Netakimab is a humanized anti-interleukin 17A antibody approved for the treatment of moderate-to-severe plaque psoriasis.
Phase three clinical trial PATERA evaluated the effects of netakimab on signs and symptoms of psoriatic arthritis, including disease activity, skin manifestation and quality of life.
It included 194 eligible adult patients with psoriatic arthritis who received either 120 mg of netakimab (97 patients in the first treatment arm) or placebo (97 patients in the second arm) subcutaneously during 24 weeks.
Baseline demographics and disease characteristics were similar across treatment arms. Patients from placebo arm who did not meet ACR20 (20% improvement of the American College of Rheumatology criteria) by week 16, were switched to 120 mg dose of netakimab.
The results of the clinical trials have shown that 80 patients (82%) in netakimab arm and 9 (9%) in the placebo arm achieved ACR20 at week 24. 70% of patients in netakimab arm achieved ACR50 compared to 6% of patients in placebo arm.
As for PsARC (Psoriatic arthritis response criteria) response, it was achieved by 87% of patients in netakimab arm. DAPSA (Disease Activity Index for Psoriatic Arthritis) remission was achieved by 36% in netakimab arm.
As for skin manifestations that negatively affect the quality of life of patients with psoriatic arthritis, 24-week treatment with netakimab at the dose of 120?mg resulted in significant improvement in skin manifestations in patients with psoriatic arthritis: about a half of the patients with ?3% body surface area involvement at baseline achieved complete skin clearance. Netakimab also leads to sustained improvement in axial disease in patients with inflammatory back pain at baseline.
Netakimab was well tolerated, and most adverse effects were mild to moderate. No treatment-related severe adverse effects were reported and no anti-drug antibodies were detected.
Netakimab was registered for treatment of ankylosing spondylitis and psoriatic arthritis in spring 2020 in Russia. According to Phase 3 clinical study BCD-085-5/ASTERA, 40% of patients with ankylosing spondylitis achieve an ASAS40 response after 16 weeks of therapy.
The netakimab molecule is based on the llama immunoglobulin which is as close as possible to human immunoglobulins which helps to achieve a sustainable effect from the therapy.