Pharma, Novartis, PRCL Research, Regeneron, Roche, Sanofi- Aventis/Genzyme, Sun Pharma, Takeda, UCB, and Valeant.
Jonathan Silverberg has been a consultant, speaker, or data safety monitoring board member and/or received travel support from Pfizer Inc., AbbVie, Anaptysbio, Asana, Boehringer Ingelheim, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Kiniksa, LEO Pharma, Menlo, Novartis, Realm Therapeutics, and Regeneron-Sanofi.
Debra Sierka, Anna Tallman, and William Ports were employees and stockholders of Pfizer Inc., at the time of this work.
Chuanbo Zang and Michael Zielinski are employees and stockholders of Pfizer Inc.
Jonathan Silverberg has been a consultant, speaker, or data safety monitoring board member and/or received travel support from Pfizer Inc., AbbVie, Anaptysbio, Asana, Boehringer Ingelheim, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Kiniksa, LEO Pharma, Menlo, Novartis, Realm Therapeutics, and Regeneron-Sanofi.
Debra Sierka, Anna Tallman, and William Ports were employees and stockholders of Pfizer Inc., at the time of this work.
Chuanbo Zang and Michael Zielinski are employees and stockholders of Pfizer Inc.
ACKNOWLEDGMENTS
Editorial/medical writing support under the guidance of authors
was provided by Jennifer M. Kulak, PhD, and Corey Mandel,
PhD, at ApotheCom, San Francisco, CA, and was funded by Pfizer
Inc., New York, NY, USA, in accordance with Good Publication
Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461-464).
REFERENCES
1. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387:1109-1122.
2. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.
3. Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol. 1980;60:44-47.
4. Silverberg JI, Simpson EL. Associations of childhood eczema severity: a US population-based study. Dermatitis. 2014;25:107-114.
5. Carroll CL, Balkrishnan R, Feldman SR, et al. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005;22:192- 199.
6. Mollanazar NK, Sethi M, Rodriguez RV, et al. Retrospective analysis of data from an itch center: integrating validated tools in the electronic health record. J Am Acad Dermatol. 2016;75:842-844.
7. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71:116-132.
8. Schneider L, Tilles S, Lio P, et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol. 2013;131:295-299.e227.
9. Charman CR, Morris AD, Williams HC. Topical corticosteroid phobia in patients with atopic eczema. Br J Dermatol. 2000;142:931-936. 10. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75:494-503.e496.
11. Murrell DF, Gebauer K, Spelman L, et al. Crisaborole topical ointment, 2% in adults with atopic dermatitis: a phase 2a, vehicle-controlled, proof-of-concept study. J Drugs Dermatol. 2015;14:1108-1112.
12. Stein Gold LF, Spelman L, Spellman MC, et al. A phase 2, randomized, controlled, dose-ranging study evaluating crisaborole topical ointment, 0.5% and 2% in adolescents with mild to moderate atopic dermatitis. J Drugs Dermatol. 2015;14:1394-1399.
13. Tom WL, Van Syoc M, Chanda S, et al. Pharmacokinetic profile, safety, and tolerability of crisaborole topical ointment, 2% in adolescents with atopic dermatitis: an open-label phase 2a study. Pediatr Dermatol. 2016;33:150-159.
14. Zane LT, Kircik L, Call R, et al. Crisaborole topical ointment, 2% in patients ages 2 to 17 years with atopic dermatitis: a phase 1b, open-label, maximaluse systemic exposure study. Pediatr Dermatol. 2016;33:380-387.
15. Griffiths CE, Van Leent EJ, Gilbert M, et al; Cipamyflline Study Group. Randomized comparison of the type 4 phosphodiesterase inhibitor cipamfylline cream, cream vehicle and hydrocortisone 17-butyrate cream for the treatment treatment of atopic dermatitis. Br J Dermatol. 2002;147:299-307.
