Cosentyx® (secukinumab): Safety profile and side effects
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1
Please refer to the Summary of Product Characteristics (SmPC) for further information. The UK SmPC can be found here.
Cosentyx has a consistent safety profile across indications, demonstrated by a decade of real-world clinical experience*1,2
*Since first indication in 2015 for eligible adults with moderate to severe plaque psoriasis.2
1.6 million+ patients treated globally, across indications, since launch3
No discontinuations in pooled clinical trial data and real-world evidence (RWE) due to Candida infections, with all being non-serious and mild to moderate in severity, except four cases in the PsO pool that were considered severe4
No trend towards increased rates of major adverse cardiovascular event (MACE), malignancy or inflammatory bowel disease (IBD) reported over time in clinical trials or RWE5
In paediatric patients with PsO, Cosentyx demonstrated a safety profile consistent with adult indications1
The safety and efficacy of Cosentyx
in children with PsO and in JIA categories of ERA and JPsA below the age of 6 years have not been established1
Please read the full warnings and precautions (found in the SmPC) when prescribing Cosentyx.
RWE shows a consistent safety profile up to 9 years in adult indications1
No trend towards increased adverse event (AE) rates over time (pooled data; AS, PsA and PsO in a PSUR including exposure in clinical trials and marketing experience).5
Successive time periods of PSUR shown with cumulative rate: 26 Dec 2014 to 25 June 2015; 26 June 2015 to 25 Dec 2015; 26 Dec 2015 to 25 June 2016; 26 June 2016 to 25 Dec 2016; 26 Dec 2016 to 25 Dec 2017; 26 Dec 2017 to 25 Dec 2018; 26 Dec 2018 to 25 Dec 2019; 26 Dec 2019 to 25 Dec 2020; 26 Dec 2020 to 25 Dec 2023.5
Cosentyx has the potential to increase the risk of infections.1
Cosentyx is not recommended in patients with IBD.1
Please refer to the SmPC for special warnings and precautions for use.1
Source: Novartis Data on File, 2025.5
Safety profile findings comparable across Cosentyx 300 mg Q2W and Q4W regimens in patients with PsO weighing ≥90 kg6
The recommended dose is Cosentyx 300 mg SC with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.1 Based on clinical response, a maintenance dose of 300 mg every 2 weeks may provide additional benefit for patients with a body weight of 90 kg or higher.1
Treatment-emergent AEs, n (%) | Cosentyx | Cosentyx | Cosentyx |
All AEs | 127 (77.0) | 97 (72.4) | 24 (77.4) |
AEs possibly related to Cosentyx | 34 (20.6) | 29 (21.6) | 5 (16.1) |
All nonfatal SAEs | 14 (8.5) | 17 (12.7) | 4 (12.9) |
Deaths | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Discontinued study treatment due to AEs | 4 (2.4) | 9 (6.7) | 2 (6.5) |
Treatment-emergent SAEs by system organ class term‡ | |||
Infections and infestations | 1 (0.6) | 6 (4.5) | 2 (6.5) |
Injury, poisoning and procedural complications | 3 (1.8) | 3 (2.2) | 1 (3.2) |
Gastrointestinal disorders | 0 (0.0) | 4 (3.0) | 1 (3.2) |
Cardiac disorders | 1 (0.6) | 3 (2.2) | 1 (3.2) |
Respiratory, thoracic and mediastinal disorders | 3 (1.8) | 1 (0.7) | 0 (0.0) |
Musculoskeletal and connective tissue disorders | 3 (1.8) | 0 (0.0) | 0 (0.0) |
General disorders and administration site conditions | 2 (1.2) | 1 (0.7) | 0 (0.0) |
Most frequent AEs by preferred term§ | |||
Nasopharyngitis | 32 (19.4) | 22 (16.4) | 5 (16.1) |
Upper respiratory tract infection | 12 (7.3) | 9 (6.7) | 3 (9.7) |
Headache | 11 (6.7) | 6 (4.5) | 1 (3.2) |
Diarrhoea | 10 (6.1) | 6 (4.5) | 2 (6.5) |
Arthralgia | 7 (4.2) | 6 (4.5) | 2 (6.5) |
Oropharyngeal pain | 3 (1.8) | 7 (5.2) | 2 (6.5) |
Cough | 7 (4.2) | 2 (1.5) | 2 (6.5) |
Back pain | 3 (1.8) | 6 (4.5) | 2 (6.5) |
AEs of special interest |
|
|
|
Infections and infestations (SOC) | 76 (46.1) | 63 (47.0) | 18 (58.1) |
Hypersensitivity (SMQ narrow) | 14 (8.5) | 6 (4.5) | 0 (0.0) |
Candida infections (HLT) | 3 (1.8) | 6 (4.5) | 1 (3.2) |
Neutropenia (NMQ narrow) | 7 (4.2) | 5 (3.7) | 3 (9.7) |
IBD (NMQ narrow) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
MACE (NMQ) | 0 (0.0) | 2 (1.5) | 0 (0.0) |
Table adapted from Augustin M, et al. 2022.6
