An anti-interleukin 20 recombinant human monoclonal antibody, dubbed NNC0109-0012, was effective in patients with seropositive rheumatoid arthritis who had not responded to methotrexate therapy in a phase IIa, double-blind, placebo-controlled trial. The study comprised 67 patients.
Dr. Ladislav Šenolt and his associates reported notable improvement with NNC0109-0012 treatment within the first week of treatment. During the 12-week trial period, there was an overall improvement of 0.88 points on the 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) over placebo. The result was driven by the improvement of seropositive RA patients, who had a decline of 1.66 points on DAS28-CRP when compared with placebo. No significant improvement was found in seronegative patients.
Just under 60% of seropositive patients achieved American College of Rheumatology 20 level of response, while 21% of those in the placebo group achieved ACR 20. Just under half of seropositive patients achieved ACR 50, compared with 14% of the placebo group, and 35% of seropositive patients achieved ACR 70, a marker no one in the placebo group reached.
The most common side effects were injection site reactions and infections; no serious infections or side effects associated with NNC0109-0012 were reported, the investigators said.
Find the full study in Arthritis & Rheumatology (doi:10.1002/art.39083).