Results from the ongoing, open-label, phase 4 CONTROL trial shows that adding adalimumab to the treatment regimen of methotrexate results in better outcomes than methotrexate dose escalation in patients with psoriatic arthritis who did not respond sufficiently to initial methotrexate therapy .
The study, presented by Dr Laura Coates (Oxford University, United Kingdom), enrolled 245 biologic-naïve patients with active psoriatic arthritis despite treatment with methotrexate 15 mg every week for at least 4 weeks. Patients were randomised to add-on adalimumab 40 mg every 2 weeks (n=123) or methotrexate dose escalation to a maximum of 20-25 mg/week (n=122; the average dose of methotrexate was 21.8 mg/week).
Baseline characteristics were similar between groups. At week 16, the results showed that 41.5% of patients who were treated with adalimumab achieved minimal disease activity (MDA) compared with 13.1% of patients who received methotrexate escalation treatment. The significantly higher rates of MDA in the adalimumab group occurred irrespective of prior methotrexate treatment duration; rates were 42.2% versus 9.8% for patients treated for up to 3 months and 40.7% versus 16.4% for those treated for a longer period of time. Significant differences in MDA rates between the 2 groups were seen after 4 weeks of treatment. The between-group difference increased with time over the 16-week study period.
The American College of Rheumatology (ACR)20, ACR50, and ACR70 response rates also showed superiority of adalimumab, and significantly higher Psoriasis Area and Severity Index (PASI)75, PASI90, and PASI100 response rates were seen in adalimumab-treated patients who suffered from significant psoriasis compared with those treated with escalated methotrexate. The occurrence of adverse events of any grade was similar in both treatment groups from baseline to week 16 (61.8 vs 57.4% for adalimumab and methotrexate dose-escalation group, respectively). There were no reports of any opportunistic infections, deaths, or tuberculosis or malignancy. The study is currently ongoing and is evaluating whether treatment modification with adalimumab or methotrexate impacts on the achievement and maintenance of MDA.
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