Prescribing information

 

See the safety profile of Cosentyx across PsO, PsA and AS.

Click below to see the safety profile of Cosentyx from different studies, or refer to the summary of product characteristics for full safety information.

Icons with a shield with the number 5 inside and 2 shields in different colours and Less than 1%

*Some of the doses and dose regimes used in these studies are not approved for use. See below for Cosentyx licensed dosing** or refer to the Cosentyx SmPC for full prescribing information.

Tabulated list of adverse reactions from the SmPC8

System Organ Class Frequency Adverse reaction
Infections and infestations Very common Upper respiratory tract infections
  Common Oral herpes
    Tinea pedis
  Uncommon Oral candidiasis
    Otitis externa
    Lower respiratory tract infections
  Not known Mucosal and cutaneous candidiasis (including oesophageal candidiasis)
Blood and lymphatic system disorders Uncommon Neutropenia
Immune system disorders Rare Anaphylactic reactions
Nervous system disorders Common Headache
Eye disorders Uncommon Conjunctivitis
Respiratory, thoracic and mediastinal disorders Common Rhinorrhoea
Gastrointestinal disorders Common Diarrhoea
    Nausea
  Uncommon Inflammatory bowel disease
Skin and subcutaneous tissue disorders Uncommon Urticaria
  Rare Exfoliative dermatitis
General disorders and administration site conditions Common Fatigue

*Placebo-controlled, phase III clinical studies in PsO, PsA, AS and nr-axSpA. Some of the doses and dose regimes used in these studies are not approved for use. See below for Cosentyx licensed dosing.**

AEs captured include patients exposed to Cosentyx 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (PsO) or 16 weeks (PsA, AS and nr-axSpA) of treatment duration; please refer to the Cosentyx SmPC for full prescribing information.
Corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Cases were reported in patients with psoriasis diagnosis.

Safety data and selected AEs from 21 clinical trials1

  PsO studies
Any Cosentyx (N=5181)
PsA studies
Any Cosentyx (N=1380)
AS studies
Any Cosentyx (N=794)
Total exposure, patient-years 10,416.9 3866.9 1943.1
Min–max exposure (days) 1−1825 8−1827 1−1530
Death, n (%) 9 (0.2) 11 (0.8) 5 (0.6)
Discontinuations due to AEs, n (%) 331 (6.4) 104 (7.5) 58 (7.3)
  EAIR per 100 patient-years (95% CI)
Any AE 204.4 (198.4, 210.5) 147.0 (138.9, 155.5) 140.1 (129.8, 151.0)
Any serious AE 6.9 (6.3, 7.4) 7.9 (7.0, 8.9) 6.3 (5.2, 7.6)
Most common AEs*      
Viral URTI 21.0 (19.9, 22.0) 12.1 (10.9, 13.4) 9.8 (8.4, 11.5)
Headache 6.2 (5.8, 6.8) 3.8 (3.2, 4.5) 5.3 (4.3, 6.5)
Diarrhoea 3.8 (3.4, 4.2) 3.7 (3.1, 4.4) 5.2 (4.2, 6.4)
URTI 5.4 (4.9, 5.9) 9.1 (8.1, 10.2) 5.2 (4.2, 6.4)
Selected AEs      
Serious infections 1.4 (1.2, 1.6) 1.9 (1.5, 2.4) 1.2 (0.8, 1.8)
Candida infections§ 2.2 (1.9, 2.5) 1.5 (1.1, 2.0) 0.7 (0.4, 1.2)
IBD 0.01 (0.00, 0.05) 0.05 (0.01, 0.2) 0.1 (0.0, 0.3)
Crohn’s disease 0.05 (0.02, 0.1) 0.08 (0.02, 0.2) 0.4 (0.2, 0.8)
Ulcerative colitis 0.1 (0.07, 0.2) 0.08 (0.02, 0.2) 0.2 (0.1, 0.5)
MACE| 0.3 (0.2, 0.5) 0.4 (0.3, 0.7) 0.6 (0.3, 1.1)
Neutropenia 0.3 (0.2, 0.4) 0.2 (0.1, 0.4) 0.5 (0.3, 1.0)
Uveitis 0.02 (0.0, 0.07) 0.1 (0.0, 0.2) 1.4 (0.9, 2.0)
Malignancy# 0.8 (0.6, 1.0) 1.1 (0.8, 1.5) 0.5 (0.2, 0.9)

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). Please see below for Cosentyx licensed dosing** or refer to the Cosentyx SmPC for full prescribing information.

