Adalimumab Effective in Children and Adolescents with Severe Psoriasis

By Will Boggs MD

NEW YORK (Reuters Health) - Adalimumab offers benefits over methotrexate in children and adolescents with severe chronic plaque psoriasis, according to a phase 3 trial.

The tumor necrosis factor (TNF) inhibitors etanercept and adalimumab are approved by the European Medicines Agency for treating severe plaque psoriasis in children as young as 4 years. But only etanercept is approved for the pediatric indication in the U.S.

Dr. Kim Papp from Probity Medical Research, in Waterloo, Canada, and colleagues from 38 clinics in Europe and North America investigated the safety and efficacy of adalimumab compared with methotrexate in 114 children and adolescents with severe plaque psoriasis.

At week 16, the proportion of patients who achieved at least a 75% improvement from baseline in Psoriasis Area and Severity Index score (PASI75) was significantly higher with adalimumab 0.8 mg/kg (22/38, 58%) than with methotrexate (12/37, 32%). With adalimumab 0.4 mg/kg, 44% of patients (17/39) achieved PASI75.

More patients in the adalimumab 0.8 mg/kg group (61%) than in the methotrexate group (41%) or adalimumab 0.4 mg/kg group (41%) also achieved a physician global assessment (PGA) score of clear (0) or minimal (1) after 16 weeks, but the differences fell short of statistical significance.

Children's dermatology life quality index scores improved to a nonsignificantly greater extent with adalimumab 0.8 mg/kg than with methotrexate. And pediatric quality of life scores were significantly better in the higher-dose adalimumab group than in the methotrexate group, the researchers report in The Lancet, online May 4.

Treatment withdrawal led to loss of disease control in most patients, but retreatment with adalimumab successfully recovered therapeutic responses in many patients, the researchers note.

More than two-thirds of patients reported adverse events, and adverse event profiles were similar between the groups.

"Our findings suggest that adalimumab is a safe and efficacious treatment option for severe pediatric plaque psoriasis," the researchers conclude.

Dr. Alan Menter from Baylor University Medical Center, in Dallas, Texas, who coauthored an accompanying editorial, told Reuters Health by email, "As adalimumab is approved for 2 other pediatric indications, i.e., Crohn’s and Juvenile Idiopathic Arthritis (JIA), I do believe it will play an important role in pediatric psoriasis once approved.”

He added, “Psoriasis, as compared to other immune-mediated diseases - rheumatoid arthritis, Crohn’s, ulcerative colitis - has 10 major comorbidities, including arthritis in 35% of patients, cardiovascular issues, ​etc., yet the use of any form of systemic therapy for patients with moderate-severe psoriasis is extremely low in the U.S.; for both adults and kids, i.e., only 21% (approx. 300,000) of the eligible 1.4 million patients in the U.S. with moderate-severe psoriasis are being treated with any form of systemic or biologic therapy . . .”

“Long-term safety data have yet to be reported,” the editorial, coauthored by Dr. Dario Kivelevitch, also at Baylor, concluded. “However, available long-term studies in pediatric patients with other immune-mediated disorders have shown adalimumab to be associated with higher risks of serious adverse events and infections but not with severe infections, malignancies, or death compared with methotrexate. Further studies are required to assess the short-term and long-term efficacy and safety of systemic treatments in children and adolescents with psoriasis.”

Dr. Awatef Kelati from University Hospital Hassan II in Fez, Morocco, who recently discussed concerns with comorbidities among pediatric psoriasis patients, told Reuters Health by email, "In addition to the treatment of the symptoms and before making the decision of biologic treatment for severe psoriasis, it is obligatory to search for comorbidities in children, especially metabolic syndrome, because these comorbidities may make the treatment more difficult and the disease more resistant, and it was proven that the management of the comorbidities may improve psoriasis and reduce its severity.”

“Treatment with adalimumab 0.8 mg/kg may be a good option for the treatment of severe plaque psoriasis in children aged more than 4 years old and adolescents,” Dr. Kelati concluded.

Dr. Papp did not respond to a request for comments.

AbbVie funded the study, employed three of the authors and had various relationships with the rest and with Dr. Menter.

SOURCE: http://bit.ly/2r7T06l and http://bit.ly/2qanNl6

Lancet 2017.

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