Results from the ongoing 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 (PsA) 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 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).
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% MDA 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 ACR20, ACR50, and ACR70 response rates also showed the superiority of adalimumab, and significantly higher PASI75, PASI90, and PASI100 response rates were seen in adalimumab-treated patients who suffered from significant psoriasis.
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.
1. Coates LC, et al. Adalimumab Introduction Versus Methotrexate Dose Escalation in Patients with Inadequately Controlled Psoriatic Arthritis: Results from Randomized Phase 4 CONTROL Study. Abstract OP0050. EULAR E-Congress, 3-6 June 2020.