*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

  Cosentyx 300 mg
  Year 1
N=168
Year 2
N=168
Year 3
N=157
Year 4
N=142
Year 5
N=134
  n (incidence rate per 100 subject-years)
Duration of exposure (patient-years)* 168.0 162.8 148.8 136.5 142.0
All AEs 131 (204.6) 126 (166.3) 109 (139.2) 91 (118.5) 77 (87.2)
All non-fatal SAEs 14 (8.8) 11 (6.9) 13 (9.1) 13 (10.1) 11 (8.0)
Death 0 0 0 0 1 (0.7)
Most frequent AEs          
Nasopharyngitis 30 (20.1) 27 (18.1) 25 (18.8) 17 (13.5) 15 (11.1)
Hypertension 11 (6.8) 8 (5.1) 3 (2.0) 7 (5.3) 5 (3.6)
Back pain 7 (4.3) 9 (5.7) 9 (6.2) 3 (2.2) 3 (2.1)
URTI 12 (7.5) 11 (7.1) 5 (3.5) 5 (3.8) 5 (3.6)
Headache 10 (6.2) 7 (4.4) 4 (2.7) 3 (2.2) 1 (0.7)
Selected rare AEs          
Opportunistic infections (other than TB and candidiasis) 0 0 0 0 0
TB 0 0 0 0 0
Candida infections          
Vulvovaginal candidiasis 3 (1.8) 3 (1.9) 1 (0.7) 0 0
Oral candidiasis 0 1 (0.6) 0 1 (0.7) 1 (0.7)
Neutropenia 0 0 0 0 0
MACE 0 0 0 1 (0.7) 1 (0.7)
Crohn’s disease 0 0 0 0 0
Ulcerative colitis 0 2 (1.2) 1 (0.7) 0 0
Malignant or unspecified tumours (excluding NMSC) 0 2 (1.2)§ 0 0 1 (0.7)

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

  Any Cosentyx
300mg (N=467)
Etanercept
(N=323)
Placebo
(N=327)
Exposure to study treatment, days* 320.7±75.3 331.9±89.7 95.3±61.0
  no. of patients with event (no. of cases per 100 patient-years)
Any adverse event 376 (252.0) 253 (243.4) 168 (329.7)
Death 0 0 0
Non-fatal serious adverse event 27 (6.8) 20 (7.0) 7 (8.3)
Discontinuation due to adverse event 14 12 3
Infection or infestation 269 (105.4) 170 (91.4) 65 (89.5)
Common adverse events§      
Nasopharyngitis 122 (35.2) 86 (35.7) 26 (32.8)
Headache 58 (15.7) 40 (15.2) 24 (29.6)
Diarrhoea 38 (9.9) 22 (7.9) 7 (8.4)
Pruritus 16 (4.0) 16 (5.7) 11 (13.2)
Arthralgia 24 (6.0) 23 (8.2) 10 (12.1)
URTI 26 (6.6) 18 (6.4) 3 (3.5)
Back pain 31 (7.9) 26 (9.3) 6 (7.1)
Cough 30 (7.6) 12 (4.2) 4 (4.8)
Hypertension 20 (5.0) 14 (4.9) 4 (4.7)
Nausea 11 (2.7) 7 (2.4) 7 (8.3)
Oropharyngeal pain 25 (6.3) 10 (3.5) 7 (8.3)

Data from the 150 mg group have not been presented here, as this dose is not approved for use in PsO. See below for Cosentyx licensed dosing** 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

Variable Cosentyx 300 mg (N=335)
n (incidence rate per 100
subject-years) [95% CI]
Ustekinumab (N=336)
n (incidence rate per 100
subject-years) [95% CI]
Any AE 286 (280.9) [249.3–315.4] 278 (250.1) [221.6–281.3]
Serious AEs 30 (9.6) [6.5–13.7] 26 (8.5) [5.5–12.4]
Death 0 1
Discontinued treatment due to AE 10 9
System organ class    
 Infections and infestations* 197 (98.4) [85.1–113.1] 194 (95.8) [82.8–110.3]
Most frequent individual AEs    
 Nasopharyngitis 77 (27.1) [21.4–33.8] 83 (31.0) [24.7–38.5]
 Headache 40 (13.5) [9.7–18.4] 41 (14.2) [10.2–19.3]
 Upper respiratory tract infection 31 (10.1) [6.9–14.3] 30 (9.9) [6.7–14.2]
 Arthralgia 25 (8.1) [5.3–12.0] 28 (9.2) [6.1–13.3]
 Diarrhoea 23 (7.5) [4.7–11.2] 24 (7.9) [5.1–11.8]
 Back pain 22 (7.1) [4.4–10.7] 26 (8.5) [5.6–12.5]

See below for Cosentyx licensed dosing** or refer to the Cosentyx SmPC for full prescribing information.

