The use of isotretinoin in the treatment of acne vulgaris clinical considerations and future directions

Journal of Clinical and Aesthetic Dermatology

Volumn 7, Issue 2 SUPPL., 2014, Pages

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

ISOTRETINOIN;

ACNE VULGARIS; ANTIBIOTIC THERAPY; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BIOEQUIVALENCE; CALORIE; CHEILITIS; CLINICAL PRACTICE; DEPRESSION; DISTRESS SYNDROME; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG DOSE REGIMEN; DRUG ERUPTION; DRUG EXPOSURE; DRUG MEGADOSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRY EYE; DRY SKIN; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; FOOD INTAKE; HEPATITIS; HUMAN; INFLAMMATORY BOWEL DISEASE; INGESTION; LONG TERM CARE; MAXIMUM PLASMA CONCENTRATION; MEAL; MEDICAL HISTORY; MYALGIA; PANCREATITIS; PATHOPHYSIOLOGY; PATIENT COMPLIANCE; PHARMACOKINETICS; PHASE 3 CLINICAL TRIAL (TOPIC); PREGNANCY; PREGNANCY TEST; PSYCHOLOGIC ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; RECURRENCE RISK; RECURRENT DISEASE; REMISSION; RETREATMENT; SHORT COURSE THERAPY; SKIN CARE; STEADY STATE; SUICIDAL IDEATION; TERATOGENICITY; TREATMENT DURATION; TREATMENT RESPONSE; XEROPHTHALMIA; XEROSIS;

EID: 84897495763     PISSN: 19412789     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (104)

1. Accutane FDA information. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsand Providers/ucm 094305.htm. Accessed on 01/02/014.
2. Osofsky MG, Strauss JS. Isotretinoin. In: Shalita AR, Del Rosso JQ, Webster GF, eds. Acne Vulgaris. London: Informa HealthCare; 2011:134-345.
3. Peck GL, Olsen TG, Butkus D, et al. Isotretinoin versus placebo in the treatment of cystic acne: A randomized double-blind study. J Am Acad Dermatol. 1982;6:735-745.
4. Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med. 1985;313:837-841.
5. Lynberg MC, Khoury MJ, Lammer EJ, et al. Sensitivity, specificity, and positive predictive value of multiple malformations in isotretinoin embryopathy surveillance. Teratology. 1990;42: 513-519.
6. Jick SS, Kremers HM, Vasilakis-Scaramozza C. Isotretinoin use and risk of depression, psychotic symptoms, suicide, and attempted suicide. Arch Dermatol. 2000;136:1231-3236.
7. Chia CY, Lane W, Chibnall J, et al. Isotretinoin therapy and mood changes in adolescents with moderate and severe acne: A cohort study. Arch Dermatol. 2005;141:557-560.
8. Merqueling AL, Zane LT. Depression and suicidal behavior in acne patients treated with isotretinoin: A systematic review. Arch Dermatol. 2007;26:210-220.
9. Lasek RJ, Chren MM. Acne vulgaris and the quality of life of adult dermatology patients. Arch Dermatol. 1998;134:454-458.
10. Kaymak Y, Taner E, Taner Y. Comparison of depression, anxiety, and life quality in acne vulgaris patients who were treated with either isotretinoin or topical agents. Int J Dermatol. 2009;48:41-46.
11. Hahm BJ, Min SU, Yoon MY, et al. Changes of psychiatric parameters and their relationships by oral isotretinoin in acne patients. J Dermatol. 2009 May;36(5):255-261.
12. Stobaugh DJ, Deepak P, Ehrenpreis ED. Alleged isotretinoinassociated inflammatory bowel disease: Disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System. J Am Acad Dermatol. 2013;69:393-398.
13. Bernstein CN, Nugent Z, Longobardi T, Blanchard JF. Isotretinoin is not associated with inflammatory bowel disease: A population-based case-control study. Am J Gastroenterol. 2009;104(11):2774-2778.
14. Crockett SD, Gulati A, Sandler RS, Kappelman MD. A causal association between isotretinoin and inflammatory bowel disease has yet to be established. Am J Gastroenterol. 2009; 104(10):2387-2393.
