A real-world, non-interventional, prospective study of the effectiveness and safety of apremilast in bio-naïve adults with moderate plaque psoriasis treated in the routine care in Greece - the 'APRAISAL' study

J Eur Acad Dermatol Venereol. 2022 Nov;36(11):2055-2063. doi: 10.1111/jdv.18166. Epub 2022 May 21.

Abstract

Background: Real-world data in patients with moderate psoriasis treated with apremilast is limited.

Objectives: To evaluate the effectiveness and safety of apremilast in bio-naïve patients with moderate psoriasis in real-world clinical settings.

Methods: This was a 52-week multicenter, observational, prospective study of adult outpatients with moderate psoriasis {[10% < body surface area < 20% or 10 < psoriasis area severity index (PASI) < 20] and 10 < dermatology quality of life index (DLQI) < 20} initiated on apremilast ≤7 days before enrollment. Missing data were imputed using the last observation carried forward method.

Results: A total of 287 eligible patients (median age: 54.2 years; median psoriasis duration: 9.8 years) were consecutively enrolled. At baseline, the median DLQI and PASI scores were 12.0 and 11.8, respectively. The 52-week DLQI ≤ 5 and PASI75 response rates were 68.3% and 61.0%. At 52 weeks, 70.8% and 72.7% of the patients shifted from moderate/severe/very severe to clear/minimal scalp and palmoplantar psoriasis involvement, respectively; the pruritus severity state improved in 67.2%. The 52-week Kaplan-Meier estimated drug continuation rate was 85.3%. The adverse drug reaction rate was 19.9%.

Conclusions: Apremilast is a safe and effective treatment for bio-naïve patients with moderate psoriasis and specific psoriasis manifestations.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Greece
  • Humans
  • Middle Aged
  • Prospective Studies
  • Psoriasis* / drug therapy
  • Quality of Life*
  • Severity of Illness Index
  • Thalidomide / analogs & derivatives
  • Treatment Outcome

Substances

  • Thalidomide
  • apremilast

Grants and funding