Baricitinib, with optional methotrexate, may be beneficial in RA
medwireNews: Baricitinib monotherapy may be a suitable maintenance strategy for some patients with rheumatoid arthritis (RA), but some may also need methotrexate, suggest findings from a post-hoc analysis.
Roy Fleischmann (University of Texas Southwestern Medical Center, Dallas, USA) and fellow researchers analyzed data from 423 patients who completed RA-BEGIN – a 1-year randomized trial comparing baricitinib 4 mg/day, methotrexate, and a combination of both agents – and went on to receive baricitinib monotherapy in RA-BEYOND. They note that participants could also receive methotrexate in RA-BEYOND at the investigator’s discretion.
As reported in Arthritis Care & Research, approximately half of the patients who were either treated with baricitinib in both studies or switched from methotrexate to baricitinib monotherapy experienced improvements in disease activity and function over 24 weeks in RA-BEYOND.
For the 57 patients who received baricitinib monotherapy in both studies, the ACR20 response rate decreased slightly from 94.7% at the time of entry into RA-BEYOND to 87.7% at week 24, while average CDAI scores decreased from 5.48 to 3.89 points and HAQ-DI scores increased from 0.46 to 0.51 points.
And for the 67 participants who switched from methotrexate to baricitinib monotherapy, ACR20 response rates increased from 83.6% to 82.1%, while mean CDAI and HAQ-DI scores decreased from 8.89 to 4.93 points and 0.67 to 0.48 points, respectively.
Fleischmann and colleagues note that “those patients who responded well to baricitinib monotherapy in RA-BEGIN as a group showed further improvement in their clinical response at 24 weeks in RA-BEYOND,” and that many patients treated with methotrexate alone in RA-BEGIN experienced a “rapid and pronounced” reduction in disease activity and function after switching to baricitinib monotherapy in RA-BEYOND.
For the 76 patients who switched from baricitinib plus methotrexate in RA-BEGIN to baricitinib monotherapy in RA-BEYOND, ACR20 response rates decreased from 97.4% at the beginning of RA-BEYOND to 86.8% at week 24, and average HAQ-DI score worsened slightly from 0.45 to 0.50 points.
“Collectively, these data indicate that baricitinib 4-mg monotherapy can be an effective treatment for early active RA, either initially or following [methotrexate] or combination therapy, in many patients but not all,” write the researchers.
Fleischmann and team also investigated outcomes among the 223 study participants who were given methotrexate treatment in addition to baricitinib in RA-BEYOND, finding that these patients had higher average disease activity and function scores at the time of entry into RA-BEYOND, as well as greater improvements in these scores over 24 weeks, compared with those receiving baricitinib monotherapy.
Nonetheless, they say that, overall, the trends in disease activity and function scores “were generally similar to those of the patients remaining on baricitinib monotherapy throughout RA-BEYOND.”
The investigators caution that their study had a number of limitations, including its nonrandomized, open-label design, and concede that “[a]pplication of these findings to clinical practice is limited by this population of patients being naïve to previous DMARDs.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
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