A Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice (APPRECIATE)

APPRECIATE (Apremilast Clinical Treatment Experience in Psoriasis): A Multi-center, Retrospective Observational Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice

This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians' and patients' treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Patient questionnaire

• Study Type: Observational
• Enrollment (Actual): 610

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz
  • Großwarasdorf, Austria, 7304
    • Praxis Dr. Wolfgang Fuchs
  • Klagenfurt, Austria, 9020
    • Praxis Dr. Schicher
  • Landeck, Austria, 6500
    • Praxis Dr. Wilhelm
  • Linz, Austria, 4021
    • Kepler Universitätsklinikum
  • Linz, Austria, 4040
    • Praxis Dr. Dunst-Huemer
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen GmbH
  • Wien, Austria, 1090
    • Medizinische Universität Wien
  • Wien, Austria, 1130
    • Krankenhaus Hietzing
  • Wien, Austria, 1030
    • Krankenanstalt Rudolfstiftung
  • Wien, Austria, 1100
    • Praxis Dr. Göttfried
  • Wien, Austria, 1100
    • Praxis Dr. Holub-Hoberger
  • Wien, Austria, 1170
    • Praxis Dr. Nordberg
  • Wien, Austria, 1190
    • Praxis Dr. Menzinger
  • Wien, Austria, 1190
    • Praxis Dr. Sator
  • Wien, Austria, 1200
    • Praxis Dr. Perl-Convalexius
  • Wiener Neustadt, Austria, 2700
    • Landesklinikum Wiener Neustadt
• Croatia
  • Osijek, Croatia, 31 000
    • Klinički bolnički centar Osijek Zavod za dermatologiju i venerologiju
  • Rijeka, Croatia, 51000
    • Klinički bolnički centar Rijeka Klinika za dermatovenerologiju
  • Split, Croatia, 21 000
    • Klinički bolnički centar Split Klinika za kožne i spolne bolesti
  • Zagreb, Croatia, 10 000
    • Klinički bolnički centar Sestre milosrdnice Klinika za kožne i spolne bolest
  • Zagreb, Croatia, 10 000
    • Klinički bolnički centar Zagreb Klinika za dermatovenerologiju
• Czechia
  • Jihlava, Czechia, 586 33
    • Nemocnice Jihlava příspěvková organizace
  • Plzen, Czechia, 301 00
    • FN Plzen Bory Dermatovenerologické oddělení
  • Novy Hradec Králové
    • Hradec Králové, Novy Hradec Králové, Czechia, 500 05
      • Fakultní nemocnice Hradec Králové Klinika nemocí kožních a pohlavních
  • Pardubice IV
    • Pardubice, Pardubice IV, Czechia, 530 03
      • Nemocnice Pardubického kraje
  • Praha 1
    • Praha, Praha 1, Czechia, 110 00
      • Sanatorium profesora Arenberger
  • Praha 2
    • Praha, Praha 2, Czechia, 128 08
      • Vseobecna fakultni nemocnice v Praze
  • Praha 5
    • Praha, Praha 5, Czechia, 150 06
      • Fakultni nemocnice v Motole
• Germany
  • Aachen, Germany, 52062
    • Praxis Dr. Harst
  • Aachen, Germany, 52066
    • Praxis Dr. Wagner-Schiffler
  • Ampfing, Germany, 84539
    • Praxis Dr. Dietz
  • Andernach, Germany, 56626
    • Praxis Dr. Bell
  • Augsburg, Germany, 86179
    • Licca Clinical Research Institute
  • Blaustein, Germany, 89134
    • Gefäß- und Hautzentrum Blaustein
  • Bochum, Germany, 44791
    • St. Josef und St. Elisabeth Hospital gGmbH
  • Bonn, Germany, 53127
    • Rheinische Friedrich-Wilhelms-Universität Bonn
  • Brühl, Germany, 50321
    • Praxis Dr. Jordan
  • Buxtehude, Germany, 21614
    • Elbe Klinikum Buxtehude
  • Dachau, Germany, 85221
    • Praxis Dr. Schneider
  • Delmenhorst, Germany, 27753
    • Praxis Dr. Thelen
  • Dortmund, Germany, 44137
    • Klinikum Dortmund
  • Dresden, Germany, 01217
    • Praxis Dr. Scheibner
  • Düren, Germany, 52349
    • Praxis Dr. Korge
  • Eltville, Germany, 65343
    • Praxis für Dermatologie und Venerologie, Allergologie
  • Endingen, Germany, 79346
    • Praxis Dr. Schurhammer-Fuhrmann
  • Erlangen, Germany, 91054
    • Uniklinikum Erlangen
  • Euskirchen, Germany, 53879
    • Praxis Dr. Huerkamp
  • Euskirchen, Germany, 53879
    • Praxis Dr. Swirski
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Freiberg, Germany, 09599
    • Praxis Dr. Kämmerer
  • Freising, Germany, 85354
    • Praxis Dr. Kurzen
  • Gelsenkirchen, Germany, 45883
    • GP Dr. Rotterdam & Kollegen
  • Gilching, Germany, 82205
    • Praxis Dr. med W. Klövekorn, Dr. med. A. Tepe, Dr. med. O. Wilde
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Kusel, Germany, 66869
    • Praxis Dr. Schmidt
  • Malchow, Germany, 17231
    • Praxis Birgit Zimmermann
  • Mechernich, Germany, 53894
    • Praxis Dr. Piontek
  • Memmingen, Germany, 87700
    • Dermatologische Praxis Dr. med. Schwinn
  • Memmingen, Germany, 87700
    • Praxis Büchler
  • Mühldorf, Germany, 84453
    • Praxis Dr. Antal
  • Mühlheim, Germany, 56218
    • Praxis Dr. Cords
  • München, Germany, 80331
    • Praxis Dr. Liebich
  • München, Germany, 80802
    • Technische Universität München
  • Regensburg, Germany, 93053
    • Universitatsklinikum Regensburg
  • Rosenheim, Germany, 83022
    • Praxis Dr. Prell
