A new study looking at the promise of biologics in pediatric patients with moderate to severe psoriasis found that the therapy had high efficacy rates and a favorable side effect profile.
In recent years, a large number of randomized controlled trials have been published evaluating the safety, efficacy and irregular dosing regimen of various biologics in children with psoriasis.
However, there was no summative assessment.
Amy Paller, MD, professor and chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine, and fellow researchers chose to summarize data from existing randomized controlled trials to evaluate the safety and efficacy of biologics in the treatment of assess pediatric psoriasis.
The methods
Paller and colleagues first conducted a systematic review and meta-analysis of all available biological studies of childhood psoriasis.
Electronic searches were conducted using Medline, Embase, PubMed, the Cochrane Central Register of Controlled Trials, and the American College of Physicians Journal Club, from the start date to November 2020.
Eligibility for inclusion in the meta-analysis required completed randomized controlled trials evaluating pediatric patients with chronic plaque psoriasis. In addition, RCTs were required to compare the effect of a biologic with placebo or a non-biologic.
The abstracted efficacy outcomes were 75%, 90% and 100% improvements in Psoriasis Area and Severity Index (PASI) after 12-16 weeks of treatment.
Paller and researchers also used the physician’s global assessment *PGA) and the Child Dermatology Life Quality Index (CDLQI).
Safety endpoints included the proportion of patients who experienced 1 or more adverse reactions (AEs) and the proportion of patients who experienced 1 or more serious adverse reactions.
The findings
A total of 2,876 titles, abstracts and trial registration data were included in the study, as well as 2 studies identified from other sources. Studies focused on several biologics, including etancercept, adalimumab, ustekinumab, ixekizumab, and secukinumab.
Researchers reported that the odds ratio (OR) for achieving PASI75 at initial follow-up was 12.37 (95% CI: 6.23-24.55) with biologic treatment compared to placebo or a non-biologic agent.
Furthermore, the odds ratio to achieve PASI90 was 14.62 (95% CI: 3.81-56.09) and PASI100 was 22.96 (95% CI: 6.97-75.60) with biological treatment compared to placebo or a non-biological agent.
Meanwhile, the odds ratio of achieving PGA 0 or 1 (considered minimal psoriasis) was 12.65 (95% CI: 4.85-32.96) and the OR of achieving a CDLQI of 0/1 was 5. 26 (95% CI: 3.58-7.72). ) with biologic treatment, compared to placebo or a non-biologic agent.
For adverse events, the odds ratio at initial follow-up was 0.95 in patients treated with biologics compared to placebo or a non-biologic agent, while the odds ratio for a serious adverse event was 1.48.
Finally, Paller and colleagues recorded significant heterogeneity between studies involving patients achieving PASI75 and PASI90. The heterogeneity for all other outcomes was moderate or minimal.
“The results of this meta-analysis provide a compelling case for the use of biologic therapy in pediatric patients with moderate to severe psoriasis, as a highly effective therapy with a good safety profile at an initial follow-up of 12-16 weeks,” writes the team.
The study, “Biologics for Pediatric Psoriasis: A Systematic Review and Meta-analysis,” was published online in Pediatric Dermatology.
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