A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions

Long-term Documentation of the Utilization of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions (LAPIS-Pso)

The objective of this NIS is the collection of data on the utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented. Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast will be recorded. FPI was 3rd August 2015, LPO was 14th of June 2018. A total of 391 patients have been enrolled.

Study Overview

• Status: Completed
• Conditions: Psoriasis

Detailed Description

The objective of this NIS (according to section 4(23) of the German Medicinal Products Act) is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis.

This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional, systemic therapy or, if a contraindication is present, did not receive a systemic therapy so far, and who were diagnosed by their treating physicians to be eligible for an apremilast treatment. The treatment of Apremilast will be documented for a period of approximately 52 weeks.

• Study Type: Observational
• Enrollment (Actual): 391

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Raoul Hasert
  • Berlin, Germany, 10247
    • Klaus Spickermann
  • Berlin, Germany, 10777
    • Jens Olaf Mielcke
  • Berlin, Germany, 12489
    • Albert-Einstein-Str. 2
  • Berlin, Germany, 13187
    • Hautarztpraxis Zahn
  • Berlin, Germany, 13507
    • Maria Manasterski
  • Berlin, Germany, 13507
    • Martin Miehe
  • Bremen, Germany, 28779
    • Uwe Schwichtenberg
  • Hamburg, Germany, 20246
    • Matthias Augustin
  • Hamburg, Germany, 20354
    • Kristian Reich
  • Hamburg, Germany, 22391
    • Christian Mensing
  • Königs Wusterhausen, Germany, 15711
    • Johannes-R.-Becher-Straße 24
  • Vilshofen, Germany, 94474
    • Florian Kreuziger
  • Baden-Württemberg
    • Blaubeuren, Baden-Württemberg, Germany, 89143
      • Gertraud Krähn-Senftleben
    • Blaustein, Baden-Württemberg, Germany, 89134
      • Ralf-Uwe Peter
    • Esslingen am Neckar, Baden-Württemberg, Germany, 73728
      • Regina Renner
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Universitätsklinikum Heidelberg - Hautklinik
    • Karlsruhe, Baden-Württemberg, Germany, 76133
      • Ina Reitenbach-Blindt
    • Karlsruhe, Baden-Württemberg, Germany, 76133
      • Kaiserstraße 231-233
    • Karlsruhe, Baden-Württemberg, Germany, 76133
      • Naomi Gerhardus
    • Karlsruhe, Baden-Württemberg, Germany, 76149
      • Johannes Glutsch
    • Langenau, Baden-Württemberg, Germany, 89129
      • Beate Schwarz
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Astrid Schmieder
    • Spaichingen, Baden-Württemberg, Germany, 78549
      • Katharina Wroblewska
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Michael Sticherling
    • Freising, Bayern, Germany, 85354
      • Hjalmar Kurzen
    • Germering, Bayern, Germany, 82110
      • Claus Jung
    • Hersbruck, Bayern, Germany, 91217
      • Clarissa Allmacher
    • Krumbach, Bayern, Germany, 86381
      • Ildiko Sugar-Bunk
    • München, Bayern, Germany, 80639
      • Sabine Anders
    • München, Bayern, Germany, 80802
      • Hortensia Pfannenstiel
    • München, Bayern, Germany, 80802
      • Technische Universität München - Kilian Eyerich
    • Regensburg, Bayern, Germany, 93053
      • Universitatsklinikum Regensburg
    • Würzburg, Bayern, Germany, 97070
      • Andreas Eggert
  • Brandenburg
    • Falkensee, Brandenburg, Germany, 14612
      • Lars Freitag
    • Kleinmachnow, Brandenburg, Germany, 14532
      • Förster-Funke-Allee 104
    • Schwedt, Brandenburg, Germany, 16303
      • Silke Thies
  • Hessen
    • Eltville, Hessen, Germany, 65343
      • Christoph Hartl
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
    • Schwalmstadt, Hessen, Germany, 34613
      • Pia Freyschmidt-Paul
  • Mecklenburg-Vorpommern
    • Bergen, Mecklenburg-Vorpommern, Germany, 18528
      • Andreas Timmel
    • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17034
      • Raimund Paech
  • Niedersachsen
    • Braunschweig, Niedersachsen, Germany, 38114
      • Jutta Ramaker-Brunke
    • Buxtehude, Niedersachsen, Germany, 21614
      • Andreas Kleinheinz
