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

Abstract

Patients with rheumatoid arthritis (RA) may experience residual pain and functional impairment despite good control of disease activity. This study compared improvements in pain and physical function in patients with well-controlled RA after 24 weeks' treatment with baricitinib, adalimumab or placebo in the 52-week RA-BEAM phase III study. Adults with active RA and inadequate response to methotrexate received baricitinib 4 mg once daily, adalimumab 40 mg every two weeks or placebo, with background methotrexate. Patients (N = 1010) were categorised as in remission, in remission or low disease activity, or not in remission or low disease activity at week 24. For patients in remission or low disease activity (n = 310), improvements in mean pain and physical function scores at week 24 were significantly greater with baricitinib than placebo (p < 0.001 and p < 0.01, respectively) and adalimumab (p < 0.05 for both). For both outcomes, differences between adalimumab and placebo were not significant. The proportions of patients in remission or low disease activity with minimal or no pain and with normalised physical function were numerically greater with baricitinib than placebo. Baricitinib 4 mg once daily provided enhanced improvement in pain and physical function in patients with well-controlled RA, suggesting it may produce effects beyond immunomodulation.

Keywords: baricitinib; fatigue; pain; productivity; recovery of function; rheumatoid arthritis.

Figure 1

Change from baseline in pain VAS score at week 24 by remission status in patients from RA-BEAM. * p < 0.05, ** p < 0.01, *** p < 0.001 vs. placebo; ^ǂ p < 0.05 vs. adalimumab. Error bars indicate standard deviation. Change in pain VAS score based on numbers of patients from RA-BEAM in remission (DAS28-ESR <2.6): PBO+MTX n = 24, BARI+MTX n = 87, ADA+MTX n = 57; in remission or low disease activity (DAS28-ESR ≥2.6 and ≤3.2): PBO+MTX n = 46, BARI+MTX n = 154, ADA+MTX n = 110; and not in remission or low disease activity: PBO+MTX n = 276, BARI+MTX n = 266, ADA+MTX n = 157. One patient was missing from the BARI+MTX group for patients not in remission or low disease activity. ADA adalimumab, BARI baricitinib, DAS28-ESR Disease Activity Score for 28-joint count with erythrocyte sedimentation rate, PBO placebo, MTX methotrexate, VAS visual analogue scale.

Figure 2

Change from baseline in HAQ-DI score at week 24 by remission status in patients from RA-BEAM. * p < 0.05, ** p < 0.01, *** p < 0.001 vs. placebo; ^ǂ p < 0.05 vs. adalimumab. Error bars indicate standard deviation. Change in HAQ-DI score based on numbers of patients from RA-BEAM in remission (DAS28-ESR <2.6): PBO+MTX n = 24, BARI+MTX n = 87, ADA+MTX n = 57; in remission or low disease activity (DAS28-ESR ≥2.6 and ≤3.2): PBO+MTX n = 46, BARI+MTX n = 154, ADA+MTX n = 110; and not in remission or low disease activity: PBO+MTX n = 276, BARI+MTX n = 266, ADA+MTX n = 156. One patient was missing from the BARI+MTX group and one from the ADA+MTX group for patients not in remission or low disease activity. ADA adalimumab, BARI baricitinib, DAS28-ESR Disease Activity Score for 28-joint count with erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire-Disability Index, MTX methotrexate, PBO placebo.

Figure 3

Patients from RA-BEAM with (a) minimal/no pain and (b) normalised physical function at week 24, by remission status. Proportions of patients from RA-BEAM with (a) minimal or no pain (pain VAS ≤10 mm) and (b) normalised physical function (HAQ-DI <0.5) based on numbers of patients in remission (DAS28-ESR <2.6): PBO+MTX n = 24, BARI+MTX n = 87, ADA+MTX n = 57; in remission or low disease activity (DAS28-ESR ≥2.6 and ≤3.2): PBO+MTX n = 46, BARI+MTX n = 154, ADA+MTX n = 110; and not in remission or low disease activity (DAS28-ESR >3.2): PBO+MTX n = 276, BARI+MTX n = 266, ADA+MTX n = 156. One patient was missing from the BARI+MTX group and one from the ADA+MTX group for patients not in remission or low disease activity. For the pain analysis, the number of patients not in remission or low disease activity was PBO+MTX n = 276, BARI+MTX n = 210, ADA+MTX n = 120. ADA adalimumab, BARI baricitinib, DAS28-ESR Disease Activity Score for 28-joint count with erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire-Disability Index, MTX methotrexate, PBO placebo, VAS visual analogue scale.

Figure 4

FACIT-F scores in patients from RA-BEAM by remission status (a) at baseline and (b) change at week 24. Error bars indicate standard deviation. FACIT-F scores at baseline and change in FACIT-F scores based on numbers of patients from RA-BEAM in remission (DAS28-ESR <2.6): PBO+MTX n = 24, BARI+MTX n = 87, ADA+MTX n = 57; in remission or low disease activity (DAS28-ESR ≥2.6 and ≤3.2): PBO+MTX n = 46, BARI+MTX n = 154, ADA+MTX n = 110; and not in remission or low disease activity (DAS28-ESR >3.2): PBO+MTX n = 276, BARI+MTX n = 266, ADA+MTX n = 156. One patient was missing from the BARI+MTX group and one from the ADA+MTX group for patients not in remission or low disease activity. ADA adalimumab, BARI baricitinib, DAS28-ESR Disease Activity Score for 28-joint count with erythrocyte sedimentation rate, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, MTX methotrexate, PBO placebo.