Clinical Measures Insufficient for Capturing Full Patient Experience for Psoriasis

Despite improvements in quality of life and clinical signs and symptoms following guselkumab therapy, a new post-hoc analysis suggests there are a subset of patients reporting complete skin clearance and continued residual effects of their plaque psoriasis.¹

The VOYAGE 1 clinical trial had yielded results suggesting that the interleukin (IL)-23p19 subunit inhibitor known as guselkumab led to clinical and patient-reported outcome (PRO) measure improvements among patients with psoriasis.² Nevertheless, researchers had additional questions about the findings.

A post-hoc analysis of the VOYAGE 1 clinical trial was created to address these inquiries. The analysis was authored by investigators such as Luis Puig, MD, PhD, from the department of dermatology at the Universitat Autònoma de Barcelona Hospital de Santa Creu i Sant Pau in Barcelona.

“The objective of this analysis was to assess the patterns of signs, symptoms and (quality of life) PRO measures in patients with moderate-to-severe plaque psoriasis who maintained complete skin clearance (PASI = 0) for ≥ 156 consecutive weeks with guselkumab treatment,” Puig et al. wrote.¹

Trial Design

The research team described the VOYAGE 1 clinical study, during which patients with an Investigator Global Assessment (IGA) score of 3 or more and a Psoriasis Area and Severity Index (PASI) score of 12 or more were evaluated after being found suitable for systemic or phototherapy.

There was a 48-week double-blind period of this research, during which subjects were randomly assigned to receive treatment with guselkumab therapy. Specifically, they would be given 100 mg at the 0, 4, and 12-week marks, followed by a dose every 8 weeks until the 44-week mark.

Other subjects would be given a placebo at the 0, 4, and 12-week marks followed by 100 mg of guselkumab at Weeks 16 and 20, and every 8 weeks through to the 44-week mark. Otherwise, subjects were in a cohort treated with 80 mg of adalimumab at Week 0, 40 mg of the drug at the 1-week mark, and 40 mg on a dosage of every 2 weeks until the 47-week mark.

Following the investigators’ blinded phase, all of those participating in the research were shifted to the trial’s open-label extension. This meant they would be treated with 100 mg of guselkumab at the 52-week mark and every 8 weeks following, up until Week 252.

For their post hoc analysis, subjects given guselkumab who maintained a 0 PASI score for 156 consecutive weeks at least were compared to those who did not in terms of their baseline demographics as well as their clinical features.

The research team looked at several different baseline and disease characteristics, some of which included body mass index (BMI), age, IGA score, history of depression, weight, smoking history, sex duration of disease, age at the time of diagnosis, percentage of body surface area (BSA) affected by psoriasis, Dermatology Life Quality Index (DLQI) score, and Psoriasis Symptom and Sign Diary (PSSD) score.

Both the DLQI and PSSD tools were utilized by the investigators for the purposes of evaluating PROs in life quality as well as psoriasis symptoms and signs, respectively. The team assessed subjects’ mean scores for the individual domains of the DLQI and PSSD among individuals who maintained complete skin clearance.

They also looked at the baseline characteristics of participants who reported DLQI scores of 0 or 1 and PSSD scores of 0, comparing such scores with subjects who did not.

Conclusions

The research team concluded that 22.2% of the 329 individuals included in their post-hoc analysis had maintained PASI = 0 for ≥ 156 weeks. Among these subjects, there was a numerically lower proportion of them who reported depression, obesity, and prior use of biologics. The team noted a higher proportion of subjects who had never smoked.

Those maintaining PASI = 0 were shown to have generally reported positive DLQI and PSSD outcomes. Despite this, the investigators did report that some effects of residual disease were observed, specifically in the DLQI “Symptoms and feelings” sub-scale as well as the PSSD components “Redness”, “Dryness,” and “Itch.”

Those subjects who reported continued disease effects despite sustaining PASI = 0 were shown by the research team to have had greater severity of their condition at the point of baseline compared to subjects with DLQI = 0/1 and PSSD = 0.

“This work highlights that analysis and reporting of clinical measures do not capture the full patient experience, and PRO measures ought to be used in conjunction with these to provide a more comprehensive assessment of an individual’s response to treatment," they wrote.

References

1. ^{Puig L, Costanzo A, de Jong EMGJ, et al. Progression of Quality of Life in Patients with Plaque Psoriasis Who Achieved Three or More Years of Complete Skin Clearance with Guselkumab Treatment: a Post hoc Analysis of the VOYAGE 1 Clinical Trial. Dermatol Ther (Heidelb) (2024). https://doi.org/10.1007/s13555-024-01245-6.}
2. ^{Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, et al. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021;185:1146–59.}