Late-Breaking Research Shows Four-Year Efficacy and Safety of Secukinumab in Patients with Ankylosing Spondylitis

On Tuesday at the 2017 annual meeting of the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP), researchers presented late-breaking data from an extension of the MEASURE 1 study, demonstrating that secukinumab, a fully human anti-interleukin-17A monoclonal antibody, is safe and effective over four years in patients with ankylosing spondylitis (AS), a form of arthritis that primarily affects the spine.

Jürgen Braun, MD, of Rheumazentrum Ruhrgebiet in Heme, Germany, presented results that show a sustained low rate of radiographic structural progression in patients with active AS who were treated with secukinumab 150 mg. At four years, the majority of patients (78.9%) demonstrated no radiographic progression (based on modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS] change from baseline <2).

This is the first study of secukinumab to report long-term efficacy and safety, as well as low radiographic structural progression through four years in patients with active AS. The findings from this four-year analysis are consistent with earlier outcomes from MEASURE 1, which found that about 80% of AS patients had no spinal radiographic structural progression through two years of secukinumab therapy.

Also of note, the researchers reported numerically lower mSASSS progression in patients treated with secukinumab 150 mg compared with 75 mg. Mean change (± standard deviation) in mSASSS from baseline to week 208 was lower with secukinumab 150 mg (1.2 ± 3.91) compared with 75 mg (1.7 ± 4.70). Mean mSASSS changes at week 208 were higher in males versus females, as well as patients with elevated versus normal baseline high-sensitivity C-reactive protein, and patients with baseline syndesmophytes versus those without.

 

The current analysis found a safety profile similar to that previously reported in studies of secukinumab for AS, psoriatic arthritis, and psoriasis. Across the entire treatment period (mean secukinumab exposure 3.4 ± 1.44 years), exposure-adjusted incidence rates for serious infections, Crohn’s disease, uveitis, and malignant/unspecified tumors were 1.0, 0.6, 1.8, and 0.5 per 100 patient-years, respectively.

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