Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: Results from a phase IIb randomized, controlled study

Health and Quality of Life Outcomes

Volumn 11, Issue 1, 2013, Pages

  Strand, Vibeke ^a   Fiorentino, David ^b   Hu, ChiaChi ^c   Day, Robert M ^c   Stevens, Randall M ^c   Papp, Kim A ^d  

^a STANFORD UNIVERSITY   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CELGENE CORPORATION   (United States)

^d PROBITY MEDICAL RESEARCH   (Canada)

Author keywords

Apremilast; Dermatology Life Quality Index; Phosphodiesterase 4; Psoriasis; Quality of life; SF 36

Indexed keywords

APREMILAST;

ADULT; ARTICLE; CONTROLLED STUDY; DERMATOLOGY LIFE QUALITY INDEX; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRURITUS; PSORIASIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; TREATMENT OUTCOME; VISUAL ANALOG SCALE;

ADULT; FEMALE; HUMANS; MALE; MIDDLE AGED; PHOSPHODIESTERASE 4 INHIBITORS; PSORIASIS; QUALITY INDICATORS, HEALTH CARE; QUALITY OF LIFE; QUESTIONNAIRES; SELF REPORT; THALIDOMIDE; TREATMENT OUTCOME;

EID: 84877248086     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/1477-7525-11-82     Document Type: Article

References (39)

1. Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003-2004. J Am Acad Dermatol 2009, 60:218-224. 10.1016/j.jaad.2008.09.022, 19022533.
2. Augustin M, Reich K, Glaeske G, Schaefer I, Radtke M. Co-morbidity and age-related prevalence of psoriasis: analysis of health insurance data in Germany. Acta Derm Venereol 2010, 90:147-151. 10.2340/00015555-0770, 20169297.
3. Kimball AB, Jacobson C, Weiss S, Vreeland MG, Wu Y. The psychosocial burden of psoriasis. Am J Clin Dermatol 2005, 6:383-392. 10.2165/00128071-200506060-00005, 16343026.
4. Reich A, Hrehorow E, Szepietowski JC. Pruritus is an important factor negatively influencing the well-being of psoriatic patients. Acta Derm Venereol 2010, 90:257-263.
5. Meyer N, Paul C, Feneron D, Bardoulat I, Thiriet C, Camara C, Sid-Mohand D, Le Pen C, Ortonne JP. Psoriasis: an epidemiological evaluation of disease burden in 590 patients. J Eur Acad Dermatol Venereol 2010, 24:1075-1082.
6. Kurd SK, Troxel AB, Crits-Christoph P, Gelfand JM. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol 2010, 146:891-895. 10.1001/archdermatol.2010.186, 2928071, 20713823.
7. Strand V, Sharp V, Koenig AS, Park G, Shi Y, Wang B, Zack DJ, Fiorentino D. Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment. Ann Rheum Dis 2012, 17:1143-1150.
8. Krueger GG, Langley RG, Finlay AY, Griffiths CE, Woolley JM, Lalla D, Jahreis A. Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial. Br J Dermatol 2005, 153:1192-1199. 10.1111/j.1365-2133.2005.06948.x, 16307657.
9. Lebwohl M, Papp K, Han C, Schenkel B, Yeilding N, Wang Y, Krueger GG. Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial. Br J Dermatol 2010, 162:137-146. 10.1111/j.1365-2133.2009.09491.x, 19903183.
10. Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, Li S, Dooley LT, Griffiths CE. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005, 366:1367-1374. 10.1016/S0140-6736(05)67566-6, 16226614.
11. Saurat JH, Guerin A, Yu AP, Latremouille-Viau D, Wu EQ, Gupta SR, Bao Y, Mulani PM. High prevalence of potential drug-drug interactions for psoriasis patients prescribed methotrexate or cyclosporine for psoriasis: associated clinical and economic outcomes in real-world practice. Dermatology 2010, 220:128-137. 10.1159/000275198, 20130383.
12. Ravindran V, Scott DL, Choy EH. A systematic review and meta-analysis of efficacy and toxicity of disease modifying anti-rheumatic drugs and biological agents for psoriatic arthritis. Ann Rheum Dis 2008, 67:855-859. 10.1136/ard.2007.072652, 17827183.
13. Richards HL, Fortune DG, Griffiths CE. Adherence to treatment in patients with psoriasis. J Eur Acad Dermatol Venereol 2006, 20:370-379. 10.1111/j.1468-3083.2006.01565.x, 16643132.
14. Serezani CH, Ballinger MN, Aronoff DM, Peters-Golden M. Cyclic AMP: master regulator of innate immune cell function. Am J Respir Cell Mol Biol 2008, 39:127-132. 10.1165/rcmb.2008-0091TR, 2720142, 18323530.
15. Tasken K, Aandahl EM. Localized effects of cAMP mediated by distinct routes of protein kinase A. Physiol Rev 2004, 84:137-167. 10.1152/physrev.00021.2003, 14715913.
16. Houslay MD, Schafer P, Zhang KY. Keynote review: phosphodiesterase-4 as a therapeutic target. Drug Discov Today 2005, 10:1503-1519. 10.1016/S1359-6446(05)03622-6, 16257373.
17. Baumer W, Hoppmann J, Rundfeldt C, Kietzmann M. Highly selective phosphodiesterase 4 inhibitors for the treatment of allergic skin diseases and psoriasis. Inflamm Allergy Drug Targets 2007, 6:17-26. 10.2174/187152807780077318, 17352685.
18. Schafer PH, Parton A, Gandhi AK, Capone L, Adams M, Wu L, Bartlett JB, Loveland MA, Gilhar A, Cheung Y-F, Baillie GS, Houslay MD, Man H-W, Muller GW, Stirling DI. Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br J Pharmacol 2010, 159:842-855. 10.1111/j.1476-5381.2009.00559.x, 2829210, 20050849.
19. Salari P, Abdollahi M. Phosphodiesterase inhibitors in inflammatory bowel disease. Expert Opin Investig Drugs 2012, 21:261-264. 10.1517/13543784.2012.658915, 22303952.
20. Papp K, Cather J, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu A, Day RM. The efficacy of apremilast, a phosphodiesterase-4 inhibitor, in the treatment of moderate to severe psoriasis: results of a phase 2 randomised study. Lancet 2012, 380:738-746. 10.1016/S0140-6736(12)60642-4, 22748702.
21. Schett G, Wollenhaupt J, Papp K, Joos R, DeVlam KL, Rodrigues JF, Vessey A, Hu CC, Stevens R. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2012, 64:3156-3167. 10.1002/art.34627, 22806399.
22. Gottlieb AB, Strober B, Krueger JG, Rohane P, Zeldis JB, Hu CC, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin 2008, 24:1529-1538. 10.1185/030079908X301866, 18419879.
23. Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol 2008, 159:997-1035.
24. Strand V, Bombardier C, Maetzel A, Scott D, Crawford B. Use of minimum clinically important differences (MCID) in evaluating patient responses to treatment of rheumatoid arthtitis (RA) [abstract 810]. Arthritis Rheum 2001, 44(suppl 9):S187.
25. Strand V, Scott DL, Emery P, Kalden JR, Smolen JS, Cannon GW, Tugwell P, Crawford B. Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis. J Rheumatol 2005, 32:590-601.
26. Hazes JM, Taylor P, Strand V, Purcaru O, Coteur G, Mease P. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology (Oxford) 2010, 49:1900-1910.
27. Tugwell P, Wells G, Strand V, Maetzel A, Bombardier C, Crawford B, Dorrier C, Thompson A. Clinical improvement as reflected in measures of function and health-related quality of life following treatment with leflunomide compared with methotrexate in patients with rheumatoid arthritis: sensitivity and relative efficiency to detect a treatment effect in a twelve-month, placebo-controlled trial. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum 2000, 43:506-514. 10.1002/1529-0131(200003)43:3<506::AID-ANR5>3.0.CO;2-U, 10728742.
28. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean?. J Invest Dermatol 2005, 125:659-664. 10.1111/j.0022-202X.2005.23621.x, 16185263.
29. Strand V, Crawford B, Singh J, Choy E, Smolen JS, Khanna D. Use of "spydergrams" to present and interpret SF-36 health-related quality of life data across rheumatic diseases. Ann Rheum Dis 2009, 68:1800-1804. 10.1136/ard.2009.115550, 2950749, 19910301.
30. Ara R, Brazier J. Deriving an algorithm to convert the eight mean SF-36 dimension scores into a mean EQ-5D preference-based score from published studies (where patient level data are not available). Value Health 2008, 11:1131-1143. 10.1111/j.1524-4733.2008.00352.x, 18489495.
31. Ara R, Brazier J. Predicting the short form-6D preference-based index using the eight mean short form-36 health dimension scores: estimating preference-based health-related utilities when patient level data are not available. Value Health 2009, 12:346-353. 10.1111/j.1524-4733.2008.00428.x, 18647248.
32. Ware J, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36 Health Survey 2000, Lincoln, RI: QualityMetric Inc.
33. Cohen J. Statistical Power Analysis for the Behavioral Sciences 1988, Hillsdale, NJ: Lawrence Erlbaum Associates, Inc., 2.
34. National Psoriasis Foundation Report on the Psycho-Social Impacts of Psoriasis [http://www.psoriasis.org/Document.DOC?id=619], National Psoriasis Foundation.
35. Devrimci-Ozguven H, Kundakci TN, Kumbasar H, Boyvat A. The depression, anxiety, life satisfaction and affective expression levels in psoriasis patients. J Eur Acad Dermatol Venereol 2000, 14:267-271. 10.1046/j.1468-3083.2000.00085.x, 11204514.
36. Kimball AB, Gladman D, Gelfand JM, Gordon K, Horn EJ, Korman NJ, Korver G, Krueger GG, Strober BE, Lebwohl MG. National Psoriasis Foundation clinical consensus on psoriasis comorbidities and recommendations for screening. J Am Acad Dermatol 2008, 58:1031-1042. 10.1016/j.jaad.2008.01.006, 18313171.
37. Kimball AB, Bensimon AG, Guerin A, Yu AP, Wu EQ, Okun MM, Bao Y, Gupta SR, Mulani PM. Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: Subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial. Am J Clin Dermatol 2011, 12:51-62. 10.2165/11530640-000000000-00000, 21110526.
38. Flytstrom I, Stenberg B, Svensson A, Bergbrant IM. Methotrexate vs. ciclosporin in psoriasis: effectiveness, quality of life and safety. A randomized controlled trial. Br J Dermatol 2008, 158:116-121.
39. Reich K. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe psoriasis: 16-week results of a phase 3, randomized, controlled trial (ESTEEM 1) [oral presentation] 2013, Miami, FL: Presented at: the 71st Annual Meeting of the American Academy of Dermatology.