Results from a new study presented at the 2018 annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals indicated that treatment with secukinumab (SEC) was associated with a low incidence of immunogenicity over 52 weeks in patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS), similar to results seen in patients with plaque psoriasis.
The researchers, led by Atul A. Deodhar, MD, of Oregon Health and Science University in Portland, examined immunogenicity with SEC, a fully human monoclonal IgG1 antibody that selectively targets interleukin-17A, because monoclonal antibody therapies may be associated with immunogenicity and the production of anti-drug antibodies. This can lead to adverse events and/or affect drug pharmacokinetics and clinical response.
The sample included 1,414 patients with PsA who were receiving SEC in the FUTURE studies, as well as 1,163 patients with AS who were receiving SEC in the MEASURE studies. Patients were evaluated for immunogenicity at baseline and at weeks 16 (patients with AS only), 24, and 52. If anti-drug antibodies were found, the researchers analyzed the samples through week 52 for drug-neutralizing potential, immunogenicity-related adverse events, and impact on SEC pharmacokinetics and efficacy.
In the PsA group, five patients (0.35%) developed anti-drug antibodies; in the AS group, eight patients (0.68%) developed them. The researchers did not observe any associations between the presence of anti-drug antibodies and SEC dose, frequency, or mode of administration. In addition, anti-drug antibodies had a neutralizing effect in only one patient (from the PsA group). They were not associated with any immunogenicity-related adverse events. Overall, patients with anti-drug antibodies had normal secukinumab pharmacokinetics and did not lose treatment efficacy over 52 weeks.