†One patient who did not receive any treatment after randomisation was excluded from the Q4W safety analyses.6
‡n≥3 in the overall study population.6
§n≥10 in the overall study population.6
Cosentyx showed a comparable safety profile across both Q2W and Q4W maintenance dosing in eligible PsO patients6
Data from SUNSHINE and SUNRISE show a consistent safety profile in HS7
In SUNSHINE and SUNRISE ≤3% of patients discontinued treatment due to any AE.7
| SUNSHINE (n=541) | SUNRISE (n=543) | ||||
Outcome (Week 16) | Cosentyx | Cosentyx | Placebo | Cosentyx | Cosentyx | Placebo |
Patients with any AEs, n (%) | 122 (67) | 118 (66) | 120 (67) | 113 (63) | 114 (63) | 116 (63) |
Most common AEs by preferred term, n (%) | ||||||
Headache | 17 (19) | 20 (11) | 14 (8) | 21 (12) | 17 (9) | 15 (8) |
Nasopharyngitis | 20 (11) | 16 (9) | 13 (7) | 13 (7) | 9 (5) | 16 (9) |
Hidradenitis | 11 (6) | 5 (3) | 24 (13) | 10 (6) | 11 (6) | 14 (8) |
Most common serious AEs by preferred term (two or more events in any group) | ||||||
Hidradenitis | 1 (1) | 0 (0) | 2 (1) | 1 (1) | 0 (0) | 0 (0) |
Patients with serious or other significant events, n (%) | ||||||
Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
Non-fatal SAEs | 3 (2) | 3 (2) | 6 (3) | 6 (3) | 6 (3) | 5 (3) |
Discontinued study | 5 (3) | 1 (1) | 1 (1) | 1 (1) | 4 (2) | 4 (2) |
AEs of special interest, n (%) | ||||||
Infections and infestations | 59 (33) | 51 (28) | 53 (29) | 52 (29) | 59 (33) | 62 (34) |
URTI | 33 (18) | 26 (14) | 22 (12) | 27 (15) | 21 (12) | 29 (16) |
Fungal infectious disorders | 12 (7) | 1 (1) | 7 (4) | 7 (4) | 13 (7) | 3 (2) |
Candida infections | 2 (1) | 1 (1) | 4 (2) | 5 (3) | 5 (3) | 2 (1) |
Hypersensitivity | 12 (7) | 9 (5) | 9 (5) | 7 (4) | 5 (3) | 7 (4) |
IBD¶ | 0 (0) | 0 (0) | 0 (0) | 1 (1) | 1 (1) | 0 (0) |
Malignant or unspecified tumours | 0 (0) | 0 (0) | 1 (1) | 0 (0) | 2 (1) | 1 (1) |
MACE | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Adapted from Kimball AB, et al. 2023.7
¶One case of IBD and one case of ulcerative colitis were reported.6
Cases of IBD have been reported with Cosentyx; therefore, it is not recommended in patients with IBD. Please refer to the SmPC for full safety information.1
Summary of AEs from clinical trials and post-marketing experience4
The most frequently reported AEs were upper respiratory tract infections (17.1%; most frequently nasopharyngitis, rhinitis). The safety profile is consistent across indications.1
Adapted from Cosentyx SmPC.1
Please refer to the SmPC for full prescribing information and safety profile.1
Safety considerations and precautions1
Cosentyx is contraindicated in:
Patients with hypersensitivity to active substance or to any of the excipients
Clinically important, active infection, e.g., active tuberculosis
Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated.
Cases of new or exacerbations of inflammatory bowel disease have been reported with Cosentyx. Cosentyx is not recommended in patients with IBD. If a patient develops signs or symptoms of IBD or experiences an exacerbation of pre-existing IBD, Cosentyx should be discontinued and appropriate medical management should be initiated.
Cosentyx has the potential to increase the risk of infections. Serious infections have been observed in patients receiving Cosentyx in the post-marketing setting. Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or a history of recurrent infection. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and Cosentyx should not be administered until the infection resolves. Please see the SmPC for full information.
Rare cases of anaphylactic reactions and angioedema have been observed in patients receiving Cosentyx. If an anaphylactic reaction, angioedema or other serious allergic reaction occurs, administration of Cosentyx should be discontinued immediately and appropriate therapy initiated.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment. As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy. Because of the potential for adverse reactions in nursing infants from Cosentyx, a decision on whether to discontinue breastfeeding during treatment and up to 20 weeks after treatment, or to discontinue therapy with Cosentyx, must be made, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the woman.
