Guselkumab administered at 100 mg for 5 weeks and then every 8 weeks was superior to secukinumab at 300 mg for 5 weeks and then every 4 weeks in inducing a ≥90% reduction in the Psoriasis Area and Severity Index (PASI 90) response at 48-week follow-up, a phase 3 study in the Lancet suggests.
Patients aged ≥18 years who had moderate to severe plaque-type psoriasis were enrolled in the trial. The study was a comparator-controlled analysis conducted at 142 outpatient centers in nine countries. Only patients who were candidates for phototherapy or systemic therapy were eligible to participate. Study investigators randomly assigned patients to either 100 mg guselkumab at week 0 and week 4 and then every 8 weeks (n=534) or 300 mg secukinumab at weeks 0, 1, 2, 3, and 4, and then every 4 weeks (n=514).
The proportion of patients who achieved a ≥90% reduction in PASI 90 response at week 48 comprised the primary endpoint. Additional secondary endpoints included the proportion of patients who achieved a PASI 75 response at weeks 12 and 48, PASI 90 response at week 12, PASI 75 response at week 12, PASI 100 response at week 48, Investigator’s Global Assessment score of 0 (cleared) at 48 weeks, and Investigator’s Global Assessment score of 0 or 1 (minimal) at 48 weeks. In patients who received ≥1 dose of their assigned study drug from week 0 to week 56, safety was also assessed.
At 48 weeks, a higher proportion of patients who achieved a PASI 90 response was observed in the guselkumab group vs the secukinumab group (84% vs 70%, respectively; P <.0001). Guselkumab was noninferior to secukinumab in terms of the proportion of patients who achieved a PASI 75 response at both week 12 and week 48 (85% vs 80%, respectively; treatment difference, 4.3 percentage points; 95% CI, –0.2 to 8.9; P <.0001). The researchers were unable to establish superiority of guselkumab for PASI 75 at these time points (P =.0616). There was no difference between the groups with regard to the rate of adverse events, infections, or serious adverse events.
Limitations of the study were the lack of assessment of drug concentrations as well as the data projecting longer than 1 year.
The researchers added that “blocking the regulatory capacity of the [interleukin]-23 pathway” with guselkumab rather than directly targeting interleukin-17A with secukinumab “might be useful for maintaining a durable response and preventing recurrence of disease” in patients with psoriasis.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831-839.