15. Wolverton SE, Harper JC. Important controversies associated with isotretinoin therapy for acne. Am J Clin Dermatol. 2013;14: 71-76.
16. Etminan M, Bird ST, Delaney JA, et al. Isotretinoin and risk for inflammatory bowel disease: A nested case-control study and metaanalysis of published and unpublished data. JAMA Dermatol. 2013;149:216-220.
17. Femia AN, Ann Vleugels R. Toward improved understanding of a potential association between isotretinoin and inflammatory bowel disease. J Invest Dermatol. 2013;133:866-868.
18. Marron SE, Tomas-Aragones L, Boira S. Anxiety, depression, quality of life and patient satisfaction in acne patients treated with oral isotretinoin. Acta Derm Venereol. 2013;93:701-706.
19. iPLEDGE. http://www.ipledgeprogram.com. Accessed on 01/02/14.
20. iPLEDGE, American Academy of Dermatology. http://www.aad.org. Accessed on 01/02/14.
21. Palmer A. What is iPLEDGE? Updated July 31, 2013. http://www.acne.about. com/od/acnetreatments/f/whatisipledge.htm. Accessed on 01/02/14.
22. iPLEDGE. Pharmacy registration. https://www.ipledgeprogram.com/ PharmacyRegistrationPage.aspx. Accessed on 01/02/14.
23. Drug safety and risk management advisory committee: Dermatologic and ophthalmic drugs advisory committee. http://www.fda.gov/AdvisoryCommittees/ Calendar/ucm275806.htm. Accessed on 12/15.13.
24. Patton TJ, Ferris LK. Systemic retinoids. In: Wolverton SE, ed. Comprehensive Dermatologic Drug Therapy, 3rd ed. Edinburg: Elsevier-Saunders; 2013: 252-268.
25. Gollnick H, Cunliffe W, Berson D, et al. Management of acne: A report from the global alliance to improve outcomes in acne. J Am Acad Dermatol. 2003;49(1Suppl):S1-S37.
26. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J Med. 1979;300:329-333.
27. Ward A, Brogden RN, Heel RC, et al. Isotretinoin: A review of its pharmacologic properties and therapeutic efficacy in acne and other skin disorders. Drugs.1984;28:6-37.
28. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: Results of a multicenter dose response study. J Am Acad Dermatol. 1984;10(3):490-496.
29. Layton A. The use of isotretinoin in acne. Dermatoendocrinology. 2009;1(3):162-369.
30. Layton AM, Knaggs H, Taylor J, et al. Isotretinoin for acne vulgaris-10 years later: A safe and successful treatment. Br J Dermatol. 1993;129(3):292-296.
31. Haryati I, Jacinto SS. Profile of acne patients in the Philippines requiring a second course of oral isotretinoin. Int J Dermatol. 2005;44(12):999-3001.
32. Cunliffe WJ, Norris JFB. Isotretinoin-an explanation for its longterm benefit. Dermatologica. 1987;175(Suppl 1):133-337.
33. Lehucher CD, de la Salmoniere P, et al. Predictive factors for failure of isotretinoin treatment in acne patients: Results from a cohort of 237 patients. Dermatology. 1999;198:278-283.
34. Stainforth JM, Layton AM, Taylor JP, et al. Isotretinoin for the treatment of acne vulgaris: Which factors may predict the need for more than one course? Br J Dermatol. 1993;129:297-301.
35. White GM, Chen W. Recurrence rates after first course of isotretinoin. Arch Dermatol. 1998;134:376-378.
36. Chivot M, Midoun H. Isotretinoin and acne-a study of relapses. Dermatologica. 1986;172:148-353.
37. American Academy of Dermatology Position Statement On Isotretinoin (approved by the Board of Directors December 9, 2000; amended by the Board of Directors March 25, 2003, March 11, 2004, and November 13, 2010), http://www.aad.org/Forms/Policies/Uploads/PS/PS-Isotretinoin.pdf. Accessed on 01/02/14.
38. Rigopoulos D, Larios G, Katsambas AD. The role of isotretinoin in acne therapy: Why not as first-line therapy? facts and controversies. Clin Dermatol. 2010;28(1):24-30.
39. Cooper AJ. Australian Roaccutane Advisory Board. Treatment of acne with isotretinoin: Recommendations based on Australian experience. Australas J Dermatol. 2003;44:97-305.
