Previous results reported from the phase III MEASURE 2 study showed that secukinumab provided sustained improvement in signs and symptoms of ankylosing spondylitis (AS) over two years. On Monday, at the 2017 annual meeting of the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP), researchers presented evidence of the treatment’s sustained efficacy and safety over a longer period of three years.
The study randomized 219 patients with active AS to subcutaneous secukinumab 150 mg (n = 72), 75 mg (n = 73) or placebo (n = 74 pts) at baseline. At week 16, those assigned to the placebo arm were re-randomized to one of the secukinumab arms, regardless of clinical response. Analysis included all patients initially randomized to secukinumab and those who switched at week 16 (n = 106 patients receiving secukinumab 150 mg and n = 105 secukinumab 75 mg).
Mean exposure to secukinumab [± standard deviation] was 914.3 ± 315.5 days. At week 156, patients who received the 150 mg dose had a high study completion rate, higher than those at the 75 mg dose (81.1% versus 72.4%), mostly due to lack of treatment efficacy or patient or guardian decision. The 150 mg group also had better responses to treatment.
The authors, led by Alan J. Kivitz, MD, of the Altoona Center for Clinical Research in Duncansville, Pa., found that secukinumab’s safety and tolerability profile was consistent with previous reports. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection, diarrhea and bronchitis. The exposure-adjusted incidence rates for adverse events of particular interest with secukinumab (per patient-years) were serious infections and infestations (1.5), Crohn’s disease (0.6), malignant and unspecified tumours (0.6) and major cardiovascular events (0.6).