July 16, 2019
2 min read

Baricitinib Improves RA in Patients Unresponsive to Methotrexate

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Roy M.

Baricitinib monotherapy improves disease control in many patients with rheumatoid arthritis who were did not respond to methotrexate, according to data published in Arthritis Care & Research.

“Many patients and physicians prefer monotherapy treatment for numerous reasons including cost and decreased potential toxicity,” Roy M. Fleischmann, MD, of the University of Texas Southwestern Medical Center, told Healio Rheumatology. “This post hoc analysis was designed to investigate what percentage of patients could do well clinically, ascertained by [Simplified Disease Activity Index] remission of [low disease activity], on baricitinib monotherapy 4 mg and what were the major characteristics that could predict doing so.”

“Only approximately one-third of patients with RA achieve sustained remission or low disease activity with [methotrexate] while many others may discontinue their treatment due to intolerance,” Fleischmann and colleagues wrote. “For this reason, alternative treatment strategies are utilized, including adding or switching to other [conventional synthetic] DMARDs, biological DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs).”

To evaluate the long-term efficacy and safety of maintaining baricitinib (Olumiant, Eli Lilly) monotherapy among patients with RA, including those who switched to the drug from methotrexate monotherapy or ceased methotrexate as part of combination therapy with both, Fleischmann and colleagues conducted a post hoc analysis of patients from the phase 3 RA-BEGIN study, and its follow-up RA-BEYOND.

According to the researchers, RA-BEGIN was a 52-week, double-blind, active-controlled study that included 588 adults with RA and no previous use of methotrexate. Participants were randomly assigned to receive 20-mg weekly doses of methotrexate, 4-mg doses of baricitinib daily or 4 mg of baricitinib plus methotrexate.

Image of arthritic hand 
Baricitinib monotherapy improves disease control in many patients with RA who were did not respond to methotrexate, according to data.
Source: Adobe

At week 52, 451 participants entered the ongoing RA-BEYOND long-term extension, in which all patients were treated with 4-mg daily doses of baricitinib monotherapy while remaining blinded to their original regimen in RA-BEGIN. However, methotrexate could be added at the researchers’ discretion. For their post hoc analysis, Fleischmann and colleagues studied data from the 423 RA-BEYOND participants who had not been rescued during RA-BEGIN. They assessed clinical efficacy at weeks 0, 12 and 24 of RA-BEYOND, based on ACR20, ACR50 and ACR70 criteria, compared with RA-BEGIN baseline. Safety was assessed based on incidence of adverse events in RA-BEYOND.

According to the researchers, among the 423 RA-BEYOND participants included in the analysis, 47% continued baricitinib monotherapy, while 53% received additional methotrexate. Participants with lower disease activity at RABEYOND baseline generally continued their success with baricitinib monotherapy, based on scores from the Simplified Disease Activity Index (SDAI), the Clinical Disease Activity Index (CDAI) and the Health Assessment QuestionnaireDisability Index.

Participants who received methotrexate demonstrated higher disease activity at RABEYOND baseline. The addition of methotrexate improved disease activity in these cases. Safety outcomes were similar across all treatment groups.

“Many patients responded well to continued baricitinib monotherapy 4 mg or to switching to baricitinib monotherapy 4 mg from methotrexate monotherapy, or baricitinib 4 mg plus methotrexate, showing sustained or improved disease control,” Fleischmann said. “The groups of patients who had less disease control on their original therapies showed sustained or improved disease control with the addition of methotrexate to baricitinib 4 mg. A patient on baricitinib plus methotrexate who has achieved a sustained level of good disease control ascertained by SDAI or CDAI, most likely will continue to do well with baricitinib monotherapy.” – by Jason Laday

Disclosure: Fleischmann reports consulting and/or speaking fees from AbbVie, Asahi Kasei Medical, Astellas Pharma, AstraZeneca, Bristol-Myers-Squibb, Celltrion Healthcare, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Eisai, Janssen, Merck Serono, Mitsubishi Tanabe Pharma, Nippon Kayaku, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical, and UCB Japan. Please see the full study for additional authors’ disclosures.