EXPERT ANALYSIS FROM THE ANNUAL SOUTH BEACH SYMPOSIUM
MIAMI BEACH (FRONTLINE MEDICAL NEWS) – Two of the newest treatments available for psoriasis – apremilast and secukinumab – are true “game-changers,” according to Dr. David M. Pariser.
Apremilast (Otezla), a recently approved oral phosphodiesterase 4 inhibitor, will be a particularly attractive treatment option for many dermatologists and patients, he said at the South Beach Symposium.
Apremilast has a very limited effect on the immune system, and it’s an oral therapy and thus requires no needles. It is very safe – with “strikingly few” serious adverse events – and no laboratory monitoring is required, he explained.
Efficacy results with apremilast are modest. In the phase III ESTEEM trial , for example, 33% of patients achieved at least 75% improvement (PASI-75), compared with 5% of patients who received placebo, said Dr. Pariser of Eastern Virginia Medical School, Norfolk, and an investigator for the trial.
Further, the drug can be used for almost any patient and type of psoriasis; it is an option for those who want systemic therapy, but who don’t want to go on a biologic or methotrexate, and its use is not precluded by a history of cancer or infections, as is the case with biologics, he added.
Apremilast also will be attractive for dermatologists who do not currently prescribe systemic therapy for psoriasis, or who don’t use aggressive systemic therapy for psoriasis, he said.
“If a prescriber feels safety is more important than efficacy, this might be a good choice,” he said.
Secukinumab (Cosentyx), on the other hand, is a “big gun,” Dr. Pariser said of the biologic, which was approved in January 2015 for the treatment of adults with moderate to severe plaque psoriasis.
“It’s the biggest gun we’ve got now … and it really has a safety profile similar to existing biologics so far,” he said.
The fully human monoclonal antibody inhibits interleukin-17A and is administered by subcutaneous injection. Its safety and efficacy were demonstrated in numerous of studies involving about 4,500 patients. Treatment was associated with significant improvement, compared with placebo, said Dr. Pariser, who also was an investigator on secukinumab trials.
Of note, while the PASI-75 findings for secukinumab are “a nice number but not dramatically higher than things we have had in the past,” the PASI-90 and PASI-100 scores are remarkable, he said.
At the highest dose studied (300 mg given at weeks 1, 2, 3, 4, and 8, and monthly thereafter), PASI-90 was achieved by 59% of patients in one study, and PASI-100 was achieved in 28%.
“That’s significant. We haven’t had that before, and that is really, really, really nice,” he said.
Further, the primary efficacy endpoint of the study was outcome at 12 weeks, but patients continued to improve at least until 16 weeks.
PASI-100 – no psoriasis whatsoever – was 40% at 16 weeks, he said.
In another phase III trial, secukinumab was again shown to be superior to placebo, but it also compared favorably with etanercept, he noted.
Safety was reasonable in the secukinumab trials. No deaths occurred, but there were more serious adverse events and discontinuations in the active treatment group. Nasopharyngitis was the most common serious adverse events, and it occurred in all groups. Upper respiratory tract infections appeared to be more common in the secukinumab patients, he noted.
An important consideration with secukinumab, however, is the need for continuous treatment, he said.
“The bottom line, really, is that patients should stay on it. They will lose effectiveness if they go off of it or take it on an as-needed basis,” he said.
Dr. Pariser is a consultant and/or researcher for Amgen, AbbVie, Celgene, Eli Lilly, Janssen Pharmaceuticals, Merck, and Pfizer.
