Cosentyx (secukinumab) is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation. Cosentyx is used to treat plaque psoriasis, ankylosing spondylitis, active psoriatic arthritis, active non-radiographic axial spondyloarthritis (nr-axSpA), and active enthesitis-related arthritis, in specific patients. Cosentyx belong to a group of medicines called interleukin inhibitors.

How long does Cosentyx take to work for skin plaque psoriasis ?

• When taking Cosentyx (300mg) for skin psoriasis the time it takes to get a 50% skin clearance is 3 weeks (median).
• To measure the severity of psoriasis, a score is used called the PASI (Psoriasis Area and Severity Index). This looks at how severe the skin lesions are and also the area of the body that is affected. This is what they use in studies to measure how well skin psoriasis medicines work. In studies they look for a reduction in PASI score eg a PASI 25 would be a reduction in severity of psoriasis by 25%.
• By 12 weeks of Cosentyx treatment, the number of patients who had a 75% reduction in their psoriasis (PASI 75) was 77.1% of patients. Then by 16 weeks, the number of patients with a PASI 75 had increased to 86.7% of patients. The effect of Cosentyx on skin psoriasis starts within the first couple of weeks of starting the medication and skin keeps improving even up to 4 months.

How long does Cosentyx take to work for psoriatic arthritis?

• In clinical trials to measure how well or how fast psoriatic arthritis medicines work, a criteria was designed by ARC (American College of Rheumatology) that takes in consideration the different aspects of psoriatic arthritis. It measures the percentage of improvement there has been in psoriatic arthritis symptoms. An ACR20 is a 20% improvement in symptoms, and ARC50 is a 50% improvement in symptoms.
• In psoriatic arthritis, the time it takes for Cosentyx (300mg) to work to get 50% of the patients to have an ACR20 is just over 4 weeks.
• By 16 weeks the number of psoriatic arthritis patients who had reached ARC20 was 62.6 %, and the percentage of patients who had reached ARC50 was 39.6%.
• To measure the success of treatment for psoriatic arthritis medicines it is also important to look whether there is a reduction or stoppage of disease progression. In the FUTURE 5 study it showed that 91.8% of patients on Cosentyx 300mg had no radiographic disease progression throughout the 52 weeks studied.

How long does Cosentyx take to work for Ankylosing Spondylitis?

• Ankylosing Spondylitis (AS) response to medicines is measured by Assessment of SpondyloArthritis International Society (ASAS) response criteria. This looks at four different areas of assessment (called domains) of AS. An ASAS20 is an improvement of at least 20%, plus an absolute improvement of 1 unit of three domains without a worsening of the other domain. An ASAS40 is an improvement of at least 40%.
• When on Cosentyx (150mg) for ankylosing spondylitis the time it takes to get 50% of the patients to have an ASAS20 (20% improvement in AS) response is approximately 3 weeks. The ASAS40 response at 3 weeks is over 20%, and the number of patients in this group continues to increase up until 8 weeks.
• By 16 weeks the number of patients who had an ASAS20 response in their AS had increased up to 61.1% of patients, and the number of patients who had an ASAS40 response was 36.1%.
• Ankylosing spondylitis is a disease that causes health to worsen over time, if it is not treated. The success of ankylosing spondylitis treatment can also be measured by whether there is a reduction or halt of disease progression. In the MEASURE 1 study, x rays showed that 79% of patients on long-term Cosentyx 150 mg therapy had no definite disease progression.

How long does Cosentyx take to work for Non-radiographic Axial Spondyloarthritis?

• Non-radiographic Axial Spondyloarthritis response to medicines is measured by the percentage of people who have a 40% improvement in Assessment of Spondyloarthritis International Society (ASAS40).
• In the clinical trial called nr-axSpA1 by 16 weeks 13% of patients with non-radiographic axial spondyloarthritis had a response of ASA40 (40% improvement) and this increased to 19% by week 52. This was the difference between using a placebo and Cosentyx 150 mg monthly.

How long does Cosentyx take to work for enthesitis-related arthritis?

• In clinical trials to measure how well or how fast medicines work for the types of juvenile idiopathic arthritis (JIA), they use the system designed by ARC (American College of Rheumatology). It takes into consideration core set variables (CRV) and the percentage of improvement in symptoms. JIA ACR30 response criteria is defined as a greater than or equal to 30% improvement in three or more of six CRVs, with no more than one of the remaining CRVs worsening by greater than 30%. Enthesitis-related arthritis (ERA) is a subtype of juvenile idiopathic arthritis (JIA).
• In the clinical trial (Phase III JUNIPERA trial - NCT03031782) using secukinumab to treat JIA (both enthesitis-related arthritis and juvenile psoriatic arthritis), in week one 33.7% of patients had a JIA ACA30. By week four, JIA ACA30 had increased to 81.4%, and by week 12, JIA ACA30 was 87.2%.
• In the same trial using secukinumab to treat ERA, at week 12 of the trial 84.6% had a JIA ACA30, 78.8% had a JIA ACA50, 65.4% had a JIA ACR70, 32.7% had a JIA ACA90, and 26.9% had a JIA ACR100. The number of patients at 12 weeks with the inactive disease was 38.5%. The number of patients at 12 weeks who had a resolution of enthesitis was 72.3%, and 50% had resolution of dactylitis.

What conditions is Cosentyx an approved medicine by the FDA?

Cosentyx is FDA-approved to specifically to treat these patients:

• moderate to severe plaque psoriasis (raised, silvery flaking of the skin) in patients 6 years and older, who are who are candidates for systemic therapy or phototherapy.
• active psoriatic arthritis (PsA) for patients 2 years and older.
• active ankylosing spondylitis (AS) in adults.
• active non-radiographic axial spondyloarthritis (nr-axSpA) in adults, who have objective signs of inflammation.
• active enthesitis-related arthritis (ERA) in patients who are 4 years and older.

Bottom line:

• The time it takes to get a 50% skin clearance (PASI 50) for psoriasis is 3 weeks (median) when using 300mg dose of Cosentyx.

• In psoriatic arthritis the time it takes for Cosentyx (300mg) to get 50% of the patients to have an ACR20 is just over 4 weeks.

• When on a dose of 150mg Cosentyx for ankylosing spondylitis the time it takes to get 50% of the patients to have an ASA20 response is just 3 weeks. The ASA40 response at 3 weeks is over 20% and number of patients getting to ASA40 continues to increase up until 8 weeks.

• For non-radiographic axial spondyloarthritis 13% of patients have an ASA40 (40% improvement) at 16 weeks which increases up to 19% by 52 weeks. These figures are the difference between using placebo and Cosentyx 150 mg monthly.
• For enthesitis-related arthritis by week four 81.4% had achieved JIA ACA30.