Secukinumab demonstrates sustained response, consistent safety profile in AS

Alan J. Kivitz

SAN DIEGO — Secukinumab provided sustained improvements in signs and symptoms of ankylosing spondylitis among patients who completed three years of treatment, according to data presented at the American College of Rheumatology Annual Meeting.

In addition to sustained improvements in physical function at 3 years, secukinumab also demonstrated a safety profile consistent with previous data for this population.

“Secukinumab (Cosentyx, Novartis) provided sustained improvement in the signs and symptoms of AS over 2 years in the MEASURE 2 study,” Alan J. Kivitz, MD, of the Altoona Center for Clinical Research in Pennsylvania, and colleagues wrote. “Here, we report the efficacy and safety of secukinumab over 3 years.”

The researchers examined data from Week 156 of the phase 3 MEASURE 2 study, in which 219 patients with active AS were randomly assigned to receive subcutaneous secukinumab 150 mg (n = 72), 75 mg (n = 73) or placebo (n = 74) at baseline. Patients in the placebo arm were reassigned 1:1 to either secukinumab 150 mg or 75 mg at Week 16, regardless of clinical response.

The analysis included patients who were assigned, originally, to treatment with secukinumab as well as those who initiated treatment with secukinumab after placebo (150 mg, n = 106; 75 mg, n = 105). Assessment of Spondyloarthritis International Society 5/6, 20, 40 and partial remission classification criteria, Ankylosing Spondylitis Disease Activity Score-C-reactive protein inactive disease, Bath Ankylosing Spondylitis Disease Activity Index and SF-36 physical component summary were evaluated at Week 156.

Pre-specified analyses were classified according to prior treatment with tumor necrosis factor-alpha (TNF-alpha) inhibitors and included patients who had not been treated previously with these agents as well as patients who had an inadequate response to them. Safety analyses were conducted for all patients treated with one or more doses of secukinumab.

Mean exposure to secukinumab over the course of the full study period was 914.3 ± 315.5 days. The completion rate at Week 156 was greater among patients treated with the 150-mg dose (81.1%; 86/106) compared with the 75-mg dose (72.4%; 76/105). Greater rates of treatment discontinuation occurred among patients in the 75-mg group due, in part, to “lack of efficacy or patient/guardian decision,” according to the study findings.

The researchers observed that improvements in ASAS 20 and ASAS 40 responses were maintained in both patients who had not been treated previously with TNF-alpha inhibitors and in patients with an inadequate response to those agents. Responses to all other study outcomes, including ASAS 5/6 and partial remission classification criteria, ASDAS-CRP inactive disease, BASDAI and SF-36 PCS, were higher in patients treated with the 150-mg dose.

Adverse events reported most often with secukinumab included nasopharyngitis, upper respiratory tract infection, diarrhea and bronchitis. Exposure-adjusted incidence rates for adverse events of interest included serious infections/infestations (1.5), Crohn’s disease (0.6), malignant/unspecified tumors (0.6) and major adverse cardiovascular events (0.6) per 100 patient-years.

The 150-mg dose of secukinumab demonstrated a “sustained response” in reducing the signs and symptoms of disease and improving physical function in patients with AS, according to the researchers. In addition, “the safety profile remained favorable and was consistent with previous reports.” – by Julia Ernst, MS

Reference:

Kivitz AJ, et al. Abstract 1539. Presented at: ACR Annual Meeting; Nov. 3-8, 2017; San Diego.

Disclosures: Kivitz reports associations with AbbVie, Celgene, Genentech, Pfizer, Sanofi/Regeneron and UCB. Please see the full study for a list of all other researchers’ relevant financial disclosures.