Study data published in Rheumatology support the sustained efficacy and safety of secukinumab through 4 years of treatment for ankylosing spondylitis (AS).
The MEASURE 1 study (ClinicalTrials.gov identifier: NCT01863732) randomly assigned patients with AS to receive 2 years of subcutaneous secukinumab 150 mg (n=87) or 75 mg (n=100) every 4 weeks. An additional 87 patients were randomly assigned to placebo at baseline and reassigned to secukinumab after at least 16 weeks of treatment. Twenty-five patients initially assigned to 75 mg secukinumab were later approved for “up-titration” to 150 mg. Data from patients initially assigned to placebo were used in safety but not in efficacy analyses. Efficacy was assessed in patients originally randomly assigned to secukinumab according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and additional radiographic assessment methods. A 20% or 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS20 and ASAS40, respectively) response was also used as a touchstone for secukinumab efficacy.
Among patients originally assigned to receive 150 mg or 75 mg secukinumab, 89.7% and 93.0% completed the treatment course, respectively. Mean changes in mSASSS were 1.2 for patients receiving 150 mg, 1.8 for patients receiving 75 mg, and 1.6 for “up-titrated” patients. No radiographic progression was observed in 79% of patients receiving either secukinumab dose, indicating that the drug lessens structural progression in AS. ASAS20 and ASAS40 response levels were 79.7% and 60.8% for the 150-mg group, 71.0% and 43.5% for the 75-mg group, and 80.0% and 76.0% for the “up-titrated” group, respectively. Adverse events were rare and introduced no new safety signals beyond those currently noted in the literature. Adverse effects observed included serious infections, Candida infections, Crohn disease, ulcerative colitis, and malignant/unspecified tumors, each with incidence rates less than 1 per 100 patient-years.
These data indicate sustained efficacy for secukinumab in minimizing radiographic progression and inflammation in patients with AS. Secukinumab also displayed a favorable safety profile, with few adverse events. Further research is necessary to identify the optimal secukinumab dose, however, as the present study was not sufficiently powered to compare the 75-mg and 150-mg groups.
Braun J, Baraliakos X, Deodhar A, et al. Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study [published online December 19, 2018]. Rheumatology (Oxford). doi:10.1093/rheumatology/key375