Swiss drugmaker Novartis says re-treatment with Cosentyx (secukinumab) for moderate to severe plaque psoriasis helps patients rapidly regain clear or almost clear skin (Psoriasis Area Severity Index, PASI 100 or 90) following relapse during a treatment pause. Results also revealed that during the re-treatment, there were no anti-Cosentyx antibodies in patients’ blood.
Novartis presented these results and other scientific abstracts at the 2017 American Academy of Dermatology (AAD) Annual Meeting, held March 3-7 in Orlando, Florida.
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. The analysis comes from two Phase 3 clinical trials FIXTURE (NCT01358578), and ERASURE (NCT01365455), which evaluated the safety and efficacy of Cosentyx compared to placebo in patients with plaque psoriasis.
The primary endpoint in both trials was the efficacy of Consentyx compared to placebo in reducing the PASI score by 75 percent after 12 weeks of treatment. PASI measures the redness, scaling and thickness of psoriatic plaques, and the extent of involvement in four regions of the body.
Secondary endpoints included the assessment of 90 percent reduction or better as measured by the PASI 90 and 100, which are higher standards of skin clearance compared to PASI 75. Other secondary measures included assessing how many patients developed anti-Consentyx antibodies, as well as maintaining PASI scores through 52 weeks of treatment.
The analysis comprised 181 patients treated with Cosentyx 300 mg who achieved a PASI 75 response after 52 weeks. These patients were then re-randomized to a placebo drug for every four weeks until they relapsed. At that point, they were re-retreated with 300 mg of Cosentyx.
With previous studies showing that it’s better to treat patients with Consetyx continuously rather than intermittently, this new analysis shows that if patients relapse during treatment pauses, most can still achieve previous efficacy levels after only 16 weeks of re-treatment with Cosentyx.
“It is very clear that patients get the best results from continuous treatment,” Vasant Narasimhan, global head of drug development at Novartis, said in a news release. “However, if for some reason treatment has been interrupted, this analysis gives patients and clinicians the peace of mind that Cosentyx is likely to help people quickly achieve clear skin once again.”
The U.S. Food and Drug Administration has approved Cosentyx to treat plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
Among the 136 patients who had previously achieved PASI 75 and who relapsed after treatment discontinuation, researchers found that after 16 weeks of re-treatment with Cosentyx, 94 percent of them regained a PASI 75 response. In addition, 117 patients (79 percent) who previously achieved PASI 90 score regained the same score after the 16 weeks of re-treatment with Cosentyx, while 67 percent of prior PASI 100 responders (67 patients) regained a PASI 100 response after the 16 weeks. The median time to relapse was 28 weeks.
The safety profile found in this analyses was consistent with that seen in previous Consetyx clinical trials. No patients tested positive for anti-Cosentyx antibodies. The most commonly observed adverse events in experienced by patients treated with Cosentyx were nasopharyngitis, arthralgia and infections of the upper respiratory tract.
“This study addresses a common issue in clinical practice that happens when plaque psoriasis patients are on biologic therapy and have to stop for any number of reasons, and then re-start the biologic,” said Andrew Blauvelt, MD, MBA, president of the Oregon Medical Research Center and lead study investigator. “Importantly, we found that stopping and re-starting Cosentyx led to good re-capture of clinical responses. Low immunogenicity associated with Cosentyx may offer a partial explanation of these results and warrants further analysis.”