Live vaccinations should not be given concurrently with Cosentyx. Please see the SmPC for full information regarding vaccinations.
The removable needle cap of Cosentyx 150 mg in pre-filled syringe and 150 mg pre-filled pen contains a derivative of natural rubber (latex). Use in latex-sensitive individuals has not been studied and there is therefore a potential risk of hypersensitivity reactions which cannot be completely ruled out.
In psoriasis studies, the safety and efficacy of Cosentyx in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. Cosentyx was administered concomitantly with MTX, sulfasalazine and/or corticosteroids in arthritis studies (including in patients with PsA and AS). Caution should be exercised when considering concomitant use of other immunosuppressants and Cosentyx.
Hepatitis B virus (HBV) reactivation can occur in patients treated with Cosentyx. In accordance with clinical guidelines for immunosuppressants, testing patients for HBV infection is to be considered before initiating treatment with Cosentyx. Patients with evidence of positive HBV serology should be monitored for clinical and laboratory signs of HBV reactivation during Cosentyx treatment. If reactivation of HBV occurs while on Cosentyx, discontinuation of the treatment should be considered, and patients should be treated according to clinical guidelines.
Please refer to the SmPC for detailed safety profile data and full prescribing and administration information, including dosing in special populations and warnings/precautions.1
Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated. Please refer to the Cosentyx SmPC for full product information before prescribing.1
Study designs
Augustin et al: Multicentre, double-blind, parallel-group trial (N=331) in adult patients with moderate to severe PsO weighing ≥90 kg, randomised to receive Cosentyx 300 mg Q2W or Q4W. The primary endpoint was PASI 90 response at Week 16. Secondary endpoints included the proportion of patients achieving an IGA mod 2011 score of 0 or 1 (indicating clear or almost clear skin) at Week 16, and clinical safety and tolerability measures (clinical laboratory parameters, vital signs, electrocardiograms and AEs) up to Week 52. At Week 16, Q2W dosing (n=165) led to significantly higher PASI 90 responses vs Q4W (n=166) with 73.2% vs 55.5%, respectively (OR: 2.3; 95% CI: 1.4–3.8; p=0.0003).6
SUNSHINE and SUNRISE: Identical, multicentre, randomised, placebo-controlled, double-blind Phase III trials. They were conducted in 219 primary sites in 40 countries. Patients (SUNSHINE N=541; SUNRISE N=543) were randomised to receive 300 mg Cosentyx Q2W, Cosentyx 300 mg Q4W group or placebo in a double-dummy fashion as per treatment assignment. Efficacy assessments included HS clinical response, abscess and inflammatory nodule count, flares and skin pain. The primary objective of both trials was clinical efficacy at Week 16. Secondary endpoints included mean percentage change from baseline in abscess and inflammatory nodule count at Week 16, the proportion of patients with flares over 16 weeks and the proportion of patients at Week 16 with a 30% or more reduction and reduction of two units or more of skin pain on a continuous numeric rating scale (NRS30) (assessed in patients with a baseline numeric rating of three or more). For both groups, the primary endpoint was met in the Cosentyx Q2W group. In SUNRISE, the Q4W also met the primary endpoints. In SUNSHINE, the primary endpoint was not met in the Cosentyx Q4W group.7
Therapeutic indications1
Cosentyx is indicated for the treatment of moderate to severe PsO in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active PsA in adult patients (alone or in combination with MTX) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active AS in adults who have responded inadequately to conventional therapy; active nr-axSpA with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe HS (acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active ERA in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active JPsA in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1
AE, adverse event; AS, ankylosing spondylitis; EAIR, exposure-adjusted incidence rate; ERA, enthesitis-related arthritis; HBV, hepatitis B virus; HLT, high-level term; HS, hidradenitis suppurativa; IBD, inflammatory bowel disease; IGA, investigator global assessment; JPsA, juvenile psoriatic arthritis; MACE, major adverse cardiovascular event; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; NRS30, numeric rating scale 30; NMQ, Novartis MedDRA query; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; RWE, real-world evidence; SAE, serious adverse event; SmPC, summary of product characteristics; SMQ, standardised MedDRA queries; SOC, standard of care; URTI, upper respiratory tract infection.
References
Cosentyx® (secukinumab) Summary of Product Characteristics.
European Medicines Agency. Summary of positive opinion EMA/CHMP/670/0627/2015. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cosentyx_en.pdf [Accessed June 2025].
Novartis Data on File. Secukinumab (SEC018). February 2025.
Deodhar A, et al. Arthritis Res Ther 2019;21(1):111.
Novartis Data on File. Secukinumab (SEC020). April 2025.
Augustin M, et al. Br J Dermatol 2022;186(6):942–954.
Kimball AB, et al. Lancet 2023;401(10378):747–761
UK | June 2025 | FA-11328326-1
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.