Novartis announces study data demonstrating Cosentyx reduced signs and symptoms of psoriatic arthritis while inhibiting progression of joint structural damage.
Novartis announced 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. The Phase III data were presented Tuesday for the first time as a late breaker during the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Diego.
PsA is estimated to affect up to 2 million people in the U.S. and is characterized by joint pain and stiffness.2
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 percent (300 mg), 80 percent (150 mg), 84 percent (150 mg without LD), and 74 percent (placebo).1 The mTSS is a detailed scoring method evaluating erosion in the joints.3
“People living with psoriatic arthritis deal with the daily impact of pain, tender joints, as well as the potential of reduced mobility, and irreversible joint damage,” said Philip Mease, M.D., director of the Rheumatology Clinical Research Division of Swedish Medical Center and lead study investigator and clinical professor at the University of Washington School of Medicine in Seattle. “A treatment that reduces the signs and symptoms of psoriatic arthritis and addresses the disease on a structural level by slowing the progression of joint damage could offer a significant benefit for patients.”
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.1 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 percent (300 mg, P < 0.0001), 55 percent (150 mg, P < 0.0001), 59 percent (150 mg without LD, P < 0.0001), and 27 percent (placebo).1
“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).1,2 Further, efficacy across all endpoints was greater in patients who had not been previously treated with anti-TNF therapies.1 Participants taking the 300 mg and 150 mg dosages with LD had an earlier onset of response versus participants who received 150 mg without LD.1
The safety profile was consistent with that observed in previous studies and similar across arms, with no new adverse events (AEs) identified.1,4 The most common AEs at week 16 were upper respiratory tract infection, headache, hypertension, and urinary tract infection.4
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References:
1 Mease, PJ et al. Subcutaneous Secukinumab Inhibits Radiographic Progression in Psoriatic Arthritis: Primary Results from a Large Randomized, Controlled, Double-Blind Phase 3 Study. Presented as a late-breaker at the Annual Meeting of the American College of Rheumatology. November 7, 2017.
2 National Psoriasis Foundation. Media Kit. Available at: https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Last accessed October 2017.
3 van der Heijde, D. Psoriatic arthritis imaging: a review of scoring methods. BMJ. 2005; 64(Suppl II):ii61–ii64. doi: 10.1136.
4 Data on File. CAIN457F2342 (FUTURE 5) Data Analysis Report. Novartis Pharmaceuticals Corp; Sept 2017
(Source: Novartis Pharmaceuticals Corp.)
Filed Under: Drug Discovery