Consensus on the therapeutic management of atopic dermatitis ‒ Brazilian Society of Dermatology: an update on phototherapy and systemic therapy using e-Delphi technique

Orfali, Raquel Leao; Lorenzini, Daniel; Bressan, Aline; Tanaka, Anber Ancel; Cerqueira, Ana Maria Mósca de; Hirayama, André da Silva; Ramos, Andréa Machado Coelho; Proença, Carolina Contin; Silva, Claudia Marcia de Resende; Laczynski, Cristina Marta Maria; Carneiro, Francisca Regina; Duarte, Gleison; Hans Filho, Gunter; Gonçalves, Heitor de Sá; Melo, Ligia Pessoa de; Azulay-Abulafia, Luna; Weber, Magda Blessmann; Rivitti-Machado, Maria Cecília; Zaniboni, Mariana Colombini; Ogawa, Marília; Pires, Mario Cezar; Ianhez, Mayra; Felix, Paulo Antonio Oldani; Bonamigo, Renan; Takaoka, Roberto; Lazzarini, Rosana; Cestari, Silmara; Mayor, Silvia Assumpção Soutto; Cestari, Tania; Oliveira, Zilda Najjar Prado de; Spuls, Phyllis I.; Gerbens, Louise A.A.; Aoki, Valeria

doi:10.1016/j.abd.2023.04.003

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Special Article • An. Bras. Dermatol. 98 (6) • Nov-Dec 2023 • https://doi.org/10.1016/j.abd.2023.04.003 copy

Consensus on the therapeutic management of atopic dermatitis ‒ Brazilian Society of Dermatology: an update on phototherapy and systemic therapy using e-Delphi technique^☆ ☆ Study conducted at the Brazilian Society of Dermatology, Rio de Janeiro, RJ, Brazil.

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

This publication is an update of the “Consensus on the therapeutic management of atopic dermatitis - Brazilian Society of Dermatology” published in 2019, considering the novel, targeted-oriented systemic therapies for atopic dermatitis. The initial recommendations of the current consensus for systemic treatment of patients with atopic dermatitis were based on a recent review of scientific published data and a consensus was reached after voting. The Brazilian Society of Dermatology invited 31 experts from all regions of Brazil and 2 international experts on atopic dermatitis who fully contributed to the process. The methods included an e-Delphi study to avoid bias, a literature search and a final consensus meeting. The authors added novel approved drugs in Brazil and the indication for phototherapy and systemic therapy for AD. The therapeutical response to systemic treatment is hereby reported in a suitable form for clinical practice and is also part of this updated manuscript.

Keywords
Atopic dermatitis; Delphi technique; Medication therapy management; Phototherapy

Outcome	BSD experts’ votes
The diagnosis of AD will be defined according to clinical criteria (Hanifin & Rajka¹⁸18 Hanifin JM, Rajka G. Diagnostic Features of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1980;92:44-7. or UK working party's diagnostic criteria)²⁰20 Williams HC, Burney PG, Strachan D, Hay RJ. The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. II. Observer variation of clinical diagnosis and signs of atopic dermatitis. Br J Dermatol. 1994;131:397-405.
For clinical practice, the recommended instruments for assessing patient-reported symptoms are: PO-SCORAD; POEM; NRS-11 in past 24h; PROMIS® Itch Questionnaire - average 1-week NRS itch and peak 1-week NRS itch⁵5 homeforeczema.org [Internet]. UK: Harmonizing Outcome Measures for Eczema (HOME). [cited 2023 Apr 4]. Available from: http://www.homeforeczema.org/. http://www.homeforeczema.org/...
For clinical practice, the recommended instruments for evaluating long-term disease control are: ADCT, RECAP, and PGA⁵5 homeforeczema.org [Internet]. UK: Harmonizing Outcome Measures for Eczema (HOME). [cited 2023 Apr 4]. Available from: http://www.homeforeczema.org/. http://www.homeforeczema.org/...
The following core outcome domains and instruments should be measured and reported in ALL AD trials: Clinician-reported signs - EASI; Patient-reported symptoms: POEM and NRS-11 in past 24h; Quality of Life - DLQI (adults), CDLQI (children), IDQoL (infants); Long-term control - RECAP or ADCT⁵5 homeforeczema.org [Internet]. UK: Harmonizing Outcome Measures for Eczema (HOME). [cited 2023 Apr 4]. Available from: http://www.homeforeczema.org/. http://www.homeforeczema.org/...

