PRIMARY ENDPOINT
SUCCESS
IN ISGA

FOR THE TREATMENT OF MILD-TO-MODERATE ATOPIC DERMATITIS IN PATIENTS 2 YEARS AND OLDER

Significantly more EUCRISA patients achieved success in ISGA at Day 29, the primary efficacy endpoint1-3

Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline1

ISGA=Investigator’s Static Global Assessment.


FOR THE TREATMENT OF MILD-TO-MODERATE ATOPIC DERMATITIS IN PATIENTS 2 AND OLDER

EUCRISA was studied as monotherapy in both treatment-naïve and treatment-experienced patients3

Actual patient treated with EUCRISA in clinical trials, who achieved success in ISGA, the primary efficacy endpoint.*

All patients may not respond to treatment with EUCRISA. Individual results may vary.

 
Day 8
 
Day 15
 
Day 22
 
Day 29

*Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline at Day 29.1


References

  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. 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(3):494-503.e4.
  3. Data on File. Pfizer Inc, New York, NY.
  4. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AV. Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125(4):659-664.
  5. Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Children's Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.
  6. Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992.
  7. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.
  8. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AV. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.
  9. Schünemann HJ, Guyatt GH. Commentary goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res. 2005;40(2):593-597.
  10. Langley RG, Paller AS, Hebert AA, et al. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase Ill randomized controlled trial. J Am Acad Dermatol. 2011;64(1):64-70.
  11. Lewis-Jones MS, Finlay AV. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;19(3):210-216.
  12. Eichenfield LF, Tom WL, Berger TJ, 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(1)116-132.
  13. 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(2):338-351.

SECONDARY ENDPOINT
TIME TO SUCCESS
IN ISGA
CLEAR OR ALMOST
CLEAR

FOR THE TREATMENT OF MILD-TO-MODERATE ATOPIC DERMATITIS IN PATIENTS 2 YEARS AND OLDER

Success in ISGA was achieved by an almost 3 times higher percentage of EUCRISA patients vs vehicle at Day 81,3*

*Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline.1

ISGA=Investigator’s Static Global Assessment.


Approximately half of EUCRISA patients achieved an ISGA of Clear (0) or Almost Clear (1) at Day 29, a prespecified secondary endpoint2,3

These results include patients with a 1-grade improvement in ISGA. Disease severity is a continuous variable, and each ISGA category represents a small range of disease severity. A 1-grade improvement in ISGA may not have been clinically meaningful in some patients.

ISGA=Investigator’s Static Global Assessment.


References

  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. 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(3):494-503.e4.
  3. Data on File. Pfizer Inc, New York, NY.
  4. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AV. Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125(4):659-664.
  5. Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Children's Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.
  6. Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992.
  7. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.
  8. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AV. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.
  9. Schünemann HJ, Guyatt GH. Commentary goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res. 2005;40(2):593-597.
  10. Langley RG, Paller AS, Hebert AA, et al. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase Ill randomized controlled trial. J Am Acad Dermatol. 2011;64(1):64-70.
  11. Lewis-Jones MS, Finlay AV. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;19(3):210-216.
  12. Eichenfield LF, Tom WL, Berger TJ, 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(1)116-132.
  13. 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(2):338-351.

ADDITIONAL ENDPOINT
QUALITY OF LIFE
ASSESSMENTS

FOR THE TREATMENT OF MILD-TO-MODERATE ATOPIC DERMATITIS IN PATIENTS 2 YEARS AND OLDER

Quality of life (QoL) assessments: mean changes from baseline at Day 29 for EUCRISA and vehicle3

Pooled results from 2 pivotal studies3

Baseline scores in the pivotal trials reflect a moderate effect of atopic dermatitis on patient lives. Composite scores are based on a scale of 0-304-6

The higher the score, the greater the impairment of QoL.7

MCID (or MID, as it is sometimes referred to) is the smallest difference in score that suggests there has actually been a meaningful change in studied patients’ quality of life since the previous measurement of his/her scores that would lead the patient or clinician to consider a change in management.8,9

Dermatology Life Quality Index (DLQI): Patients ≥16 years of age3

Comparisons between EUCRISA and vehicle cannot be made as the study was not designed for this purpose.

DLQI domains7

  • Symptoms and feelings
  • Personal relationships
  • Work/school
  • Leisure
  • Daily activities
  • Treatment

Children's Dermatology Life Quality Index (CDLQI): Patients 2-15 years of age3

CDLQI is validated for use in children 4-16 years of age and can be completed with the help of the child's parent or guardian. The data presented includes patients 2-15 years of age. These results are consistent with the findings of a sub-group analysis in patients 4-15 years of age.6

Comparisons between EUCRISA and vehicle cannot be made as the study was not designed for this purpose.

CDLQI domains11

  • Symptoms and feelings
  • Personal relationships
  • School or vacations
  • Leisure
  • Sleep
  • Treatment

References

  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. 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(3):494-503.e4.
  3. Data on File. Pfizer Inc, New York, NY.
  4. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AV. Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125(4):659-664.
  5. Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Children's Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.
  6. Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992.
  7. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.
  8. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AV. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.
  9. Schünemann HJ, Guyatt GH. Commentary goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res. 2005;40(2):593-597.
  10. Langley RG, Paller AS, Hebert AA, et al. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase Ill randomized controlled trial. J Am Acad Dermatol. 2011;64(1):64-70.
  11. Lewis-Jones MS, Finlay AV. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;19(3):210-216.
  12. Eichenfield LF, Tom WL, Berger TJ, 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(1)116-132.
  13. 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(2):338-351.