Treatment with Novartis’ Cosentyx (secukinumab) led to a significant reduction in disease activity compared to placebo in patients with non-radiographic axial spondyloarthritis (nr-axSpA), according to results from the ongoing Phase 3 PREVENT trial.
Novartis announced that Cosentyx achieved its 16-week primary endpoint as well as all secondary endpoints. Moreover, Cosentyx’s favorable safety profile was similar to that seen in previous clinical studies.
“These study results for Cosentyx build on our longstanding experience in ankylosing spondylitis (AS) and are a step toward a new treatment option that could allow patients to realize relief much earlier in axial spondyloarthritis,” John Tsai, MD, head of global drug development and chief medical officer of Novartis, said in a press release.
Axial spondyloarthritis is a type of arthritis that mainly affects the joints of the spine, causing chronic pain and lifelong physical disability. The disease can be categorized into AS, when joint damage is visible through imaging techniques called radiographs (X-rays), or (nr-axSpA), when joint damage is not visible on plain-film radiographs.
Cosentyx is a human monoclonal antibody that works by inhibiting the pro-inflammatory cytokine, or immune protein, interleukin-17A, preventing exacerbated inflammation and immune reactions in chronic inflammatory diseases.
The PREVENT study (NCT02696031) is an international, 176-center trial evaluating the effectiveness and safety of Cosentyx compared to a placebo in patients with active nr-axSpA.
A total of 555 adult patients with active nr-axSpA undergoing treatment with at least two non-steroidal anti-inflammatory drugs (NSAIDs) up to four weeks before the study start were enrolled. Patients may have been previously treated with an anti-TNF (tumor necrosis factor) therapy but had had an inadequate response to it. However, most patients (90%) were biologic naive.
Patients were randomized to receive either Cosentyx delivered subcutaneously (under the skin) as a 150 mg monthly dose, with or without an induction phase (150 mg administered weekly for four weeks) or a placebo.
The trial’s primary objective was to determine the proportion of patients who met the Assessment of Spondyloarthritis International Society response criteria (ASAS40) — defined as an improvement of at least 40% and an increase of at least 10 units (on a scale of 0 to 100) in at least three of four main ASAS domains — at weeks 16 and 52, as a measure of efficacy.
Additional (secondary) endpoints included improvements in disease activity as measured by the AS Disease Activity Score (ASDAS)-CRP and the Bath AS Disease Activity Index (BASDAI) SCORES.
The ASDAS-CRP is an index that combines five variables into one score to evaluate disease activity, along with C-reactive protein values, a known marker of inflammation. The Bath AS Disease Activity Index is a diagnostic test that evaluates discomfort, pain, and fatigue (on a 0–10 scale) to help clinicians determine the effectiveness of a therapy.
Cosentyx is already approved for adults with ankylosing spondylitis, as well as for adults with psoriatic arthritis or plaque psoriasis. Novartis has now submitted to the European Medicines Agency for approval in nr-axSpA, which, if accepted, would be “the fourth indication for Cosentyx,” Tsai said.
According to the company, data from the trial’s 52-week endpoint are expected later this year and will be used to support a U.S. Food and Drug Administration (FDA) submission.