Questions About DUPIXENT

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DUPIXENT Basics

Per the indication for DUPIXENT, patients aged 12 years and older with moderate-to-severe atopic dermatitis are considered uncontrolled when their disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1

Itch reduction was evaluated as a key secondary endpoint in 3 randomized, double-blind, placebo-controlled trials that enrolled 2119 subjects, 18 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical prescription medication(s).1 Click here for additional clinical trial design information.

Itch reduction with DUPIXENT was rapid and sustained. A significantly greater proportion of adult patients had improvement on the Peak Pruritus NRS score vs placebo (defined as at least a 4-point improvement) as early as Week-2 (≈9% of DUPIXENT patients achieved ≥4-point reduction in NRS score at Week-2 vs ≈3% with placebo [P=0.0097]).1,2

  • 41% of patients achieved a ≥4-point improvement in the Peak Pruritus Numerical Rating Scale (NRS) with DUPIXENT at Week-16 in Trial 1 vs 12% with placebo1
  • 36% of patients achieved a ≥4-point improvement in the Peak Pruritus NRS with DUPIXENT at Week-16 in Trial 2 vs 10% with placebo1

In addition, in Trial 31,3:

  • 59% of patients achieved a ≥4-point improvement in the Peak Pruritus NRS with DUPIXENT + TCS at Week-16 vs 20% in placebo + TCS
  • 51% of patients experienced rapid and sustained itch reduction through 52 weeks with DUPIXENT + TCS in Trial 3 vs 13% with placebo + TCS
Review Adult Peak Pruritus NRS Results

Itch reduction was evaluated as a key secondary endpoint in the adolescent trial that enrolled 251 subjects, aged 12 to 17 years with moderate-to-severe atopic dermatitis not adequately controlled by topical prescription medication(s).1

A greater proportion of subjects randomized to DUPIXENT achieved an improvement in the Peak Pruritus NRS compared with placebo (defined as ≥4-point improvement as early as Week-4; 22% with DUPIXENT vs 5% with placebo).1,3

  • 37% of adolescent patients treated with DUPIXENT achieved a ≥4-point improvement in the Peak Pruritus NRS at Week-16 vs 5% with placebo (P<0.0001)1,2
Review Adolescent Peak Pruritus NRS Results

Clinical Trials

Trial 3 was a 52-week pivotal clinical trial evaluating the efficacy and safety of DUPIXENT in adult patients with uncontrolled moderate-to-severe atopic dermatitis. 421 adult patients were randomized to DUPIXENT + TCS or placebo + TCS.1

Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1

Trial 3 results demonstrated significant improvement with DUPIXENT + TCS in achieving clear (IGA 0) or almost-clear skin (IGA 1) (the primary endpoint at 16 weeks) and lesion extent and severity (EASI) at Weeks 16 and 52 vs placebo + TCS.1,3

  • 39% of adult patients treated with DUPIXENT + TCS achieved clear or almost-clear skin at 16 weeks vs 12% with placebo + TCS (P<0.0001)1,3
  • 36% of adult patients achieved clear or almost-clear skin (IGA 0 or 1) with DUPIXENT + TCS at 52 weeks vs 13% with placebo + TCS in Trial 3 (P<0.0001)1,3

View Adult IGA Results

  • 69% and 65% of adult patients treated with DUPIXENT + TCS demonstrated improvement in EASI-75 at 16 weeks and 52 weeks vs 23% and 22% with placebo + TCS, respectively (P<0.0001)1,3
  • On average, adult patients experienced an 85% mean improvement in EASI score from baseline with DUPIXENT + TCS vs 61% with placebo + TCS (P=0.0015)2

Explore Adult EASI Results

The most common adverse reactions (incidence ≥1%) in atopic dermatitis patients are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.

Additionally, the adult safety profile of DUPIXENT + TCS through Week-52 was generally consistent with the safety profile observed at Week-16 in adults.1

In the adult 52-week trial1:

  • Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group
  • Conjunctivitis was reported in 16% of the DUPIXENT + TCS group and in 9% of the placebo + TCS group
  • Discontinuation rates due to adverse events were 1.8% in the DUPIXENT + TCS group and 7.6% in the placebo + TCS group

The pivotal clinical trial evaluating the efficacy and safety of DUPIXENT in adolescent patients aged 12 to 17 years with uncontrolled moderate-to-severe atopic dermatitis lasted for 16 weeks.

However, the long-term safety of DUPIXENT in adolescent patients with moderate-to-severe atopic dermatitis who had participated in previous clinical trials of DUPIXENT was assessed in an open-label extension trial (Trial 7). The safety profile of DUPIXENT in adolescent subjects followed through Week-52 was similar to the safety profile observed at Week-16 in Trial 6. The long-term safety profile of DUPIXENT observed in adolescents was consistent with that seen in adults with atopic dermatitis.1

Review the Adolescent Data

Since atopic dermatitis is a chronic disease, you should evaluate your patients often and consider making any changes to their treatment regimen based on your clinical judgment.

