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Novartis’s Cosentyx Demonstrated Phase III Clinical Efficacy in Reducing Psoriatic Arthritis Pain

November 8, 2017
Investigational biologic may relieve joint pain and tenderness in patients with PsA.

Joint pain and tenderness are leading symptom of psoriatic arthritis, which affects 30 percent of the 7.5 million Americans, including children, diagnosed with psoriasis.1,2

A promising new biologic from Novartis, secukinumab (“Cosentyx”), may help to reduce these and other common PsA symptoms, according to results of the company’s FUTURE 5 study.3

Arthritic footNovartis's new biologic may reduce foot and other pain caused by psoriatic arthritis.

Announced at the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in San Diego, Phase III data demonstrated that the investigational drug significantly inhibited the progression of joint structural damage in psoriatic arthritis (PsA) patients compared to placebo at 24 weeks.

In the randomized, controlled study including just over 1,000 participants (n=996), subjects were given 300 mg of secukinumab with loading dosage (LD), 150 mg with LD, 150 mg without LD, or placebo. Groups received medication or placebo at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks. “At week 24, more participants treated with Cosentyx had no worsening of joint structural damage compared to placebo, as measured by the modified total van der Heijde Sharp score (mTSS) <=0.5; 88% (300 mg), 80% (150 mg), 84% (150 mg without LD), and 74% (placebo),” according to the release.

Using American College of Rheumatology response criteria (ACR20), which assessed tender and swollen joints, pain and physical functioning, study participants taking the medication versus placebo also reported significant improvements in PsA signs and symptoms compared to placebo at 16 weeks, the study’s primary endpoint.  The number of ACR20 responders at week 16 were: 62% (300 mg, p < 0.0001), 55% (150 mg, p < 0.0001), 59% (150 mg without LD, p < 0.0001), and 27% (placebo), according to the study results.   

In fact, all but one hierarchical endpoint for the Phase III trial of secukinumab demonstrated significance at the primary endpoint for all treatment arms: the 150 mg without LD in resolving enthesitis (ie, tenderness or pain at the bottom of the foot, heel, or elbow) and dactylitis (ie, sausage-like swelling of fingers or toes). Researchers reported that efficacy across all endpoints was lower in patients who had previously received anti-TNF therapies. Participants who received 300 mg and 150 mg dosages with LD reported an earlier onset of response compared to those who received 150 mg without LD.

Last updated on: November 9, 2017
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