40. Del Rosso JQ. Face to face with oral isotretinoin: A closer look at the spectrum of therapeutic outcomes and why some patients need repeated courses. J Clin Aesthet Dermatol. 2012;5:17-24.
41. Azoulay L, Oraichi D, Berard A. Isotretinoin therapy and the incidence of acne relapse: A nested case-control study. Br J Dermatol. 2007;157:1240-3248.
42. Harms M, Masouye I, Radeff B. The relapses of cystic acne after isotretinoin treatment are age related: A long-term follow-up study. Dermatologica. 1986;172:148-353.
43. Quereaux G, Volteau C, N'Nuyen JM et al. Prospective study of risk factors of relapse after treatment of acne with oral isotretinoin. Dermatology. 2006;212:168-376.
44. Shahidullah M, Tham SN, Goh CL. Isotretinoin therapy in acne vulgaris: A 10-year restrospective study in Singapore. Int J Dermatol. 1994;33:60-63.
45. Ng PP, Goh CL. Treatment outcome of acne vulgaris with oral isotretinoin in 89 patients. Int J Dermatol. 1999;38:213-216.
46. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: Evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol. 1980;3:602-611.
47. Goldstein JA, Socha-Szott A, Thomsen RJ, et al. Comparative effect of isotretinoin on acne and sebaceous gland secretion. J Am Acad Dermatol. 1982;6(4Pt2 Suppl):760-765.
48. Del Rosso JQ. Clinical relevance of skin barrier changes associated with the use of oral isotretinoin: The importance of barrier repair therapy in patient management. J Drugs Dermatol. 2013;12:626-631.
49. Nelson AM, Zhao W, Gilliland KL, at al. Neutrophil gelatinaseassociated lipocalin mediates 13-cis retinoic acid-induced apoptosis of human sebaceous gland cells. J Clin Invest. 118:1468-3478.
50. Dispenza MC, Wolpert EB, Gilliland KL, et al. Systemic isotretinoin therapy normalizes exaggerated TLR-2-mediated innate immune responses in acne patients. J Invest Dermatol. 2012;132: 2198-2205.
51. Nelson AM, Zhao W, Gilliland KL, et al. Temporal changes in gene expression in the skin of patients treated with isotretinoin provide insight into its mechanism of action. Dermatoendocrinol. 2009;1:177-387.
52. Nelson AM, Zhao W, Gilliland KL, et al. Isotretinoin temporally regulates distinct sets of genes in patient skin. J Invest Dermatol. 2009;129:1038-3042.
53. Del Rosso JQ, Kircik LH. The sequence of inflammation, relevant biomarkers, and the pathogenesis of acne vulgaris: What does recent research show and what does it mean to the clinician? J Drugs Dermatol. 2013;12(8 Suppl):s109-s115.
54. Accutane (isotretinoin capsules) [package insert]. Nutley, New Jersey: Roche Laboratories; 2000-2010.
55. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA resource listing of approved drug products with therapeutic equivalence evaluations. http://www.accessdata.fda.gov/scripts/cder/ob/default. cfm. Accessed on 01/02/14.
56. Frequently Asked Questions on The Orange Book. http://www.fda.gov/Drugs/ InformationOnDrugs/ucm114166.htm. Accessed on 01/02/14.
57. ANDA (Generic) Drug Approvals. http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/HowDrugsareDevelopedand Approved/ DrugandBiologicApprovalReports/ANDAGenericDrug Approvals/default.htm. Accessed on 01/02/14.
58. Welcome iPLEDGE Pharmacy Screen: Fill Prescription Stage. iPLEDGE program. http//:www.ipledgeprogram.com. Accessed on 12/06/13.
59. Jackson JM. Fraser J. Bioequivalence study results of DRL233 isotretinoin capsules. Poster presentaed at: Winter Clinical Dermatology Meeting; Kohala Coast Hawaii; January 2013.
60. Absorica (isotretinoin) [package insert]. Princeton, New Jersey: Ranbaxy Laboratories; May 2012.
61. Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: A randomized, 4-treatment, crossover study. J Am Acad Dermatol. 2013;69(5):762-767.
