Therapeutics Focus: Psoriasis

Brodalumab Treatment Efficacious

Brodalumab, an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis, achieved 100 percent reduction in psoriasis symptoms in twice as many patients as a second, commonly used treatment, according to the results of a multicenter clinical trial led by Mount Sinai researchers and published in the New England Journal of Medicine.

After 12 weeks, 44 percent of patients randomized to receive the greater 210mg every-other-week dosage of brodalumab in one study had achieved PASI 100, compared with 22 percent of patients treated with ustekinumab. In the second study, 37 percent of patients randomized to receive the greater 210-mg every-other-week dosage of brodalumab achieved PASI 100, compared with 19 percent of patients treated with Stelara. With greater dosage of brodalumab, 86 percent of patients achieved PASI 75. Frequencies of the most common adverse events were similar in both groups.

AstraZeneca and Valeant Pharmaceuticals recently entered into an agreement under which Valeant will have an exclusive license to develop and commercialize brodalumab.

Ustekinumab for Adolescent Patients

To evaluate ustekinumab in patients age 12 to 17 years with moderate-to-severe psoriasis, patients, 110 subjects were randomly assigned to ustekinumab standard dosing (SD; 0.75 mg/kg [≤60 kg], 45 mg [>60-≤100 kg], and 90 mg [>100 kg]) or half-standard dosing at weeks 0 and 4 and every 12 weeks or placebo at weeks 0 and 4 with crossover to ustekinumab SD or HSD at week 12. At week 12, 67.6 percent and 69.4 percent of patients receiving ustekinumab HSD and SD, respectively, achieved PGA 0/1 versus 5.4 percent for placebo. Significantly greater proportions receiving ustekinumab achieved PASI 75 (HSD, 78.4 percent; SD, 80.6 percent; placebo, 10.8 percent) or PASI 90 (HSD, 54.1 percent; SD, 61.1 percent; placebo, 5.4 percent) at week 12.

—J Am Acad Dermatol. Vol 73, Issue 4: 594-603.

Baxalta, Momenta Pharma Initiate M923 Trial in Chronic Plaque Psoriasis

Baxalta and Momenta Pharmaceuticals, Inc. initiated a pivotal clinical trial for M923, a biosimilar version of adalimumab. The trial will compare the safety, efficacy and immunogenicity of M923 with adalimumab. The companies are targeting first regulatory submission in 2017 and commercial launch in 2018.

Clinical Conversations: Psoriasis

Jerry Bagel, MD and Neil J. Korman, MD discuss topical treatment options for psoriasis and share insights about the effect of vehicles on adherence.

“It’s really critical that if you want people to be adherent to their therapy that you talk to them when they know and say ‘I want an ointment’..or ‘I want a cream’ or ‘I want a gel’...,” says Dr. Korman.

Watch the full episode of Clinical Conversations:
dermtube.com/series/clinical-conversations-vehicles/topical-treatment-considerations-for-psoriasis/

Psoriasis Linked to Depression

Psoriasis was associated with the risk of major depression, and the risk was unrelated to the severity of the disorder, according to an article published online by JAMA Dermatology. Study authors examined the relationship between psoriasis and major depression in a nationally representative group, after adjusting for cardiovascular risk because prior research has suggested depression and psoriasis are associated with CVD.

Authors identified 351 (2.8 percent) cases of psoriasis and 968 (7.8 percent) cases of major depression among 12,382 US residents. There were 58 (16.5 percent) patients with psoriasis who met the criteria for a diagnosis of major depression. The average patient questionnaire score was higher among patients with a history of psoriasis than those without. Further analyses suggested the risk of major depression was not different between patients with limited vs. extensive psoriasis.

Trends in Biologic Treatment Market

Decision Resources Group finds that Abbvie’s Humira (adalimumab) is the biologic most prescribed for moderate to severe psoriasis, although Amgen/Pfizer’s Enbrel (etanercept) has a more favorable reimbursement environment. The survey suggests that Humira and Enbrel will experience erosion as payers expect to make biosimilar adalimumab available at preferential formulary positions, and institute policies to encourage their use. Read more on DermWire.com. n