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Meta-analysis

Clinical efficacy and safety of topical difamilast in the treatment of patients with atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials

ORCID Icon, , , ORCID Icon & ORCID Icon
Pages 1471-1478 | Received 22 Jun 2022, Accepted 04 Oct 2022, Published online: 11 Oct 2022

References

  • Bieber T. Atopic dermatitis. N Engl J Med. 2008;358(14):1483–1494.
  • Schneider L, Tilles S, Lio P, et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol. 2013;131(2):295–299.e291–227.
  • Santamaria-Babí LF. Atopic dermatitis pathogenesis: lessons from immunology. Dermatol Pract Concept. 2022;12(1):e2022152.
  • Yang N, Chen Z, Zhang X, et al. Novel targeted biological agents for the treatment of atopic dermatitis. BioDrugs. 2021;35(4):401–415.
  • Li H, Zhang Z, Zhang H, et al. Update on the pathogenesis and therapy of atopic dermatitis. Clin Rev Allergy Immunol. 2021;61(3):324–338.
  • 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(1):116–132.
  • Nygaard U, Deleuran M, Vestergaard C. Emerging treatment options in atopic dermatitis: topical therapies. Dermatology. 2017;233(5):333–343.
  • Li H, Zuo J, Tang W. Phosphodiesterase-4 inhibitors for the treatment of inflammatory diseases. Front Pharmacol. 2018;9:1048.
  • Janjua S, Fortescue R, Poole P. Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2020;5(5):Cd002309.
  • Luo J, Yang L, Yang J, et al. Efficacy and safety of phosphodiesterase 4 inhibitors in patients with asthma: a systematic review and meta-analysis. Respirology. 2018;23(5):467–477.
  • Janosova V, Calkovsky V, Pedan H, et al. Phosphodiesterase 4 inhibitors in allergic rhinitis/rhinosinusitis. Front Pharmacol. 2020;11:1135.
  • Distel J, Cazzaniga S, Seyed Jafari SM, et al. Long-term effectiveness and drug survival of apremilast in treating psoriasis: a real-world experience. Dermatology. 2022;238(2):267–275.
  • Yang H, Wang J, Zhang X, et al. Application of topical phosphodiesterase 4 inhibitors in mild to moderate atopic dermatitis: a systematic review and meta-analysis. JAMA Dermatol. 2019;155(5):585–593.
  • Ahluwalia J, Udkoff J, Waldman A, et al. Phosphodiesterase 4 inhibitor therapies for atopic dermatitis: progress and outlook. Drugs. 2017;77(13):1389–1397.
  • Saeki H, Baba N, Ito K, et al. Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial. Br J Dermatol. 2022;186(1):40–49.
  • Saeki H, Ito K, Yokota D, et al. Difamilast ointment in adult patients with atopic dermatitis: a phase 3 randomized, double-blind, vehicle-controlled trial. J Am Acad Dermatol. 2022;86(3):607–614.
  • Hanifin JM, Ellis CN, Frieden IJ, et al. OPA-15406, a novel, topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (AD): a phase-II randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2016;75(2):297–305.
  • Saeki H, Baba N, Oshiden K, et al. Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis. J Dermatol. 2020;47(1):17–24.
  • Saeki H, Kawashima M, Sugaya S, et al. Efficacy and safety of topical OPA-15406, a new phosphodiesterase 4 inhibitor, in Japanese patients with atopic dermatitis for 8 weeks: a phase 2, randomized, double-blind, placebo-controlled study. J Dermatol. 2019;46(8):672–679.
  • Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339(jul21 1):b2535.
  • Futamura M, Leshem YA, Thomas KS, et al. A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: many options, no standards. J Am Acad Dermatol. 2016;74(2):288–294.
  • Hanifin JM, Thurston M, Omoto M, et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI evaluator group. Exp Dermatol. 2001;10(1):11–18.
  • 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.
  • Reich A, Heisig M, Phan NQ, et al. Visual analogue scale: evaluation of the instrument for the assessment of pruritus. Acta Derm Venereol. 2012;92(5):497–501.
  • Charman CR, Venn AJ, Ravenscroft JC, et al. Translating Patient-Oriented Eczema Measure (POEM) scores into clinical practice by suggesting severity strata derived using anchor-based methods. Br J Dermatol. 2013;169(6):1326–1332.
  • Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
  • Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol. 1980;92(Suppl):44–47.
  • Saeki H. Management of atopic dermatitis in Japan. J Nippon Med Sch. 2017;84(1):2–11.
  • Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/study/NCT03961529?term=NCT03961529&draw=2&rank=1 Accessed on April 25, 2022.

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