Pain Relief and Functional Score Improvement in Patients with Low Rheumatoid Arthritis Activity: Baricitinib vs. Adalimumab

Methodology and Study Progress

RA-BEAM was a randomized, placebo-controlled, double-blind phase III study that compared the addition of baricitinib (4 mg once daily) or adalimumab (40 mg every 2 weeks) for 52 weeks in adult patients with RA inadequately controlled on methotrexate.

A total of 1010 patients were divided into groups achieving remission, remission or low disease activity, or not achieving remission or low disease activity. Remission was defined as achieving a DAS28-ESR score (Disease Activity Score for 28 joints with erythrocyte sedimentation rate) < 2.6, and low disease activity as DAS28-ESR in the range of 2.6–3.2.

The exploratory post hoc analysis focused on 310 patients who achieved remission or low disease activity and evaluated pain relief on a 100-point visual analog scale (VAS) and improvement in functional score HAQ-DI (Health Assessment Questionnaire – Disability Index) after 24 weeks of treatment with baricitinib, adalimumab, or placebo.

Results

In the group achieving remission or low disease activity, the average pain reduction with baricitinib treatment (-45 on the VAS scale) was significantly greater than with placebo (-27; p < 0.001) and adalimumab (-38; p < 0.05). The difference between adalimumab and placebo was not statistically significant. The proportion of patients achieving minimal or no pain was highest with baricitinib (65.5%) compared to 61.4% with adalimumab and 41.7% with placebo.

The benefit of baricitinib was also observed in terms of improvement in functional score (p < 0.001), which was significantly greater compared to placebo (p < 0.01) and adalimumab (p < 0.05). The proportion of patients with normalization of physical functions was again highest with baricitinib (75.9%). With adalimumab treatment, it reached 70.2%, and with placebo, 50.0%.

Conclusion

The results of this post hoc analysis of the RA-BEAM study suggested that in patients with RA achieving remission or low disease activity, the administration of baricitinib added to methotrexate is associated with more effective pain relief and improvement in physical functions compared to the administration of adalimumab + methotrexate or methotrexate alone.

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Source: Fautrel B., Kirkham B., Pope J. E. et al. Effect of baricitinib and adalimumab in reducing pain and improving function in patients with rheumatoid arthritis in low disease activity: exploratory analyses from RA-BEAM. J Clin Med 2019 Sep 5; 8 (9), pii: E1394, doi: 10.3390/jcm8091394.