    • Cloppenburg, Niedersachsen, Germany, 49661
      • Marco Averbeck
    • Hannover, Niedersachsen, Germany, 30159
      • Florian Schenck
    • Hannover, Niedersachsen, Germany, 30167
      • Ulrike Stein
    • Hildesheim, Niedersachsen, Germany, 31134
      • Holger Petering
    • Holzminden, Niedersachsen, Germany, 37603
      • Silke Reinecke
    • Lüneburg, Niedersachsen, Germany, 21335
      • Reinhard Knöll
    • Vechta, Niedersachsen, Germany, 49377
      • Christian Kock
    • Winsen, Niedersachsen, Germany, 21423
      • Gesundheitszentrum Winsen
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52062
      • Theaterplatz 9
    • Bielefeld, Nordrhein-Westfalen, Germany, 33647
      • Isaak Effendy
    • Duisburg, Nordrhein-Westfalen, Germany, 47249
      • Volker Riesopp
    • Düren, Nordrhein-Westfalen, Germany, 52349
      • Bernhard Korge
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40237
      • Herderstr.71 b
    • Eschweiler, Nordrhein-Westfalen, Germany, 52249
      • Dechant-Deckers-Straße 5-7
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitätsklinikum Essen
    • Euskirchen, Nordrhein-Westfalen, Germany, 53879
      • Christina Huerkamp
    • Gelsenkirchen-Feldmark, Nordrhein-Westfalen, Germany, 45883
      • Sebastian Rotterdam
    • Gladbeck, Nordrhein-Westfalen, Germany, 45964
      • Jörg Brinkmann
    • Kleve, Nordrhein-Westfalen, Germany, 47533
      • Hautartzpraxis
    • Minden, Nordrhein-Westfalen, Germany, 32429
      • Rudolf Stadler
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
      • Rolf Ostendorf
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Athanasios Tsianakas
    • Rheinbach, Nordrhein-Westfalen, Germany, 53359
      • Stefanie Montag
    • Stolberg (Rheinland), Nordrhein-Westfalen, Germany, 52222
      • Hautarztpraxis, Steinfeldstr. 5
    • Velbert, Nordrhein-Westfalen, Germany, 42551
      • Oliver Mainusch
    • Wesel, Nordrhein-Westfalen, Germany, 46485
      • Kurt-Kräcker-Str. 47
  • Rheinland Pfalz
    • Bendorf, Rheinland Pfalz, Germany, 56170
      • Ulrich Blaese
  • Rheinland-Pfalz
    • Andernach, Rheinland-Pfalz, Germany, 56626
      • Magnus Bell
    • Koblenz, Rheinland-Pfalz, Germany, 56068
      • Schloss Straße 17
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Petra Staubach-Renz
    • Maxdorf, Rheinland-Pfalz, Germany, 67133
      • Dirk Maaßen
    • Neuwied, Rheinland-Pfalz, Germany, 56564
      • Marktstr. 20
    • Prüm, Rheinland-Pfalz, Germany, 54595
      • Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn
    • Selters, Rheinland-Pfalz, Germany, 56242
      • Ralph von Kiedrowski
    • Simmern, Rheinland-Pfalz, Germany, 55469
      • Mohammad Asefi
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09116
      • Karolin Schneider
    • Dresden, Sachsen, Germany, 01097
      • Beatrice Gerlach
    • Dresden, Sachsen, Germany, 01159
      • Liane John
    • Dresden, Sachsen, Germany, 01219
      • Mary-Krebs-Straße 1
    • Dresden, Sachsen, Germany, 01307
      • Stefan Beissert
    • Leipzig, Sachsen, Germany, 04277
      • Bernhard-Göring-Str. 162
    • Leipzig, Sachsen, Germany, 04317
      • Riebeckstraße 65
    • Wurzen, Sachsen, Germany, 04808
      • Schweizergartenstr. 2a
  • Sachsen-Anhalt
    • Eilenburg, Sachsen-Anhalt, Germany, 04838
      • Puschkinstr. 110
    • Magdeburg, Sachsen-Anhalt, Germany, 39104
      • Franckestr. 1
    • Quedlinburg, Sachsen-Anhalt, Germany, 06484
      • Jens Ulrich
    • Weißenfels, Sachsen-Anhalt, Germany, 06667
      • Gabriela Fiedler
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24148
      • Harald Brüning
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Universitatsklinikum Schleswig-Holstein
    • Neumünster, Schleswig-Holstein, Germany, 24534
      • Christian Meewes
  • Thüringen
    • Artern, Thüringen, Germany, 06556
      • Jens Thieme
    • Heiligenstadt, Thüringen, Germany, 37308
      • Mario Pawlak

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

A total of 500 patients with moderate to severe plaque psoriasis are planned to be enrolled in this NIS. In- and exclusion criteria are derived from the Summary of product characteristics (SmPC) of Apremilast.