  • Rostock, Germany, 18055
    • Praxis Dr. Blank
  • Rostock, Germany, 18059
    • Praxis Dr. Hoene
  • Sankt Ingbert, Germany, 66386
    • Praxis Dr. Schenkelberger
  • Stolberg, Germany, 52222
    • Praxis Dr. Neisius
  • Straubing, Germany, 94315
    • Praxis Dr. Steinborn
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Vilshofen, Germany, 94474
    • Gemeinschaftspraxis Dr. Christian Fischer, Florian Kreuziger
  • Wasserburg am Inn, Germany, 83512
    • Praxis Dr. Dehmel
  • Wesseling, Germany, 50389
    • Praxis Dr. Schmeel
  • Wildau, Germany, 15745
    • Praxis Dr. Buttgereit
  • Wittlich, Germany, 54516
    • Praxis Dr. Süß
  • Westerwald
    • Selters, Westerwald, Germany, 56242
      • Company for Medical Study & Service
• Ireland
  • Dublin 7, Ireland
    • Mater Misericordiae University Hospital
  • Galway, Ireland, H91 YR71
    • University Hospital Galway
  • County Kerry
    • Tralee, County Kerry, Ireland
      • Bon Secours Hospital
• Slovenia
  • Maribor, Slovenia, 2000
    • Uniiverzitetni klinični center Maribor Oddelek za kožne in spolne bolezni
• Spain
  • Benalmádena, Spain, 29631
    • Vithas Xanit Iinternational Hospital
  • Granada, Spain, 18016
    • Hospital Universitario San Cecilio (PTS)
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Fundacion Alcorcon, Madrid
• Sweden
  • Eskilstuna, Sweden, 631 88
    • Hudkliniken Mälarsjukhuset
  • Göteborg, Sweden, 413 45
    • Hudkliniken SU/ Sahlgrenska
  • Karlskoga, Sweden, 69181
    • Hudmottagningen Karlskoga Lasarett
  • Lindesberg, Sweden, 711 35
    • Hudmottagningen Lindesbergs Lasarett
  • Lund, Sweden, 222 21
    • Capio Citykliniken Lund
  • Malmö, Sweden, 211 18
    • Diagnostiskt Centrum Hud Malmö
  • Malmö, Sweden, 214 28
    • SUS Malmö Hudkliniken
  • Norrköping, Sweden, 601 82
    • Hudkliniken Vrinnevisjukhuset Norrköping
  • Stockholm, Sweden, 111 37
    • Diagnostiskt Centrum Hud Stockholm
  • Stockholm, Sweden, 113 22
    • Cutisgruppen/Stockholm Hud
  • Stockholm, Sweden, 118 83
    • Hudkliniken SÖS
  • Stockholm, Sweden, 133 30
    • Hudcentrum Hagastaden
  • Stockholm, Sweden, 17176
    • Karolinska Psoriasis Center
  • Stockholm, Sweden, 182 88
    • Hudkliniken Danderyds Sjukhus
  • Trelleborg, Sweden, 231 85
    • Hudmottagningen Trelleborg
  • Västervik, Sweden, 593 33
    • Hudmottagningen Västervik
• Switzerland
  • Basel, Switzerland, 4051
    • Dermatologie Aesche
  • Basel, Switzerland, 4052
    • Somamedica
  • Bellinzona, Switzerland, 6500
    • Ospedale Bellinzona e Valli EOC
  • Bern, Switzerland, 3010
    • Insel Gruppe AG
  • Genève, Switzerland, 1201
    • Clinique dermatologie du Seujet
  • Herzogenbuchsee, Switzerland, 3360
    • Hautarzt Oberaargau AG
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Lugano, Switzerland, 6900
    • Studio medico Dr. Pelloni
  • Martigny, Switzerland, 1920
    • Practice Dr. Niklaus
  • Olten, Switzerland, 4600
    • Pallas Klinik Olten
  • St. Gallen, Switzerland, 9000
    • Haut und Laserzentrum Dr. Zuder
  • St. Gallen, Switzerland, 9000
    • Praxis Dr. med. Christian Schuster
  • Uster, Switzerland, 8610
    • Haut und Allergiezentrum Brunnehof
  • Weinfelden, Switzerland, 8570
    • Dr. Tomi Haut- und Laserzentrum
  • Winterthur, Switzerland, 8400
    • Hautpraxis Dermateam
  • Wohlen, Switzerland, 5610
    • Praxisgemeinschaft Bünz AG
  • Zug, Switzerland, 6300
    • Zug Hautarzt
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZB
    • Aberdeen Royal Infirmary
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Teaching Hospitals NHS
  • Bury St Edmunds, United Kingdom, IP33 2QZ
    • West Suffolk NHS Foundation
  • Canterbury, United Kingdom, CT1 3NG
    • East Kent & Canterbury Hospital
  • Dumfries, United Kingdom, DG1 4AP
    • NHS Dumfries and Galloway
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon & Exeter NHS Foundation Trust
  • Isleworth, United Kingdom, TW7 6AF
    • West Middlesex University Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Chapel Allerton Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas's NHS Foundation Trust
  • London, United Kingdom, SW10 9NH
    • Chelsea & Westminster NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Royal Victoria Infirmary
  • Salford, United Kingdom, M6 8HD
    • University of Manchester
  • Warwick, United Kingdom, CV34 5BW
    • Warwick Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient charts will be selected for data abstraction by participating dermatologists and will be determined eligible for study enrollment based on the inclusion criteria. All consecutive adult psoriasis patients who can be contacted 6 months (+/- 1 month) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection. All eligible patients will be included in consecutive order regarding the date of the signed Informed Consent.

