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Highlights from

American College of Rheumatology

annual meeting 2018

Chicago, Illinois 19-24 October 2018

Efficacy and safety profile outcomes of switching from adalimumab to baricitinib: long-term data in patients with rheumatoid arthritis

Take-home messages
  • RA-BEYOND is an extension study to RA-BEAM, a phase III trial evaluating the efficacy and safety of baricitinib in patients with moderately to severely active rheumatoid arthritis
  • Switching from adalimumab to baricitinib without adalimumab washout was associated with maintenance of disease control through 48 weeks post switch, with some non-responders being able to achieve low disease activity (LDA) as well
  • There was no increase in treatment-emergent AEs or serious AEs or infections
“Switching from adalimumab to baricitinib was associated with maintenance of disease control through 48 weeks post switch.”

Dr Michael Weinblatt Co-Director, Clinical Rheumatology, Brigham and Women’s Hospital, Boston, US

Recent data from the long-term, open-label extension study RA-BEYOND were presented at the 2018 American College of Rheumatology/ Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting and showed that patients who switched from adalimumab to baricitinib demonstrated improvements in disease control through 24 weeks post switch, without evidence of worsening through the following 24 weeks, and showed further small improvements in patient-reported outcomes (PROs) assessment of pain and physical function (health assessment questionnaire-disability index (HAQ-DI)) through to week 48.

RA-BEYOND is an open-label, extension study to the phase III clinical trial RA-BEAM, which completed in September 2015 and demonstrated that baricitinib 4 mg once daily showed clinical improvements compared with placebo and with adalimumab in methotrexate-inadequate-responder patients.

After 52 weeks in RA-BEAM, patients were able enter RA-BEYOND and switch treatment from adalimumab to baricitinib or continue on baricitinib. In RA-BEYOND, all patients received open-label baricitinib but remained blinded to originally randomised treatment in RA-BEAM. No adalimumab washout period was applied.

In patients who continued to receive baricitinib throughout RA-BEAM and RA-BEYOND, Dr Michael Weinblatt, Co-Director, Clinical Rheumatology, Brigham and Women’s Hospital, Boston, US, who presented the results, reported, “There remained consistent responses over time with 78% at the end of 100 weeks being in low disease activity and 32% in remission.”

Regarding patients that switched from adalimumab to baricitinib, Dr Weinblatt continued, “74% at the end of 100 weeks are in low disease activity and 28% in remission.”

Among patients who completed RA-BEAM without rescue, n=381 (97%) baricitinib (continued baricitinib) and n=238 (99%) adalimumab (switched to baricitinib) patients entered RA-BEYOND ≥48 weeks before the cut-off date and were included in the analysis.

Patients who switched to baricitinib showed further small improvements in PROs of physical function and pain (HAQ-DI) throughout 48 weeks, which remained constant.

Of the patients that were non-responders (clinical disease activity index; CDAI >10) at the time of switch (28% and 31% in baricitinib and adalimumab groups, respectively), approximately half reached low disease activity (CDAI ≤10) by week 48 (54% and 50%, respectively).

In addition, Dr Weinblatt highlighted that “23% of [non-responder] patients that had been on baricitinib for a year actually achieved LDA after another 4 weeks.”

Exposure-adjusted incidence rates for treatment-emergent adverse events (AEs) and infections, including serious AEs, were similar for patients who switched from adalimumab to baricitinib and those who continued baricitinib. For patients who continued on baricitinib treatment, 1.8% experienced AEs that led to permanent study drug discontinuation, compared with 2.5% of patients who made the switch from adalimumab.

Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor approved for the treatment of moderately to severely active rheumatoid arthritis in adults in over 50 countries, including European countries, the United States and Japan.

Based on Weinblatt M E, Taylor P C et al. Efficacy and safety of switching from adalimumab to baricitinib: long-term data from phase 3 extension study in patients with rheumatoid arthritis (abstract 886). Presented on Sunday 21 October 2018.

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Article image: © Barb Elkin

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.

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