16. Paller AS, Nimmagadda S, Schachner L, et al. Fluocinolone acetonide 0.01% in peanut oil: therapy for childhood atopic dermatitis, even in patients who are peanut sensitive. J Am Acad Dermatol. 2003;48:569-577.
17. Hebert AA, Cook-Bolden FE, Basu S, et al; Desonide Hydrogel Study Group. Safety and efficacy of desonide hydrogel 0.05% in pediatric subjects with atopic dermatitis. J Drugs Dermatol. 2007;6:175-181.
18. Gong JQ, Lin L, Lin T, et al. Skin colonization by Staphylococcus aureus in patients with eczema and atopic dermatitis and relevant combined topical therapy: a double-blind multicentre randomized controlled trial. Br J Dermatol. 2006;155:680-687.
19. Abramovits W, Oquendo M. Hydrocortisone butyrate 0.1% lipocream in pediatric patients with atopic dermatitis. Skinmed. 2010;8:72-79.
20. Cato A, Swinehart JM, Griffin EI, et al. Azone enhances clinical effectiveness of an optimized formulation of triamcinolone acetonide in atopic dermatitis. Int J Dermatol. 2001;40:232-236.
21. Larsen FS, Simonsen L, Melgaard A, et al. An efficient new formulation of fusidic acid and betamethasone 17-valerate (fucicort lipid cream) for treatment of clinically infected atopic dermatitis. Acta Derm Venereol. 2007;87:62-68.
22. Maloney JM, Morman MR, Stewart DM, et al. Clobetasol propionate emollient 0.05% in the treatment of atopic dermatitis. Int J Dermatol. 1998;37:142-144.
23. Breneman D, Fleischer AB Jr, Kaplan D, et al. Clobetasol propionate 0.05% lotion in the treatment of moderate to severe atopic dermatitis: a randomized evaluation versus clobetasol propionate emollient cream. J Drugs Dermatol. 2005;4:330-336.
24. Ruzicka T, Bieber T, Schopf E, et al. A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group. N Engl J Med. 1997;337:816-821.
25. Boguniewicz M, Fiedler VC, Raimer S, et al; Pediatric Tacrolimus Study Group. A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. J Allergy Clin Immunol. 1998;102:637-644.
26. Schachner LA, Lamerson C, Sheehan MP, et al; US Tacrolimus Ointment Study Group. Tacrolimus ointment 0.03% is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric patients: results from a randomized, double-blind, vehicle-controlled study. Pediatrics. 2005;116:e334-342.
27. Breneman D, Fleischer AB Jr, Abramovits W, et al; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-timesweekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008;58:990-999.
28. Kaufmann R, Bieber T, Helgesen AL, et al; multicentre investigator group. Onset of pruritus relief with pimecrolimus cream 1% in adult patients with atopic dermatitis: a randomized trial. Allergy. 2006;61:375-381.
29. Guttman-Yassky E, Ungar B, Malik K, et al. Molecular signatures order the potency of topically applied anti-inflammatory drugs in patients with atopic dermatitis. J Allergy Clin Immunol. 2017;140:1032-1042.e1013.
30. Spergel JM, Boguniewicz M, Paller AS, et al. Addition of topical pimecrolimus to once-daily mid-potent steroid confers no short-term therapeutic benefit in the treatment of severe atopic dermatitis; a randomized controlled trial. Br J Dermatol. 2007;157:378-381.
31. Bangert C, Strober BE, Cork M, et al. Clinical and cytological effects of pimecrolimus cream 1% after resolution of active atopic dermatitis lesions by topical corticosteroids: a randomized controlled trial. Dermatology. 2011;222:36-48.
32. Breuer K, Braeutigam M, Kapp A, et al. Influence of pimecrolimus cream 1% on different morphological signs of eczema in infants with atopic dermatitis. Dermatology. 2004;209:314-320.
33. Leung DY, Hanifin JM, Pariser DM, et al. Effects of pimecrolimus cream 1% in the treatment of patients with atopic dermatitis who demonstrate a clinical insensitivity to topical corticosteroids: a randomized, multicentre vehicle-controlled trial. Br J Dermatol. 2009;161:435-443.
