New Phase 3 Data Suggest Twice-Daily Tofacitinib Etocomil Effective for Atopic Dermatitis

Biopharmaceutical company Minghui Pharmaceutical announced that topline results from its new phase 3 study on tofacitinib etocomil (MH004) ointment 1.0% suggest that the drug may be effective for patients aged 12 years and older with mild-to-moderate atopic dermatitis.¹

Prior research has suggested that 2.6% of the global population is impacted by atopic dermatitis, with a total of 204 million people. Among these patients, it has been suggested that 101 million are adults and 103 million are children.²

“Atopic dermatitis is a chronic inflammatory condition, particularly prevalent in children, underscoring the urgent need for effective, fast-acting topical therapies beyond corticosteroids.” Jianzhong Zhang, MD, lead investigator and professor of Peking University People’s Hospital, said in a statement. “While corticosteroids are reasonably effective, their long-term use is often limited due to local side effects and safety concerns.”¹

Tofacitinib etocomil ointment is a topical therapy for those with the inflammatory condition containing a Janus Kinase (JAK) inhibitor designed and formulated with Minghui’s proprietary technologies. The ointment is expected to have improved skin permeability to achieve extensive target inhibition in local skin tissues without systemic toxicities that have been reported for oral JAK inhibitors.

The twice-per-day pan-JAK inhibitor was assessed by Zhang and colleagues during the aforementioned randomized, double-blind, vehicle-controlled phase 3 trial. Multiple centers were used to evaluate the safety profile and efficacy of tofacitinib etocomil 1.0%, with 377 participants being enrolled and randomized in a 2:1 ratio to either the active ointment or a vehicle placebo.

The administration of the drug occurred twice each day for a total of 8 weeks. After the conclusion of this initial treatment period, the study’s subjects began a 44-week open-label extension phase for the purposes of assessing the medication’s long-term safety results.

In terms of primary objectives, the research team’s aims included identifying the proportion of subjects achieving an Investigator Global Assessment (IGA) score of “clear” or “almost clear,” a 75% improvement in the Eczema Area and Severity Index (EASI-75) and at least a two-grade IGA improvement by the 4-week mark (IGA-TS) by this same time point.

The investigators reported that at the 4-week mark, 58.2% of the participants treated with the ointment successfully reached EASI-75, as opposed to the 19.8% who were in the vehicle arm (P < .0001). In terms of the team’s secondary endpoints, which included as IGA-TS and EASI-75 at the 8-week mark and a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS4), statistically significant results were also reported favoring tofacitinib over placebo.¹

The investigators highlighted that the ointment was well-tolerated and that its safety profile aligned with the data resulting from earlier phase 2 research. In terms of treatment-related adverse events, such events were noted by the research team as mild to moderate.

They concluded that there were no severe drug-related adverse events during the analysis that were reported. These findings were noted by the Mingui announcement as underscoring the potential of tofacitinib etocomil 1.0% as a safe and efficacious option for individuals who have mild-to-moderate atopic dermatitis.¹

“[Tofacitinib etocomil] demonstrated superior clinical efficacy in this pivotal phase Ⅲ study, achieving the co-primary endpoints of IGA-TS and EASI-75,” Zhang said in his statement. “The treatment also exhibited a favorable safety profile, and as the leading PI of this study, I am highly encouraged by these results and optimistic about [tofacitinib etocomil’s] potential to advance [atopic dermatitis] care.”¹

References

1. ^{Minghui Pharmaceutical Announces Positive Topline Results from Phase Ⅲ Trial of MH004 (Tofacitinib Etocomil) Ointment in Mild to Moderate Atopic Dermatitis. December 2, 2024. https://www.biospace.com/press-releases/minghui-pharmaceutical-announces-positive-topline-results-from-phase-%E2%85%B2-trial-of-mh004-tofacitinib-etocomil-ointment-in-mild-to-moderate-atopic-dermatitis. Date accessed: December 2, 2024.}
2. ^{A study about how many people around the world have atopic dermatitis, British Journal of Dermatology, Volume 190, Issue 1, January 2024, Page e6, https://doi.org/10.1093/bjd/ljad462.}