*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*

  Cosentyx
300 mg SC
(N=426)
Adalimumab
40 mg SC
(N=427)
Duration of exposure, mean days (SD) 351.7 (77.9) 332.9 (94.2)
Number of patients with any AE, n (%) 330 (77) 338 (79)
Number of patients with serious or other significant events    
 Death, n 1 0
 Non-fatal SAE, n (%) 32 (8) 28 (7)
 Discontinued study treatment due to AE, n (%) 17 (4) 32 (7)
AEs of interest, n (%)    
 Infections and infestations 237 (56) 234 (55)
  Serious infections 7 (2) 6 (1)
  Candida infections (high-level term) 16 (4) 7 (2)
 Viral infectious disorders 66 (15) 65 (15)
 Injection-site reactions 17 (4) 47 (11)
 Hypersensitivity 39 (9) 60 (14)
 MACE 2 (<1) 0
 IBD 2 (<1) 0
  Crohn’s disease 1 (<1) 0
  Ulcerative colitis 2 (<1) 0
 Malignancies 2 (<1) 3 (1)
Most frequent TEAEs, n (%)    
 Nasopharyngitis 81 (19) 80 (19)
 Upper respiratory tract infection 41 (10) 49 (11)
 Headache 35 (8) 32 (7)
 Diarrhoea 31 (7) 35 (8)
 Hypertension 27 (6) 23 (5)
 Oropharyngeal pain 25 (6) 15 (4)
 Psoriasis 24 (6) 25 (6)
 Arthralgia 23 (5) 29 (7)
 Psoriatic arthropathy 20 (5) 26 (6)
 Back pain 14 (3) 31 (7)
 Bronchitis 14 (3) 23 (5)
 Rash 8 (2) 21 (5)
 Injection-site reactions 4 (1) 28 (7)

See below for Cosentyx licensed dosing** or refer to the Cosentyx SmPC for full prescribing information.

*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

**In PsO, the recommended dose of Cosentyx is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as two subcutaneous injections of 150 mg. In PsA, for patients with concomitant moderate to severe PsO or who are anti-TNFɑ inadequate responders, the recommended dose is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as two subcutaneous injections of 150 mg. For other PsA patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 300 mg. In AS, the recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Based on clinical response, the dose can be increased to 300 mg. Each 300 mg dose is given as two subcutaneous injections of 150 mg. In nr-axSpA, the recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.8

AE, adverse event; AS, ankylosing spondylitis; CI, confidence interval; CV, cardiovascular; CRP, C-reactive protein;  CVA, cardiovascular accident; DMARD, disease-modifying anti-rheumatic drug; EAIR, exposure-adjusted incidence rate; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; MedDRA, Medical Dictionary for Regulatory Activities; MI, myocardial infarction; MTX, methotrexate; N, number of patients in the analysis; n, number of patients with a response; NMSC, non-melanoma skin cancer; nr-axSpA, non-radiographic axial spondyloarthritis; PASI, psoriasis area severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; RCT, randomised controlled trial; SAE, serious adverse event; SC, subcutaneous; SD, standard deviation; SmPC, summary of product characteristics; TEAE, treatment-emergent adverse event; TB, tuberculosis; TNF, tumour necrosis factor; URTI, upper respiratory tract infection.

References

  1. Deodhar A et al. Arthritis Res Ther 2019;21:111.
  2. Bissonnette R et al. J Eur Acad Dermatol Venereol 2018;32:1507–1514.
  3. Mease PJ et al. ACR Open Rheum 2020;2:18–25.
  4. Baraliakos X et al. RMD Open 2019;5:e001005.
  5. Langley RG et al. N. Engl J Med 2014;371:326–338.
  6. Blauvelt A et al. J Am Acad Dermatol 2017;76:60–69.
  7. McInnes IB et al. Lancet 2020;395(10235):1496–1505.
  8. Cosentyx Summary of Product Characteristics.
COS20-C008e(1) September 2020
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
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