Novartis will announce new evidence on Cosentyx for psoriatic arthritis

[Fred]

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Novartis announced today results from the FUTURE 5 study showing Cosentyx (secukinumab) reduced the signs and symptoms of psoriatic arthritis (PsA) while significantly inhibiting the progression of joint structural damage in PsA patients compared to placebo at 24 weeks.

Study participants (n=996) were randomized to receive Cosentyx, 300 mg with loading dosage (LD), 150 mg with LD, 150 mg without LD, or placebo. 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). mTSS is a detailed scoring method evaluating erosion in the joints.

Participants taking Cosentyx achieved significant improvements in the signs and symptoms of PsA compared to placebo, as measured by the ACR response criteria (ACR20) at 16 weeks, the study's primary endpoint. ACR is a standard tool used to assess improvement of PsA signs and symptoms such as tender and swollen joints, pain and physical functioning. 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 27.4% (placebo).

"With nearly 1,000 patients included in the study, FUTURE 5 is the largest randomized controlled trial of a biologic conducted to date in psoriatic arthritis," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. ""The results are encouraging as they provide important information about the ability of Cosentyx to address key areas of concern for physicians when managing the symptoms and the underlying progression of joint structural damage of psoriatic arthritis."

All hierarchical endpoints were significant for Cosentyx versus placebo at week 16 for all treatment arms, except for the 150 mg without LD in resolving enthesitis (tenderness or pain often occurring in the bottom of the foot, heel or elbow) and dactylitis (sausage-like swelling in the fingers or toes). Further, efficacy across all endpoints was greater in patients who had not been previously treated with anti-TNF therapies. Participants taking the 300 mg and 150 mg dosages with LD had an earlier onset of response versus participants who receive 150 mg without LD.

The safety profile was consistent with that observed in previous studies and similar across arms, with no new adverse events (AEs) identified.

Source: novartis.com