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Treatment Option for Moderate-to-Severe Plaque Psoriasis
San Diego—Approximately 2.2% of the US population has psoriasis, making it the most common autoimmune disease in the United States. This disease greatly impacts quality of life, especially the lives of those diagnosed with moderate-to- severe psoriasis, which is approximately one-fourth of all psoriasis patients. “We call this moderate-to-severe psoriasis, but this is a level of psoriasis at which patients are really suffering,” said Steven Feldman, MD, PhD, professor, Wake Forest Baptist Medical Center, during a science and innovation theater at AMCP.
Earlier this year, the FDA approved secukinumab for the treatment of moderate-to-severe plaque psoriasis. Dr. Feldman reviewed the current findings on this drug focusing on its efficacy as a treatment option. The science and innovation theater was sponsored by Novartis Pharmaceuticals Corporation.
Secukinumab is a human interleukin-17A antagonist approved for the treat- ment of plaque psoriasis in adults who are authorized to receive phototherapy or systemic therapy. The recommended dose is 300 mg delivered by subcutaneous injection at the start of treatment and at Week 1, 2, 3, and 4. After Week 4, a 300 mg dose is given every 4 weeks. A dose of 150 mg may be adequate for some patients. Secukinumab may be administered via a single-use Sensoready® pen or a single-use prefilled syringe. Secukinumab is not approved for use in patients hypersensitive to secukinumab or any of its excipients.
Clinical Trials
“A lot of what we know about drugs does not come from the mechanism of action, it comes from doing the clinical trials,” said Dr. Feldman. Secukinumab was assessed in 4 mulitcenter, randomized, double-blind, placebo-controlled trials in 2403 participants with plaque psoriasis who demonstrated a minimum body surface area involvement of 10% and a Psoriasis Area and Severity Index (PASI) score of ≥12. All the participants were candidates for phototherapy or systemic therapy.
Of the 2403 participants, 691 were given secukinumab 300 mg, 692 were given secukinumab 150 mg, 694 were given the placebo, and 323 received a biologic active control.
In trial 1, a PASI score of 90 was achieved at Week 12 with secukinumab 300 mg and secukinumab 150 mg compared to placebo in 59% of participants and 39% of participants versus 1% of participants, respectively. In Trial 2, a PASI score of 90 was achieved at Week 12 with secukinumab 300 mg and secukinumab 150 mg compared to placebo in 54% of participants and 42% of participants versus 2% of participants in Trial 2, respectively. Trial 3 and 4 experienced similar results.
Of the participants in Trial 1 who achieved a PASI score of 75 at Week 12, 81% of those receiving secukinumab 300 mg maintained their responses at 52 weeks as well as 72% of participants who received secukinumab 150 mg.
Trial 2 also saw similar results. Of the participants who achieved a PASI score of 75 at 12 weeks, 84% who received secukinumab 300 mg maintained their responses, while 82% of participants who received secukinumab 150 mg maintained their responses.
Adverse Reactions
Adverse reactions that were reported in >1% of participants through Week 12 in Trials 1, 2, 3, and 4 included nasopharyngitis (secukinumab 300 mg, 11.4%; secukinumab 150 mg, 12.3%), diarrhea (secukinumab 300 mg, 4.1%; secukinumab 150 mg, 2.6%), and upper respiratory tract infection (secukinumab 300 mg, 2.5%; secukinumab 150 mg, 3.2%).
Warnings and Precautions
Serious infections did occur in patients taking secukinumab. Avoid prescribing to patients with tuberculosis. The clinical trials saw exacerbations in some patients with Crohn’s disease. Healthcare professionals should exercise caution when prescrib- ing secukinumab in patients with active Crohn’s disease.—Melissa D. Cooper
