Abstract
Background: Baricitinib, a selective Janus kinase (JAK)1/JAK2 inhibitor, is approved for treatment of moderate-to-severe atopic dermatitis (AD) in adults. Objectives: We report integrated baricitinib safety data in patients with up to 3.9-years exposure. Methods: Three datasets from the integrated AD clinical trial program were analyzed: placebo-controlled, 2-mg–4-mg extended, and All-bari. Data cutoffs were up to 21-December-2021 for long-term extension studies. Proportions of patients with events and incidence rates (IR)/100 patient years (PY) at risk were calculated. Results: 2636 patients received baricitinib for 4628.4 PY. Discontinuation due to adverse events was low (IR = 3.4). IRs in All-bari were: serious adverse events, 5.2; infection, 67.2 (any infection), 6.7 (herpes simplex), 2.8 (herpes zoster), and 0.3 (opportunistic infections). Adverse events of special interest in All-bari included seven patients with positively adjudicated major adverse cardiovascular events (MACE) (IR = 0.15), three pulmonary emboli (PE) (IR = 0.06), 14 malignancies excluding nonmelanoma skin cancer (IR = 0.3), one gastrointestinal perforation (IR = 0.02), and four deaths (IR = 0.1). No deep vein thromboses (DVT) or tuberculosis were reported. Conclusion: In this analysis, baricitinib maintained a similar safety profile to earlier analyses with no new safety signals. Rates of MACE, DVT/PE, malignancies, and serious infections were within ranges of background rates in patients with AD. Clinicaltrials.gov: NCT02576938 (JAHG), NCT03334396 (JAHL; BREEZE-AD1), NCT03334422 (JAHM; BREEZE-AD2), NCT03334435 (JAHN; BREEZE-AD3), NCT03428100 (JAIN; BREEZE-AD4), NCT03435081 (JAIW; BREEZE-AD5), NCT03559270 (JAIX; BREEZE-AD6), NCT03733301 (JAIY; BREEZE-AD7).
| Original language | English |
|---|---|
| Article number | 2161812 |
| Journal | Journal of Dermatological Treatment |
| Volume | 34 |
| Issue number | 1 |
| ISSN | 0954-6634 |
| DOIs | |
| Publication status | Published - 2023 |
Funding
Jacob P Thyssen is an advisor for AbbVie, Almirall, Arena Pharmaceuticals, ASLAN Pharmaceuticals, Coloplast, Eli Lilly and Company, LEO Pharma, OM Pharma, Union Therapeutics, Pfizer, Regeneron, and Sanofi-Genzyme, a speaker for AbbVie, Almirall, Eli Lilly and Company, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme, and received research grants from Pfizer, Regeneron, and Sanofi-Genzyme. The authors thank the investigators and patients who have participated in the baricitinib atopic dermatitis clinical trial program. The authors also like to acknowledge Kathy Oneacre, MA (Syneos Health, Morrisville, NC, USA) who provided medical writing support and Antonia Baldo (Syneos Health, Morrisville, NC, USA) who provided editing support that was funded by Eli Lilly and Company. This study was designed jointly by consultant experts and representatives of the funder, Eli Lilly and Company. Data were collected by investigators and analyzed by the funder. Safety data were reviewed at regular intervals by an independent data monitoring committee. All authors participated in the data analysis or interpretation, drafting, and critical review of the manuscript, and provided final approval for the publication of the manuscript. The authors had full access to the data and verified the veracity, accuracy, and completeness of the data and analyses as well as the fidelity of this report to the protocol. All authors made the decision to submit the manuscript for publication. Baricitinib is developed by Eli Lilly and Company, under license from Incyte Corporation. The authors thank the investigators and patients who have participated in the baricitinib atopic dermatitis clinical trial program. The authors also like to acknowledge Kathy Oneacre, MA (Syneos Health, Morrisville, NC, USA) who provided medical writing support and Antonia Baldo (Syneos Health, Morrisville, NC, USA) who provided editing support that was funded by Eli Lilly and Company.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
- Centers: Center for Research on Inflammation of the Skin (CRIS)
DFG Research Classification Scheme
- 2.22-19 Dermatology