34. Eichenfield LF, Lucky AW, Boguniewicz M, et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol. 2002;46:495-504.
35. Meurer M, Folster-Holst R, Wozel G, et al; CASM-DE-01 study group. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology. 2002;205:271-277.
36. Zuberbier T, Heinzerling L, Bieber T, et al. Steroid-sparing effect of pimecrolimus cream 1% in children with severe atopic dermatitis. Dermatology. 2007;215:325-330.
37. Sigurgeirsson B, Ho V, Ferrandiz C, et al; Pimecrolimus 1% cream in (paediatric) Eczema: Prevention of Progression multi-centre investigator study group. Effectiveness and safety of a prevention-of-flare-progression strategy
2. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.
3. Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol. 1980;60:44-47.
4. Silverberg JI, Simpson EL. Associations of childhood eczema severity: a US population-based study. Dermatitis. 2014;25:107-114.
5. Carroll CL, Balkrishnan R, Feldman SR, et al. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005;22:192- 199.
6. Mollanazar NK, Sethi M, Rodriguez RV, et al. Retrospective analysis of data from an itch center: integrating validated tools in the electronic health record. J Am Acad Dermatol. 2016;75:842-844.
7. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71:116-132.
8. Schneider L, Tilles S, Lio P, et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol. 2013;131:295-299.e227.
9. Charman CR, Morris AD, Williams HC. Topical corticosteroid phobia in patients with atopic eczema. Br J Dermatol. 2000;142:931-936. 10. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75:494-503.e496.
11. Murrell DF, Gebauer K, Spelman L, et al. Crisaborole topical ointment, 2% in adults with atopic dermatitis: a phase 2a, vehicle-controlled, proof-of-concept study. J Drugs Dermatol. 2015;14:1108-1112.
12. Stein Gold LF, Spelman L, Spellman MC, et al. A phase 2, randomized, controlled, dose-ranging study evaluating crisaborole topical ointment, 0.5% and 2% in adolescents with mild to moderate atopic dermatitis. J Drugs Dermatol. 2015;14:1394-1399.
13. Tom WL, Van Syoc M, Chanda S, et al. Pharmacokinetic profile, safety, and tolerability of crisaborole topical ointment, 2% in adolescents with atopic dermatitis: an open-label phase 2a study. Pediatr Dermatol. 2016;33:150-159.
14. Zane LT, Kircik L, Call R, et al. Crisaborole topical ointment, 2% in patients ages 2 to 17 years with atopic dermatitis: a phase 1b, open-label, maximaluse systemic exposure study. Pediatr Dermatol. 2016;33:380-387.
15. Griffiths CE, Van Leent EJ, Gilbert M, et al; Cipamyflline Study Group. Randomized comparison of the type 4 phosphodiesterase inhibitor cipamfylline cream, cream vehicle and hydrocortisone 17-butyrate cream for the treatment treatment of atopic dermatitis. Br J Dermatol. 2002;147:299-307.
16. Paller AS, Nimmagadda S, Schachner L, et al. Fluocinolone acetonide 0.01% in peanut oil: therapy for childhood atopic dermatitis, even in patients who are peanut sensitive. J Am Acad Dermatol. 2003;48:569-577.
17. Hebert AA, Cook-Bolden FE, Basu S, et al; Desonide Hydrogel Study Group. Safety and efficacy of desonide hydrogel 0.05% in pediatric subjects with atopic dermatitis. J Drugs Dermatol. 2007;6:175-181.
18. Gong JQ, Lin L, Lin T, et al. Skin colonization by Staphylococcus aureus in patients with eczema and atopic dermatitis and relevant combined topical therapy: a double-blind multicentre randomized controlled trial. Br J Dermatol. 2006;155:680-687.
19. Abramovits W, Oquendo M. Hydrocortisone butyrate 0.1% lipocream in pediatric patients with atopic dermatitis. Skinmed. 2010;8:72-79.
