Novartis : PREVENT data show Cosentyx helps patients realize early and lasting relief in axial spondyloarthritis

Basel - Novartis, a leader in rheumatology and immuno-dermatology, today announced the full 52-week results from the Phase III PREVENT trial, which reinforce the substantial and sustained benefits of Cosentyx (secukinumab) across the axial spondyloarthritis (axSpA) spectrum.

The study found patients treated with Cosentyx 150 mg showed significant and sustained improvements in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 52 weeks. nr-axSpA is a painful and debilitating condition affecting 1.7 million people in the top five EU countries and the US2. However, because nr-axSpA is underdiagnosed, with an average delay in diagnosis of more than seven years, that number may be higher3.

'Axial spondyloarthritis can have a serious impact on a patient's quality of life and ability to carry out everyday tasks. PREVENT demonstrated the efficacy and safety of secukinumab in non-radiographic axial spondyloarthritis, showing early and sustained relief from the signs and symptoms of this often painful disease,' said Jurgen Braun, MD, Professor of Rheumatology at Ruhr-University Bochum, Germany, and an investigator in the secukinumab clinical trial program.

The PREVENT trial met its primary endpoint of 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) in biologic treatment-naive patients at Week 16 and Week 52 versus placebo (41.5% vs 29.2%: P=4) and who had been taking at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest dose up to 4 weeks prior to study start. Patients may have previously taken a TNF inhibitor (not more than one) but had an inadequate response. Of the 555 patients enrolled in the study, 501 (90.3%) were biologic-naive. Patients were allocated to one of three treatment groups: Cosentyx 150 mg subcutaneously with loading dose (induction: 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance with 150 mg secukinumab monthly); Cosentyx 150 mg no loading dose (150 mg secukinumab subcutaneously monthly), or placebo (induction of subcutaneously weekly for 4 weeks, followed by maintenance of once-monthly).

The primary endpoints are the proportion of patients achieving an ASAS40 response with Cosentyx 150 mg at Weeks 16 and 52 in TNF-naive patients. Secondary endpoints include among others change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP)1.

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References

1. Braun J, Blanco R, Dokoupilova E, et al. Secukinumab 150 mg Significantly Improved Signs and Symptoms of Non-radiographic Axial Spondyloarthritis: 52-week Results from the Phase III PREVENT Study. Abstract OP0106 presented at EULAR e-congress 2020.

2. DRG Epidemiology Database. Axial Spondyloarthritis: Disease Landscape & Forecast [online] August 2019. Available from: https://decisionresourcesgroup.com/report/716950-biopharma-axial-spondyloarthritis-landscape-forecast/ [Last accessed: May 2020].

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4. Novartis press release. Novartis Cosentyx gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum [online]. Available from: https://www.novartis.com/news/media-releases/novartis-cosentyx-gains-fourth-indication-eu-first-class-approval-axial-spondyloarthritis-spectrum [Last accessed: May 2020].

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7. Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70:1661-70.

8. Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: May 2020].

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12. Bissonnette R, Luger T, Thaci D, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. J Eur Acad Dermatol Venereol. 2018;32:1507-14.

13. Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab provides sustained improvements in the signs and symptoms of psoriatic arthritis: Final 5-year results from the Phase 3 FUTURE 1 study. ACR Open Rheumatol. 2020; 2:18-25.

14. Deodhar A, Blanco R, Dokoupilova E, et al. Secukinumab 150 mg Significantly Improved Signs and Symptoms of Non-radiographic Axial Spondyloarthritis: Results from a Phase 3 Double-blind, Randomized, Placebo-controlled Study. Abstract presented at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals; Nov 8-13 2019; Atlanta, GA.

15. Novartis data on file.

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