Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison study
Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro‐inflammatory and anti‐inflammatory mediator production. Objective Assess apremilast efficacy and safety in moderate to severe plaque psoriasis. Methods Phase II, 12‐week, multi...
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| Published in | Journal of the European Academy of Dermatology and Venereology Vol. 27; no. 3; pp. e376 - e383 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.03.2013
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro‐inflammatory and anti‐inflammatory mediator production.
Objective Assess apremilast efficacy and safety in moderate to severe plaque psoriasis.
Methods Phase II, 12‐week, multicenter, double‐blind, placebo‐controlled, parallel‐group, dose‐comparison study of 259 subjects randomized 1 : 1 : 1 to placebo, apremilast 20 mg QD or apremilast 20 mg BID.
Results More subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI‐75) vs. placebo (24.4% vs. 10.3%; P = 0.023). A similar proportion of subjects receiving apremilast 20 mg QD and placebo achieved PASI‐75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20 mg QD (P = 0.021 vs. placebo) and 52.1% for apremilast 20 mg BID (P < 0.001). Apremilast 20 mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P < 0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (> 90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20 mg QD (knee surgery) and in one receiving apremilast 20 mg BID (worsening psoriasis). The panic attack was considered treatment‐related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported.
Conclusion Apremilast 20 mg BID for 12 weeks was effective and well tolerated in subjects with moderate to severe plaque psoriasis. |
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| AbstractList | Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production.BACKGROUNDApremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production.Assess apremilast efficacy and safety in moderate to severe plaque psoriasis.OBJECTIVEAssess apremilast efficacy and safety in moderate to severe plaque psoriasis.Phase II, 12-week, multicenter, double-blind, placebo-controlled, parallel-group, dose-comparison study of 259 subjects randomized 1 : 1 : 1 to placebo, apremilast 20 mg QD or apremilast 20 mg BID.METHODSPhase II, 12-week, multicenter, double-blind, placebo-controlled, parallel-group, dose-comparison study of 259 subjects randomized 1 : 1 : 1 to placebo, apremilast 20 mg QD or apremilast 20 mg BID.More subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI-75) vs. placebo (24.4% vs. 10.3%; P = 0.023). A similar proportion of subjects receiving apremilast 20 mg QD and placebo achieved PASI-75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20 mg QD (P = 0.021 vs. placebo) and 52.1% for apremilast 20 mg BID (P < 0.001). Apremilast 20 mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P < 0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (> 90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20 mg QD (knee surgery) and in one receiving apremilast 20 mg BID (worsening psoriasis). The panic attack was considered treatment-related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported.RESULTSMore subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI-75) vs. placebo (24.4% vs. 10.3%; P = 0.023). A similar proportion of subjects receiving apremilast 20 mg QD and placebo achieved PASI-75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20 mg QD (P = 0.021 vs. placebo) and 52.1% for apremilast 20 mg BID (P < 0.001). Apremilast 20 mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P < 0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (> 90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20 mg QD (knee surgery) and in one receiving apremilast 20 mg BID (worsening psoriasis). The panic attack was considered treatment-related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported.Apremilast 20 mg BID for 12 weeks was effective and well tolerated in subjects with moderate to severe plaque psoriasis.CONCLUSIONApremilast 20 mg BID for 12 weeks was effective and well tolerated in subjects with moderate to severe plaque psoriasis. Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro‐inflammatory and anti‐inflammatory mediator production. Objective Assess apremilast efficacy and safety in moderate to severe plaque psoriasis. Methods Phase II, 12‐week, multicenter, double‐blind, placebo‐controlled, parallel‐group, dose‐comparison study of 259 subjects randomized 1 : 1 : 1 to placebo, apremilast 20 mg QD or apremilast 20 mg BID. Results More subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI‐75) vs. placebo (24.4% vs. 10.3%; P = 0.023). A similar proportion of subjects receiving apremilast 20 mg QD and placebo achieved PASI‐75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20 mg QD (P = 0.021 vs. placebo) and 52.1% for apremilast 20 mg BID (P < 0.001). Apremilast 20 mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P < 0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (> 90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20 mg QD (knee surgery) and in one receiving apremilast 20 mg BID (worsening psoriasis). The panic attack was considered treatment‐related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported. Conclusion Apremilast 20 mg BID for 12 weeks was effective and well tolerated in subjects with moderate to severe plaque psoriasis. Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production. Assess apremilast efficacy and safety in moderate to severe plaque psoriasis. Phase II, 12-week, multicenter, double-blind, placebo-controlled, parallel-group, dose-comparison study of 259 subjects randomized 1 : 1 : 1 to placebo, apremilast 20 mg QD or apremilast 20 mg BID. More subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI-75) vs. placebo (24.4% vs. 10.3%; P = 0.023). A similar proportion of subjects receiving apremilast 20 mg QD and placebo achieved PASI-75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20 mg QD (P = 0.021 vs. placebo) and 52.1% for apremilast 20 mg BID (P < 0.001). Apremilast 20 mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P < 0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (> 90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20 mg QD (knee surgery) and in one receiving apremilast 20 mg BID (worsening psoriasis). The panic attack was considered treatment-related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported. Apremilast 20 mg BID for 12 weeks was effective and well tolerated in subjects with moderate to severe plaque psoriasis. Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro‐inflammatory and anti‐inflammatory mediator production. Objective Assess apremilast efficacy and safety in moderate to severe plaque psoriasis. Methods Phase II, 12‐week, multicenter, double‐blind, placebo‐controlled, parallel‐group, dose‐comparison study of 259 subjects randomized 1 : 1 : 1 to placebo, apremilast 20 mg QD or apremilast 20 mg BID. Results More subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI‐75) vs. placebo (24.4% vs. 10.3%; P = 0.023). A similar proportion of subjects receiving apremilast 20 mg QD and placebo achieved PASI‐75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20 mg QD ( P = 0.021 vs. placebo) and 52.1% for apremilast 20 mg BID ( P < 0.001). Apremilast 20 mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P < 0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (> 90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20 mg QD (knee surgery) and in one receiving apremilast 20 mg BID (worsening psoriasis). The panic attack was considered treatment‐related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported. Conclusion Apremilast 20 mg BID for 12 weeks was effective and well tolerated in subjects with moderate to severe plaque psoriasis. Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production. Methods Phase II, 12-week, multicenter, double-blind, placebo-controlled, parallel-group, dose-comparison study of 259 subjects randomized 1 : 1 : 1 to placebo, apremilast 20mg QD or apremilast 20mg BID. Results More subjects receiving apremilast 20mg BID achieved greater than or equal to 75% reduction in Psoriasis Area and Severity Index (PASI-75) vs. placebo (24.4% vs. 10.3%; P=0.023). A similar proportion of subjects receiving apremilast 20mg QD and placebo achieved PASI-75 at week 12 [9/87 (10.3%, each group)]. Mean per cent reduction in PASI from baseline was 17.4% for placebo, 30.3% for apremilast 20mg QD (P=0.021 vs. placebo) and 52.1% for apremilast 20mg BID (P<0.001). Apremilast 20mg BID significantly decreased mean body surface area involvement vs. placebo (30.8% vs. 3.2%; P<0.001). The most common adverse events were headache, nasopharyngitis, diarrhoea and nausea. Most events (>90%) were mild to moderate and did not lead to study discontinuation. Serious adverse events occurred in four placebo subjects (panic attack, hospitalization for rehabilitation, hospitalization for alcoholism, worsening psoriasis), one receiving apremilast 20mg QD (knee surgery) and in one receiving apremilast 20mg BID (worsening psoriasis). The panic attack was considered treatment-related; both cases of worsening psoriasis occurred after medication discontinuation. No deaths or opportunistic infections were reported. Conclusion Apremilast 20mg BID for 12weeks was effective and well tolerated in subjects with moderate to severe plaque psoriasis.Original Abstract: Objective Assess apremilast efficacy and safety in moderate to severe plaque psoriasis. |
