5-Year favorable and consistent safety profile across 24 studies in PsO and PsA
Adapted from reference 2
AEs=adverse events; EAIR=exposure-adjusted incidence rate; IBD=inflammatory bowel disease;
MACE=major adverse cardiovascular event; PsA=psoriatic arthritis; PsO=plaque psoriasis; PY=patientyears.
*Rates for system organ class.
†Rates for high-level terms.
‡ Opportunistic infections were bronchopulmonary aspergillosis, cytomegalovirus gastroenteritis, gastrointestinal candidiasis, herpes zoster cutaneous disseminated, herpes zoster infection neurological, Mycobacterium avium complex infection, esophageal candidiasis, Pneumocystis jirovecii pneumonia, toxoplasmosis, tuberculosis.
§Rates for preferred terms.
|| Rates for Novartis MedDRA Query terms.
¶Rates for standardized MedDRA Query terms—“malignancies and unspecified tumor.”
MedDRA=Medical Dictionary for Regulatory Activities.
Safety and experience
Uncommon and easily managed Candida infections2
No increase in incidence of IBD (UC and CD) over time2
No new safety signals, across any indication. 2
Less than 1% immunogenicity3
Cosentyx is not recommended for patients with Inflammatory bowel disease.4
CD=Crohn’s disease; IBD=inflammatory bowel disease; UC=ulcerative colitis.
Dosing
Flexible dosing based on your patient’s need1
The Cosentyx Uno ready pen delivers a positive injection experience 1
Cosentyx API
Cosentyx API
References
Egyptian Drug Authority (EDA), Cosentyx leaflet approval date: 23/03/2025.
Gottlieb AB, Deodhar A, Mcinnes IB, Baraliakos X, Reich K, Schreiber S, Bao W, Marfo K, Richards HB, Pricop L, Shete A. Long-term safety of secukinumab over five years in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis: update on integrated pooled clinical trial and post-marketing surveillance data. Acta Dermato Venereologica. 2022 Apr 27;102.
Cosentyx Summary of Products characteristics. Available at: Cosentyx, INN-secukinumab, Last Accessed: 18/06/2025. Last updated: 25/11/2024.
EMA Cosentyx Overview. Available at : https://www.ema.europa.eu/en/documents/overview/cosentyx-epar-medicine-overview_en.pdf, Last Accessed: 25/07/2023. Last Updated :03/06/2023.
Sigurgeirsson B, Browning J, Tyring S, Szepietowski JC, RiveraDíaz R, Effendy I, Keefe D, Bruin G, Paguet B, Fu R, Hampele I. Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52week results from MATURE, a randomized, placebocontrolled trial. Dermatologic Therapy. 2022 Mar;35(3):e15285.
Approved by Egyptian Drug Authority: BF0424OA4706/082025. Invalidation date: 28/08/2027.
Kindly report any violated online promotional, educational and awareness material not having this message to The General administration for Regulation of Marketing & Advertising Materials at: www.edaegypt.gov.eg
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BF0424OA4706/082025 28/08/2027 |
Adverse Events Reporting We encourage using the following Electronic reporting tool for reporting into the safety database directly: |