
PsA safety in pivotal trials through Week 161
There were cases of Crohn’s disease and ulcerative colitis that included patients who experienced either exacerbations or the development of new disease. There were 3 cases of inflammatory bowel disease, of which 2 patients received COSENTYX® and 1 received placebo.1
If a serious infection develops, discontinue COSENTYX until the infection resolves.1
If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy.1
In FUTURE 3, COSENTYX did not show any new or unexpected safety signals through Week 16.4
In MAXIMISE, COSENTYX did not show any new or unexpected safety signals through 1 year.5
*AEs listed are those occurring in at least 2% of patients in pooled secukinumab dose group up to Week 16.2
†Includes 75 mg, 150 mg, and 300 mg doses (pooled outcome).2
‡Pivotal PsA program was FUTURE 1 and FUTURE 2.3
§Some patients were IV loaded (10 mg/kg) at Weeks 0, 2, and 4.3
IIRate of injection site reactions means the percentage of patients affected by 1 or more injection site reaction(s) during the first 16 weeks of the pooled FUTURE 1 and 2 trials.6
A robust safety profile that is tried through 5 years
3800+ patient-years of exposure7
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Pooled analysis of long-term safety profile demonstrated in 1380 patients across 3 phase 3 trials (FUTURE 1-3)7,8
PsA safety profile through Year 5
Robust results seen in FUTURE 5 (N=996)10,11
NO trend toward increased AE incidence rates of MACE, malignancy, or IBD7-9
NO boxed warning1
NO required routine lab monitoring during treatment1
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Evaluate patients for TB infection prior to initiating treatment1
NO known clinically relevant interactions with drugs metabolized by CYP3A41‡‡
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Results from a drug-drug interaction study in patients with moderate to severe PsO1
Over 5 years, <1% of patients had immunogenicity12
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Neutralizing antibodies developed in approximately 0.6% of patients with PsO and were not associated with loss of efficacy12§§
Please see Important Safety Information, including CONTRAINDICATIONS.
¶Rates are for the system organ class “infections and infestations,” which includes multiple associated PTs.7
#Rates are for Candida infections high-level term, which includes multiple associated PTs.7
**Data are displayed to 2 decimals where N>1000 and to 1 decimal if N<1000.
††Rates are for the Novartis MedDRA Query term, which comprises (1) any myocardial infarction, any CV accident, and (2) all other CV events that are fatal, out of a listing of 2200+ terms.7
‡‡Upon initiation or discontinuation of COSENTYX in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and consider dosage adjustment of the CYP450 substrate as needed.1
§§The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.