| Author | Thaçi, D. Papp, K.A. Hu, C. Rohane, P. Kaufmann, R. Sutherland, D. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23030767$$D View this record in MEDLINE/PubMed |
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| Notes | ArticleID:JDV4716 istex:23584A1E69B3C5034041BC58A20A20BBB89D1DBC ark:/67375/WNG-31PM7HTT-X Dr Papp is a consultant and investigator for Celgene Corporation, Abbott, Amgen, Centocor, Janssen‐Ortho, Merck, Novartis and Pfizer and an investigator for Astellas, Leo Pharma and Galderma, receiving honoraria and grants. Dr Kaufmann is an investigator for Abbott, Centocor, Leo, Novartis, Wyeth and Celgene Corporation, but has not received financial compensation. The Department of Dermatology received investigator fees for performing the clinical trials. He served as a speaker for Basilea and Allmiral and received honoraria from each. Dr Thaçi is on the advisory board of and is a consultant, investigator and speaker for Abbott, Leo, Novartis, Pfizer, Biogen‐Idec, Janssen‐Cilag and MSD, and received honoraria from each. He is also an investigator for Celgene Corporation. The Department of Dermatology received honoraria/compensation for conducting studies; no direct compensation was received. Ms Hu receives a salary as an employee of Celgene Corporation. Ms Sutherland receives a salary, stocks and stock options as an employee of Celgene Corporation. Dr Rohane received a salary and stock options as a former employee of Celgene Corporation. Conflicts of Interest Funding source Supported by Celgene Corporation. ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
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| PublicationPlace | Oxford, UK |
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| PublicationTitle | Journal of the European Academy of Dermatology and Venereology |
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| Publisher | Blackwell Publishing Ltd |
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| References | Krueger GG, Papp KA, Stough DB et al. A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. J Am Acad Dermatol 2002; 47: 821-833. Menter A, Hamilton TK, Toth DP et al. Transitioning patients from efalizumab to alternative psoriasis therapies: findings from an open-label, multicenter, Phase IIIb study. Int J Dermatol 2007; 46: 637-648. Tyring S, Gordon KB, Poulin Y et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol 2007; 143: 719-726. 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. Enbrel (etanercept) [package insert]. Immunex Corporation, Thousand Oaks, CA, 2011. Reich K, Nestle FO, Papp K et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005; 366: 1367-1374. Leonardi C, Matheson R, Zachariae C et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med 2012; 366: 1190-1199. Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol 2012; 83: 1583-1590. Hick J, Feldman SR. Eligibility creep: a cause for placebo group improvement in controlled trials of psoriasis treatments. J Am Acad Dermatol 2007; 57: 972-976. Pathirana D, Ormerod AD, Saiag P et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol 2009; 23(Suppl 2): 1-70. Sobell JM, Hallas SJ. Systemic therapies for psoriasis: understanding current and newly emerging therapies. Semin Cutan Med Surg 2003; 22: 187-195. Rheumatrex (methotrexate) [package insert]. DAVA Pharmaceuticals, Inc., Fort Lee, NJ, 2009. Augustin M, Reich K, Glaeske G et al. Co-morbidity and age-related prevalence of psoriasis: analysis of health insurance data in Germany. Acta Derm Venereol 2010; 90: 147-151. Papp K, Cather J, Rosoph L et al. 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. Schett G, Wollenhaupt J, Papp K et al. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2012; 21Jun Doi:10.1002/art.34580. [Epub ahead of print]. Nast A, Kopp I, Augustin M et al. German evidence-based guidelines for the treatment of Psoriasis vulgaris (short version). Arch Dermatol Res 2007; 299: 111-138. Saurat JH, Stingl G, Dubertret L et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol 2008; 158: 558-566. Richards HL, Fortune DG, Griffiths CE. Adherence to treatment in patients with psoriasis. J Eur Acad Dermatol Venereol 2006; 20: 370-379. Gottlieb AB, Strober B, Krueger JG et al. 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. Brunasso AM, Puntoni M, Salvini C et al. Tolerability and safety of biological therapies for psoriasis in daily clinical practice: a study of 103 Italian patients. Acta Derm Venereol 2011; 91: 44-49. 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. Schafer PH, Parton A, Gandhi AK et al. 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. Lebwohl M. Psoriasis. Lancet 2003; 361: 1197-1204. Saurat JH, Guerin A, Yu AP et al. 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. 2009; 23 2012; 83 2007; 299 2002; 47 2006; 20 2012; 366 2011 2011; 91 2009; 60 2005; 366 2007; 143 2010; 159 2012; 380 2010; 220 2009 2008; 67 2008; 24 2008; 158 2010; 90 2007; 46 2012; 21 2007; 57 2003; 22 2003; 361 e_1_2_7_5_2 e_1_2_7_4_2 e_1_2_7_3_2 e_1_2_7_2_2 e_1_2_7_9_2 e_1_2_7_8_2 (e_1_2_7_11_2) 2011 e_1_2_7_7_2 e_1_2_7_6_2 e_1_2_7_19_2 e_1_2_7_18_2 e_1_2_7_17_2 e_1_2_7_16_2 e_1_2_7_15_2 e_1_2_7_14_2 e_1_2_7_25_2 e_1_2_7_13_2 e_1_2_7_24_2 e_1_2_7_23_2 e_1_2_7_22_2 e_1_2_7_10_2 e_1_2_7_21_2 (e_1_2_7_12_2) 2009 Schett G (e_1_2_7_20_2) 2012; 21 |
