Drug survival, effectiveness and safety of guselkumab for moderate-to-severe psoriasis for up to 4 years.

BACKGROUND

Guselkumab has been shown to be safe and effective for the treatment of psoriasis in numerous randomized clinical trials and real-life studies. Real-life data on treatment up to 4 years are lacking.

OBJECTIVES

The present study aims to estimate the drug survival, effectiveness and safety of guselkumab over a period of 208 weeks.

METHODS

We included all consecutive patients with psoriasis or psoriatic arthritis receiving at least one dose of guselkumab. Effectiveness was evaluated as achieving 100% or ≥ 90% improvement in the Psoriasis Area and Severity Index (PASI 100 or PASI 90) and absolute PASI ≤ 3. Drug survival was evaluated using the Kaplan-Meyer curves.

RESULTS

In total, 202 patients were studied. Their mean PASI decreased from 10.9 (SD 5.76) at baseline to 0.48 at week 208. Rates of PASI 100 response improved over time: the outcome was achieved in 30.0% and 65% of patients at weeks 16 and 208, respectively. For PASI 90 and PASI ≤ 3 we found similar trends. After 208 weeks of treatment, the estimated rate of drug survival was 68.5% in observed cases. Being super responders (SRs) according to our definition (P = 0.005) and the GUIDE definition (P < 0.001) reduced the risk of drug interruption, as did cardiovascular comorbidities. In our population, none of the baseline characteristics showed a clear impact on the effectiveness of guselkumab. Considering both SR definitions, in our cohort, being an SR was associated with a better response in the long term when considering PASI 100 and 90 in both linear and multivariate analyses.

CONCLUSIONS

Our study confirms the good effectiveness and favourable safety profile of guselkumab in a real-world setting up to 4 years.