medwireNews: Combination therapy with tocilizumab and methotrexate is not always more effective than tocilizumab monotherapy for the prevention of radiographic progression in rheumatoid arthritis (RA), study findings indicate.
Maxime Verhoeven (Utrecht University, the Netherlands) and co-investigators report that although the combination generally prevents more radiographic damage, individuals with early RA and more joint damage and/or a lower DAS28 score at baseline and those with established RA and longer disease duration may not benefit from additional methotrexate.
The findings arose from a combined analysis of individual patient data from three randomized trials (ACT-RAY, FUNCTION, and U-Act-Early) comparing tocilizumab monotherapy with tocilizumab plus methotrexate.
The researchers found that, among the 1089 patients with early RA, the chances of not having any radiographic progression at 2 years, according to the total Sharp van der Heijde score, were numerically lower when tocilizumab was given alone rather than in combination with methotrexate, with a nonsignificant relative risk (RR) of 0.96.
However, Verhoeven and team point out in Arthritis Care & Research that the association was significantly modified by baseline joint damage and DAS28 score.
Specifically, the nonsignificant RRs for tocilizumab monotherapy versus tocilizumab plus methotrexate were 1.02 and 1.04, respectively, in people with more baseline joint damage or a lower baseline DAS28 score, respectively, compared with 0.91 and 0.92 in those with less joint damage and a higher DAS28 score, respectively.
To put it another way, the researchers calculated that there was an absolute risk difference of 1% for the prevention of radiographic progression with tocilizumab monotherapy versus tocilizumab plus methotrexate in the subgroup with high-level baseline joint damage compared with 8% in patients with low-level baseline joint damage.
For the individuals with low versus high disease activity, the absolute risk differences were 3% versus 7%, respectively.
In the 417 patients with established RA the overall RR for prevention of radiographic progression was a nonsignificant 0.96 with tocilizumab monotherapy versus tocilizumab plus methotrexate, and in this case was modified significantly by disease duration. The RR was a nonsignificant 0.83 for individuals with shorter disease duration and a nonsignificant 1.04 for those with longer disease duration.
This translated to an absolute risk difference of 10% in the subgroup with shorter baseline disease duration compared with 2% in those with longer baseline disease duration.
Verhoeven et al conclude that tocilizumab plus methotrexate “may have no additional advantage regarding prevention of radiographic progression” when compared with tocilizumab monotherapy in patients with early RA and more joint damage and/or lower DAS28 score or in those with in established RA patients and a longer disease duration.
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