More moving moments are possible with COSENTYX

At Week 16 vs placebo

Cosentyx Patient Experiences, AS Clinical Trials

*MEASURE 2 (AS 1): A multicenter, randomized, double-blind, placebo-controlled trial that evaluated 219 adult patients with active AS who received COSENTYX 150 mg (n=72) or placebo (n=74) subcutaneously at Weeks 0, 1, 2, 3, and 4 followed by the same dose every 4 weeks. The primary end point was ASAS20 at Week 16. At Week 16, patients who received placebo were rerandomized to either COSENTYX 75 mg or 150 mg every 4 weeks. Patients had active disease that was defined by a BASDAI score ≥4 despite use of NSAIDs, corticosteroids, or DMARDs. At baseline, up to 11% of patients used methotrexate and up to 14% of patients used sulfasalazine. Responses were similar in patients regardless of concomitant therapies.1,2

BASFI results: 35% mean reduction with COSENTYX 150 mg vs 11% with placebo (P=0.0001) at Week 16. Mean baseline score of BASFI: 6.2 (in 150-mg group), 6.1 (in placebo group). Mean change at Week 16: -2.2, -0.7, respectively.1-3

BASMI results: 14% mean improvement in spinal mobility with COSENTYX 150 mg vs 5% with placebo at Week 16. Mean baseline score of BASMI: 3.6 (in 150-mg group), 3.9 (in placebo group). Mean change at Week 16: -0.5, -0.2, respectively.1-3

§Spinal pain results: 43% reduction in total spinal pain with COSENTYX 150 mg vs 16% with placebo (P=0.0001). As 1 of the 4 domains in the ASAS improvement criteria, total spinal pain is measured on a 0-mm (no symptoms) to 100-mm (severe symptoms) VAS. Mean baseline score of total spinal pain: 66.2 (in 150-mg group), 69.2 (in placebo group). Mean change at Week 16: -28.5, -10.9, respectively.1-3

||Dosing: 150 mg once a week for the first 5 weeks and monthly thereafter.1

Get your patients started on COSENTYX >

ASAS response rates remained consistent through 3 years4#

Anti–TNF Naive Patients Achieved ASAS20 and ASAS40 Response Rates Through 3 Years, Graph

#MEASURE 2 uncontrolled exploratory analysis: As observed in a subgroup from baseline through Week 156.4

After Week 16, patients knew they were taking the active treatment but remained blind to the dose. After 1 year, patients were unblinded and continued to receive the same active dose as open-label treatment and were assessed every 8 weeks through 2 years and then every 12 weeks through 3 years.4

As with other uncontrolled extension studies, this phase of the study has limitations (eg, no placebo comparisons). 75-mg arm was included in this study, but not shown here as it is not an approved dose.4

About 1/3 of patients were anti–TNF-α experienced but responses were seen regardless of prior anti–TNF-α exposure.1,4

All data presented are as observed; patients with missing data at a specific time point are not included in the analysis.4

ASAS20/40 response rates as observed were lower in the mixed population (n=72).4

n is the total number of subjects in the treatment group with ASAS20 evaluation.4

ASAS is a tool used to assess improvement in signs and symptoms of AS. Response criteria include improvements in physical function (BASFI), spinal pain, patient global assessment, and inflammation (morning stiffness).2

Get your patients started on COSENTYX > Cosentyx Adverse Reactions Table, AS Clinical Trials Cosentyx Selected Adverse Events Table, AS Program

**Adverse reactions listed are ≥2% and at a higher proportion in the COSENTYX groups than the placebo groups.1

††75 mg or 150 mg administered as IV or subcutaneous dose (pooled outcome).5

‡‡The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.1

Get your patients started on COSENTYX >

AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society criteria; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; BASMI=Bath Ankylosing Spondylitis Metrology Index; DMARDs=disease-modifying antirheumatic drugs; NSAIDs=nonsteroidal anti-inflammatory drugs; TNF=tumor necrosis factor; VAS=visual analog scale.

References: 1. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018. 2. Data on file. CAIN457F2310 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2014. 3. Data on file. Conversion data tables for ankylosing spondylitis. Novartis Pharmaceuticals Corp; January 2016. 4. Data on file. CAIN457F2310 Abbreviated Clinical Study Report. Novartis Pharmaceuticals Corp; June 2017. 5. Data on file. AIN457H Summary of Clinical Safety in (Ankylosing Spondylitis). Novartis Pharmaceuticals Corp; February 2015.