The LIBERTY Atopic Dermatitis clinical trial program was designed to evaluate the safety and efficacy of dupilumab for the treatment of uncontrolled moderate-to-severe atopic dermatitis. The LIBERTY Atopic Dermatitis clinical trial program consisted of the following trials4:

  • Trial 1 (SOLO 1 [AD-1334]): a phase 3,16-week monotherapy study in adults
  • Trial 2 (SOLO 2 [AD-1416]): a phase 3,16-week monotherapy study in adults
  • Trial 3 (CHRONOS [AD-1224]): a phase 3 efficacy and long-term safety study in adults of 52-week concomitant therapy with topical corticosteroids
  • Trial 4 (R668-AD-1021): a randomized phase 2 dose-ranging study in adults
  • Trial 5 (SOLO-Continue [AD-1415]): a phase 3 maintenance study for adult patients who completed SOLO 1 or SOLO 2 and achieved an IGA of 0 or 1 or EASI 75
  • Trial 6 (R668-AD-1526): a phase 3,16-week monotherapy study in adolescent patients
  • Trial 7 (R668-AD-1434 Open label Extension [OLE]): a phase 3 OLE study assessing the long-term safety of dupilumab in adolescent patients 12 to 17 years of age

Using DUPIXENT

The adolescent dosing is weight-based. For your adolescent patients (12 to 17 years of age) who weigh ≥60 kg (132 lb), the dosing will be the same as patients aged 18 years and older. Specifically, an initial dose of 600 mg (two 300 mg injections in different injection sites) followed by 300 mg given every other week.

For your adolescent patients (12 to 17 years of age) who weigh <60 kg (132 lb), the recommended dose is an initial dose of 400 mg (two 200 mg injections in different injection sites) followed by 200 mg given every other week.

DUPIXENT can be used with or without TCS.1

Review Dosing and Administration

DUPIXENT can be used with or without TCS. Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

The 52-week adult study was designed to evaluate therapy with DUPIXENT in combination with TCS at Week-16 and long-term efficacy and safety at Week 52.1,3

The adult safety profile of DUPIXENT + TCS through Week-52 is generally consistent with the safety profile observed at Week-16 in adults and adolescents.1

In the adult 52-week trial1:

  • Keratitis was reported in 4% of the DUPIXENT + TCS group and in 0% of the placebo + TCS group
  • Conjunctivitis was reported in 16% of the DUPIXENT + TCS group and in 9% of the placebo + TCS group
  • Discontinuation rates due to adverse events were 1.8% in the DUPIXENT + TCS group and 7.6% in the placebo + TCS group

The most common adverse reactions (incidence ≥1%) in atopic dermatitis patients are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.1

Yes, DUPIXENT can be used concomitantly with topical calcineurin inhibitors (TCIs), but, as stated in the DUPIXENT label, they should be reserved for problem areas only, such as the face, neck, and intertriginous and genital areas.1

In the adult 52-week Trial 3, patients were permitted to use TCIs as needed for problem areas only.1

Review Dosing and Administration

Because DUPIXENT may be used with or without topical medications, continuing with or stopping concomitant use is at your discretion based on your patient’s condition. Do not discontinue topical corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician.

Atopic dermatitis is a chronic disease, and you may consider treating continuously with DUPIXENT based on your clinical judgment. Individual patient responses may vary.

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Reference:
References:
  1. DUPIXENT Prescribing Information. March 2019.
  2. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  3. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
  4. Data on file, Regeneron Pharmaceuticals, Inc.
  5. Gittler JK, Shemer A, Suárez-Fariñas M, et al. Progressive activation of Th2/Th22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012:130(6):1344-1354.
  6. DUPIXENT Prescribing Information. March 2019.
  7. Wei W, Anderson P, Gadhari A, et al. Extent and consequences of inadequate disease control among adults with atopic dermatitis. J Dermatol. 2018;45(2):150-157.
  8. DUPIXENT Prescribing Information. March 2019.
  9. DUPIXENT Prescribing Information. March 2019.
  10. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M; the EASI Evaluator Group. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol. 2001;10(1):11-18.
  11. Data on file, Regeneron Pharmaceuticals, Inc.
  12. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebocontrolled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
  13. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  14. EASI User Guide. HOME-Harmonising Outcome Measures for Eczema website. Http://www.homeforeczema.org/documents/easi-user-guide-jan-2017-v3.pdf. Accessed January 4, 2019.
  15. DUPIXENT Prescribing Information. March 2019.
  16. Data on file, Regeneron Pharmaceuticals, Inc.
  17. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderateto-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
  18. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  19. DUPIXENT Prescribing Information. March 2019.
  20. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348.
  21. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502-507.
  22. Data on file, Regeneron Pharmaceuticals, Inc.
  23. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
  24. DUPIXENT Prescribing Information. March 2019.
  25. Data on file, Regeneron Pharmaceuticals, Inc.
  26. DUPIXENT Prescribing Information. March 2019.
  27. Data on file, Regeneron Pharmaceuticals, Inc.
  28. DUPIXENT Prescribing Information. March 2019.
  29. Boguniewicz M, Alexis AF, Beck LA, et al. Expert perspectives on management of moderateto-severe atopic dermatitis: a multidisciplinary consensus addressing current and emerging therapies. J Allergy Clin Immunol Pract. 2017;5(6):1519-1531.
  30. DUPIXENT Prescribing Information. March 2019.
  31. Data on file. Regeneron Pharmaceuticals, Inc.
  32. DUPIXENT Prescribing Information. March 2019.
  33. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303.
  34. Data on file, Regeneron Pharmaceuticals, Inc.
  35. DUPIXENT Prescribing Information. March 2019.
  36. Gittler JK, Shemer A, Suárez-Fariñas M, et al. Progressive activation of Th2/Th22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012;130(6):1344-1354.
  37. DUPIXENT Prescribing Information. March 2019.
  38. DUPIXENT Prescribing Information. March 2019.
  39. Data on file, Regeneron Pharmaceuticals, Inc.