COSENTYX® is involved in normal inflammatory and immune responses.

COSENTYX® (secukinumab), the first and only fully
human interleukin 17A (IL-17A) antagonist, is indicated for the treatment of adult
patients with active AS, PsA, and moderate to severe plaque PsO. COSENTYX was
initially approved for the treatment of moderate to severe plaque PsO in adult
patients who are candidates for systemic therapy or phototherapy in January
2015. In January of 2016, the FDA approved expanded indications for COSENTYX
for the treatment of active PsA and AS in adult patients.

 

Mechanism of
Action

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IL-17A is a naturally occurring cytokine that is
involved in normal inflammatory and immune responses. Elevated levels of IL-17A
are found in psoriatic plaques, and increased quantities of IL-17A–producing
lymphocytes and innate immune cells and increased levels of IL-17A have also
been found in the blood of patients with PsA and AS. As shown in Figure 1, COSENTYX
is a monoclonal antibody that selectively binds to the IL-17A cytokine and
inhibits its interaction with the IL-17 receptor.

 The COSENTYX mechanism of action. COSENTYX selectively binds to IL-17A, thus
inhibiting the

interaction between IL-17A and its receptor. The clinical significance of the COSENTYX
mechanism of action is unknown.

“When treating patients with PsO, PsA, and AS, it’s important
that COSENTYX has a distinct mechanism because…” – Dr Mease

COSENTYX
for Patients With Active AS

 

AS is an inflammatory condition that affects
roughly 0.5% of Americans. Patients with AS experience sacroiliitis, spinal
inflammation, and enthesitis (Figure 2). A definitive diagnosis of AS requires
the presence of x-ray evidence of sacroiliitis, along with other clinical
criteria. AS typically appears first in young adulthood, with an average age of
disease onset estimated to be ~25 years of age. However, patients on average
experience a delay of nearly 9 years between disease onset and diagnosis,
placing the average age at diagnosis in the mid-30s. 

“We often see patients with AS who have been previously
misdiagnosed or were living with undiagnosed symptoms for some time…”

“Some common reasons for delays in AS diagnosis include…” –
Dr Schwartzman

 

Overview of the MEASURE
Clinical Trial Program

MEASURE 1 and MEASURE 2, two multicenter,
randomized, double-blind, placebo-controlled studies, evaluated the safety and
efficacy of COSENTYX in 590 adult patients aged 18 years and older with active
AS. MEASURE 1 was a phase 3 study of the efficacy and safety of intravenous (IV)
loading and subcutaneous (SC) maintenance dosing of COSENTYX versus placebo in
patients with active AS. MEASURE 2 was a phase 3 study of the efficacy and
safety of COSENTYX versus placebo in patients with AS that utilized SC loading
and maintenance dosing. COSENTYX is approved for administration by SC injection
for patients with AS. Therefore, we will focus on results from the MEASURE 2
study.

 

A schematic of the study design for MEASURE 2 is
presented in Figure 3. MEASURE 2 evaluated 219 adult patients with active AS,
defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
?4 despite the therapeutic use of nonsteroidal anti-inflammatory drugs (NSAIDs),
corticosteroids, or disease modifying antirheumatic drugs (DMARDs). The study
population included patients who were anti-tumor necrosis factor-? (TNF?) naive
(two-thirds of patients) and anti-TNF? experienced (one-third of patients).
Patients received an initial loading dose of COSENTYX 150 mg SC once weekly for
5 weeks, and continued with injections every 4 weeks thereafter. At week 16,
patients initially receiving placebo were assigned to an active drug arm and began
receiving COSENTYX on a monthly maintenance dosing regimen. The primary end
point was Assessment of SpondyloArthritis iternational NR5 Society
(ASAS) 20 response at week 16.

Efficacy of
COSENTYX in Patients With AS—Results From MEASURE 2

In MEASURE 2, patients treated with COSENTYX 150
mg demonstrated significantly greater improvements compared with placebo in ASAS20
(61% vs 28%, P1% of patients being nasopharyngitis, diarrhea, and upper respiratory tract
infection. Less than 1% of patients treated with COSENTYX developed antibodies
to secukinumab in up to 52 weeks of treatment—approximately 0.5% of patients
had antibodies that were classified as neutralizing, but neutralizing
antibodies were not associated with loss of efficacy.

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