TOPLINE:

Baricitinib, used alone or with methotrexate, was associated with a rapid and sustained control of disease activity in patients with rheumatoid arthritis (RA), with similar drug survival and remission rates, improvements in patient-reported outcomes, and an acceptable safety profile up to 6 years of follow-up.

METHODOLOGY:

• Researchers conducted a prospective observational cohort study between 2017 and 2023 to compare the long-term effectiveness, drug survival, and safety of baricitinib, a JAK inhibitor, when used alone or with methotrexate in RA.
• They included 219 adults (mean age, 59.8 years; 157 women) with RA at a single centre in Germany.
• Patients started 4 mg once-daily baricitinib either as a monotherapy (n = 165) or as a combination therapy with methotrexate (n = 54) within routine, on-label care.
• Data on clinical assessments, including Disease Activity Score 28 joints with erythrocyte sedimentation rate, Boolean remission, patient-reported outcomes, and safety events were collected every 3 months. Follow-up lasted up to 72 months.

TAKEAWAY:

• Both monotherapy and combination therapy groups showed rapid clinical improvement, with disease activity stabilising in the low range by 6 months of treatment.
• Overall, 33% of patients achieved Boolean remission, with no significant difference observed between the two groups (P = .35). Patient-reported outcomes improved in both groups.
• The median drug survival was 36 months and was similar between monotherapy and combination therapy groups over 72 months (log-rank P = .82).
• Adverse events led to discontinuation in 10.9% of patients, with four thrombotic events noted in those with preexisting cardiovascular risk factors. No new cardiovascular events or malignancies were observed during follow-up.

IN PRACTICE:

"[The study's] long-term data provide strong evidence that baricitinib maintains its clinical efficacy, drug survival and acceptable safety profile as MONO [monotherapy] over several years in a real-world setting," the authors of the study wrote.

SOURCE:

This study was led by Alp Temiz, Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany. It was published online on December 17, 2025, in RMD Open.

LIMITATIONS:

The observational design of this study did not allow a firm recommendation against a combination therapy. Wide CIs for some estimates indicated greater variability.

DISCLOSURES:

One author reported receiving funding from the Deutsche Forschungsgemeinschaft. Another author reported receiving funding from the German Research Council through the Leibniz award.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.