Description

Inclusion Criteria:

1. Must have understood and voluntarily signed the Informed Consent Form (ICF).
2. Age ≥ 18 years at the time of signing the ICF.
3. Diagnosed with plaque psoriasis.
4. Initiated treatment with apremilast 6 months (+/- 1 month) previously (patients may or may not have completed 6 months of apremilast treatment)

Exclusion Criteria:

1. Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial.
2. Started apremilast as part of a clinical trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psoriasis patients; Single cohort of psoriasis patients treated with OTEZLA (apremilast)	Other: Patient questionnaire; Patients will be asked to complete a questionnaire regarding their expectations, experience and satisfaction in taking OTEZLA (apremilast) treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Patient Benefit Index (PBI) outcome score	Is a questionnaire regarding patient expectations and benefit of psoriasis treatment with apremilast, eg, effect on specific symptoms.	Up to approximately 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score	The TSQM-9 is a self-administrated instrument to understand a subject's satisfaction on the current therapy	Up to approximately 7 months
Percentage of patients achieving PASI75	PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.	Up to approximately 7 months
Percentages of patients achieving PASI50	PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.	Up to approximately 7 months
Mean change in Dermatology Life Quality Index (DLQI)	DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.	Up to approximately 7 months
Percentages of patients achieving ≥5 point improvement in DLQI	DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.	Up to approximately 7 months
Percentages of patients achieving PASI50 plus ≥5 point improvement in DLQI	PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease	Up to approximately 7 months
Mean change in Body Surface Area (BSA)	BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area.	Up to approximately 7 months
Mean change in PGA	The PGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the assessor factors in areas that have already cleared (ie, have scores of 0) and not just remaining lesions for severity, ie, the severity of each sign was to be averaged across all areas of involvement, including cleared lesions	Up to approximately 7 months
Percentage of patients achieving PGA 0/1 (clear/almost clear)	The PGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the assessor factors in areas that have already cleared (ie, have scores of 0) and not just remaining lesions for severity, ie, the severity of each sign was to be averaged across all areas of involvement, including cleared lesions	Up to approximately 7 months
Adverse Events (AEs)	Number of patients with adverse events	Up to approximately 7 months

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• Pedro Herranza, Lidia Trasobaresb, Almudena Mateuc, Esperanza Martínezd, Ricardo Ruiz-Villaverdee, Ofelia Baniandrésf, Javier Mataixg, Natalia Jiménez-Gómezh, Marta Serrai, Diana Patricia Ruiz Genaoj, Noelia Riverak, Jesús Tercedor-Sánchezl, Carmen Garciam, Myriam Cordeyn, Enrique Herrera-Acostao. Characterization and outcomes of patients treated with apremilast in the Spanish routine clinical practice: Results from the APPRECIATE study. Actas Dermosifiliogr.
• Cetkovska P, Dediol I, Sola M, Kojanova M, Trcko K, Carija A, Ceovic R, Ledic-Drvar D, Kastelan M, Hrabar A, Missoup MC, Mamun K. Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe. Adv Ther. 2023 Apr;40(4):1787-1802. doi: 10.1007/s12325-023-02468-3. Epub 2023 Mar 2.

Helpful Links

• AmgenTrials clinical trials website
• Expanded Access for CC-10004

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Actual): October 27, 2021
• Study Completion (Actual): October 27, 2021

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimated): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; Observational; Apremilast; Dermatology; Retrospective; APPRECIATE
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CC-10004-PSOR-013