Patients with moderate-to-severe atopic dermatitis experienced improvements in both clinical and patient-reported outcomes after treatment with baricitinib plus topical corticosteroids when compared with topical corticosteroids alone, according to phase 2 study data presented at the European Academy of Dermatology and Venereology Annual Congress in Geneva.
The analysis included 38 patients treated with 4-mg baricitinib (Olumiant, Eli Lilly) plus topical corticosteroids (TCS), 37 patients treated with 2-mg baricitinib plus TCS, and 49 patients treated with TCS alone. Patients received 16 weeks of treatment and were assessed for disease severity using the Eczema Area and Severity Index (EASI-50) score.
A 50% or greater reduction in overall disease severity occurred in 61% of patients in the 4-mg baricitinib group and 37% of those in the TCS group (P < .05), according to the findings. Other results showed that 57% of participants in the 2-mg baricitinib dose arm reached the EASI-50 goal, which was a nonsignificant improvement compared with the TCS arm (P = .065).
At 4 weeks, 68% of patients in the 4-mg group and 62% of patients in the 2-mg group reached the EASI-50 mark compared with 16% of those treated with TCS alone (P < .001).
Treatment-emergent adverse event rates were 71% among patients treated with 4-mg baricitinib, 46% among those treated with 2-mg of the study drug, and 49% for those treated with TCS alone. The most common treatment-emergent adverse events for the 4-mg baricitinib group were upper respiratory tract infections, nasopharyngitis, headaches and increases in lab parameters such as creatine phosphokinase.
“Importantly, in this study, patients had to fail four weeks of supervised therapy with a mid-potency topical corticosteroid before randomization, selecting for a difficult to treat patient population,” lead investigator Emma Guttman-Yassky, MD, PhD, Sol and Clara Kest professor of dermatology, Icahn School of Medicine, Mount Sinai Medical Center, New York, said in a press release. “These new results suggest that baricitinib may have the potential to become an oral treatment option for patients suffering from atopic dermatitis who are unable to achieve adequate control with TCS.”
Baricitinib is a once-daily oral janus kinase (JAK) inhibitor. It received approval for the treatment of rheumatoid arthritis in the European Union in February 2017. In April 2017, FDA issued a complete response letter for the new drug application. The agency requested additional data to determine appropriate doses and characterize safety concerns across treatment arms. It is currently being tested in autoimmune and inflammatory diseases. – by Rob Volansky
Editor's Note: This story was updated on Sept. 14, 2017, to provide additional information on the FDA status of this drug in the U.S.
Guttman-Yassky E, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple dose study. Presented at: European Academy of Dermatology and Venereology Annual Congress; Sept. 13-17, 2017; Geneva.
Disclosures: Guttman-Yassky reports serving on the scientific advisory board for Anacor Pharmaceuticals Inc., Glenmark Generics Inc., MedImmune LLC, Pfizer and Sanofi-Aventis; occasionally giving industry-supported lectures for Dermira, MedImmune LLC and Stiefel Laboratories Inc.; serving on the board of directors for Stiefel Laboratories Inc.; and having a relationship with LEO Pharma A/S, Merck & Co. Inc. and Regeneron Pharmaceuticals.