Novartis announces new Cosentyx data in psoriasis treatment, including long-term study

Researchers presented new data on the use of the fully human IL-17A inhibitor Cosentyx (secukinumab, Novartis) in moderate-to-severe psoriasis, at the 25^th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, September 28 through October 2, 2016.

Among the studies presented, four-year data from A2304E1, a multicenter, double-blind, open-label extension study, evaluating the drug’s long-term safety and efficacy in the treatment of moderate-to-severe plaque psoriasis.

Six hundred and forty-two patients who had completed 52 weeks of the core SCULPTURE and STATURE studies entered the extension study. But the results presented at the meeting represent 168 patients who continued on Cosentyx 300 mg every four weeks. Other groups in the study took lower doses of the drug. At baseline, there were 168 patients on Cosentyx 300 mg. At year one, 165 patients remained and at year four, there were 131 patients remaining.

According to the release, 68.5 percent of patients taking Cosentyx 300 mg every 4 weeks achieved a Psoriasis Area Severity Index (PASI) 90 in year one, or week 52. Nearly 62 percent of those patients had PASI 90 at year three and PASI 90 was maintained in 66.4 percent of patients at year four.

At year one, 43.8 percent of patients had completely clear skin, or PASI 100. At year three, 41.7 percent of patients were completely clear, and that was maintained in 43.5 percent of patients at year four.

Nearly 89 percent of patients achieved PASI 75 at year one; 78.4 percent at year three and that was maintained in 88.5 percent of patients at year four.

The two most common adverse events were nasopharyngitis, occurring in 12.1 percent of those taking Cosentyx, and upper respiratory tract infection, in 3.5 percent of those in the study. Those findings were similar to the data researchers observed at year one, according to the release. 

In another study presented at the same meeting, researchers shared data suggesting Cosentyx benefitted patients with palmoplantar psoriasis for up to 1.5 years. Researchers compared Cosentyx to placebo in patients with moderate-to-severe palmoplantar plaque psoriasis and reported that, at week 16, about 40 percent of patients achieved clear or almost clear palms and soles with Cosentyx 300 mg every 4 weeks. Outcomes continued to improve with about 60 percent of patients achieving clear or almost clear palms and soles at 1.5 years.

At week 80, 47 of the 69 patients taking Cosentyx in the palmoplantar study reported adverse effects, compared to 27 of the 68 patients taking placebo.

Researchers also presented at the European meeting on a study looking at the use of Cosentyx for moderate-to-severe scalp psoriasis and reported that 52.9 percent of patients taking Cosentyx 300 mg achieved Psoriasis Scalp Severity Index (PSSI) 90 versus 2 percent on placebo at week 12.

Slightly more than half of patients in the treatment arm experienced adverse events; interestingly, 49 percent of controls also reported adverse events.

Dermatologist Lindsey Bordone, M.D., at Columbia Doctors and assistant professor in dermatology at Columbia University Medical Center, says encouraging data is always good news for psoriasis patients. The more options; the merrier. But, Dr. Bordone says she doesn’t worry about biologics losing their effectiveness with time.

“If I'm going to start a biologic, it's because the patient is not doing well on topicals, and [the] psoriasis has covered enough of his or her skin that he or she is uncomfortable, embarrassed or impaired in his or her day to day life,” Dr. Bordone says. “So, even if the biologic may lose effectiveness over time, they may still have many years of feeling great and enjoying life while on medication.”

Dr. Bordone says she has psoriasis patients who have been on TNF inhibitors, such as Enbrel (etanercept, Amgen) and Humira (adalimumab, Abbvie), for six to eight years without loss of efficacy.

“During this time, other medications such as Stelara (ustekinumab, Janssen), Otezla (apremilast, Celgene), and Cosentyx have been developed. Thus, my thought process is don't … worry about what may happen in several years. Make this patient comfortable today, and when one medication isn't working as well anymore, move onto the next…,” she says. “…by the time that one isn't helping, there will be several other new options as drug development progresses for psoriasis. 

Dr. Bordone has no conflicts of interest on this topic.