medwireNews: Among rheumatoid arthritis (RA) patients in sustained remission on combination therapy, withdrawal of methotrexate is associated with better outcomes than withdrawal of etanercept, indicate findings from the SEAM-RA trial presented at the ACR Convergence 2020 virtual meeting.
“The practical implications […] are that if you’re going to take away one of those two therapies […] you’re almost certainly better off to take away the methotrexate and keep etanercept in place,” lead investigator Jeffrey Curtis (University of Alabama at Birmingham, USA) told medwireNews.
Jeffrey Curtis on SEAM-RA: Better outcomes with etanercept vs methotrexate monotherapy in RA (9:53)
The phase 3 study included 253 adult RA patients in remission – according to an SDAI score of 3.3 points or lower – who were on stable treatment with etanercept 50 mg/week plus methotrexate 10–25 mg/week for at least 6 months and remained in remission during a 24-week run-in period. After this time, participants were randomly assigned to withdraw methotrexate (n=101) or etanercept (n=101), or to continue with both treatments (n=51), for a 48-week period.
Presenting the results, Curtis told delegates that at week 48, a significantly higher proportion of patients treated with etanercept versus methotrexate monotherapy remained in SDAI remission without disease worsening – the study’s primary endpoint – at 49.5% versus 28.7%.
When comparing participants on etanercept monotherapy versus those who continued with both treatments, Curtis noted that the proportion of patients who achieved the remission endpoint at week 48 was “quite similar,” at 49.5% and 52.9%, respectively.
The presenter said that people on monotherapy who did not maintain remission during the SEAM-RA trial were reallocated to rescue therapy with etanercept plus methotrexate, while those on combination therapy continued with the same treatment.
“Regardless of treatment arm, almost all patients who needed rescue therapy were able to recapture either remission or at least low disease activity,” he reported. There were no significant between-group differences in time to achieving remission after switching to rescue therapy; rates of remission ranged from 71% to 80% across the groups, and rates of low disease activity ranged from 75% to 96%.
These findings suggest that the risk associated with withdrawal of methotrexate or etanercept “is quite low, because the likelihood that you can regain where you were before is quite good,” said Curtis.
In the safety analysis, he reported that “nothing particularly unexpected” occurred, with similar adverse event (AE) profiles between the treatment arms. Infections were the most commonly occurring AE, affecting 26–31% of patients across treatment groups, followed by musculoskeletal and connective tissue disorders, with a higher rate of these AEs in the methotrexate monotherapy group (33%) than the etanercept monotherapy (19%) and combination arms (21%).
“For both patients and physicians seeking to reduce overall RA treatment burden, these data are […] useful to inform decision making,” said Curtis.
“Future studies will focus on more detailed analyses of predictors of remission maintenance,” he concluded.
Peter Taylor: How will the SEAM-RA results impact clinical practice? (9:05)
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