Outcome	BSD experts’ votes
When selecting systemic treatment modalities for individual AD patients; it is relevant to ask the medical history for comorbidities
Physicians should be aware of AD associated atopic and non-atopic comorbidities when considering treatment options
Start of a therapeutic option (topical; phototherapy or systemic therapy) in AD should be a shared decision between patients; caretakers; and physicians
Systemic therapy for AD is recommended when the disease lacks control after topical treatment with anti-inflammatory drugs; removing triggers; educational programs (when needed); phototherapy. Needs to be considered: respecting patients’ preferences and evaluating AD impact on personal life, financial implications, and comorbidities

Outcome	BSD experts’ votes
Phototherapy may be indicated as an alternative treatment for moderate-to-severe and refractory to topical treatment AD
NB-UVB and UVA1 are considered useful phototherapies in patients with moderate-to-severe AD
Short-term treatment with oral glucocorticoids may be considered for adults and in exceptional cases also for children and adolescents with severe AD to control flares and to prepare them for other subsequent therapeutic modalities after discontinuation of a previous systemic therapeutic option. Exceptional cases include: lack of other treatment options; as a bridge to other systemic therapies or phototherapy; during acute flares in need of immediate relief; in anticipation of a major life event; or in the most severe and recalcitrant cases
Systemic glucocorticoids treatment should be limited to short-term use with a long-term plan for therapy using non-steroid systemic drugs
Ciclosporin (CsA) may be considered a systemic option for severe AD (licensed in Brazil) when it is not possible to taper potent topical steroids
CsA initial dose varies from 2.5 to 5.0 mg/kg/day. Usage of higher initial dose of 4-5 mg/kg/day may lead to a more rapid response
The recommended length of treatment with CSA for patients with AD is up to 1 year
CsA as a systemic treatment for AD may be extended for a period above 1 year, if well tolerated
Tapering CsA is possible after achievement of marked clinical improvement in AD; with recommended reduction of 0.5-1.0 mg/kg/day every two weeks
The expected risk-benefit ratio needs to be evaluated before using CsA in AD patients, in comparison with other systemic therapeutic alternatives
Monitoring blood pressure levels and renal function are recommended before initiation and during follow-up in AD patients on CsA
After extensive UV therapy, CsA usage is not ideal due to the increased risk of skin cancer
MTX may be considered as a long-term systemic treatment for moderate-to-severe AD when it is not possible to taper potent topical steroids (off-label in Brazil)

