medwireNews: Introducing adalimumab results in better outcomes than methotrexate dose escalation among patients with psoriatic arthritis (PsA) and an inadequate response to initial methotrexate therapy, suggest findings from the CONTROL trial.
The phase 4 study, presented at the EULAR 2020 E-Congress, included 245 biologic-naïve patients with active PsA despite treatment with methotrexate 15 mg/week for at least 4 weeks. Participants were randomly assigned to receive add-on adalimumab 40 mg every 2 weeks or methotrexate dose escalation to a maximum of 20–25 mg/week (average 21.8 mg/week).
The investigators, led by Laura Coates (University of Oxford, UK), found that 41.5% of the 123 patients in the adalimumab group achieved minimal disease activity (MDA) at week 16. This was significantly higher than the 13.1% MDA rate for the 122 participants in the methotrexate escalation group.
Coates told delegates that participants in the adalimumab arm had significantly higher rates of MDA than those in the methotrexate escalation arm regardless of prior methotrexate treatment duration, with rates of 42.2% versus 9.8% for those with a treatment duration of up to 3 months, and 40.7% versus 16.4% for those with a longer treatment duration.
She added that significant differences in MDA rates between the two groups were seen after 4 weeks of treatment, with the between-group difference increasing with time over the 16-week study period.
Moreover, analysis of ACR20, 50, and 70 response rates “also confirmed superiority of adalimumab,” and “this was also reflected in the skin responses for those with significant psoriasis,” with significantly higher PASI75, 90, and 100 response rates in the adalimumab arm, said Coates.
A similar proportion of patients in the adalimumab and methotrexate escalation groups experienced adverse events of any grade from baseline to week 16 (61.8 vs 57.4%), and no opportunistic infections, deaths, or cases of tuberculosis or malignancy were reported.
“The safety results in this study were consistent with the known safety profiles of the drugs involved,” said Coates.
She concluded that “the CONTROL study is still ongoing, with part two further evaluating whether treatment modification with adalimumab or methotrexate impacts on the achievement and maintenance of MDA.”
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