Guselkumab demonstrates high efficacy rates for psoriasis
Continued treatment with the anti-interleukin (IL)-23 monoclonal antibody guselkumab generated high efficacy response rates in patients with moderate-to-severe plaque psoriasis, according to findings from the ongoing phase III VOYAGE 2* trial presented at the 2018 American Academy of Dermatology Annual Meeting (AAD 2018) held in San Diego, California, US.
VOYAGE 2 initially involved a 28-week active-comparator phase wherein guselkumab 100 mg was compared against placebo (week 0–16) and adalimumab (week 0–24). Efficacy analysis ran through week 24; safety was evaluated through week 28. After which, guselkumab responders who achieved a PASI90** response (n=375) were rerandomized to continue treatment with guselkumab 100 mg (maintenance arm; n=193) or transition to placebo (withdrawal arm; n=182) through week 72. Placebo recipients who lost ≥50 percent PASI improvement were retreated with guselkumab (n=173). [AAD 2018, abstract 6748]
The divergence in PASI90 response between the maintenance and the withdrawal arms was observed at week 32 and was sustained through week 48 (88.6 percent vs 36.8 percent), [J Am Acad Dermatol 2017;76:418-431] and through week 72 (86 percent vs 11.5 percent).
Median time to loss of PASI90 response in the withdrawal arm was 15.2 weeks. This was considered relevant, the researchers pointed out, given the significant discontinuation rates in the use of psoriasis biologics through 1 year. [J Am Acad Dermatol 2016;74:1057-1065; J Dermatolog Treat 2013;24:369-373; J Eur Acad Dermatol Venereol 2015;29:215-223]
Adverse event rates were comparable in both the maintenance and the withdrawal arms through week 48, with nasopharyngitis being the most common (11.5 percent vs 12.6 percent) followed by upper respiratory tract infection (4.7 percent vs 5.5 percent) and headache (1.6 percent vs 1.1 percent). Only one case of serious infection (ie, appendicitis) was reported in the maintenance arm.
A majority of the participants (87.6 percent) who transitioned from placebo to guselkumab achieved PASI90 within 6 months of starting retreatment.
“Maintenance of PASI90 response after drug withdrawal was associated with continued suppression of IL-17A, IL-17F, [and] IL-22***, while loss of response was associated with increased levels of these circulating cytokines,” said Dr Kristian Reich from the Dermatologikum and SCIderm Research Institute in Hamburg, Germany.
Overall, guselkumab-treated patients maintained PASI90 response, while placebo recipients had gradually recurring psoriasis and a reduced health-related quality of life, noted the researchers.
The findings support the initially reported VOYAGE 2 results demonstrating the efficacy of guselkumab in treating moderate-to-severe psoriasis, and highlight its potential as an alternative to other psoriasis medications, said the researchers.