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No statistically significant differences in retention rates were observed among those treated with baricitinib monotherapy or in combination with methotrexate.
The retention rates of baricitinib among patients with rheumatoid arthritis (RA) at 12 and 24 months were 75.1% and 69.3%, respectively, according to a study published in Frontiers in Medcine.1 Concomitant methotrexate treatment had no impact on treatment persistence, although retention was reduced in those receiving steroidal treatment and/or those with multi-failure.
Early diagnosis and treatment of RA have been shown to reduce the clinical symptoms and signs of the condition and lessen the burden of disease by preventing the development of chronic sequelae. A multitude of drug options, using different treatment mechanisms, have been approved since the European Alliance of Associations for Rheumatology (EULAR) created their recommendations for the management of RA with both synthetic and biologic disease-modifying antirheumatic drugs (bDMARDs).2
“The recent understanding of the pivotal pathogenic role of Janus kinases (JAK) in RA lead to the development of a novel class of targeting synthetic (ts) DMARDs, the JAK inhibitors (JAKi),” Caterina Baldi, MD, Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Italy, and colleagues. “This class of medications represents a new cornerstone in the treatment of RA, due to both their oral route of administration and their inhibition of a large number of pro-inflammatory cytokines.”
Patients with RA, diagnosed using the 2010 American College of Rheumatology (ACR)/EULAR criteria, were enrolled in the study. Besides retention rates, other outcomes compared the impact on treatment persistence of monotherapy and other variables, including disease duration, sex, biomarkers positivity, line of treatment, Herpes Zoster virus infection, and systemic corticosteroid use. Information including demographics, therapeutical data, and clinical data were collected retrospectively. The follow-up period was 104 weeks.
A total of 95 patients were ultimately included in the study. Baricitinib was given at a dosage of 4 mg in 81% (n = 77) of patients and 2 mg in 18.9% (n = 18) of patients. The mean treatment duration was 49.9 weeks and approximately half (51.6%) received the drug as monotherapy.
At the end of the follow-up period, the overall retention rate was 69.3%. No statistically significant differences in retention rates were observed among those treated with baricitinib monotherapy or in combination with methotrexate (P = .638). Additionally, no differences in retention rates were reported in patients receiving 2 mg or 4 mg (P = .226). However, patients receiving steroidal treatment had a significantly reduced treatment retention (P = .028).
When patients were treated with baricitinib as a first-line b/tsDMARD, they reported a higher drug retention (P = .002) compared with further treatment lines. Univariate analysis revealed steroid employment, steroid dosage, and previous bDMARD treatment were linked to the risk of treatment discontinuation (P = .028, P < .001, and P = .002, respectively). The multivariate analysis further confirmed the significance for higher steroid dosage and previous bDMARD use (P = .002 and P = .046, respectively).
During the observation period, no adverse events were reported, including deep venous thrombosis, tubercular infection/reactivation, and pulmonary embolism.
Investigators noted limitations, such as the absence of controls, a lack of disease activity data, and the small sample size, which may have negatively affected the detection of less common adverse events, including thromboembolic diseases or cancer.
“Further and larger studies are needed to confirm those results, especially concerning cardiovascular and neoplastic adverse events,” investigators concluded. “These novel findings may provide new insight for the management of baricitinib treatment in clinical practice.”