REPORTING FROM THE EADV CONGRESS
GENEVA (FRONTLINE MEDICAL NEWS) – The interleukin-23 inhibitor guselkumab generates the same impressive improvement in skin disease in psoriatic arthritis patients as has been seen in psoriasis without joint disease, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
However, psoriatic arthritis patients’ improvement in Dermatology Life Quality Index (DLQI) scores is less robust than in patients with psoriasis only, added Dr. Kimball , professor of dermatology at Harvard Medical School, Boston, and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center.
She presented a secondary analysis of 1,829 patients with moderate to severe plaque psoriasis who participated in the pivotal phase 3, randomized, double-blind VOYAGE 1 and VOYAGE 2 trials, which helped guselkumab win Food and Drug Administration approval as Tremfya for treatment of psoriasis in July 2017. The purpose was to see how guselkumab stacked up in terms of efficacy and safety in the 335 participants with psoriatic arthritis versus the 1,494 without the rheumatologic disease.
The psoriatic arthritis group as a whole had more severe psoriasis, with a baseline mean PASI score of 24.3 and involvement of 32.7% of their body surface area as compared with a PASI score of 21.2 and 27.2% BSA in psoriasis patients without arthritis. A total of 28% of the psoriatic arthritis patients had previously been on other biologics and 77% had been on nonbiologic systemic agents, compared with 19% and 60% of the psoriasis patients, respectively. The psoriatic arthritis group had a mean 19.2-year history of psoriasis, 1.9 years longer than the psoriasis-only group.
Participants were randomized to 100 mg of guselkumab administered subcutaneously at weeks 0, 4, 12, and 20; placebo through week 12, followed by a switch to adalimumab (Humira); or adalimumab at 80 mg at week 0, then 40 mg at week 2 and 40 mg again every 2 weeks until week 23.
The key findings:
The PASI 90 response rate – that is, at least a 90% improvement in Psoriasis Area and Severity Index – in guselkumab-treated patients at week 16 was 72% in patients with psoriatic arthritis and 71% in those without. At week 24, the PASI 90 rate was 74% in guselkumab-treated patients with psoriatic arthritis and similar at 78% in those without. In contrast, the PASI 90 rate at week 24 in patients on adalimumab was significantly lower: 48% in the psoriatic arthritis group and 55% in those with psoriasis only. The PASI 90 rate in placebo-treated controls was single digit.
At week 24, 82% of psoriatic arthritis patients on guselkumab had clear or almost clear skin as reflected in an Investigator’s Global Assessment score of 0 or 1, as did 84% of psoriasis-only patients.
A DLQI score of 0 or 1, meaning the dermatologic disease had no impact on patient quality of life, was documented at week 16 in 46% of psoriatic arthritis patients and 55% of psoriasis-only patients, a trend that didn’t achieve statistical significance. However, by week 24 the difference became significant, with a DLQI of 0 or 1 in 48% of the psoriatic arthritis patients, compared with 62% of psoriasis-only patients.
VOYAGE 1 and 2 were dermatologic studies that didn’t measure changes in joint symptom scores or other psoriatic arthritis outcomes. Guselkumab as a potential treatment for psoriatic arthritis is under investigation in other studies.
The VOYAGE trials and this analysis were sponsored by Janssen. Dr. Kimball reported receiving research funding from and serving as a consultant to Janssen and numerous other pharmaceutical companies.
SOURCE: Kimball A et al. https://eadvgeneva2017.org/