Original articleEfficacy and Safety of Intravenous Secukinumab in Noninfectious Uveitis Requiring Steroid-Sparing Immunosuppressive Therapy
Section snippets
Study Design
This double-masked, dose-ranging study was conducted at 10 sites in the United States and 4 sites in Germany. Eligible patients were stratified by uveitis severity (vitreous haze <2+ vs. ≥2+) and then randomly assigned (1:1:1) to receive secukinumab 300 mg SC every 2 weeks (days 1, 15, 29, and 43), secukinumab 10 mg/kg IV every 2 weeks, or secukinumab 30 mg/kg IV every 4 weeks (days 1 and 29). Intravenous or SC saline was administered as needed to maintain masking of treatment groups.
Patient Disposition and Demographics
Thirty-seven patients were randomly allocated to the 3 treatment groups (Fig 1). Of these, 33 patients (89.2%) completed the study and 4 patients discontinued early (10.8%), including 2 patients who withdrew consent, 1 patient who had an AE (uveitis flare), and 1 patient who had an unsatisfactory therapeutic effect. All randomized patients were included in the safety analysis, and all except 1 patient with no valid post-baseline efficacy assessment were included in the efficacy analyses. The
Discussion
The results of this small dose-ranging study in patients with active noninfectious uveitis demonstrate that IV administration of secukinumab produced statistically superior responder rates compared with SC dosing following 8 weeks of treatment. In addition, IV dosing showed numeric trends for greater remission rates, faster responses, greater reductions in vitreous haze, and protection from visual acuity loss compared with the SC dose. Pharmacokinetic analyses showed that IV administration
Acknowledgments
The authors thank the following Novartis employees who contributed greatly to completion of the study: Karen Holopigian (clinical operations), Karin Meiser (statistical support), and Petra Brinkmann (statistical programming/analysis support). Editorial support for the preparation of this manuscript was provided by BioScience Communications, New York, New York, and supported by Novartis Pharma AG. The authors thank Barry Weichman for assistance in drafting the manuscript and Andrew Horgan of
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∗Supplemental material is available at www.aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s): E.L.: Grants – Novartis.
S.Y.: Grants – Novartis, AbbVie; Advisory/consultancy services – Bausch & Lomb, Santen Inc, Clearside.
C.S.F.: Grants – AbbVie, Alcon Laboratories, Allergan, Eyegate, Lux Biosciences, Novartis; Compensation from consultancy services – AbbVie, Alcon Laboratories, Allergan, Ista Pharmaceuticals, Lux Biosciences, Novartis, Bausch & Lomb; compensation from speaking services – Alcon Laboratories, Allergan, Inspire Pharmaceuticals, Ista Pharmaceuticals, Lux Biosciences; Ownership of stock and/or stock options – Eyegate.
M.B.: Salary and stock – Novartis Institutes for BioMedical Research.
C.L.G.: Employee – Novartis Institutes for BioMedical Research.
Funded by Novartis Pharma AG, Basel, Switzerland. The study sponsor participated in the design and conduct of the study; the collection, management, analysis, and interpretation of data; and the preparation, review, and approval of the manuscript.
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List of AIN457A2208 Study Group available at www.aaojournal.org.