Practical Recommendations on Laboratory Monitoring in Patients with Atopic Dermatitis on Oral JAK Inhibitors

Mark G Kirchhof^{1

2}, Vimal H Prajapati^{2

3

4

5}, Melinda Gooderham^{2

6

7}, Chih-Ho Hong^{2

8

9}, Charles W Lynde^{2

10

11}, Catherine Maari^{12

13}, Irina Turchin^{2

14

15}, Kim A Papp^{16

17}

Affiliations

¹ Dermatology Division, Department of Medicine, University of Ottawa and The Ottawa Hospital, Ottawa, ON, Canada.
² Probity Medical Research Inc., 135 Union St. E., Waterloo, ON, N2J 1C3, Canada.
³ Division of Dermatology, Department of Medicine, Section of Community Pediatrics, Department of Pediatrics; and Section of Pediatric Rheumatology, Department of Pediatrics, University of Calgary, Calgary, AB, Canada.
⁴ Skin Health and Wellness Centre, Calgary, AB, Canada.
⁵ Dermatology Research Institute, Calgary, AB, Canada.
⁶ Department of Dermatology, Queen's University, Kingston, ON, Canada.
⁷ SKiN Centre for Dermatology, Peterborough, ON, Canada.
⁸ Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.
⁹ Dr. Chih-Ho Hong Medical Inc., Surrey, BC, Canada.
¹⁰ Department of Medicine, University of Toronto, Toronto, ON, Canada.
¹¹ Lynde Dermatology, Toronto, ON, Canada.
¹² Division of Dermatology, Department of Medicine, Montreal University Hospital Center, Montreal, QC, Canada.
¹³ Innovaderm Research Inc., Montreal, QC, Canada.
¹⁴ Department of Medicine, Dalhousie University, Halifax, NS, Canada.
¹⁵ Brunswick Dermatology Center, Fredericton, NB, Canada.
¹⁶ Probity Medical Research Inc., 135 Union St. E., Waterloo, ON, N2J 1C3, Canada. kapapp@probitymedical.com.
¹⁷ K Papp Clinical Research, Waterloo, ON, Canada. kapapp@probitymedical.com.

PMID: 39115712
PMCID: PMC11393246
DOI: 10.1007/s13555-024-01243-8

Practical Recommendations on Laboratory Monitoring in Patients with Atopic Dermatitis on Oral JAK Inhibitors

Mark G Kirchhof et al. Dermatol Ther (Heidelb). 2024 Sep.

. 2024 Sep;14(9):2653-2668.

doi: 10.1007/s13555-024-01243-8. Epub 2024 Aug 8.

Authors

Affiliations

¹ Dermatology Division, Department of Medicine, University of Ottawa and The Ottawa Hospital, Ottawa, ON, Canada.
² Probity Medical Research Inc., 135 Union St. E., Waterloo, ON, N2J 1C3, Canada.
³ Division of Dermatology, Department of Medicine, Section of Community Pediatrics, Department of Pediatrics; and Section of Pediatric Rheumatology, Department of Pediatrics, University of Calgary, Calgary, AB, Canada.
⁴ Skin Health and Wellness Centre, Calgary, AB, Canada.
⁵ Dermatology Research Institute, Calgary, AB, Canada.
⁶ Department of Dermatology, Queen's University, Kingston, ON, Canada.
⁷ SKiN Centre for Dermatology, Peterborough, ON, Canada.
⁸ Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.
⁹ Dr. Chih-Ho Hong Medical Inc., Surrey, BC, Canada.
¹⁰ Department of Medicine, University of Toronto, Toronto, ON, Canada.
¹¹ Lynde Dermatology, Toronto, ON, Canada.
¹² Division of Dermatology, Department of Medicine, Montreal University Hospital Center, Montreal, QC, Canada.
¹³ Innovaderm Research Inc., Montreal, QC, Canada.
¹⁴ Department of Medicine, Dalhousie University, Halifax, NS, Canada.
¹⁵ Brunswick Dermatology Center, Fredericton, NB, Canada.
¹⁶ Probity Medical Research Inc., 135 Union St. E., Waterloo, ON, N2J 1C3, Canada. kapapp@probitymedical.com.
¹⁷ K Papp Clinical Research, Waterloo, ON, Canada. kapapp@probitymedical.com.

PMID: 39115712
PMCID: PMC11393246
DOI: 10.1007/s13555-024-01243-8

Abstract

Oral Janus kinase inhibitors (JAKi), a class of advanced targeted systemic therapy, have demonstrated efficacy and safety in the treatment of moderate-to-severe atopic dermatitis (AD). Like other small molecules, oral JAKi have the potential for off-target effects including laboratory-related adverse events (AEs). Product labels for oral JAKi recommend an initial laboratory assessment and follow-up 4-12 weeks later to monitor for potential changes, based on evidence from clinical trials across therapeutic indications for oral JAKi, which may not reflect a population of moderate-to-severe AD patients typically seen in routine clinical practice. To address this gap, a panel of eight dermatologists with clinical and research experience with oral JAKi for the management of AD conducted a targeted review of the literature focused on key laboratory-related AEs associated with oral JAKi in the moderate-to-severe AD population. Based on the synthesis of evidence and informed opinion, a set of best practice statements related to fundamental standards of care and consensus recommendations on laboratory monitoring were suggested, and level of agreement was ascertained using a Likert scale from 0 to 100. There was a high level of agreement on three of the four suggested recommendations related to assessment and monitoring of key laboratory parameters and to dose reduction or switching in response to laboratory changes; there was a lower level of agreement related to the frequency of ongoing laboratory monitoring. Appropriate patient selection and laboratory assessment is an important strategy to mitigate the potential risks associated with oral JAKi when treating AD.

