Itching in Atopic Dermatitis: Patient- and Physician-reported Outcomes in the German Atopic Dermatitis Registry TREATgermany

Authors

  • Elke Weisshaar Occupational Dermatology, Department of Dermatology, University of Heidelberg
  • Philipp Bentz Occupational Dermatology, Department of Dermatology, University of Heidelberg https://orcid.org/0000-0002-6474-192X
  • Christian Apfelbacher Institute of Social Medicine and Health Systems Research, Otto von Guericke University Magdeburg, Magdeburg, Germany; Institute for Epidemiology and Preventive Medicine/Medical Sociology, University of Regensburg, Regensburg, Germany https://orcid.org/0000-0003-3805-8219
  • Eva Haufe Center of Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden
  • Luise Heinrich 4. Center of Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden
  • Annice Heratizadeh Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover
  • Susanne Abraham Department of Dermatology, University Allergy Center, Medical Faculty Carl Gustav Carus, TU Dresden https://orcid.org/0000-0001-7457-6481
  • Inken Harder Center for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel https://orcid.org/0000-0002-3079-0440
  • Andreas Kleinheinz Clinics for Dermatology, Elbe Klinikum Buxtehude https://orcid.org/0000-0002-0379-4403
  • Andreas Wollenberg Clinics and Outpatient Clinics for Dermatology and Allergy, LMU Munich https://orcid.org/0000-0003-0177-8722
  • Knut Schäkel Department of Dermatology, University of Heidelberg https://orcid.org/0000-0001-6344-7799
  • Franca Wiemers Practice Dr. med. Franca Wiemers, Leipzig
  • Julia Ertner Practice Dr. med. Konstantin Ertner, Nuernberg
  • Matthias Augustin Institute for Health Services Research in Dermatology, University Medical Center Hamburg Eppendorf https://orcid.org/0000-0002-4026-8728
  • Julia Wildberger Practice Dr. med. Julia Wildberger, Hautmedizin, Bad Soden
  • Ralph von Kiedrowski Focus Practice for chronic inflammatory dermatoses, skin cancer and allergology and also Study Center CMS3 (Company for Medical Study and Service), Selters/Westerwald
  • Margitta Worm Department of Dermatology, Allergy and Venereology, Charité Berlin https://orcid.org/0000-0002-3449-1245
  • Alexander Zink https://orcid.org/0000-0001-9313-6588
  • Isaak Effendy Department of Dermatology, OWL University Hospital of Bielefeld University, Campus Clinic Bielefeld https://orcid.org/0000-0002-8293-6616
  • Andrea Asmussen Practice Dr. med. Andrea Asmussen, Dermatology at Lesum, Bremen
  • Mario Pawlak Practice Dr. med. Anika Hünermund and Mario Pawlak, Heiligenstadt
  • Michael Sticherling 21. Department of Dermatology, German Center for Immunotherapy, University of Erlangen https://orcid.org/0000-0001-9396-3938
  • Melanie Hilgers Clinics for Dermatology and Allergy, University Hospital Aachen
  • Christiane Handrick Practice Dr. med. Christiane Handrick, Berlin
  • Sven Quist Dermatology Clinic, Helix Medical Excellence Center, Mainz https://orcid.org/0000-0002-9548-7813
  • Beate Schwarz Practice Dr. med. Beate Schwarz, Langenau
  • Magnus Bell Practice Dr. med. Magnus Bell, Andernach
  • Petra Staubach-Renz Clinic for Dermatology, University Hospital, Mainz https://orcid.org/0000-0002-2276-0284
  • Sung-Hei Hong-Weldemann Practice Dr. med. Sung-Hei Hong-Weldemann, Freiburg
  • Bernhard Homey Department of Dermatology and Allergology, University Hospital Duesseldorf https://orcid.org/0000-0002-5784-4146
  • Jens-Joachim Brücher Practice Dr. med. Jens-Joachim Brücher, Hautambulatorium Magdeburg
  • Stephan Weidinger Center for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel https://orcid.org/0000-0003-3944-252X
  • Thomas Werfel Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover
  • Jochen Schmitt Center of Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden https://orcid.org/0000-0003-0264-0960

DOI:

https://doi.org/10.2340/actadv.v103.4426

Keywords:

EASI, POEM, Pruiritus, Quality of Life, Registry

Abstract

TREATgermany is an investigator-initiated prospective disease registry. It investigates physician- and patient-reported disease severity (Eczema Area and Severity Index (EASI), objective Scoring Atopic Dermatitis (oSCORAD), Investigator Global Assessment, Patient-Oriented Eczema Measure (POEM), Patient Global Assessment (PGA)), patient-reported symptoms (itch, sleep loss, depressive symptoms), therapy courses and dermatological quality of life (DLQI) in moderate-to-severe atopic dermatitis with SCORAD > 20. 1,134 atopic dermatitis patients (mean age 41.0 ± 14.7 years, 42.5% females) were enrolled by 40 German recruiting sites (dermatological clinics and practices) between June 2016 and April 2021. The current analysis focuses on itch scores obtained with a numerical rating scale (NRS)) documented for the previous 3 days prior to baseline visit. The results show that 97.2% (1,090 of 1,121) patients experienced itch. Itch severity correlated moderately with severity of atopic dermatitis oSCORAD (rho = 0.44 (0.39–0.48)) and EASI score (rho = 0.41 (0.36–0.46)). A strong correlation was found with self-reported disease severity as PGA (rho = 0.68 (0.65–0.71)), POEM sum score (rho = 0.66 (0.63–0.69)) and dermatological quality of life impairment DLQI (rho = 0.61 (0.57–0.65)). Itch as a subjective complaint is more closely correlated with patient-reported outcomes than with objective assessments by the physician.

Downloads

Download data is not yet available.

References

Heratizadeh A, Haufe E, Stolzl D, Abraham S, Heinrich L, Kleinheinz A, et al. Baseline characteristics, disease severity and treatment history of patients with atopic dermatitis included in the German AD Registry TREATgermany. J Eur Acad Dermatol Venereol 2020; 34: 1263-1272.

https://doi.org/10.1111/jdv.16078 DOI: https://doi.org/10.1111/jdv.16078

Schmitt J, Abraham S, Trautmann F, Stephan V, Folster-Holst R, Homey B, et al. Usage and effectiveness of systemic treatments in adults with severe atopic eczema: First results of the German Atopic Eczema Registry TREATgermany. J Dtsch Dermatol Ges 2017; 15: 49-59.

https://doi.org/10.1111/ddg.12958 DOI: https://doi.org/10.1111/ddg.12958

Abraham S, Haufe E, Harder I, Heratizadeh A, Kleinheinz A, Wollenberg A, et al. Implementation of dupilumab in routine care of atopic eczema: results from the German national registry TREATgermany. Br J Dermatol 2020; 183: 382-384.

https://doi.org/10.1111/bjd.18958 DOI: https://doi.org/10.1111/bjd.18958

Bieber T. Atopic dermatitis. N Engl J Med 2008; 358: 1483-1494.

https://doi.org/10.1056/NEJMra074081 DOI: https://doi.org/10.1056/NEJMra074081

Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet 2020; 396: 345-360.

https://doi.org/10.1016/S0140-6736(20)31286-1 DOI: https://doi.org/10.1016/S0140-6736(20)31286-1

Wollenberg A, Christen-Zach S, Taieb A, Paul C, Thyssen JP, de Bruin-Weller M, et al. ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children. J Eur Acad Dermatol Venereol 2020; 34: 2717-2744.

https://doi.org/10.1111/jdv.16892 DOI: https://doi.org/10.1111/jdv.16892

Darsow U., Ripphoff E., J. R. Pathophysiology and clinical manifestation of itch in atopic eczema. In: Ring J., Przybilla B., Ruzicka T., editors. Handbook of Atopic Eczema. 2 ed. Berlin, Heidelberg, New York: Springer 2006: p. 222-227.

https://doi.org/10.1007/3-540-29856-8_21 DOI: https://doi.org/10.1007/3-540-29856-8_21

Martin SA, Brown TM, Fehnel S, Deal LS, Katz EG, Chiou CF. The atopic dermatitis itch scale: development of a new measure to assess pruritus in patients with atopic dermatitis. J Dermatolog Treat 2020; 31: 484-490.

https://doi.org/10.1080/09546634.2020.1713971 DOI: https://doi.org/10.1080/09546634.2020.1713971

Weisshaar E, Diepgen TL, Bruckner T, Fartasch M, Kupfer J, Lob-Corzilius T, et al. Itch intensity evaluated in the German Atopic Dermatitis Intervention Study (GADIS): correlations with quality of life, coping behaviour and SCORAD severity in 823 children. Acta Derm Venereol 2008; 88: 234-239.

