Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults

Journal of the American Academy of Dermatology

Volumn 74, Issue 3, 2016, Pages 491-498

  Simpson, Eric L ^a   Bieber, Thomas ^b   Eckert, Laurent ^c   Wu, Richard ^d   Ardeleanu, Marius ^d   Graham, Neil M H ^d   Pirozzi, Gianluca ^c   Mastey, Vera ^d  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b UNIVERSITY OF BONN   (Germany)

^c SANOFI   (France)

^d REGENERON PHARMACEUTICALS INC   (United States)

Author keywords

adults; atopic dermatitis; burden of illness; patient reported outcomes; pruritus; quality of life

Indexed keywords

DUPILUMAB; MONOCLONAL ANTIBODY;

5 DIMENSION EUROQOL; 5 DIMENSION PRURITUS SCALE; ADULT; ARTICLE; ATOPIC DERMATITIS; COMORBIDITY; DERMATOLOGY LIFE QUALITY INDEX; FEMALE; GENERAL ASPECTS OF DISEASE; HEALTH BURDEN; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PATIENT ORIENTED ECZEMA MEASURE; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; QUALITY OF LIFE ASSESSMENT; SCORING AD; SELF REPORT; SKIN DISEASE ASSESSMENT; ADOLESCENT; CHILD; CLINICAL TRIAL; CONTROLLED STUDY; COST OF ILLNESS; DERMATITIS, ATOPIC; DRUG ERUPTIONS; PHASE 2 CLINICAL TRIAL; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL; CHILD; CHILD, PRESCHOOL; COST OF ILLNESS; DERMATITIS, ATOPIC; DRUG ERUPTIONS; FEMALE; HUMANS; MALE; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 84958182074     PISSN: 01909622     EISSN: 10976787     Source Type: Journal    
DOI: 10.1016/j.jaad.2015.10.043     Document Type: Article

References (41)