Description

Inclusion Criteria:

• The decision for a therapy with Apremilast was made before enrolment and independent of this study.
• Patient ≥ 18 years of age
• Diagnosis of moderate to severe plaque psoriasis
• Inadequate response or intolerance to a previous systemic treatment, or contraindication for systemic therapies.
• Written informed consent by the patient for data recording, statistical analysis, filing and forwarding of the data

Exclusion Criteria:

• Pregnancy
• Hypersensitivity to apremilast or any of the excipients of the film-coated tablet
• Other criteria according to the Summary of product characteristics (SmPC).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with ≤ 1 conventional, systemic pre-treatment; After failure (inadequate response/intolerance) to or contraindication for ≤ 1 conventional, systemic pre-treatment
Patients with > 1 conventional, systemic pre-treatment; After failure (inadequate response/intolerance) to or contraindication for > 1 conventional, systemic pre-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline	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.	Approximately 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline.	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 52 weeks
Change in the Physician Global Assessment (PGA) Score	The PGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis.	Up to approximately 52 weeks
Percent Change in Percent of Affected Body Surface Area (BSA)	BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmer surface or "handprint" excluding DIPs), which equates to approximately 1% of total body surface area.	Up to approximately 52 weeks
Percent Change in the Psoriasis Area Severity Index (PASI) Score	Psoriasis Area Severity Index (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 total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.	Up to approximately 52 weeks
Change in the Patient's Global Assessment (PaGA)	The PaGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis by the patient.	Up to approximately 52 weeks
Patient Preference Questionnaire (PPQ)	PPQ is a questionnaire consisting of 5 questions. PPQ asks the patient for his preference of the actual therapy versus the previous systemic therapy.	Approximately 4 months
Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ)	STAQ; patient questionnaire on patient benefit, communication physician/patient, patient knowledge, and treatment satisfaction with the current systemic treatment (38 questions).	Approximately 13 months
Change in Pain (Visual Analogue Scale; VAS)	The Pain Visual Analog Scores (VAS) is used to measure the amount of pain a participant experiences. Participants are asked: How much pain do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease.	Up to approximately 52 weeks
Adverse Events (AEs)	All Serious Adverse Events (SAEs), irrespective of relationship to Apremilast, and all non-serious AEs considered at least possibly related to Apremilast administration [non-serious adverse drug reactions (NS ADRs)], must be recorded within 24 hours of the physician's knowledge to the Sponsors' Drug Safety Department. AEs will be reported by the sponsor as required to Regulatory Authorities and Ethics Committees as applicable, in accordance with the national requirements for marketing authorization holders.	Up to approximately 52 weeks
Change in Itch (Pruritus) (Visual Analogue Scale; VAS)	The Itch Visual Analog Scores (VAS) is used to measure the amount of itch a participant experiences. Participants are asked: How much itch do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease.	Up to approximately 52 weeks
Change in Scalp Involvement -Physician's Global Assessment (PGA)	PGA: 5-point scale for the physician's global assessment of the severity of scalp psoriasis.	Up to approximately 52 weeks
Change in Scalp Involvement - Patient's Global Assessment (PaGA)	PaGA: 5-point scale for the patient's global assessment of the severity of scalp psoriasis.	Up to approximately 52 weeks
Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI)	NAPSI: Assessment of target fingernail for nail bed and nail matrix involvement, each can be scored 0-4. Total score ranges from 0-8.	Up to approximately 52 weeks
Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA)	Fingernail Patient Global Assessment ; 5-point scale on the patient's global assessment of the fingernail involvement, substituted with a 0-100 Visual analog scale (VAS) for the assessment of the impairment caused by this nail involvement.	Up to approximately 52 weeks
Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA)	PGA: 5-point scale for the physician's global assessment of the severity of palmoplantar involvement.	Up to approximately 52 weeks
Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA)	PaGA: 5-point scale for the patient's global assessment of the severity of palmoplantar involvement.	Up to approximately 52 weeks

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Reich K, Korge B, Magnolo N, Manasterski M, Schwichtenberg U, Staubach-Renz P, Kaiser S, Roemmler-Zehrer J, Gomez NN, Lorenz-Baath K. Quality-of-Life Outcomes, Effectiveness and Tolerability of Apremilast in Patients with Plaque Psoriasis and Routine German Dermatology Care: Results from LAPIS-PSO. Dermatol Ther (Heidelb). 2022 Jan;12(1):203-221. doi: 10.1007/s13555-021-00658-x. Epub 2021 Dec 15.

Helpful Links

• Expanded Access for CC-10004

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2015
• Primary Completion (Actual): June 8, 2017
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Observational; CC-10004; Apremilast; Plaque psoriasis; Germany; Otezla®; LAPIS-Pso; non-interventional
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CC-10004-PPSO-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No