Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial

Abstract

Background

Patients who completed the originating studies, BREEZE-AD1 (NCT03334396), BREEZE-AD2(NCT03334422), and BREEZE-AD7 (NCT03733301), were eligible for enrollment in the multicenter,phase-3, long-term extension study BREEZE-AD3 (NCT03334435).

Methods

At week 52, responders and partial responders to baricitinib 4 mg were re-randomized (1:1) into the sub-study to dose continuation (4 mg, N = 84), or dose down-titration (2 mg, N = 84). Maintenance of response was assessed from week 52 to 104 of BREEZE-AD3. Physician-rated outcomes included vIGA-AD (0,1), EASI75, and mean change from baseline in EASI. Patient-reported outcomes included DLQI, P OEM total score, HADS, and from baseline: WPAI (presenteeism, absenteeism, overall work impairment, daily activity impairment) and change from baseline in SCORAD itch and sleep loss.

Results

With continuous treatment with baricitinib 4 mg, efficacy was maintained up to week 104 in vIGA-AD (0,1), EASI75, EASI mean change from baseline, SCORAD itch, SCORAD sleep loss, DLQI, P OEM, HADS, and WPAI (all scores). Patients down-titrated to 2 mg maintained most of their improvements in each of these measures.

Conclusion

The sub-study of BREEZE AD3 supports flexibility in baricitinib dosing regimens. Patients who continued treatment with baricitinib 4 mg and down-titrated to 2 mg maintained improvements in skin, itch, sleep, and quality of life for up to 104 weeks.

Keywords:

• Atopic dermatitis
• baricitinib
• long-term extension

Acknowledgment

The authors thank the patients, investigators, and study staff who were involved in these studies. The patients in this manuscript have given written informed consent to publication of their casedetails.

The authors would also like to acknowledge Sarah Ryan, of Eli Lilly and Company, who provided editing support.

Disclosure statement

AW: Has received personal fees for lectures or advisory boards, grants, or nonfinancial support from AbbVie, Almirall, Arena, Beiersdorf, Galderma, Leo Pharma, Eli Lilly, L’Oreal, Maruho, MedImmune, Novartis, Pfizer, Pierre Fabre, Regeneron, and Sanofi-Aventis.

SB: Is an investigator or speaker for Almirall, Sanofi-Genzyme, AbbVie, Novartis, Janssen, Leo Pharma, Pfizer, Eli Lilly, UCB Pharma, Chiesi.

HH: Has received: grant funding from Pfizer, Janssen, and Merck Serono; honoraria and/or consultancy fees and/or travel bursaries from La Roche-Posay, Janssen, Abbvie, UCB, Sanofi-Genzyme, Regeneron, Novartis, Almirall, Leo, Eli Lilly DICE Therapeutics and UNION Therapeutics and has acted as an investigator for Janssen, Abbvie, UCB, Sanofi-Genzyme, Novartis, Almirall, Leo, Eli Lilly, DICE Therapeutics, UNION Therapeutics, and Evelo Biosciences Inc.

TW: Has received personal fees from AbbVie, Almirall, Eli Lilly, Galderma, Janssen/JNJ, Leo Pharma, Novartis, Pfizer, Regeneron/Sanofi for lectures or advisory boards.

JPT: An advisor for AbbVie, Almirall, Arena Pharmaceuticals, Coloplast, OM Pharma, Aslan Pharmaceuticals, Union Therapeutics, Eli Lilly & Co, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme, a speaker for AbbVie, Almirall, Eli Lilly & Co, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme, and received research grants from Pfizer, Regeneron, and Sanofi-Genzyme.

AB, LC, LS, EP: Employees and stockholders at Eli Lilly and Company.

NL: is an employee of Precision Statistics Consulting.

Data availability statement

Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the United States and the European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.

Additional information

Funding

Baricitinib is developed by Eli Lilly and Company (Indianapolis, Indiana, USA) under license from Incyte Corporation.