Seven recent developments in psoriasis

Research finding that Otezla demonstrated an acceptable safety profile through at least 3 years of treatment among patients with psoriasis was among the recent developments reported on Healio.com/Dermatology.

Other developments included findings that patients with psoriasis treated with biologics have minimal risk of hepatitis B, C reactivation, and the FDA acceptance of a biologics license application for tildrakizumab for treating moderate-to-severe psoriasis:

Otezla demonstrates safety up to 3 years in patients with psoriasis

Otezla demonstrated an acceptable safety profile through at least 3 years of treatment among patients with psoriasis, according to recently published study results in the Journal of the American Academy of Dermatology.

Researchers studied safety findings from 0 to at least 156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2 trials. Read more

FDA accepts biologics license application for tildrakizumab for treating psoriasis

Sun Pharma announced that the FDA has accepted a biologics license application for tildrakizumab for treating moderate-to-severe plaque psoriasis.

The filing was based on two phase 3 randomized, placebo-controlled, multicenter, three-part studies trials of more than 1,800 patients with moderate-to-severe plaque psoriasis. Read more

Factors of methotrexate-induced epidermal necrosis identified

Researchers identified early signs and risk factors of methotrexate-induced epidermal necrosis, and physicians should use caution when deciding when to prescribe methotrexate to high-risk patients, according to recently published study results in the Journal of the American Academy of Dermatology.

The researchers in Taiwan enrolled 24 patients with methotrexate-induced epidermal necrosis (MEN; mean age, 65.8 years; 13 men) and 150 methotrexate-tolerant controls (mean age, 40.7 years; 86 men) between 2007 and 2016. Read more

European committee gives positive opinion for brodalumab for psoriasis

The European Committee for Medicinal Products for Human Use has given a positive opinion to recommend marketing authorization for brodalumab for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, according to LEO Pharma.

Brodalumab, a fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A, is not currently licensed in the European Union, LEO Pharma reported in a news release. Read more

Patients with psoriasis treated with biologics have minimal risk of hepatitis B, C reactivation

Patients with moderate-to-severe psoriasis without hepatitis who were seropositive for hepatitis B core antibody only or hepatitis C infection, and who were being treated with biologic therapies, had minimal or no risk for viral reactivation, according to study results recently published in the Journal of the American Academy of Dermatology.

“Up to 37.2% of patients with moderate-to-severe psoriasis are treated with biologic therapies,” Igor Snast, MD, of the dermatology department, Rabin Medical Center Beilinson Hospital, Petach Tikva, Israel, and colleagues wrote. Read more

FDA approves biosimilar for infliximab

Today, the FDA has approved Merck and Samsung Bioepis’ infliximab biosimilar for injection, which is known as infliximab-abda (Renflexis). It will maintain the same indications as the reference product.

“Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the United States by offering them treatment options at a lower cost,” Christopher Hansung Ko, President and CEO of Samsung Bioepis, said in a press release. Read more

Valeant announces pricing for Siliq for plaque psoriasis

Valeant Pharmaceuticals International announced that the company will list Siliq injection at $3,500 per month for patients with moderate-to-severe plaque psoriasis.

The FDA approved Siliq (brodalumab) injection as treatment for moderate-to-severe plaque psoriasis in February. Read more