PMID- 34913153
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220410
IS  - 2193-8210 (Print)
IS  - 2190-9172 (Electronic)
VI  - 12
IP  - 1
DP  - 2022 Jan
TI  - Quality-of-Life Outcomes, Effectiveness and Tolerability of Apremilast in 
      Patients with Plaque Psoriasis and Routine German Dermatology Care: Results from 
      LAPIS-PSO.
PG  - 203-221
LID - 10.1007/s13555-021-00658-x [doi]
AB  - 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.
CI  - (c) 2021. The Author(s).
FAU - Reich, Kristian
AU  - Reich K
AD  - Translational Research in Inflammatory Skin Diseases, Institute for Health 
      Services Research in Dermatology and Nursing, University Medical Center 
      Hamburg-Eppendorf, Martinistrasse 52, Building West 38/Room 514, 20246, Hamburg, 
      Germany. k.reich@uke.de.
FAU - Korge, Bernhard
AU  - Korge B
AD  - Hautarztpraxis Priv. Doz. Dr. med. Bernhard Korge, Duren, Germany.
FAU - Magnolo, Nina
AU  - Magnolo N
AD  - Department of Dermatology, University Hospital Muenster, Munster, Germany.
FAU - Manasterski, Maria
AU  - Manasterski M
AD  - Hautarztpraxis Manasterski und Dues, Berlin, Germany.
FAU - Schwichtenberg, Uwe
AU  - Schwichtenberg U
AD  - Derma Nord Hautarztpraxen Dr. med. Schwichtenberg, Bremen, Germany.
FAU - Staubach-Renz, Petra
AU  - Staubach-Renz P
AD  - Department of Dermatology, University Medical Center, Mainz, Germany.
FAU - Kaiser, Stephan
AU  - Kaiser S
AD  - Amgen GmbH, Munchen, Germany.
FAU - Roemmler-Zehrer, Josefine
AU  - Roemmler-Zehrer J
AD  - Amgen GmbH, Munchen, Germany.
FAU - Gomez, Natalie Nunez
AU  - Gomez NN
AD  - Bristol Myers Squibb, Summit, NJ, USA.
FAU - Lorenz-Baath, Katrin
AU  - Lorenz-Baath K
AD  - Amgen GmbH, Munchen, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02626793
PT  - Journal Article
DEP - 20211215
PL  - Switzerland
TA  - Dermatol Ther (Heidelb)
JT  - Dermatology and therapy
JID - 101590450
PMC - PMC8776950
OTO - NOTNLM
OT  - Apremilast
OT  - Effectiveness
OT  - Observational
OT  - Patient-reported outcome measures
OT  - Pruritus
OT  - Psoriasis
OT  - Quality of life
OT  - Real-world
EDAT- 2021/12/17 06:00
MHDA- 2021/12/17 06:01
PMCR- 2021/12/15
CRDT- 2021/12/16 06:42
PHST- 2021/06/11 00:00 [received]
PHST- 2021/11/27 00:00 [accepted]
PHST- 2021/12/17 06:00 [pubmed]
PHST- 2021/12/17 06:01 [medline]
PHST- 2021/12/16 06:42 [entrez]
PHST- 2021/12/15 00:00 [pmc-release]
AID - 10.1007/s13555-021-00658-x [pii]
AID - 658 [pii]
AID - 10.1007/s13555-021-00658-x [doi]
PST - ppublish
SO  - Dermatol Ther (Heidelb). 2022 Jan;12(1):203-221. doi: 10.1007/s13555-021-00658-x. 
      Epub 2021 Dec 15.