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11th June 2021
Psoriasis is a chronic, inflammatory conditions that affects 1% of children and adolescents in the US. Moreover, due to the visible nature of the condition, psoriasis can have a negative impact on children’s quality of life.
The interleukin-17A (IL-17A) inhibitor, secukinumab (brand name Cosentyx) can now be used for the treatment of moderate-to-severe psoriasis in children from the age of six who are candidates for systemic or phototherapy because of the severity of their psoriasis. The drug has more than 14 years of clinical experience and long-term, 5-year clinical data. The approved dosing is 75 or 150mg, depending on the child’s weight (i.e., 75mg for those < 50kg and 150mg > 50kg) and the drug is administered by subcutaneous injection every four weeks after an initial loading regime. A further advantage is that after suitable counselling, the dose can be given by an adult carer, hence avoiding the need to visit a healthcare professional.
The approval of Cosentyx was based on the results of two Phase III trials that were undertaken in children aged between 6 and 18 years. The first trial was a 52-week, randomised, double-blind, placebo controlled study with 162 children with severe plaque psoriasis. The study had a co-primary endpoint: the proportion achieving a psoriasis area severity index (PASI) 75 score (i.e., a 75% improvement in disease severity) and an investigator’s global assessment of either “clear” (no psoriasis) or “almost clear” at week 12.
Among children <50kg, after 12 weeks, 55% vs 10% (Cosentyx vs placebo) had achieved a PASI 75. Similarly in those weighing >50kg, the corresponding PASI 75 values were 86% vs 19% (Cosentyx vs placebo). For children weighing <50kg, the proportion achieving a score of clear or almost clear was 32% vs 5% (Cosentyx vs placebo). Similarly, among children weighing > 50kg, the corresponding values were 81% vs 5%.
The second trial was designed to assess safety although the press release contains no data from this study and at present, neither study has been published.
Discussing the new approval, Randy Beranek, President and CEO of the National Psoriasis Foundation, said “Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis“.
7th December 2020
Real-world data can be derived from patient registries and are of value because they illustrate whether the expected efficacy determined in a randomised trial holds up in practice. Using information held in the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), a team from the Centre for Dermatology, Salford, UK, examined the comparative effectiveness of two biologics, secukinumab and ustekinumab used in patients with moderate to severe psoriasis, defined in terms of a psoriasis and area severity index (PASI) of 12 or more prior to starting with either biologic. The PASI serves as a measure of disease severity with scores above 10, indicating at least moderate disease severity. The researchers restricted the drug initiation dates to on or after September 2013 (when both drugs became available) and before September 2018, to allow for patients to have completed at least 12 months of therapy. The primary outcome for the study was the difference in the proportion of patients who achieved a PASI of 2 or lower (i.e. virtually disease free) after 12 months of therapy. The authors used the results of a recent RCT in which the two biologics were studied head-to-head, as a baseline to compare the effectiveness data derived from the BADBIR registry.
A total of 1231 patients were included, 917 receiving ustekinumab (mean age 45 years, 40% female) and the remainder secukinumab (mean age 46 with 38% female). A PASI at 12 months post-treatment was available for only 42% and 45.5% of those given secukinumab and ustekinumab respectively. Secukinumab was superior to ustekinumab in achieving a PASI of 2 (relative risk = 1.28, 95% CI 1.06 – 1.55). However, a further and important finding from the BADBIR registry data was that the estimate of efficacy from the RCT appeared much lower in practice. For example, secukinumab and ustekinumab were 17.5% and 15.1% less effective than the RCT data would suggest.
Commenting on these findings, the authors suggested that given this discrepancy, clinicians should aim to inform patients prescribed either drug that the true effectiveness was likely to be lower than expected based on the results shown in the clinical trial.
You ZZN et al. Randomised trial replication using observational data for comparative effectiveness of secukinumab and ustekinumab in psoriasis. A study from the British Association of Dermatologists Biologics and Immunomodulators register. JAMA Dermatol 2020