AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.
However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.
“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”
In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.
A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.
Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).
“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”
She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”
She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.
The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.