For children with moderate to severe plaque psoriasis
Safety considerations
Safety profile of COSENTYX® (secukinumab) in pediatric PsO studies was consistent with adult PsO studies2
If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy.2
NO Boxed WARNING2
NO warning for suicidal ideation and behavior2
NO routine lab monitoring, including liver enzymes, during treatment2
- Evaluate patients for TB prior to initiating treatment
NO trend toward increased AE incidence rates of IBD, Candida infections, MACE, or malignancy through Year 54
<1% of patients had immunogenicity over 5 years5
Infection and neutropenia in pediatric PsO trials
One pediatric case of MRSA-TSS was reported during PBO-controlled period of Trial PsO6.
In the pediatric safety pool of Trials PsO6 and PsO7, (N=198; 287 patient years), 22 (11%) reported ≥CTCAE Grade 2 neutropenia (≥1,000 to <1500 cells/mm3).* During the 12-week PBO-controlled period of Trial PsO6, ≥CTCAE Grade 2 neutropenia was reported in 3 (4%) subjects treated with COSENTYX (n=80) compared with no subjects treated with placebo (n=41). No serious infections were associated with cases of neutropenia.
*Includes all subjects who took at least one dose of COSENTYX during the treatment periods. 57% of subjects followed for ≥1 year, 30% of subjects followed for ≥2 years.
Definitions
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; MRSA-TSS, methicillin-resistant Staphylococcus aureus toxic shock syndrome; PBO, placebo; PsO, plaque psoriasis; TB, tuberculosis.
References
1. Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008.
2. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
3. Cosentyx FDA approval history. Drugs.com. Accessed March 21, 2024. https://drugs.com/history/cosentyx.html
4. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
5. Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years. J Eur Acad Dermatol Venereol. 2019;33(9):1733-1741.