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

Autor: Reich, Kristian, Korge, Bernhard, Magnolo, Nina, Manasterski, Maria, Schwichtenberg, Uwe, Staubach-Renz, Petra, Kaiser, Stephan, Roemmler-Zehrer, Josefine, Gómez, Natalie Núnez, Lorenz-Baath, Katrin
Rok vydání: 2021
Předmět:
Zdroj: Dermatology and Therapy
ISSN: 2190-9172
2193-8210
DOI: 10.1007/s13555-021-00658-x
Popis: 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. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00658-x.
Databáze: OpenAIRE
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