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Andrew Blauvelt, M.D., M.B.A.Included in the 18 oral and poster presentations on secukinumab (Cosentyx, Novartis) given for the first time at AAD 2015: head-to-head results between secukinumab and ustekinumab (Stelara, Janssen), as well as long-term phase 3 data on the IL-17A inhibitor (American Academy of Dermatology annual meeting).
In the Phase 3b CLEAR study, secukinumab met the primary endpoint of superiority to ustekinumab, as assessed by the Psoriasis Area Severity Index (PASI) 90 response, according to Andrew Blauvelt, M.D., M.B.A., president of the Oregon Medical Research Center and lead study investigator. At week 16, 79% of secukinumab patients achieved a PASI 90 versus 57.6% of those on ustekinumab.
“The secondary endpoint found 50% of Cosentyx patients achieved PASI 75 at week four, compared to 20.6% of Stelara patients…,” Dr. Blauvelt writes in an email to Dermatology Times. “In an exploratory analysis, completely clear skin (PASI 100) at week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara (44.3% versus 28.4%). The safety profile of Cosentyx was comparable to Stelara and consistent with previously reported phase III clinical trials for Cosentyx.”
The CLEAR data demonstrate secukinumab compares favorably to ustekinumab. And that’s an important message for psoriasis patients and the doctors who treat them, according to Dr. Blauvelt. CLEAR, which stands for comparison to assess long-term efficacy, safety and tolerability of secukinumab vs. ustekinumab, is a 52-week, multicenter, randomized, double-blind study in patients with moderate-to-severe plaque psoriasis.
“As a clinician, I have seen, first-hand, the impact that moderate-to-severe plaque psoriasis can have on patients’ lives and the frustration some feel when they are unable to achieve clear or near-clear skin,” he writes.
In the extension of the FIXTURE and ERASURE studies, 995 patients who achieved PASI 75 response after a year of therapy received either Cosentyx 300 mg, Cosentyx 150 mg or placebo for one more year. After two full years of therapy, seven out of 10 patients treated with Cosentyx 300 mg had clear or almost clear skin (PASI 90); more than 4 out of 10 had clear skin (PASI 100); and nearly 9 in 10 patients maintained a PASI 75 response at week 104, according to Dr. Blauvelt.
Among patients treated with Cosentyx 150 mg, 44.6% achieved PASI 90; 23.5% had clear skin, or PASI 100; and 75.5% maintained their PASI 75 response at week 104. In the study, 94.8% of patients who initially received placebo at the start of the extension and were switched to receive Cosentyx 300 mg after relapse, were able to achieve PASI 75. And 70.3% achieved PASI 90 within 12 weeks of re-starting Cosentyx treatment, according to the dermatologist.
“The two-year data is significant because it represents results from the longest continuous phase 3 study to date evaluating an IL-17A antagonist in the treatment of psoriasis. The study not only strengthens our understanding of the efficacy and safety of Cosentyx, but reiterates that it is an important new longer-term treatment option for patients with moderate-to-severe plaque psoriasis,” Dr. Blauvelt writes.
Cosentyx demonstrated an acceptable safety profile.
The most common adverse events for the 300mg and 150mg treatment arms were: nasopharyngitis, at 24.1% at the higher dose and 17.0% at the lower; upper respiratory tract infection, at 5.3% and 5.0%; hypertension, at 4.3% at the higher dose 5.2% at the lower; headache, at 5.6% and 2.9%; and arthralgia, at 4% and 4.2%, respectively.
Infections and infestations were reported in 53.1% of patients receiving Cosentyx 300 mg and 41.6% of those on 150 mg. Six percent of patients suffered a serious adverse event in any Cosentyx dose, but there were no deaths reported during the study, according to Dr. Blauvelt.
Still in question…
Studies still haven’t demonstrated whether long-term use of secukinumab or other biologics has a positive benefit on cardiovascular function, over time.
“I believe this will likely be the case, however, given that long-term biologic therapy for patients with rheumatoid arthritis has been associated with decreased risk of cardiovascular disease in these patients,” Dr. Blauvelt writes. “The data on IL-17A inhibitors presented at AAD continue to demonstrate the benefit of this new mechanism of action. As with any new therapy, additional long-term safety studies are needed.”
Reviewed by: Mark Lebwohl, M.D., professor and chairman, department of dermatology, Icahn School of Medicine at Mount Sinai, New York, N.Y.
For more on this topic:
Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. http://www.ncbi.nlm.nih.gov/pubmed/?term=ERASURE+and+FIXTURE+studies
Andrew Blauvelt, M.D., M.B.A.
Disclosures: Abbott, Amgen, Astellas, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Galderma, Janssen, Merck, Novartis, Pfizer and Sandoz.