Background/Purpose:  It is generally believed that a wide variety of patient-specific factors, and in particular gender, are likely to influence the response and tolerability of DMARDs in patients with rheumatoid arthritis (RA).¹ In particular, several prospective studies have suggested that women may have lower remission rates than men as a result of having greater disease burden.²Despite this, very little is known about the true extent that many of these risk factors have on RA outcomes. The purpose of this analysis is to elucidate, via a meta-regression, the suspected relationship between female sex, drug retention rates and incidence of adverse events.

Methods: An extensive literature search for all RCT’s involving treatment for RA with TNF inhibitors was performed and 18 studies were identified (including 2 studies assessing Certolizumab pegol, 6 that assessed Golimumab, 3 that assessed Infliximab and 7 that assessed Adalimumab). Meta-regression analysis, employing a random-effects model, was performed to evaluate whether gender may have influenced effect size among these four TNF-inhibitors. Outcomes evaluated included drug retention, drug discontinuation, adverse events, serious adverse events, serious infections and infusion reactions.

Results: The proportion of female participants in a given treatment arm was highly statistically significantly correlated with improved drug retention in that, for every 1% improvement in drug retention, a 1.03% increase in female participants (95% CI 0.65-1.41%, p=<0.0001) was observed. Similarly lower rates of drug discontinuation (and in particular -Lack/Loss of efficacy, Adverse events and Other- as a reason for drug discontinuation), serious adverse events, serious infections and infusion reactions were also associated with increasing proportions of female participants in the included studies. These models were adjusted for all relevant covariates of interest including age, study size and disease severity.

Conclusion:  Female gender seems to be correlated with increased drug retention and decreased rates of study discontinuation for a variety of causes. This finding belies prior consensus on this topic and warrants further research this potential relationship in larger prospective cohort trials. References: 1.- Hider Samantha L, Buckley Caitriona, Silman Alan J, et al. Factors Influencing Response to Disease Modifying Antirheumatic Drugs in Patients with Rheumatoid Arthritis. J Rheumatol January 2005 32(1):11-16 2.- Forslind K, Hafström I, Ahlmén M, Svensson B. Sex: a major predictor of remission in early rheumatoid arthritis?. BARFOT Study Group. Ann Rheum Dis. 2007 Jan; 66(1): 46–52.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/an-assessment-of-the-correlation-between-gender-and-anticipated-drug-retention-to-tnf-inhibitors-a-meta-regression-analysis/