20. Cato A, Swinehart JM, Griffin EI, et al. Azone enhances clinical effectiveness of an optimized formulation of triamcinolone acetonide in atopic dermatitis. Int J Dermatol. 2001;40:232-236.
21. Larsen FS, Simonsen L, Melgaard A, et al. An efficient new formulation of fusidic acid and betamethasone 17-valerate (fucicort lipid cream) for treatment of clinically infected atopic dermatitis. Acta Derm Venereol. 2007;87:62-68.
22. Maloney JM, Morman MR, Stewart DM, et al. Clobetasol propionate emollient 0.05% in the treatment of atopic dermatitis. Int J Dermatol. 1998;37:142-144.
23. Breneman D, Fleischer AB Jr, Kaplan D, et al. Clobetasol propionate 0.05% lotion in the treatment of moderate to severe atopic dermatitis: a randomized evaluation versus clobetasol propionate emollient cream. J Drugs Dermatol. 2005;4:330-336.
24. Ruzicka T, Bieber T, Schopf E, et al. A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group. N Engl J Med. 1997;337:816-821.
25. Boguniewicz M, Fiedler VC, Raimer S, et al; Pediatric Tacrolimus Study Group. A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. J Allergy Clin Immunol. 1998;102:637-644.
26. Schachner LA, Lamerson C, Sheehan MP, et al; US Tacrolimus Ointment Study Group. Tacrolimus ointment 0.03% is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric patients: results from a randomized, double-blind, vehicle-controlled study. Pediatrics. 2005;116:e334-342.
27. Breneman D, Fleischer AB Jr, Abramovits W, et al; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-timesweekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008;58:990-999.
28. Kaufmann R, Bieber T, Helgesen AL, et al; multicentre investigator group. Onset of pruritus relief with pimecrolimus cream 1% in adult patients with atopic dermatitis: a randomized trial. Allergy. 2006;61:375-381.
29. Guttman-Yassky E, Ungar B, Malik K, et al. Molecular signatures order the potency of topically applied anti-inflammatory drugs in patients with atopic dermatitis. J Allergy Clin Immunol. 2017;140:1032-1042.e1013.
30. Spergel JM, Boguniewicz M, Paller AS, et al. Addition of topical pimecrolimus to once-daily mid-potent steroid confers no short-term therapeutic benefit in the treatment of severe atopic dermatitis; a randomized controlled trial. Br J Dermatol. 2007;157:378-381.
31. Bangert C, Strober BE, Cork M, et al. Clinical and cytological effects of pimecrolimus cream 1% after resolution of active atopic dermatitis lesions by topical corticosteroids: a randomized controlled trial. Dermatology. 2011;222:36-48.
32. Breuer K, Braeutigam M, Kapp A, et al. Influence of pimecrolimus cream 1% on different morphological signs of eczema in infants with atopic dermatitis. Dermatology. 2004;209:314-320.
33. Leung DY, Hanifin JM, Pariser DM, et al. Effects of pimecrolimus cream 1% in the treatment of patients with atopic dermatitis who demonstrate a clinical insensitivity to topical corticosteroids: a randomized, multicentre vehicle-controlled trial. Br J Dermatol. 2009;161:435-443.
34. Eichenfield LF, Lucky AW, Boguniewicz M, et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad Dermatol. 2002;46:495-504.
35. Meurer M, Folster-Holst R, Wozel G, et al; CASM-DE-01 study group. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology. 2002;205:271-277.
36. Zuberbier T, Heinzerling L, Bieber T, et al. Steroid-sparing effect of pimecrolimus cream 1% in children with severe atopic dermatitis. Dermatology. 2007;215:325-330.
37. Sigurgeirsson B, Ho V, Ferrandiz C, et al; Pimecrolimus 1% cream in (paediatric) Eczema: Prevention of Progression multi-centre investigator study group. Effectiveness and safety of a prevention-of-flare-progression strategy
