Baricitinib Monotherapy Matches Combination Therapy in RA: Real-World Study Finds
Germany: A real-world prospective cohort study published in RMD Open: Rheumatic & Musculoskeletal Diseases suggests that baricitinib delivers comparable long-term benefits whether used alone or in combination with methotrexate in patients with rheumatoid arthritis (RA).
The findings indicate sustained disease control, similar remission rates, and acceptable safety outcomes for both treatment approaches over a follow-up period extending up to six years.
Rheumatoid arthritis is a chronic inflammatory disease requiring long-term disease-modifying therapy to control symptoms, prevent joint damage, and maintain quality of life. Janus kinase inhibitors such as baricitinib have become an important option in RA management and are commonly prescribed either as monotherapy or alongside methotrexate. However, real-world evidence directly comparing these two strategies over extended periods has been limited.
To address this gap, researchers led by Alp Temiz from the Department of Medicine 3 – Rheumatology and Immunology at Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen conducted a single-centre, prospective observational study between 2017 and 2023. The cohort included 219 adults with RA who initiated baricitinib as part of routine clinicalDZ care. Of these, 165 patients received baricitinib as monotherapy, while 54 were treated with baricitinib in combination with methotrexate.
At baseline, patients in both groups had high disease activity, with a mean DAS28-ESR score of 4.0. Clinical assessments, patient-reported outcomes, and safety data were collected every three months, allowing for detailed longitudinal analysis. Drug persistence was evaluated using Kaplan–Meier survival analysis, while changes in disease activity and other outcomes were assessed through mixed-effects statistical models.
The following were the key findings:
- Both treatment approaches were associated with rapid and sustained reductions in disease activity in patients with rheumatoid arthritis.
- Disease activity reached and remained in the low range by six months in both groups and was maintained throughout the follow-up period.
- Approximately one-third of patients achieved Boolean remission, with no significant difference in remission rates between monotherapy and combination therapy.
- Drug survival was comparable between the two treatment strategies.
- The median duration of baricitinib treatment was 36 months, with no meaningful difference observed between monotherapy and combination therapy over 72 months of follow-up.
- The addition of methotrexate did not provide an advantage in terms of treatment persistence in real-world practice.
- Baricitinib demonstrated an acceptable safety profile and was generally well tolerated.
- Discontinuation due to adverse events occurred in 10.9% of patients.
- Four thrombotic events were reported, all in patients with pre-existing cardiovascular risk factors.
- No new safety signals, including malignancies or unexpected cardiovascular events, were observed during long-term follow-up.
According to the authors, the results support the use of baricitinib as an effective long-term option for RA, even when used without methotrexate. They note that monotherapy may be particularly valuable for patients who cannot tolerate methotrexate or for whom it is contraindicated.
While acknowledging the limitations inherent to an observational study design, the researchers emphasize that their findings strengthen confidence in the durability and safety of baricitinib in routine clinical practice.
Reference:
Temiz A, Tascilar K, Kleyer A, Hueber AJ, Hartmann F, Schett G, et al. Comparison of long-term efficacy, tolerability and drug survival rates of baricitinib as monotherapy or combination therapy in RA patients: data from a real-world prospective cohort study. RMD Open. 2025;11:e006333. https://doi.org/10.1136/rmdopen-2025-006333
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