1. J.K. Gittler, A. Shemer, M. Suárez-Fariñas, and et al. Progressive activation of T(H)2/T(H)22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis J Allergy Clin Immunol 130 2012 1344 1354
2. J.S. Margolis, K. Abuabara, W. Bilker, O. Hoffstad, and D.J. Margolis Persistence of mild to moderate atopic dermatitis JAMA Dermatol 150 2014 593 600
3. S.L. Chamlin The psychosocial burden of childhood atopic dermatitis Dermatol Ther 19 2006 104 107
4. C.L. Carroll, R. Balkrishnan, S.R. Feldman, A.B. Fleischer Jr., and J.C. Manuel The burden of atopic dermatitis: impact on the patient, family, and society Pediatr Dermatol 22 2005 192 199
5. S.P. McKenna, and L.C. Doward Quality of life of children with atopic dermatitis and their families Curr Opin Allergy Clin Immunol 8 2008 228 231
6. M. Boguniewicz, and D.Y. Leung Atopic dermatitis: a disease of altered skin barrier and immune dysregulation Immunol Rev 242 2011 233 246
7. C. Yano, H. Saeki, T. Ishiji, and et al. Impact of disease severity on work productivity and activity impairment in Japanese patients with atopic dermatitis J Dermatol 40 2013 736 739
8. F.J. Dalgard, U. Gieler, L. Tomas-Aragones, and et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European Countries J Invest Dermatol 135 2015 984 991
9. J. Schmitt, P. Spuls, M. Boers, and et al. Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting Allergy 67 2012 1111 1117
10. L.F. Eichenfield, W.L. Tom, S.L. Chamlin, and et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis J Am Acad Dermatol 70 2014 338 351
11. L.A. Beck, D. Thaçi, J.D. Hamilton, and et al. Dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis N Engl J Med 371 2014 130 139
12. D. Thaçi, E.L. Simpson, L.A. Beck, and et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical therapies: a randomised, placebo-controlled dose-ranging phase 2b study Lancet 387 2015 40 52
13. L.F. Eichenfield Consensus guidelines in diagnosis and treatment of atopic dermatitis Allergy 59 Suppl 2004 86 92
14. J.M. Hanifin, M. Thurston, M. Omoto, R. Cherill, S.J. Tofte, and M. Graeber The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group Exp Dermatol 10 2001 11 18
15. B. Kunz, A.P. Oranje, L. Labrèze, J.F. Stalder, J. Ring, and A. Taïeb Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis Dermatology 195 1997 10 19
16. N.Q. Phan, C. Blome, F. Fritz, and 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 92 2012 502 507
17. S. Elman, L.S. Hynan, V. Gabriel, and M.J. Mayo The 5-D itch scale: a new measure of pruritus Br J Dermatol 162 2010 587 593
18. C.R. Charman, A.J. Venn, and H.C. Williams The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective Arch Dermatol 140 2004 1513 1519
19. A.Y. Finlay, and G.K. Khan Dermatology Life Quality Index (DLQI)-A simple practical measure for routine clinical use Clin Exp Dermatol 19 1994 210 216
20. The EuroQol Group EuroQol-A new facility for the measurement of health-related quality of life Health Policy 16 1990 199 208
21. A.S. Zigmond, and R.P. Snaith The hospital anxiety and depression scale Acta Psychiatr Scand 67 1983 361 370
22. P. Dolan Modeling valuations for EuroQol health states Med Care 35 11 1997 1095 1108
23. M.J. Bannister, and S. Freeman Adult-onset atopic dermatitis Australas J Dermatol 41 2000 225 228
24. V. Ingordo, G. D'Andria, and C. D'Andria Adult-onset atopic dermatitis in a patch test population Dermatology 206 2003 197 203
25. E. Ozkaya Adult-onset atopic dermatitis J Am Acad Dermatol 52 2005 579 582
26. D.Y. Leung, and E. Guttman-Yassky Deciphering the complexities of atopic dermatitis: shifting paradigms in treatment approaches J Allergy Clin Immunol 134 2014 769 779
27. B.G. Bender, S.B. Leung, and D.Y. Leung Actigraphy assessment of sleep disturbance in patients with atopic dermatitis: an objective life quality measure J Allergy Clin Immunol 111 2003 598 602
28. A. Wittkowski, H.L. Richards, C.E. Griffiths, and C.J. Main Illness perception in individuals with atopic dermatitis Psychol Health Med 12 2007 433 444
29. E.L. Sutton Psychiatric disorders and sleep issues Med Clin North Am 98 2014 1123 1143
30. A. Wittkowski, H.L. Richards, C.E. Griffiths, and C.J. Main The impact of psychological and clinical factors on quality of life in individuals with atopic dermatitis J Psychosom Res 57 2004 195 200
31. A. Mizara, L. Papadopoulos, and S.R. McBride Core beliefs and psychological distress in patients with psoriasis and atopic eczema attending secondary care: the role of schemas in chronic skin disease Br J Dermatol 166 2012 986 993
32. G. Schmid-Ott, H.W. Kuensebeck, B. Jaeger, and et al. Validity study for the stigmatization experience in atopic dermatitis and psoriatic patients Acta Derm Venereol 79 1999 443 447
33. R. Zachariae, C. Zachariae, H.H. Ibsen, J.T. Mortensen, and H.C. Wulf Psychological symptoms and quality of life of dermatology outpatients and hospitalized dermatology patients Acta Derm Venereol 84 2004 205 212
34. H. Kimata Prevalence of suicidal ideation in patients with atopic dermatitis Suicide Life Threat Behav 36 2006 120 124
35. J. Dieris-Hirche, U. Gieler, J.P. Kupfer, and W.E. Milch Suicidal ideation, anxiety and depression in adult patients with atopic dermatitis [in German] Hautarzt 60 2009 641 646
36. P. Yaghmaie, C.W. Koudelka, and E.L. Simpson Mental health comorbidity in patients with atopic dermatitis J Allergy Clin Immunol 131 2013 428 433
37. V. Lewis, and A.Y. Finlay Ten years experience of the Dermatology Life Quality Index (DLQI) J Investig Dermatol Symp Proc 9 2004 169 180
38. A. Langenbruch, M. Radtke, N. Franzke, J. Ring, R. Foelster-Holst, and M. Augustin Quality of health care of atopic eczema in Germany: results of the national health care study AtopicHealth J Eur Acad Dermatol Venereol 28 2014 719 726
39. B. Janssen, and A. Szende Population norms for the EQ-5D A. Szende, B. Janssen, J. Cabasés, Self-reported population health: an international perspective based on EQ-5D 2014 Springer Dordrecht (The Netherlands) 19 30
40. P.W. Sullivan, and V. Ghushchyan Preference-based EQ-5D index scores for chronic conditions in the United States Med Decis Making 26 2006 410 420
41. T. Liu, and R.R. Ji New insights into the mechanisms of itch: are pain and itch controlled by distinct mechanisms? Pflugers Arch 465 2013 1671 1685