Now approved for nr-axSpA2
Results from PREVENT, the largest-ever study of a biologic for the treatment of nr-axSpA2,3
- The PREVENT study included both biologic-naive patients (90%) and anti–TNF-α inadequate responders (10%), for a total of 555 patients2
Switch to open-label COSENTYX 150 mg SC or local standard of care was permitted anytime after Week 20 at the discretion of the investigator and patient.
ASAS=Assessment of SpondyloArthritis international Society criteria; NRI=nonresponder imputation; SC=subcutaneous; TNF=tumor necrosis factor.
Consistent safety profile
The safety profile for patients with nr-axSpA treated with COSENTYX was similar overall to the safety profile seen in patients with AS and other previous experience with COSENTYX.2
AS safety data
Convenient once-a-month (every 4 weeks) dosing2
Recommended dosing for patients with nr-axSpA:
COSENTYX 150 mg
- Administer with or without a loading dose*
COSENTYX loading dose followed by maintenance dose (once every 4 weeks)*
Administer with or without a loading dose. With a loading dose, administer 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Without a loading dose, administer 150 mg every 4 weeks.2
COSENTYX is administered subcutaneously.
The first self-injection should be performed under the supervision of a qualified healthcare professional. Patients should be trained in proper injection technique prior to self-administration.2
Administer with or without a loading dose. With a loading dose, administer 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Without a loading dose, administer 150 mg every 4 weeks.2
COSENTYX is administered subcutaneously.
The first self-injection should be performed under the supervision of a qualified healthcare professional. Patients should be trained in proper injection technique prior to self-administration.2
PsA dosing
AS dosing
PsA=psoriatic arthritis.
We've got you covered across the axSpA spectrum with guaranteed access for commercially insured patients
Coverage is the same for nr-axSpA as for other COSENTYX rheumatology indications
In rheumatology, 89% of commercially insured patients are covered first or second line for COSENTYX5
If coverage is denied, free COSENTYX for up to 2 years with the Covered Until You're Covered Program for eligible* commercial patients†
$0 co-pay for 100% of your eligible* commercial patients‡
The Medisafe app§ can help your patients stay on track with COSENTYX
If your patients have any questions, feel free to direct them to visit www.cosentyx.com or call 1-844-COSENTYX (1-844-267-3689).
Certain payers have carve-outs that restrict utilization of manufacturer support programs (eg, Kaiser).
Covered Until You're Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participating a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice. Program enrollment must occur by 12/31/20.
Limitations apply. Up to a $16,000 annual limit. Offer not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. Limitations may apply in MA and CA. For complete Terms & Conditions details, call 1-844-267-3689.
Medisafe app was developed by Medisafe Project Ltd.
COSENTYX is a registered trademark of Novartis AG.
PREVENT Study Design2,4
PREVENT is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating 555 adult patients with active nr-axSpA who met the ASAS classification criteria for axSpA and had abnormal hsCRP and/or evidence of sacroiliitis on MRI. Participants were randomized to receive 1 of 3 treatments subcutaneously: COSENTYX 150 mg load, COSENTYX 150 mg no load, or placebo. Patients were treated with COSENTYX 150 mg with load or placebo (Weeks 0, 1, 2, 3, and 4) or COSENTYX 150 mg without load (Weeks 0 and 4), followed by the same dose every 4 weeks thereafter. Starting at Week 16, dose adjustment or addition of concomitant NSAIDs and DMARDs was permitted. Starting at Week 20, patients were allowed to switch to open‐label COSENTYX 150 mg monthly or local standard of care if the patient was considered an inadequate responder for 2 consecutive visits by the discretion of the investigator and patient. The primary end point was the percentage of biologic-naive patients who achieved ASAS40 response at Week 52 in the no-load arm. The core phase of the trial ran through Week 104, with an extension phase through Week 208. Most patients (90%) were biologic-naive in this study.2,4
DMARDs=disease-modifying antirheumatic drugs; hsCRP=high-sensitivity C-reactive protein; MRI=magnetic resonance imaging; NSAIDs=nonsteroidal anti-inflammatory drugs.
References: 1. Rudwaleit M, van der Heijde D, Landewé R, et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68(6):777-783. 2. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020. 3. Cimzia [prescribing information]. Smyrna, GA: UCB, Inc; 2019. 4. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019. 5. Data on file. Cosentyx Access. Novartis Pharmaceuticals Corporation; May 13, 2020.
See the AS data