Keywords: Atopic dermatitis; JAK inhibitors; Monitoring; Safety; Tolerability.

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Conflict of interest statement

The authors disclose the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Mark G. Kirchhof has been an advisor, consultant and/or speaker for: AbbVie, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, Recordati, Sun Pharma, Therakos, and UCB. Vimal H. Prajapati has been an advisor, consultant, and/or speaker for: AbbVie, Actelion, Amgen, Apogee Therapeutics, Aralez, Arcutis, Aspen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Canadian Psoriasis Network, Celgene, Cipher, Eczema Society of Canada, Eli Lilly, Galderma, GSK, Homeocan, Janssen, LEO Pharma, L’Oréal, Medexus, Novartis, Organon, Pediapharm, Pfizer, Sanofi Genzyme, Sun Pharma, Tribute, and UCB; investigator for AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Asana, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Nimbus Lakshmi, Novartis, Pfizer, RAPT Therapeutics, Regeneron, Reistone, Sanofi Genzyme, Takeda, and UCB; and received grants from: AbbVie, Bausch Health, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme. Melinda Gooderham has been a speaker, investigator, consultant or advisory board member for: AbbVie, Acelyrin, Amgen, Akros, AnaptysBio, Apogee, Arcutis, Aristea, Aslan, Bausch Health, Boehringer Ingelheim, BMS, Coherus, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, InMagene, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharmaceuticals, Takeda, Tarsus, UCB, Union and Ventyx. Chih-ho Hong has been an investigator and/or consultant and/or speaker for: AbbVie, Amgen, Arcutis, Bausch Health, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Cutanea, Dermira, Dermavant, DS Biopharma, Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Medimmune, Merck, Mirimar, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, Roche, and UCB. Charles W. Lynde has been a speaker, consultant, or principal investigator for: AbbVie, Acelyrin, Akros, Altius, Amgen, Aralez, Arcutis, Avillion, Bausch Health, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cipher, Concert, Dermavant, Devonian, Eli Lilly, Evelo, Fresnius Kabi, Galderma, GSK, InCyte, Innovaderm, Intega Skin, Janssen, Kyowa Kirin, La Roche Posay, LEO Pharma, L’Oreal, Medexus, MedX, Merck, MoonLake, Novartis, P&G, Pediapharm, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sandoz, Sentrex, Sun Pharma, TEVA, Tribute, UCB, Valeant, Viatris, and Volo Health. Catherine Maari has been an advisor, an investigator, a consultant and/or speaker for: AbbVie, Apogee, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Nimbus, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, Tarsus, Ventyx and UCB. Irina Turchin has been a speaker, consultant, or principal investigator for AbbVie, Amgen, Arcutis, Bausch Health, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Mallinckrodt, Moonlake, Novartis, Pfizer, Sanofi, Sun Pharma, and UCB. Kim A. Papp has been a speaker, investigator, consultant, advisory board member, and/or scientific officer for: AbbVie, Acelyrin, Akros, Amgen, Anacor, Aralez Pharmaceuticals, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Celltrion, Coherus, CorEvitas, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo, Forbion, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Merck (MSD), Mitsubishi Pharma, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor.

References

1. Peck GM, Roberson FA, Feldman SR. Why do patients in the United States seek care from dermatologists? Dermatol Ther. 2022;12(4):1065–72. - PMC - PubMed
1. Simpson EL, Bruin-Weller M, Flohr C, et al. When does atopic dermatitis warrant systemic therapy? Recommendations from an expert panel of the International Eczema Council. J Am Acad Dermatol. 2017;77(4):623–33. - PubMed
1. Megna M, Napolitano M, Patruno C, et al. Systemic treatment of adult atopic dermatitis: a review. Dermatol Ther. 2016;7(1):1–23. - PMC - PubMed
1. Hunt AE, Williams LM, Lali FV, Foxwell BMJ. IL-4 regulation of p38 MAPK signalling is dependent on cell type. Cytokine. 2002;18(6):295–303. - PubMed
1. Lee PJ, Zhang X, Shan P, et al. ERK1/2 mitogen-activated protein kinase selectively mediates IL-13–induced lung inflammation and remodeling in vivo. J Clin Invest. 2006;116(1):163–73. - PMC - PubMed

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Practical Recommendations on Laboratory Monitoring in Patients with Atopic Dermatitis on Oral JAK Inhibitors

Affiliations

Practical Recommendations on Laboratory Monitoring in Patients with Atopic Dermatitis on Oral JAK Inhibitors

Authors

Affiliations

Abstract

Conflict of interest statement

References

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Miscellaneous