Cosentyx, Secukinumab (AIN457) approved for psoriasis

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Cosentyx, Secukinumab (AIN457) approved for psoriasis

Post by Mike Bartolatz » Tue Mar 03, 2015 11:41 am

Cosentyx, Secukinumab (AIN457) approved for psoriasis

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Postby Mike Bartolatz » Sun Feb 08, 2015 4:57 pm

this is a VERY big deal as IL17 blocking drug AIN457 was first tried in uveitis. this is the same drug! too few individuals for study approval by FDA because of Uveitis being a very rare condition and trials were not adequate to show possible contraindications.

this drug will be available on the orphan drug list for many conditions now and hopefully research will allow off label use in uveitis when the patient is shown to have the IL17A gene.

mike
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The US Food and Drug Administration (FDA) has approved the interleukin 17A inhibitor secukinumab (Cosentyx) for adults with moderate to severe plaque psoriasis.




Cosentyx is administered as a subcutaneous injection and may be used in combination with phototherapy.

In reports at the American College of Rheumatology meeting last November, secukinumab showed promising results against psoriatic arthritis (PsA) in Phase 3 trials. Observers have antipated that approval for psoriasis would predate any approval for Ps
.....- See more at: http://www.rheumatologynetwork.com/psor ... CTmFx.dpuf

Mike Bartolatz
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Mike Bartolatz
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Mike Bartolatz
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Re: Cosentyx, Secukinumab (AIN457) approved for psoriasis

Post by Mike Bartolatz » Tue Mar 03, 2015 3:34 pm

https://clinicaltrials.gov/ct2/results? ... numab&pg=2

study now being done in Ankylosing spondylitis
Mike Bartolatz
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Mike Bartolatz
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Re: Cosentyx, Secukinumab (AIN457) approved for psoriasis

Post by Mike Bartolatz » Tue Mar 24, 2015 5:56 pm

Efficacy and Safety of Intravenous Secukinumab in Noninfectious Uveitis Requiring Steroid-Sparing Immunosuppressive Therapy.


Ophthalmology. 2015 Jan 29. pii: S0161-6420(14)01224-X. doi: 10.1016/j.ophtha.2014.12.033. [Epub ahead of print]
Efficacy and Safety of Intravenous Secukinumab in Noninfectious Uveitis Requiring Steroid-Sparing Immunosuppressive Therapy.
Letko E1, Yeh S2, Foster CS3, Pleyer U4, Brigell M5, Grosskreutz CL5; AIN457A2208 Study Group.
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Abstract
PURPOSE:
Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibited promising activity in a proof-of-concept study when administered in intravenous (IV) doses to patients with active, chronic, noninfectious uveitis. This study compared the efficacy and safety of different IV and subcutaneous (SC) doses of secukinumab in patients with noninfectious uveitis.
DESIGN:
Multicenter, randomized, double-masked, dose-ranging, phase 2 clinical trial.
PARTICIPANTS:
Thirty-seven patients with active noninfectious intermediate uveitis, posterior uveitis, or panuveitis who required corticosteroid-sparing immunosuppressive therapy.
METHODS:
Patients were randomized to secukinumab 300 mg SC every 2 weeks for 4 doses, secukinumab 10 mg/kg IV every 2 weeks for 4 doses, or secukinumab 30 mg/kg IV every 4 weeks for 2 doses. Intravenous or SC saline was administered to maintain masking. Efficacy was assessed on day 57 (2-4 weeks after last dose).
MAIN OUTCOME MEASURES:
Percentage of patients with treatment response, defined as (1) at least a 2-grade reduction in vitreous haze score or trace or absent vitreous haze in the study eye without an increase in corticosteroid dose and without uveitis worsening or (2) reduction in corticosteroid dosages to prespecified levels without uveitis worsening. Percentage of patients with remission, defined as anterior chamber cell and vitreous haze scores of 0 or 0.5+ in both eyes without corticosteroid therapy or uveitis worsening.
RESULTS:
Secukinumab 30 mg/kg IV and 10 mg/kg IV, compared with the 300 mg SC dose, produced higher responder rates (72.7% and 61.5% vs. 33.3%, respectively) and remission rates (27.3% and 38.5% vs. 16.7%, respectively). Statistical and clinical superiority for the 30 mg/kg IV dose compared with the 300 mg SC dose was established in a Bayesian probability model. Other measures, including time to response onset, change in visual acuity, and change in vitreous haze score, showed numeric trends favoring IV dosing. Secukinumab, administered in IV or SC formulations, appeared safe and was well tolerated.
CONCLUSIONS:
Intravenous secukinumab was effective and well tolerated in noninfectious uveitis requiring systemic corticosteroid-sparing immunosuppressive therapy. Greater activity with IV dosing suggests that patients may not receive sufficient drug with SC administration. High-dose IV secukinumab may be necessary to deliver secukinumab in therapeutic concentrations.
Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
PMID: 25638011 [PubMed - as supplied by publisher]
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