Cosentyx (secukinumab) - 7 indications

Scroll down for information on each indication:

• for the treatment of plaque psoriasis in patients six years of age and older; approved January 2015; June 2021
• for the treatment of ankylosing spondylitis; approved January 2016
• for the treatment of psoriatic arthritis; approved January 2016
• for the treatment of active non-radiographic axial spondyloarthritis; approved June 2020
• for the treatment of active enthesitis-related arthritis (ERA) in patients four years and older, and active psoriatic arthritis (PsA) in patients two years and older; approved December of 2021
• for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults; approved October of 2023

General Information

Cosentyx (secukinumab) is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines. 

Cosentyx is specifically indicated for the following indications:

• moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy
• adult patients with active psoriatic arthritis
• adult patients with active ankylosing spondylitis
• adult patients with active non-radiographic axial spondyloarthritis (nraxSpA) with objective signs of inflammation
• active enthesitis-related arthritis (ERA) in patients four years and older, and active psoriatic arthritis (PsA) in patients two years and older
• moderate to severe hidradenitis suppurativa (HS) in adults

Cosentyx is supplied as a solution for subcutaneous or intravenous injection. Perform the following evaluations prior to Cosentxy initiation:

• Evaluate patients for tuberculosis (TB) infection. Cosentyx initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of Cosentyx
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with Cosentyx

Scroll down for dosing/administration recommendations for each indication.

Mechanism of Action

Cosentyx (secukinumab) is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.  

Side Effects

Adverse effects associated with the use of Cosentyx may include, but are not limited to, the following:

• nasopharyngitis
• diarrhea
• upper respiratory tract infection

Indication 1 - the treatment of plaque psoriasis in patients six years of age and older

approved January 2015 (adults); June 2021 (pediatrics)

Dosing/Administration

Adults

• The recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dosage is given as 2 subcutaneous injections of 150 mg. For some patients, a dose of 150 mg may be acceptable.

Pediatric Patients

• The recommended dosage for pediatric patients 6 years of age and older is based on body weight (see table below) and administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.

Clinical Trial Results

The FDA approval of Cosentyx for plaque psoriasis was based on four multicenter, randomized, double-blind, placebo-controlled trials in 2,403 subjects (691 randomized to Cosentyx 300 mg, 692 to Cosentyx 150 mg, 694 to placebo, and 323 to a biologic active control) 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12, and who were candidates for phototherapy or systemic therapy. In all trials, the endpoints were the proportion of subjects who achieved a reduction in PASI score of at least 75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the Investigator’s Global Assessment modified 2011 (IGA). In these studies, Cosentyx met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator's Global Assessment modified 2011 (IGA) 0/1 responses, showing significant skin clearance at Week 12.

Indication 2 - the treatment of ankylosing spondylitis

approved January 2016

Dosing/Administration

Administer Cosentyx with or without a loading dosage by subcutaneous injection. The recommended dosage:

• With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks

If a patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg every 4 weeks.

Recommended Intravenous Dosage

Cosentyx injection for intravenous use requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adult patients with active AS:

• With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage).
•  Without a loading dosage is 1.75 mg/kg every 4 weeks. Administer as an intravenous infusion over a period of 30 minutes 
• Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in patients with AS

Clinical Trial Results

The FDA approval of Cosentyx for active ankylosing spondylitis (AS) was based on the efficacy and safety outcomes from two AS and two PsA placebo-controlled Phase III studies which included more than 1,500 adult patients with either AS or PsA. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at Week 16 and a 20% reduction in the American College of Rheumatology (ACR20) response criteria at Week 24, respectively.

Indication 3 - the treatment of psoriatic arthritis

approved January 2016

Dosing/Administration

For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis.

For other psoriatic arthritis patients, administer Cosentyx with or without a loading dosage by subcutaneous injection. The recommended dosage:

• With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks

If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg every 4 weeks.

Cosentyx may be administered with or without methotrexate.