| References_xml | – reference: Leonardi C, Matheson R, Zachariae C et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med 2012; 366: 1190-1199. – reference: Saurat JH, Guerin A, Yu AP et al. 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. – reference: Krueger GG, Papp KA, Stough DB et al. A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. J Am Acad Dermatol 2002; 47: 821-833. – reference: Menter A, Hamilton TK, Toth DP et al. Transitioning patients from efalizumab to alternative psoriasis therapies: findings from an open-label, multicenter, Phase IIIb study. Int J Dermatol 2007; 46: 637-648. – reference: Rheumatrex (methotrexate) [package insert]. DAVA Pharmaceuticals, Inc., Fort Lee, NJ, 2009. – reference: 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. – reference: Lebwohl M. Psoriasis. Lancet 2003; 361: 1197-1204. – reference: Schett G, Wollenhaupt J, Papp K et al. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2012; 21Jun Doi:10.1002/art.34580. [Epub ahead of print]. – reference: Sobell JM, Hallas SJ. Systemic therapies for psoriasis: understanding current and newly emerging therapies. Semin Cutan Med Surg 2003; 22: 187-195. – reference: Reich K, Nestle FO, Papp K et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005; 366: 1367-1374. – reference: Brunasso AM, Puntoni M, Salvini C et al. Tolerability and safety of biological therapies for psoriasis in daily clinical practice: a study of 103 Italian patients. Acta Derm Venereol 2011; 91: 44-49. – reference: Papp K, Cather J, Rosoph L et al. 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. – reference: Augustin M, Reich K, Glaeske G et al. Co-morbidity and age-related prevalence of psoriasis: analysis of health insurance data in Germany. Acta Derm Venereol 2010; 90: 147-151. – reference: Nast A, Kopp I, Augustin M et al. German evidence-based guidelines for the treatment of Psoriasis vulgaris (short version). Arch Dermatol Res 2007; 299: 111-138. – reference: 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. – reference: Enbrel (etanercept) [package insert]. Immunex Corporation, Thousand Oaks, CA, 2011. – reference: Schafer PH, Parton A, Gandhi AK et al. 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. – reference: Richards HL, Fortune DG, Griffiths CE. Adherence to treatment in patients with psoriasis. J Eur Acad Dermatol Venereol 2006; 20: 370-379. – reference: Pathirana D, Ormerod AD, Saiag P et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol 2009; 23(Suppl 2): 1-70. – reference: Gottlieb AB, Strober B, Krueger JG et al. 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. – reference: Saurat JH, Stingl G, Dubertret L et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol 2008; 158: 558-566. – reference: Tyring S, Gordon KB, Poulin Y et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol 2007; 143: 719-726. – reference: Hick J, Feldman SR. Eligibility creep: a cause for placebo group improvement in controlled trials of psoriasis treatments. J Am Acad Dermatol 2007; 57: 972-976. – reference: Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol 2012; 83: 1583-1590. – volume: 60 start-page: 218 year: 2009 end-page: 224 article-title: The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003–2004 publication-title: J Am Acad Dermatol – year: 2011 – volume: 159 start-page: 842 year: 2010 end-page: 855 article-title: Apremilast, a cAMP phosphodiesterase‐4 inhibitor, demonstrates anti‐inflammatory activity in vitro and in a model of psoriasis publication-title: Br J Pharmacol – volume: 90 start-page: 147 year: 2010 end-page: 151 article-title: Co‐morbidity and age‐related prevalence of psoriasis: analysis of health insurance data in Germany publication-title: Acta Derm Venereol – volume: 67 start-page: 855 year: 2008 end-page: 859 article-title: A systematic review and meta‐analysis of efficacy and toxicity of disease modifying anti‐rheumatic drugs and biological agents for psoriatic arthritis publication-title: Ann Rheum Dis – volume: 21 year: 2012 article-title: Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double‐blind, placebo‐controlled study publication-title: Arthritis Rheum – year: 2009 – volume: 57 start-page: 972 year: 2007 end-page: 976 article-title: Eligibility creep: a cause for placebo group improvement in controlled trials of