Safe psoriasis control: A new outcome measure for the composite assessment of the efficacy and safety of psoriasis treatment

Journal of Cutaneous Medicine and Surgery

Volumn 9, Issue 6, 2005, Pages 276-283

  Papp, Kim A ^a   Henninger, Eric ^b  

^a PROBITY MEDICAL RESEARCH   (Canada)

^b Serono International SA   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

EFALIZUMAB;

ARTICLE; CONTROLLED STUDY; DISEASE CONTROL; DRUG EFFICACY; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; METHODOLOGY; OUTCOMES RESEARCH; PRIORITY JOURNAL; PSORIASIS; QUALITY OF LIFE; UNSPECIFIED SIDE EFFECT; VALIDATION PROCESS;

ANTIBODIES, MONOCLONAL; CLINICAL TRIALS; CLINICAL TRIALS, PHASE III; DATA INTERPRETATION, STATISTICAL; HUMANS; PSORIASIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS; RISK ASSESSMENT; SAFETY; TREATMENT OUTCOME;

EID: 33749362086     PISSN: 12034754     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10227-005-0121-4     Document Type: Article

References (23)

1. Gottlieb AB. Psoriasis. Dis Manag Clin Outcomes 1998; 1(6):195-202.
2. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999; 41(3 Pt 1):401-407.
3. Jacobson CC, Kimball AB. Rethinking the psoriasis area and severity index: the impact of area should be increased. Br J Dermatol 2004; 151:381-387.
4. Carlin CS, Feldman SR, Krueger JG, et al. A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis. J Am Acad Dermatol 2004; 50(6):859-866.
5. Arruda LHFde, Moraes APFDe. The impact of psoriasis on quality of life. Br J Dermatol 2001; 144(Suppl 58):33-36.
6. Kirby B, Richards HL, Woo P, et al. Physical and psychologic measures are necessary to assess overall psoriasis severity. J Am Acad Dermatol 2001; 45(1):72-76.
7. Koo J, Menter A. The Koo-Menter psoriasis instrument for identifying candidate patients for systemic therapy. In: Poster presented at the 9th International Psoriasis Symposium, New York, June 18-22, 2003.
8. Al Suwaidan SN, Feldman SR. Clearance is not a realistic expectation of psoriasis treatment. J Am Acad Dermatol 2000; 42(5 Pt 1):796-802.
9. Griffiths CEM, Sterry W, Henninger E. Safe control of psoriasis: evaluation of a new approach to assessing efficacy of psoriasis treatments. JEADV 2004; 18(suppl.2):355(Ref. P06.106).
10. Fredriksson T, Pettersson U. Severe psoriasis - oral therapy with a new retinoid. Dermatologica 1978; 157:238-244.
11. Finlay AY, Khan GK. Dermatology life quality index (DLQI) - a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19(3):210-216.
12. Juniper EF, Guyatt GH, Willan A, et al. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994; 47:81-87.
13. Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in Health Status. Med Care 1989; 27:3.
14. Cohen J. Statistical power analysis for the behavioural sciencesLawrence Earlbaum, Hillsdale, NJ 1988.
15. Kirby B, Fortune DG, Bhushan M, et al. The salford psoriasis index: an holistic measure of psoriasis severity. Br J Dermatol 2000; 142:728-732.
16. Zachariae R, Zachariae H, blomqvist K, et al. Quality of life in 6,497 Nordic patients with psoriasis. Br J Dermatol 2002; 146:1006-1016.
17. Note for Guidance on Clinical Investigation of Medicinal Products indicated for the Treatment of Psoriasis. Draft published by EMEA/CPMP on 20 November 2003.
18. Mckenna KE, Stern RS. The outcomes movement and new measures of the severity of psoriasis. J Am Acad Dermatol 1996; 34(3):534-538.
19. Touw CR, Hakkaart-Van Roijen L, Verboom P, et al. Quality of life and clinical outcome in psoriasis patients using intermittent cyclosporin. Br J Dermatol 2001; 144(5):967-972.
20. Krueger GG, Feldman SR, Camisa C, et al. Two considerations for patients with psoriasis and their clinicians: what defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis?. J Am Acad Dermatol 2000; 43(2 Pt 1):281-285.
21. Bateman ED, Bousquet J, Braunstein GL. Is overall asthma control being achieved? A hypothesis-generating study. Eur Respir J 2001; 17:589-595.
22. Bateman ED, Frith LF, Braunstein GL. Achieving guideline-based asthma control: does the patient benefit?. Eur Respir J 2001; 20:588-595.
23. Griffiths CEM, Sterry W, Henninger E. Safe control of psoriasis: evaluation of a new approach to assessing efficacy of psoriasis treatments. JEADV 2004; 18(suppl. 2):355(Ref. P06.106).