Intravenous administration in adults:

Cosentyx injection for intravenous use  requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adults with PsA:

• With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage).
•  Without a loading dosage is 1.75 mg/kg every 4 weeks. Administer as an intravenous infusion over a period of 30 minutes 
• Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults with PsA

Clinical Trial Results

The FDA approval of Cosentyx for active psoriatic arthritis (PsA) was based on the efficacy and safety outcomes from two AS and two PsA placebo-controlled Phase III studies which included more than 1,500 adult patients with either AS or PsA. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at Week 16 and a 20% reduction in the American College of Rheumatology (ACR20) response criteria at Week 24, respectively.

Indication 4 -  the treatment of active non-radiographic axial spondyloarthritis

approved June 2020

Dosing/Administration

Administer Cosentyx with or without a loading dosage by subcutaneous injection. The recommended dosage:

• With a loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks

Recommended Intravenous Dosage

Cosentyx injection for intravenous use requires dilution prior to intravenous administration. The recommended intravenous dosage regimen in adult patients with active nr-axSpA:

• With a loading dosage is 6 mg/kg loading dose given at Week 0, followed by 1.75 mg/kg every 4 weeks thereafter (maintenance dosage).
• Without a loading dosage is 1.75 mg/kg every 4 weeks. Administer as an intravenous infusion over a period of 30 minutes 
• Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in patients with nr-axSpA

Clinical Trial Results

The FDA approval of Cosentyx for active non-radiographic axial spondyloarthritis was based on the Phase 3 PREVENT trial, which demonstrated the efficacy of Cosentyx in active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of the axial spondyloarthritis (axSpA) disease spectrum. In that study, Cosentyx met the primary endpoint achieving statistically significant improvements in the signs and symptoms of nr-axSpA. 

Indication 5 and 6 - active enthesitis-related arthritis (ERA) in patients four years and older, and active psoriatic arthritis (PsA) in patients two years and older

approved December of 2021

Dosing/Administration

In children and adolescents the recommended dosing is 75 mg (body weight: 15 kg to less than 50 kg) or 150 mg (50 kg or more). Cosnetyx is administered as a subcutaneous injection by a pre-filled syringe or Sensoready pen every four weeks after initial loading doses. With appropriate guidance/instruction from a healthcare professional, Cosentyx can be administered by an adult caregiver outside of a healthcare provider's office via a single-dose prefilled syringe or Sensoready pen.

Clinical Trial Results

The FDA approval is based on data from the Phase III JUNIPERA study, a two-year, three-part, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled 86 children and adolescents aged 2 to 18 years old with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria. The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104). In children and adolescents aged 2 to 18 years old, the study demonstrated that patients with active JPsA (n = 34; mean age: 12.2) treated with Cosentyx had a longer time to flare, showing an 85% reduction in the risk of flare versus placebo. The study also demonstrated that patients with active ERA (n = 52; mean age: 13.7) treated with Cosentyx had a significantly longer time to flare, showing a 53% reduction in the risk of flare versus placebo. Safety in this pediatric population was consistent with the known safety profile of Cosentyx for the treatment of plaque psoriasis, PsA, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Indication 7 - moderate to severe hidradenitis suppurativa (HS) in adults

 approved October of 2023

Dosing/Administration

Recommended dosage is 300 mg administered by subcutaneous injection at Weeks 0, 1, 2, 3 and 4 and every 4 weeks thereafter. If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks

Clinical Trial Results

FDA approval was based on analyses from the phase 3 SUNSHINE and SUNRISE trials, in which a higher proportion of patients given Cosentyx 300 mg either every two weeks or every four weeks achieved a Hidradenitis Suppurativa Clinical Response (HiSCR50) compared to placebo. In both the SUNSHINE and SUNRISE studies, which evaluated Cosentyx across 16-week (vs placebo) and 52-week treatment periods, the onset of action of Cosentyx occurred as early as Week 2. Efficacy progressively increased to Week 16 and was observed up to Week 52.