Quality-of-Life Outcomes, Effectiveness and Tolerability of Apremilast in Patients with Plaque Psoriasis and Routine German Dermatology Care: Results from LAPIS-PSO

Abstract

Introduction: Psoriasis is a systemic inflammatory disease characterised by pruritic skin lesions that impair quality of life (QOL). Long-Term Documentation of the Utilization of Apremilast in Patients with Plaque Psoriasis under Routine Conditions (LAPIS-PSO; Clini-calTrials.gov: NCT02626793) was a 52-week, prospective, multicentre, observational cohort study conducted in real-world dermatology clinical settings in Germany. We evaluated physician-and patient-reported outcomes for QOL, effectiveness and tolerability in patients with moderate to severe psoriasis vulgaris in LAPIS-PSO. Methods: The primary endpoint was the percentage of patients achieving Dermatology Life Quality Index (DLQI) score B 5 or C 5-point improvement from baseline in DLQI score at visit 2 (* 4 months after baseline). Secondary endpoints included assessments of symptoms and disease severity. Tolerability was evaluated based on adverse events (AEs). A pre-defined subgroup analysis based on baseline Physician's Global Assessment (PGA) score (2 or 3 versus 4) was performed. Data were examined descriptively through visit 5 (* 13 months) using the lastobservation-carried-forward (LOCF) approach and data as observed.

Apremilast and biologics: Characteristics of patients treated with apremilast before, during, or after a biological treatment

“…The main reason for apremilast withdrawal was lack of adequate efficacy (58.5%), followed by adverse effects. Other studies also agree finding efficacy the first reason to discontinue 5,8,9,13,15 . In two of our patients apremilast was discontinued after good symptomatic control was achieved and maintained.…”

“…Other studies also agree finding efficacy the first reason to discontinue. 5,8,9,13,15 In two of our patients apremilast was discontinued after good symptomatic control was achieved and maintained. Other studies also describe symptom relief as the reason to discontinue treatment in a small percentage of patients (5.4%).…”

Apremilast in Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Meta-analysis

“…2020 [ 23 ] Retrospective cohort None 85 (mean baseline PPPGA 4.2) 36.1 and 83.3 (weeks 12 and 52) (as observed) Drug survival after 1 year of treatment (%): 54.9 (includes non-palmoplantar psoriasis) Reich et al . 2019 [ 26 ] LAPIS-PSO Prospective cohort None 67 (28 with baseline PPPGA ≥ 3) PPPGA 0 or 1 (baseline PPPGA ≥ 1) (%): 62.7 and 71.7 (week 16 and 52) (full analysis set) Pavia et al . 2022 [ 24 ] Retrospective cohort None 12 (11 with baseline PPPGA ≥ 3) 90.9 (week 24) Ständer et al .…”

“…In a 52-week retrospective cohort study by the Spanish Psoriasis Group [ 23 ], the rates of patients treated with apremilast ( n = 85, mean baseline PPPGA 4.2) achieving PPPGA 0 or 1 was 36.1 and 83.3% (as observed) at weeks 12 and 52, respectively. LAPIS-PSO, a 52-week, multicenter, observational cohort study in Germany investigating apremilast treatment for PP [ 26 ], resulted in 62.7 and 71.7% of patients ( n = 67) achieving PPPGA 0 or 1 at weeks 16 and 52, respectively. A single-center retrospective cohort study by Pavia et al [ 24 ] showed 90.9% ( n = 12) of subjects with moderate to severe PP (baseline PPPGA ≥ 3) achieving clearance (PPPGA 0 or 1) after 24 weeks of apremilast treatment.…”

“…1 ). These 17 publications consisted of five placebo-controlled RCTs [ 11 , 12 , 14 – 17 ], one single-arm phase II clinical trial [ 18 ], two randomized methotrexate comparative trials [ 19 , 20 ], six prospective/retrospective cohort studies [ 21 – 26 ], and three case series [ 27 – 29 ], totaling 1117 subjects with palmoplantar disease treated with apremilast or placebo. Of the 1117 subjects with palmoplantar disease, 948 cases of PP and 169 cases of PPP were represented.…”