Ustekinumab effective against moderate-to-severe plaque psoriasis in adolescent
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Ustekinumab Effective Against Moderate-to-Severe Plaque Psoriasis in Adolescents
Psoriasis is a skin disease associated with red, itchy and scaly patches. It can be observed in any age group, with one-third of the patients having symptoms before 20 years of age. Safe, effective and convenient therapies should be provided for pediatric patients with moderate-to-severe psoriasis.
There are many drugs used for the treatment of psoriasis, both in adults and children. Ustekinumab is a human monoclonal antibody targeting the p40 subunit of interleukin-12/23 and has proven to be a safe and effective treatment for mild-to-moderate psoriasis in the adult population. Most of the clinical trials, for example, PHOENIX trials, has proved that ustekinumab effectively reduces signs and symptoms of psoriasis in adults. This trial was perfomed to determine the efficacy of ustekinumab in adolescent patients of 12 to 17 years with active psoriasis.
To determine the safety and efficacy of ustekinumab in adolescent patients of age 12 to 17 years who had moderate-to-severe psoriasis.
The study was a phase 3, multicenter, double-blind, placebo-controlled study.
Dichotomous endpoints were analyzed using a Cochran Mantel Haenszel test, with baseline weight ≤ or ≥ 60 kg. Continuous variables were analyzed using analysis of variance on the van der Waerden normal scores, with baseline weight as a binary covariate.
A total of 110 patients who met inclusion criteria were included in the study and were randomly assigned to receive ustekinumab standard dose (SD) (36 patients), ustekinumab half-standard dose (HSD) (37 patients) and placebo crossover to SD in 18 patients and HSD in 19 patients.
The patients taken for the study were 12 to 17 years old. The patients should be diagnosed with moderate-to-severe plaque psoriasis, with baseline Psoriasis Area and Severity Index (PASI)≥12, a Physician’s Global Assessment (PGA) ≥ 10% body surface involved with psoriasis for more than 6 months, and psoriasis patients poorly controlled with topical therapy were included in the study.
Patients without psoriasis and patients with severe health conditions were excluded from the study.
Patients were randomly assigned (2:2:1:1) to receive ustekinumab HSD (half-standard dose) or SD (standard dose) at weeks 0, 4, 16 and thereafter every 12 weeks through week 4. Clinical response was evaluated using the PGA and PASI. The primary end point was determining the proportion of patients with a PGA 0/1 at week 12 and secondary end points were the proportion of patient’s acheiving at least 75 % and 90 % improvement in PASI at week 12. Through week 52, assessments were performed.
Net of response was rapid, nearly one third patients in each ustekinumab group achieved PGA 0/1 during the first post-baseline visit (week 4) compared to only one patient in the placebo group.
At week 12, the proportion of patients achieving PGA 0/1 and PGA 0 were significantly greater when compared to placebo group with p value was less than 0.001 for both the groups.
Similarly, the proportion of the patients achieving PASI 75 (at least 75% improvement in PASI), PASI 90 (at least 90% improvement in PASI), and PASI score of 0 (cleared) was significantly greater in HASD and SD groups compared with the placebo.
Through week 12, 51.4% of patients in the HSD group, 44.4% in the SD group and 56.8% in the placebo group reported more than one adverse events. The most common adverse event was nasopharyngitis and headache. There were no malognancies, active tuberculosis cases, infections, anaphylactic reactions through week 60.
In the patient population of 12 to 17 years, the standard ustekinumab dose provided response comparable to that in adults with no unexpected adverse events through one year.
Based on the above results, ustekinumab appears to provide a beneficial and convenient treatment option for moderate-to-severe psoriasis in the pediatric population age of 12 years and older.
Landells L, et.al. Ustekinumab in adolescent patient’s age 12 to 17 years with moderate-to-severe plaque psoriasis: Results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct; 73(4):594-603.
Available at: http://www.ncbi.nlm.nih.gov/pubmed/26259989/
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