For patients with early rheumatoid arthritis (RA), tocilizumab-based treatment strategies resulted in lower Disease Activity Score when assessing 28 joints (DAS28) and higher rates of remission compared with methotrexate plus prednisone, according to results published in the Annals of the Rheumatic Diseases.
However, the results indicated that part of the effects of tocilizumab may be the result of its effect on acute phase reactants (APRs).
The study included individual participant data from 2 studies: U-Act-Early and the 2nd Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA-II) trial. Participants had never taken disease modifying antirheumatic drugs and had early RA (duration <12 months).
The researchers performed an indirect comparison of tightly controlled treat-to-target strategies initiating tocilizumab (n=103), tocilizumab+methotrexate (n=106), or methotrexate+prednisone (n=117). Initiation of methotrexate (n=227) was used as reference. The primary outcome was DAS28 over 24 months. The researchers analyzed a disease activity composite outcome score without APRs to assess the influence of APRs. Secondary outcomes included remission, physical function, and radiographic progression. The researchers used multilevel models to account for clustering within trials and participants over time, adjusting for relevant confounders.
Over 24 months, participants taking tocilizumab+methotrexate had lower DAS28 scores compared with those taking methotrexate+prednisone (mean difference -0.62; 95% CI, -1.14 to -0.10). Compared with those taking methotrexate+prednisone, more participants in the tocilizumab+methotrexate and the tocilizumab groups achieved remission (P =.02 and P =.05, respectively).
When APRs were excluded from the disease activity outcome score, the results indicated that tocilizumab-based regimens resulted in a slightly higher modification of the Clinical Disease Activity Index compared with methotrexate+prednisone, but it was not statistically significant. The researchers did not find any statistically significant differences for outcomes between regimens.
“[methotrexate] MTX+[prednisone] pred and TCZ (with or without MTX) appear to have similar clinical effects as initial treatment options in tight-control strategies in early RA,” the researchers wrote.
Verhoeven MMA, de Hair MJH, Tekstra J, et al. Initiating tocilizumab, with or without methotrexate, compared with starting methotrexate with prednisone within step-up treatment strategies in early rheumatoid arthritis: an indirect comparison of effectiveness and safety of the U-Act-Early and CAMERA-II treat-to-target trials. [published online June 13, 2019]. Ann Rheum Dis. doi:10.1136/annrheumdis-2019-215304