Lei D, Yousaf M, Janmohamed SR, Vakharia PP, Chopra R, Chavda R, et al. Validation of four single-item patient-reported assessments of sleep in adult atopic dermatitis patients. Ann Allergy Asthma Immunol 2020; 124: 261-266.

https://doi.org/10.1016/j.anai.2019.12.002 DOI: https://doi.org/10.1016/j.anai.2019.12.002

Kunz B, Oranje AP, Labreze L, Stalder JF, Ring J, Taieb A. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology 1997; 195: 10-19.

https://doi.org/10.1159/000245677 DOI: https://doi.org/10.1159/000245677

Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol 2001; 10: 11-18.

https://doi.org/10.1034/j.1600-0625.2001.100102.x DOI: https://doi.org/10.1034/j.1600-0625.2001.100102.x

Meurer M, Folster-Holst R, Wozel G, Weidinger G, Junger M, Brautigam M, et al. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology 2002; 205: 271-277.

https://doi.org/10.1159/000065863 DOI: https://doi.org/10.1159/000065863

Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol 2004; 140: 1513-1519.

https://doi.org/10.1001/archderm.140.12.1513 DOI: https://doi.org/10.1001/archderm.140.12.1513

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) - a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210-216.

https://doi.org/10.1111/j.1365-2230.1994.tb01167.x DOI: https://doi.org/10.1111/j.1365-2230.1994.tb01167.x

Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989; 46: 1121-1123.

https://doi.org/10.1001/archneur.1989.00520460115022 DOI: https://doi.org/10.1001/archneur.1989.00520460115022

Augustin M, Radtke MA, Zschocke I, Blome C, Behechtnejad J, Schafer I, et al. The patient benefit index: a novel approach in patient-defined outcomes measurement for skin diseases. Arch Dermatol Res 2009; 301: 561-571.

https://doi.org/10.1007/s00403-009-0928-8 DOI: https://doi.org/10.1007/s00403-009-0928-8

Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159-174.

https://doi.org/10.2307/2529310 DOI: https://doi.org/10.2307/2529310

Phan NQ, Blome C, Fritz F, Gerss J, Reich A, Ebata T, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol 2012; 92: 502-507.

https://doi.org/10.2340/00015555-1246 DOI: https://doi.org/10.2340/00015555-1246

Thomas KS, Apfelbacher CA, Chalmers JR, Simpson E, Spuls PI, Gerbens LAA, et al. Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting. Br J Dermatol 2021; 185: 139-146.

https://doi.org/10.1111/bjd.19751 DOI: https://doi.org/10.1111/bjd.19751

Pilz AC, Schielein MC, Schuster B, Heinrich L, Haufe E, Abraham S, et al. Atopic dermatitis: disease characteristics and comorbidities in smoking and non-smoking patients from the TREATgermany registry. J Eur Acad Dermatol Venereol 2022; 36: 413-421.

https://doi.org/10.1111/jdv.17789 DOI: https://doi.org/10.1111/jdv.17789

Howells LM, Chalmers JR, Gran S, Ahmed A, Apfelbacher C, Burton T, et al. Development and initial testing of a new instrument to measure the experience of eczema control in adults and children: Recap of atopic eczema (RECAP). Br J Dermatol 2020; 183: 524-536.

https://doi.org/10.1111/bjd.18780 DOI: https://doi.org/10.1111/bjd.18780

Silverberg JI, Lai JS, Patel KR, Singam V, Vakharia PP, Chopra R, et al. Measurement properties of the Patient-Reported Outcomes Information System (PROMIS((R)) ) Itch Questionnaire: itch severity assessments in adults with atopic dermatitis. Br J Dermatol 2020; 183: 891-898.

