Safety data and selected AEs from 21 clinical trials¹

Adverse events were reported as exposure adjusted incident rates (EAIRs) per 100 patient-years. Analyses included all patients who received one or more doses of Cosentyx. Approximation was not done if EAIR is less than 0.1.

Some of the doses and dose regimes used in these studies are not approved for use (including 10 mg/kg intravenous loading and 75 mg subcutaneous dose). Individual patient dosing may vary - please consult the Cosentyx SmPC for full prescribing information, available at www.medicines.ie

*AEs in the secukinumab group that occurred with an incidence rate >5.0 per 100 patient-years during the entire safety period in any of the pooled groups.

^†Includes cases of common cold (low-level term)

^‡Values are based on system organ class: infections and infestations

^§Values are based on the high-level term

^¶Values are based on the preferred term

^|Values are based on Novartis Medical Dictionary for Regulatory Activities query, which comprises (1) any myocardial infarction, (2) any cardiovascular accident, and (3) all other cardiovascular events that are fatal, out of a listing of 2200+ terms

^#Values are based on standardized MedDRA query

Table adapted from Deodhar et al. 2019.¹

From an extension to the SCULPTURE study²

Only subjects who completed the SCULPTURE core study and continued into the extension are included in this analysis. A subject with multiple occurrences of the same AE in a one-year interval was counted only once, while a subject with multiple occurrences of the same AE in different year intervals was counted for each year.

*Patient exposure is calculated as a sum of individual subject durations in days divided by 365 for each interval.

^†Death was due to MACE, which was not considered by the investigators to be related to study drug; patient had ≥2 pre-existing MACE risk factors.

^‡Of the two cases of ulcerative colitis in year 2, one case was an exacerbation of previously existing ulcerative colitis; the exposure-adjusted incidence rate for new-onset ulcerative colitis cases for the entire study duration (5 years) was 0.27.

^§One case of cholangiocarcinoma, one case of invasive ductal breast carcinoma.

^¶One case of breast cancer. 

Table adapted from Bissonnette et al. 2018.²

FIXTURE double-blind RCT⁵

Data from the 150 mg group have not been presented here, as this dose is not approved for use in PsO. Individual patient dosing may vary - please consult the Prescribing Information for full details or refer to the Cosentyx SmPC for full prescribing information.

*Plus-minus values are means ± SDs.

^†Placebo patients not achieving PASI 75 at week 12, underwent randomisation to Cosentyx 150 mg or 300 mg. In this 52 week analysis, the placebo group includes all patients who received placebo during the induction period, including 16 patients who achieved PASI 75 at week 12 and continued to receive placebo during maintenance period (week 13 to week 52).

^‡Exposure-adjusted incidence rates were not calculated for discontinuations due to adverse events.

^§Events that had an incidence rate of at least 5.0 cases per 100-patient years in the combined secukinumab groups during the entire treatment period.

Table adapted from Langley et al. 2014.⁵

CLEAR double-blind RCT⁶

Individual patient dosing may vary - please consult the Cosentyx SmPC for full prescribing information, available at www.medicines.ie.

*Primary system organ class AE.

^†Preferred term AEs occurring at an incidence rate per 100 subject-years ≥5.0 in the treatment groups; sorted by descending order of incidence in the secukinumab treatment group.

Table adapted from Blauvelt et al. 2017.⁶

EXCEED double-blind RCT⁷*

Individual patient dosing may vary - the Cosentyx SmPC for full prescribing information, available at www.medicines.ie.

*Weeks 48 and 50 were the last dosing visit for Cosentyx 300 mg SC and adalimumab 40 mg SC, respectively.

^†53-year-old male patient entered the study without any reported medical history or active medical condition. On study day 85, patient had severe abdominal pain considered as a serious event, which led to discontinuation of secukinumab and study. Colon cancer was diagnosed subsequently, with fatal outcome on day 146. Event was assessed as not related to study drug by the investigator.

^‡Same patient was diagnosed with both Crohn’s and ulcerative colitis.

Table adapted from McInnes et al. 2020.⁷