psoriasis treatments publication-title: J Am Acad Dermatol – volume: 47 start-page: 821 year: 2002 end-page: 833 article-title: A randomized, double‐blind, placebo‐controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis publication-title: J Am Acad Dermatol – volume: 380 start-page: 738 year: 2012 end-page: 746 article-title: The efficacy of apremilast, a phosphodiesterase‐4 inhibitor, in the treatment of moderate to severe psoriasis: results of a phase 2 randomised study publication-title: Lancet – volume: 220 start-page: 128 year: 2010 end-page: 137 article-title: 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 publication-title: Dermatology – volume: 91 start-page: 44 year: 2011 end-page: 49 article-title: Tolerability and safety of biological therapies for psoriasis in daily clinical practice: a study of 103 Italian patients publication-title: Acta Derm Venereol – volume: 299 start-page: 111 year: 2007 end-page: 138 article-title: German evidence‐based guidelines for the treatment of (short version) publication-title: Arch Dermatol Res – volume: 361 start-page: 1197 year: 2003 end-page: 1204 article-title: Psoriasis publication-title: Lancet – volume: 23 start-page: 1 issue: Suppl 2 year: 2009 end-page: 70 article-title: European S3‐guidelines on the systemic treatment of psoriasis vulgaris publication-title: J Eur Acad Dermatol Venereol – volume: 83 start-page: 1583 year: 2012 end-page: 1590 article-title: Apremilast mechanism of action and application to psoriasis and psoriatic arthritis publication-title: Biochem Pharmacol – volume: 22 start-page: 187 year: 2003 end-page: 195 article-title: Systemic therapies for psoriasis: understanding current and newly emerging therapies publication-title: Semin Cutan Med Surg – volume: 46 start-page: 637 year: 2007 end-page: 648 article-title: Transitioning patients from efalizumab to alternative psoriasis therapies: findings from an open‐label, multicenter, Phase IIIb study publication-title: Int J Dermatol – volume: 20 start-page: 370 year: 2006 end-page: 379 article-title: Adherence to treatment in patients with psoriasis publication-title: J Eur Acad Dermatol Venereol – volume: 143 start-page: 719 year: 2007 end-page: 726 article-title: Long‐term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis publication-title: Arch Dermatol – volume: 158 start-page: 558 year: 2008 end-page: 566 article-title: Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION) publication-title: Br J Dermatol – volume: 366 start-page: 1190 year: 2012 end-page: 1199 article-title: Anti‐interleukin‐17 monoclonal antibody ixekizumab in chronic plaque psoriasis publication-title: N Engl J Med – volume: 366 start-page: 1367 year: 2005 end-page: 1374 article-title: Infliximab induction and maintenance therapy for moderate‐to‐severe psoriasis: a phase III, multicentre, double‐blind trial publication-title: Lancet – volume: 24 start-page: 1529 year: 2008 end-page: 1538 article-title: An open‐label, single‐arm pilot study in patients with severe plaque‐type psoriasis treated with an oral anti‐inflammatory agent, apremilast publication-title: Curr Med Res Opin – ident: e_1_2_7_5_2 doi: 10.1007/s00403-007-0744-y – volume: 21 year: 2012 ident: e_1_2_7_20_2 article-title: Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double‐blind, placebo‐controlled study publication-title: Arthritis Rheum – ident: e_1_2_7_10_2 doi: 10.1136/ard.2007.072652 – ident: e_1_2_7_14_2 doi: 10.1016/S0140-6736(05)67566-6 – ident: e_1_2_7_15_2 doi: 10.1001/archderm.143.6.719 – ident: e_1_2_7_2_2 doi: 10.1016/j.jaad.2008.09.022 – ident: e_1_2_7_3_2 doi: 10.2340/00015555-0770 – volume-title: Rheumatrex (methotrexate) [package insert] year: 2009 ident: e_1_2_7_12_2 – volume-title: Enbrel (etanercept) [package insert] year: 2011 ident: e_1_2_7_11_2 – ident: e_1_2_7_13_2 doi: 10.1111/j.1468-3083.2006.01565.x – ident: e_1_2_7_21_2 doi: 10.1185/030079908X301866 – ident: e_1_2_7_18_2 doi: 10.1016/j.bcp.2012.01.001 – ident: e_1_2_7_7_2 doi: 10.1016/S1085-5629(03)00042-7 – ident: e_1_2_7_8_2 doi: 10.1111/j.1365-4632.2007.03158.x – ident: e_1_2_7_9_2 doi: 10.1159/000275198 – ident: e_1_2_7_4_2 doi: 10.1016/S0140-6736(03)12954-6 – ident: e_1_2_7_19_2 doi: 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| Snippet | Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro‐inflammatory and anti‐inflammatory... Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro‐inflammatory and anti‐inflammatory... Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator... Background Apremilast, a small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate pro-inflammatory and anti-inflammatory... |
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| Title | Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison study |
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