https://doi.org/10.1111/bjd.18978 DOI: https://doi.org/10.1111/bjd.18978

Lio PA, Simpson EL, Han G, Soung J, Ball S, Sun L, et al. Improvement in sleep and itch and enhanced quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a phase 3 trial of baricitinib therapy. J Dermatolog Treat 2022; 33: 2057-2062.

https://doi.org/10.1080/09546634.2021.1914308 DOI: https://doi.org/10.1080/09546634.2021.1914308

Simpson EL, Tom WL, Bushmakin AG, Cappelleri JC, Yosipovitch G, Stander S, et al. Relationship among treatment, pruritus, investigator's static global assessment, and quality of life in patients with atopic dermatitis. Dermatol Ther (Heidelb) 2021; 11: 587-598.

https://doi.org/10.1007/s13555-021-00506-y DOI: https://doi.org/10.1007/s13555-021-00506-y

Vakharia PP, Chopra R, Sacotte R, Patel N, Immaneni S, White T, et al. Validation of patient-reported global severity of atopic dermatitis in adults. Allergy 2018; 73: 451-458.

https://doi.org/10.1111/all.13309 DOI: https://doi.org/10.1111/all.13309

Valko PO, Bassetti CL, Bloch KE, Held U, Baumann CR. Validation of the fatigue severity scale in a Swiss cohort. Sleep 2008; 31: 1601-1607.

https://doi.org/10.1093/sleep/31.11.1601 DOI: https://doi.org/10.1093/sleep/31.11.1601

Brunner PM, Silverberg JI, Guttman-Yassky E, Paller AS, Kabashima K, Amagai M, et al. Increasing comorbidities suggest that atopic dermatitis is a systemic disorder. J Invest Dermatol 2017; 137: 18-25.

https://doi.org/10.1016/j.jid.2016.08.022 DOI: https://doi.org/10.1016/j.jid.2016.08.022

Yosipovitch G, Berger T, Fassett MS. Neuroimmune interactions in chronic itch of atopic dermatitis. J Eur Acad Dermatol Venereol 2020; 34: 239-250.

https://doi.org/10.1111/jdv.15973 DOI: https://doi.org/10.1111/jdv.15973

Yosipovitch G, Reaney M, Mastey V, Eckert L, Abbe A, Nelson L, et al. Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol 2019; 181: 761-769.

https://doi.org/10.1111/bjd.17744 DOI: https://doi.org/10.1111/bjd.17744

Copley-Merriman C, Zelt S, Clark M, Gnanasakthy A. Impact of measuring patient-reported outcomes in dermatology drug development. Patient 2017; 10: 203-213.

https://doi.org/10.1007/s40271-016-0196-6 DOI: https://doi.org/10.1007/s40271-016-0196-6

Sutaria N, Parthasarathy V, Roh YS, Choi J, Bordeaux ZA, Trinh P, et al. Itch in skin of colour: a multicentre cross-sectional study. Br J Dermatol 2021; 185: 652-654.

https://doi.org/10.1111/bjd.20403 DOI: https://doi.org/10.1111/bjd.20403

Abuabara K, Silverberg JI, Simpson EL, Paller AS, Eichenfield LF, Bissonnette R, et al. International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale. BMJ Open 2020; 10: e039928.

https://doi.org/10.1136/bmjopen-2020-039928 DOI: https://doi.org/10.1136/bmjopen-2020-039928

Published

2023-01-23

How to Cite

Weisshaar, E., Bentz, P., Apfelbacher, C., Haufe, E., Heinrich, L., Heratizadeh, A. ., Abraham, S., Harder, I., Kleinheinz, A., Wollenberg, A., Schäkel, K., Wiemers, F., Ertner, J., Augustin, M., Wildberger, J., von Kiedrowski, R., Worm, M., Zink, A., Effendy, I., Asmussen, A., Pawlak, M., Sticherling, M. ., Hilgers, M., Handrick, C., Quist, S., Schwarz, B., Bell, M., Staubach-Renz, P., Hong-Weldemann, S.-H., Homey, B., Brücher, J.-J., Weidinger, S., Werfel, T., & Schmitt, J. (2023). Itching in Atopic Dermatitis: Patient- and Physician-reported Outcomes in the German Atopic Dermatitis Registry TREATgermany. Acta Dermato-Venereologica, 103, adv00854. https://doi.org/10.2340/actadv.v103.4426