Open-Label Phase 2 Pilot Study of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE)

April 2023 | Volume 22 | Issue 4 | 425 | Copyright © April 2023


Published online March 14, 2023

Sarah Alsukait MBBS, Christine Learned BA, David Rosmarin MD

Tufts Medical Center Department of Dermatology, Boston, MA

DISCLOSURES

David Rosmarin has received honoraria as a consultant for AbbVie, Abcuro, AltruBio, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Incyte, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB, VielaBio; has received research support from AbbVie, Amgen, Bristol Meyers Squibb, Celgene, Dermira, Galderma, Incyte, Janssen, Lilly, Merck, Novartis, Pfizer, and Regeneron Pharmaceuticals Inc; and has served as a paid speaker for AbbVie, Amgen, Celgene, Janssen, Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi. 

Pfizer Inc. is the maker of the drug tofacitinib and has provided funding to conduct this study. Pfizer Inc. also contributed to the study design. 

IRB approval: reviewed and approved Tufts Institutional Review Board; approval # 12376

Clinicaltrials.gov listing: NCT03159936

Funding: The sponsor of the study is Tufts Medical Center. Pfizer Inc. is the maker of the drug tofacitinib and has provided funding to conduct this study. 

REFERENCES

  1. Wenzel J. Cutaneous lupus erythematosus: new insights into pathogenesis and therapeutic strategies. Nat Rev Rheumatol. 2019 Sep;15(9):519-532.
  2. Chakka S, Krain RL, Concha JSS, Chong BF, Merola JF, Werth VP. The CLASI, a validated tool for the evaluation of skin disease in lupus erythematosus: a narrative review. Ann Transl Med. 2021;9(5):431.
  3. Klein R, Moghadam-Kia S, Taylor L, Coley C, Okawa J, LoMonico J, Chren MM, Werth VP. Quality of life in cutaneous lupus erythematosus. J Am Acad Dermatol. 2011;64(5):849-58.
  4. Bruce IN, Gomez E, Carmack T, et al. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018;392(10143):222-231.
  5. Lilly. Updates on OLUMIANT® (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis. Available at: https://investor.lilly.com/newsreleases/ news-release-details/updates-olumiantr-baricitinib-phase-3-lupusprogram- and-fda. Accessed June 05, 2022.
  6. You H, Zhang G, Wang Q, Zhang S, Zhao J, Tian X, Li H, Li M, Zeng X. Successful treatment of arthritis and rash with tofacitinib in systemic lupus erythematosus: the experience from a single center. Ann Rheum Dis. 2019;78(10):1441-1443.
  7. Bonnardeaux E, Dutz JP. Oral tofacitinib citrate for recalcitrant cutaneous lupus. JAAD Case Rep. 2021 Oct 2;20:61-64.

AUTHOR CORRESPONDENCE

David Rosmarin MD dermrese@iu.edu
Close Menu