Rheumatoid arthritis patients with differing prognoses achieved similar improvements in clinical outcomes and functional improvements with initial combination therapy but fared differently when given initial monotherapy, according to the results of a post-hoc analysis of a randomized controlled trial.
The results challenge a recent push to tailor treatment strategy to risk stratification, argued Dr. Iris Markusse of the department of rheumatology at Leiden (the Netherlands) University Medical Center and her coauthors.
The researchers examined the treatment outcomes of 508 patients with rheumatoid arthritis in a post-hoc analysis of the BEST study in which patients were randomized to one of four treatment groups: sequential monotherapy starting with methotrexate, step-up combination therapy, initial combination therapy with prednisone, or initial combination with infliximab. For this post-hoc analysis of 1-year results, the investigators combined the first two groups that both started with methotrexate monotherapy because they had very similar disease outcomes during the first year of follow-up. The third and fourth groups that received initial combination therapy were combined as well.
The results were analyzed according to whether the patients were classified by disease characteristics and radiographic progression as having a poor or nonpoor prognosis. The researchers defined poor prognosis – 417 of the 508 patients – by the presence of at least three of four poor prognostic factors: Disease Activity Score of 3.7 or greater, swollen joint count of 10 or higher, four or more erosions, and positive results for both rheumatoid factor and anti-citrullinated peptide autoantibodies.
They found little difference between the two prognostic groups, with both showing significantly higher rates of remission and functional improvements with combination therapy than monotherapy, and the differences were preserved at 1 year. Among poor-prognosis patients, 93% achieved an American College of Rheumatology 20 (ACR 20) response at 1 year, compared with 80% of those on initial monotherapy. In the non–poor prognosis patients, initial combination therapy proved significantly better than initial monotherapy at achieving ACR20 response (85% vs. 72%).
Both poor- and non–poor prognosis groups had similar improvements in Health Assessment Questionnaire scores, and there was no significant differences in the toxicity of the treatment approaches in the different prognosis groups based on the numbers of reported adverse events (Arthritis Res. Ther. 2014 Sept. 25 [doi:10.1186/s13075-014-0430-3]).
“These results suggest that prognostic factors associated with future radiographic damage progression contribute little to predict early clinical response to initial treatment, and therefore in our opinion tailored treatment based on prognosis as suggested by the EULAR [European League Against Rheumatism] guidelines is currently not feasible,” Dr. Markusse and her associates wrote.
The study was supported by grants from the Dutch Insurance Companies, Schering-Plough, and Janssen. The authors declared having no other conflicts of interest.