Gerd Burmester, MD, of CharitÃ© — UniversitÃ¤tsmedizin Berlin, discussed the results of a randomized, double-blind monotherapy study comparing the safety and efficacy of sarilumab with adalimumab in patients who cannot tolerate methotrexate.
At the Annual Meeting of the American College of Rheumatology (ACR), Gerd Burmester, MD, of Charité — Universitätsmedizin Berlin, spoke about the results of the randomized, double-blind monotherapy study he conducted.
This trial was one of the rare studies when researchers had a head-to-head comparison with another agent. Therefore, they were able to address an important question: which mode of action worked better?
No trial can take place without participants, and sometimes recruitment can be difficult. Not in this case, however, because all participants would receive active treatment—no placebo. Both drugs work well, but the purpose of the trial was to ascertain whether one might work better than the other.
Participants in the trial must have had 3 months of being diagnosed with active rheumatoid arthritis (RA), and must have demonstrated either an intolerance for methotrexate (MTX) or a lack of response to that drug.
Both groups were well balanced demographically, as well as in their baseline disease activity.
More than 364 patients participated. They received either sarilumab or adalimumab every 2 weeks. Researchers observed improvements with sarilumab as early as week 4; significantly greater proportions of sarilumab- vs adalimumab-treated patients achieved ACR responses (using criteria created by ACR to determine response rates) at week 24—the plotted graph of this demonstrating a distinct separation. Further, more patients receiving sarilumab (vs adalimumab) achieved low disease activity and remission.
Rates of discontinuation were similar between groups, as were incidences of adverse effects, including incidents of infection. Two patients in each group experienced a serious infection. There was 1 death, but it was determined not to be connected to the treatment. There were no major differences in laboratory parameters.
In patients who either were intolerant of or had an inadequate response to MTX, sarilumab demonstrated superiority in reducing disease activity, improving signs and symptoms, and improving physical function overall.
As Burmester noted, results from just 1 trial often means nothing; those results need to be confirmed. So confirmation by another completely independent trial by another agent is very important.
The overall conclusion: sarilumab is a very efficacious drug for individuals who cannot tolerate MTX, which accounts for about one-third of all patients with RA. The results specifically showed sarilumab to be more effective than the monoclone antibody adalimumab, which points the way for every new agent in this class of inhibitor of interleukin-6.