62. The Biopharmaceutics Classification System (BCS) Guidance. http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproducts andtobacco/cder/ucm128219.htm. Accessed on 11/15/13.
63. Guidance for industry: Food-effect, bioavailability, and fed bioequivalence studies., U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Silver Springs, Maryland; December 2002.
64. Colburn WA, Gibson DM, Wiens RE, Hanigan JJ. Food increases the bioavailability of isotretinoin. J Clin Pharmacol. 1983;23:534-539.
65. Marcus N. Clinical study report (Leyden JJ, Webster GF, investigators). A double-blind, randomized, phase III, parallel group study evaluating the efficacy and safety of CIP-isotretinoin in patients with severe recalcitrant nodular acne (protocol # ISOCT.08.11); Cipher Pharmaceuticals Inc; Mississauga, Ontario, Canada; October 2011 (on file at Ranbaxy Laboratories, Princeton, New Jersey).
66. Colburn WA, Gibson DM, et al. Food increases the bioavailability of isotretinoin. J Clin Pharmacol. 1983;23(11-32):534-539.
67. Brazzell RK, Vane FM, Ehmann, et al. Pharmacokinetics of isotretinoin during repetitive dosing to patients. Eur J Clin Pharmacol. 1983;24(5):695-702.
68. Khoo KC, Reik D, Colburn WA. Pharmacokinetics of isotretinoin following a single oral dose. J Clin Pharmacol. 1982;22(8-9):395-402.
69. Amnesteen (isotretinoin capsules USP) [package insert]. Morgantown, West Virginia: Mylan Laboratories; November 2007.
70. Claravis (isotretinoin capsules) [package insert]. North Wales, Pennsylvania: Barr Laboratories; August 2012.
71. Zenetane (isotretinoin capsules USP) [package insert]. Bachupally, India: Dr. Reddy's Laboratories Limited; January 2013.
72. Del Rosso JQ. An assessment of isotretinoin dosing regimens used by dermatology practitioners in the United States: Survey results. J Clin Aesthet Dermatol. 2014 (publication in progress).
73. Zane LT, Leyden WA, Marqueling AL, Manos MM. A populationbased analysis of laboratory abnormalities during isotretinoin therapy for acne vulgaris. Arch Dermatol. 2006;142(8): 1016-3022.
74. Blasiak RC, Stamey CR2, Burkhart CN. High-dose isotretinoin treatment and the rate of retrial, relapse, and adverse effects in patients with acne vulgaris. JAMA Dermatol. 2013;149(12): 1392-3398.
75. Strauss JS, Krowchuk DP, Leyden JJ, et al. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007;56(4): 651-663.
76. DiGiovanna JJ, Langman CB, Tschen EH, et al. Effect of a single course of isotretinoin therapy on bone mineral density in adolescent patients with severe, recalcitrant, nodular acne. J Am Acad Dermatol. 2004;51(5):709-717.
77. Margolis DJ, Attie M, Leyden JJ. Effects of isotretinoin on bone mineralization during routine therapy with isotretinoin for acne vulgaris. Arch Dermatol. 1996;132(7):769-774.
78. Leachman SA, Insogna KL, Katz L, et al. Bone densities in patients receiving isotretinoin for cystic acne. Arch Dermatol. 1999;135(8):961-965.
79. Cunliffe WJ, van de Kerkhof PC, Caputo R, et al. Roaccutane treatment guidelines: Results of an international survey. Dermatology (Basel, Switzerland). 1997;194(4):351-357.
80. Leyden JJ. The role of isotretinoin in the treatment of acne: Personal observations. J Am Acad Dermatol. 1998;39(2Pt3): S45-S49.
81. Nast A, Dreno B, Bettoli V, et al. European evidence-based (S3) guidelines for the treatment of acne. JEADV. 2012;26(Suppl 1):1-29.
82. Sinclair W, Jordaan HF. Acne guideline 2005 update: Global alliance to improve outcomes in acne. S Afr Med J. 2005;95(11Pt2): 881-892.
83. Abad-Casintahan F, Chow SK, Goh CL, et al. Toward evidence-based practice in acne: Consensus of an Asian Working Group. J Dermatol. 2011;38(11):1041- 3048.
