Citation

Reich K, Korge B, Magnolo N, Manasterski M, Schwichtenberg U, Staubach-Renz P, Kaiser S, Roemmler-Zehrer J, Gomez NN, Lorenz-Baath K. Dermatol. Ther. (Heidelb) 2022; 12(1): 203-221.

Copyright

(Copyright © 2022, Holtzbrinck Springer Nature Publishing Group)

DOI

10.1007/s13555-021-00658-x

PMID

unavailable

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; ClinicalTrials.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 ≤ 5 or ≥ 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 last-observation-carried-forward (LOCF) approach and data as observed.

RESULTS: In total, 257 patients were included for efficacy assessment. On LOCF analysis, most patients achieved the primary endpoint at visit 2 (66.5%); DLQI response was maintained at visit 5 (72.4%). Earlier treatment response was observed in patients with a PGA score of 2 or 3 versus 4 (visit 1 PASI ≤ 3: 20.5% versus 10.8%). Adverse events were consistent with the known safety profile of apremilast.

CONCLUSIONS: In routine clinical care in Germany, patients with moderate to severe plaque psoriasis benefited from apremilast treatment up to ~ 13 months, consistent with findings from clinical trials, with a good safety profile. © 2021, The Author(s).

Language: en

Keywords

adult; human; suicide; female; male; Germany; quality of life; depression; scoring system; disease severity; Psoriasis; major clinical study; controlled study; unclassified drug; controlled clinical trial; headache; middle aged; drug safety; seizure; long term care; drug efficacy; diarrhea; drug tolerability; nausea; drug withdrawal; multicenter study; Quality of life; patient satisfaction; bronchitis; glucocorticoid; cohort analysis; prospective study; side effect; urea; salicylic acid; treatment response; Article; observational study; methotrexate; retinoid; systemic therapy; vitamin D derivative; clinical effectiveness; treatment duration; Pruritus; upper respiratory tract infection; tension headache; dermatology; PUVA; ultraviolet B radiation; dithranol; psoriasis vulgaris; skin pain; psoralen; ultraviolet A radiation; leflunomide; pustulosis palmoplantaris; rhinopharyngitis; corticosteroid therapy; Effectiveness; Observational; clinical outcome; symptom assessment; erythrodermic psoriasis; disease severity assessment; body weight loss; skin pruritus; apremilast; patient-reported outcome; cyclosporine; Dermatology Life Quality Index; Real-world; treatment interruption; Apremilast; fumaric acid derivative; fumaric acid ester; guttate psoriasis; nail psoriasis; Patient-reported outcome measures; physician global assessment score; retinol derivative; scalp psoriasis; ultraviolet phototherapy