Quality-of-Life Outcomes, Effectiveness and Tolerability of Apremilast in Patients with Plaque Psoriasis and Routine German Dermatology Care: Results from LAPIS-PSO.
Apremilast
Effectiveness
Observational
Patient-reported outcome measures
Pruritus
Psoriasis
Quality of life
Real-world
Journal
Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
received:
11
06
2021
accepted:
27
11
2021
pubmed:
17
12
2021
medline:
17
12
2021
entrez:
16
12
2021
Statut:
ppublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 34913153
doi: 10.1007/s13555-021-00658-x
pii: 10.1007/s13555-021-00658-x
pmc: PMC8776950
doi:
Banques de données
ClinicalTrials.gov
['NCT02626793']
Types de publication
Journal Article
Langues
eng
Pagination
203-221Informations de copyright
© 2021. The Author(s).
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