84. Eichenfield LF, Krakowski AC, Piggott C, et al. Evidence-based recommendations for the diagnosis and treatment of pediatric acne. Pediatrics. 2013;131(Suppl 3):S163-S186.
85. Leyden JJ. How can we treat difficult acne patients? Dermatology (Basel, Switzerland). 1997;195(Suppl 1):29-33; discussion 38-40.
86. Colburn WA, Vane FM, Shorter HJ. Pharmacokinetics of isotretinoin and its major blood metabolite following a single oral dose to man. Eur J Clin Pharmacol. 1983;24(5):689-94.
87. Cyrulnik AA, Viola KV, Gewirtzman AJ, et al. High-dose isotretinoin in acne vulgaris: Improved treatment outcomes and quality of life. Int J Dermatol. 2012;51(9):1123-3130.
88. Borghi A, Mantovani L, Minghetti S, et al. Low-cumulative dose isotretinoin treatment in mild-to-moderate acne: Efficacy in achieving stable remission. J Eur Acad Dermatol Venereol. 2011;25(9):1094-3098.
89. Lee JW, Yoo KH, Park KY, et al. Effectiveness of conventional, lowdose and intermittent isotretinoin in the treatment of acne: A randomized, controlled comparative study. Brit J Dermatol. 2011;164(6):1369-3375.
90. Isotretinoin prescription data. IMS Health, Danbury, Connecticut; 2013 (Data on file, Ranbaxy Laboratories, Princeton, New Jersey).
91. Isotretinoin survey. Newtown, Pennsylvania: Encuity Research. Interim analysis presented at Winter Clinical Dermatology Meeting, Del Rosso JQ; Kona, Hawaii; January 19, 2014.
92. Dreno B, Thiboutot D, Gollnick H, et al. Large-scale worldwide observational study of adherence with acne therapy. Int J Dermatol. 2010;49(4):448-456.
93. Rampersaud GC, Pereira MA, Girard BL, et al. Breakfast habits, nutritional status, body weight, and academic performance in children and adolescents. J Am Diet Assoc. 2005;105(5):743-760.
94. Deshmukh-Taskar PR, Nicklas TA, O'Neil CE, et al. The relationship of breakfast skipping and type of breakfast consumption with nutrient intake and weight status in children and adolescents: The National Health and Nutrition Examination Survey 1999-2006. J Am Diet Assoc. 2010;110(6):869-878.
95. Data on file; Ranbaxy Laboratories, Princeton, New Jersey. Accessed September 2013.
96. Thiboutot DM, Cockerell CJ. iPLEDGE: A report from the front lines of dermatologic practice. Virtual Mentor. 2006;8(8): 524-528.
97. The iPLEDGE program Birth Control Workbook, http://www.fda.gov/ohrms/ dockets/ac/07/briefing/2007-4311b1-03-addendumsponsor. pdf. Accessed on 01/03/14.
98. Maloney ME, Stone SP. Isotretinoin and iPLEDGE: A view of results. J Am Acad Dermatol. 2011;65(2):418-419.
99. iPLEDGE. Most common reasons reported for an iPLEDGE pregnancy by iPLEDGE prescribers and patients. https://www.ipledgeprogram.com/documents/ BC%20Lessons%20Le arned%2006.13.2013.pdf. Accessed on 01/02/14.
100. Shin J, Cheetham TC, Wong L, et al. The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system. J Amer Acad Dermatol. 2011;65(6):1117-3125.
101. Cheetham TC, Wagner RA, Chiu G, et al. A risk management program aimed at preventing fetal exposure to isotretinoin: Retrospective cohort study. J Amer Acad Dermatol. 2006;55(3):442-448.
102. Thiboutot D, Gollnick H, Bettoli V, et al. Isotretinoin and pregnancy prevention programs. Brit J Dermatol. 2012;166(2): 466-467.
103. Schaefer C. Drug safety in pregnancy: Utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services. Congenit Anom (Kyoto). 2011;51:6-31.
104. Woodcock, J. Center for Drug Evaluation and Research, US Food and Drug Administration, Concerns regarding Accutane (isotretinoin). http://www.fda.gov/ NewsEvents/Testimony/ucm 115126.htm. Accessed on 01/05/14.