Outcome	BSD experts’ votes
When considering the need for changes in systemic therapy; two decision-points should be considered to check whether the optimal treatment target was reached (after 3 and 6 months). Each decision-point should be based on improvements in PGA plus at least one specific clinical outcome domain¹³13 De Bruin-Weller M, Biedermann T, Bissonnette R, Deleuran M, Foley P, Girolomoni G, et al. Treat-to-target in atopic dermatitis: an International Consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101:adv00402.
The initial acceptable treatment target goals after 3 months should reach: at least EASI 50 or SCORAD 50 (50% reduction compared to baseline); For Peak Pruritus NRS (0-10): a reduction of at least 3 points; For DLQI: a reduction of at least 4 points; For POEM: a reduction of at least 4 points¹³13 De Bruin-Weller M, Biedermann T, Bissonnette R, Deleuran M, Foley P, Girolomoni G, et al. Treat-to-target in atopic dermatitis: an International Consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101:adv00402.
The optimal acceptable treatment target goals after 6 months should reach at least: EASI 75 or EASI ≤ 7; SCORAD 75 (75% reduction compared to baseline) or SCORAD ≤ 24; Peak Pruritus NRS (0-10): an absolute score ≤ 4; DLQI: an absolute score ≤ 5; POEM: an absolute score ≤ 7¹³13 De Bruin-Weller M, Biedermann T, Bissonnette R, Deleuran M, Foley P, Girolomoni G, et al. Treat-to-target in atopic dermatitis: an International Consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101:adv00402.
The initial acceptable treatment target goal after 3 months should reach a reduction of at least 1 point in patient global response (e.g., PtGA 0-4)¹³13 De Bruin-Weller M, Biedermann T, Bissonnette R, Deleuran M, Foley P, Girolomoni G, et al. Treat-to-target in atopic dermatitis: an International Consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101:adv00402.
The optimal acceptable treatment target goal according to PGA (e.g., PtGA 0-4) after 6 months should reach an absolute score of ≤ 2,¹³13 De Bruin-Weller M, Biedermann T, Bissonnette R, Deleuran M, Foley P, Girolomoni G, et al. Treat-to-target in atopic dermatitis: an International Consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101:adv00402. but if target outcomes are achieved for PGA plus at least 1 specific disease domain (signs, symptoms, quality of life), treatment continuation should be considered
Changes in systemic therapy may be needed in the presence of specific or non-specific undesirable adverse events (e.g. infection) occur under pharmacotherapy; or when there is a contraindication to continuing therapy (e.g., desire to have children; becoming pregnancy)

Outcome	BSD experts’ votes
If patient is not well controlled with conventional therapies (e.g., phototherapy; CsA or MTX) introduction of systemic target-oriented therapies for adults and children approved for moderate-to-severe AD such as immunobiologics and/or Janus-kinase inhibitors should be considered; endorsed by any of the conditions above except for child wish; lactating; and pregnancy
Dupilumab should be a systemic target-oriented option for adults with AD (initially 600 mg SC day 1 followed by 300 mg Q2W); and adolescents / children (age 12-17: < 60 kg: initially 400 mg SC day 1 followed by 200 mg Q2W; when ≥ 60 kg: initially 600 mg SC day 1 followed by 300 mg Q2W); age 6-11: from 15kg to < 60 kg; initially 600 mg SC day 1 followed by 300 mg Q4W; when ≥ 60 kg; initially 600 mg SC day 1 followed by 300 mg Q2W; age 6 months-5 years: 15 to < 30 kg, initial and subsequent dosage of 300 mg Q4W, 1 x 300 mg; 5 to < 15 kg, initial and subsequent dosage 200 mg Q4W, 1 x 200 mg). (Licensed in Brazil)
Baricitinib should be a systemic target-oriented option for adults with AD (4 mg per day; reduction to 2 mg per day possible; depending on treatment response). (Licensed in Brazil)
Upadacitinib should be a systemic target-oriented option for adults: 15 or 30mg/day; age ≥ 65: 15mg/day and adolescents with AD (age 12-17 > = 30 kg bw: 15 mg per day). (Licensed in Brazil; in license for ≤ 12 years)

Sociedade Brasileira de Dermatologia Av. Rio Branco, 39 18. and., 20090-003 Rio de Janeiro RJ, Tel./Fax: +55 21 2253-6747 - Rio de Janeiro - RJ - Brazil
E-mail: revista@sbd.org.br

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[1] ⁎ Corresponding author. E-mail: raquel.orfali@fm.usp.br (R.L. Orfali).

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Consensus on the therapeutic management of atopic dermatitis ‒ Brazilian Society of Dermatology: an update on phototherapy and systemic therapy using e-Delphi technique☆ ☆ Study conducted at the Brazilian Society of Dermatology, Rio de Janeiro, RJ, Brazil.

Abstract

Consensus on the therapeutic management of atopic dermatitis ‒ Brazilian Society of Dermatology: an update on phototherapy and systemic therapy using e-Delphi technique^☆ ☆ Study conducted at the Brazilian Society of Dermatology, Rio de Janeiro, RJ, Brazil.