New 52-Week Data Finds Guselkumab Well Tolerated in Moderate to Severe Psoriasis

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Guselkumab was effective in patients with previous biologic therapies, comorbidities or psoriasis manifestation in difficult-to-treat areas.

New data from the PERSIST study found that guselkumab was well tolerated and efficacious in patients with moderate to severe psoriasis regardless of previous biologic therapies, comorbidities or psoriasis manifestation in difficult-to-treat areas.

Prevoiusly, long-term efficacy and safety of guselkumab had been demonstrated in phase 3 of both the VOYAGE 1 and VOYAGE 2 studies as well as the ECLIPSE study.

Additionally, 28-week data on PERSIST- a non-interventional study investigating guselkumab and ustekinumab treatment on long-term efficacy, safety and health related quality of life in patients with moderate to severe psoriasis, demonstrated that guselkumab was safe and effective.

In this current study, investigators led by Sascha Gerdes, PhD, from the Department of Dermatology at the University Medical Center Schleswig-Holstein, presented 52-week data from PERSIST.

The 2 year observational period of the study was conducted at 55 sites across Germany and documented eligible patients who were 18 years or older with a diagnosis of moderate to severe psoriasis.

All patients were prescribed guselkumab, and those who were initiated to another biologic therapy has discontinued. Concomitant medications for psoriasis were permitted as part of routine clinical care.

The primary endpoint of the study was the number of patients with a Dermatology Life Quality Index (DLQI) score of 1 or greater ag week 28, and secondary enpoints included HRQoL at week 52 and the effectiveness of guselkumab, which was measured by PASI, area-specific Physician’s Global Assessment (PGA) and target Nail Psoriasis Severity Index (NAPSI).

Meanwhile, safety was assessed in the evaluation of adverse events (AEs) at data cut-off.

While 303 patients were enrolled in the PERSIST study, data were available for 247 were available at week 52, and there were 38 (12.5%) patient withdrawals before week 52. Among these withdrawals, 9 (3%) were due to AEs.

Investigators observed that mean PASI score decreased to 2.4 at week 52 after the initial deduction of 3.0 at week 28.

Notably, the proportion of patients achieving an absolute PASI score of ≤1increased from 1.3% at baseline to 50.8% at week 28, and finally to 58.4% by week 52.

Improvements in PASI90 and PASI100 were also noted between week 28 and week 52, regardless of biologic treatment history.

Meanwhile, the clearance of psoriatic skin was seen in difficult to treat areas such as the scalp, palmoplantar, or anogenital regions, with 23.5% (47), 18.5% (15), and 9.3% (11) improvements, respectively.

By week 52, the proportions of patients with severe scalp, palmoplantar, or anogenital psoriasis had decreased to 0.6% (1), 1.5% (1) and 0%, respectively.

Finally, guselkumab appeared to improve HRQoL, with the mean DLQI score decreasing from 13.7 at baseline to 2.8 by week 28, and further decreasing to 2.4 by week 52. A total fo 64.6% of patients achieved a DLQI score greater than 1 by week 52.

“In conclusion, PERSIST was a large,real- world study that provides important insights on the efficacy and safety of guselkumab outside of the RCTsetting,” the team wrote.

The study, "Real-world evidence from the non-interventional, prospective, German multicentre PERSIST study of patients with psoriasis after 1 year of treatment with guselkumab," was published online in JEADV.