Background/Purpose:

In the Phase 3 RA-BEAM study, baricitinib (BARI) 4 mg once daily showed significant clinical improvements compared with placebo (PBO) and adalimumab (ADA).¹ Switching from ADA to BARI, prompted by rescue or study design, without an ADA washout was associated with improved disease control during the initial 12 weeks after the switch.² The objective of this analysis was to evaluate changes in patient-reported outcomes (PROs) from before and after rescue with BARI.

Methods:

1305 patients were randomized 3:3:2 to and treated with PBO for 24 weeks, BARI 4 mg once daily for 52 weeks, or ADA 40 mg every 2 weeks for 52 weeks. All patients received background methotrexate (MTX). Patients whose tender and swollen joint counts were reduced <20% from baseline at Week 16 were rescued to open-label BARI 4 mg once daily; after Week 16, rescue was at physician discretion. In this post hoc analysis, patients who were rescued between Weeks 16 and 24 were followed for 12 weeks after rescue. The pain visual analog scale (VAS, 0-100 mm), Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), SF-36 physical and mental component scores (PCS and MCS), and duration of morning joint stiffness (MJS) were assessed for patients rescued to BARI. Within group changes before and after rescue were assessed with sign tests for each of the evaluated PROs. The percentage of patients who met or exceeded clinically relevant thresholds at Week 12 after rescue, relative to the point of rescue, was also assessed. These analyses were not adjusted for multiplicity.

Results:

More patients randomized to PBO (26%, N=128) were rescued, than ADA (12%, N=40) or BARI (7%, N=35). Of the 203 patients rescued, 102 patients were rescued per protocol (Week 16) and 101 were rescued at the physician’s discretion. Patients who failed PBO or ADA and rescued to BARI showed significantly greater improvements in pain, HAQ-DI, FACIT-F, SF-36 PCS, and duration of MJS at 4 weeks after rescue which were sustained through 12 weeks (Table). A greater percentage of patients rescued from PBO to BARI, followed by ADA to BARI patients, tended to show clinically relevant improvements in pain, HAQ-DI, FACIT-F, and PCS compared to patients rescued from BARI to BARI (Figure).

Conclusion:

Upon treatment failure with either PBO or ADA, rescue with BARI 4 mg resulted in early, sustained, and clinically relevant improvements in PROs representing measures of quality of life and symptoms that are important to patients.  

References:

¹Taylor et al. New Engl J Med 2017;376:652-62.

²Taylor et al., Arthritis Rheumatol 2016; 68 (suppl 10)