Patients with moderate to severe psoriasis who were treated with guselkumab had substantial improvement in different body regions that was consistently maintained through week 252, according to results from a study presented at the 2022 Annual Meeting of the European Academy of Dermatology and Venerology (EADV) Congress, held from September 7 to 10, 2022 in Milano, Italy.
Investigators reported results of the post hoc analysis of pooled data from the randomized controlled, phase 3 VOYAGE 1 and 2 trials, in which patients treated with guselkumab were assessed up to week 252 to determine if response rates differed by body region.
VOYAGE 1 and 2 compared guselkumab, a fully human monoclonal antibody, with placebo or adalimumab in patients with moderate to severe plaque psoriasis. The overall Psoriasis Area and Severity Index (PASI) 90 (≥90% improvement) score at week 252 was observed in 84.1% of patients treated with guselkumab in VOYAGE1 and 82.0% in VOYAGE 2.
Adult patients in the trials were randomly assigned to receive guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (q8w), respectively; or placebo at weeks 0, 4, and 12, then guselkumab 100 mg at weeks 16 and 20, and then q8w, respectively; or adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks (q2w), respectively.
In VOYAGE 1, patients randomly assigned to adalimumab received the drug q2w through week 47, followed by guselkumab 100 mg q8w beginning at week 52. In VOYAGE 2, all patients entered a randomized withdrawal and retreatment period with guselkumab from week 28 to week 72. All patients received open-label guselkumab q8w from week 76 through the end of the study.
The last dose of guselkumab was administered at week 252 in both studies. Pooled efficacy data were analyzed for all patients who received guselkumab (n=1721), which included those initially assigned to guselkumab, those who switched from placebo to guselkumab, and those who switched from adalimumab to guselkumab.
A modified PASI was used for each body region (head, trunk, upper extremities, and lower extremities) to assess the percentage of patients who achieved 90% or greater improvement in PASI, the percentage of those who achieved 100% improvement in PASI, and the mean percentage improvement in PASI.
A majority of patients treated with guselkumab achieved 90% or greater improvement in PASI for each body region (head: 81.0%; trunk: 84.4%; upper extremities: 84.2%; lower extremities: 77.8%) and 100% improvement in PASI (head: 74.0%; trunk: 80.6%; upper extremities: 79.6%; lower extremities: 70.2%) at week 100.
The mean percentage improvement in PASI from baseline was 90% or greater across body regions from week 100 through week 252.
“Substantial improvements in PASI were observed in guselkumab-treated patients with moderate to severe psoriasis across different body regions,” concluded the researchers. “Responses were consistently maintained through week 252.”
Disclosure: Several of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures
Puig L, Foley P, Chang C-L, et al. Response to guselkumab by body region in the treatment of moderate to severe psoriasis: 5-year results from VOYAGE 1 and 2. Presented at: the 2022 European Academy of Dermatology and Venerology (EADV) Congress Annual Meeting: September 7-10, 2022. Abstract/Poster 1578