DENVER — Abrocitinib demonstrated positive efficacy and safety for treatment of moderate-to-severe chronic hand eczema (CHE) in a phase 2, randomized, multicenter trial that compared two treatment doses to placebo. Daily treatment with the oral JAK1 inhibitor was associated with significant improvements in physician ratings and patient reports of pain and pruritus at 16 weeks.

Abrocitinib (Cibinqo) was associated with a “highly statistically significant” change in modified Total Lesion Symptom Score (mTLSS) from baseline and compared with placebo, the primary study outcome. Active treatment reduced this score by 81% among those treated with 200 mg and by 78% among those treated with 100 mg compared with 46% among those treated with placebo (P < .001), reported Robert Bissonnette, MSc, MD, dermatologist and chairman of Indero, a contract research organization specializing in dermatology clinical trials.

“I think the most interesting outcome of the trial is that we observed efficacy in non-atopic CHE,” Bissonnette said during a late-breaking research session at American Academy of Dermatology (AAD) 2026 Annual Meeting. Among 44 patients with non-atopic CHE, treatment was associated with a 75%-84% reduction in mTLSS scores compared with 39% for placebo. This difference was statistically significant at all time points starting at week 4. In contrast, for the 37 participants with atopic CHE, abrocitinib treatment lowered mTLSS scores by 76%-80%, but the finding was not statistically significant compared with a decrease of 52% in the placebo group.

In terms of onset of action, “it was fast,” Bissonnette said. Reductions in mTLSS from baseline and pruritus, for example, were statistically significant starting at week 2 for the highest dose.

Abrocitinib in Context

The FDA approved abrocitinib in 2022 for the treatment of refractory, moderate-to-severe atopic dermatitis. The agency also approved the topical JAK inhibitor delgocitinib (Anzupgo) for chronic hand eczema in July 2025.

Evidence suggests the oral JAK inhibitor upadacitinib (Rinvoq) also could be efficacious for treating hand eczema. In the UP-TAINED study, for example, at 12 months, 77% of patients with moderate-to-severe hand eczema achieved clear or almost clear skin.

Chronic hand eczema is defined as eczema lasting at least 3 monthsor recurring at least twice in 1 year. An international study with more than 60,000 respondents revealed a 1-year prevalence of 4.7% of self-reported, physician-diagnosed CHE.

Methodology

In the phase 2b study of abrocitinib, the objective was to study efficacy and safety in patients with moderate-to-severe CHE of diverse etiology. Adults with a physician global assessment (PGA) of either moderate or severe CHE at baseline were randomized 1:1:1 to abrocitinib 200 mg a day, abrocitinib 100 mg a day, or placebo for 16 weeks. “This is not a big study with 27 patients per group,” Bissonnette pointed out.

Secondary endpoints included a PGA of 0 or 1 with a two-grade reduction from baseline, change from baseline in Hand Eczema Severity Index (HECSI) score, and patient ratings of pain and pruritus. In this study, investigators had to select the most affected palm to assess with the mTLSS.

Baseline demographics were similar among groups, with the exception of a higher proportion of patients with severe PGA in the placebo group compared with the abrocitinib groups.

Key Secondary Findings

A PGA 0/1 with a 2-grade decrease was observed in 56% of participants receiving abrocitinib 200 mg (P = .006) and 44% of those receiving 100 mg dose (P = .052) vs 18% of those receiving placebo. This difference was statistically significant, Bissonnette said.

In addition, there was a reduction of 87% in the HECSI score in the 200 mg group, which Bissonnette described as “really high.” He also reported an 83% decrease in the HECSI score for the 100 mg group and 39% for the placebo group. The differences between active treatment and placebo were statistically significant at all time points for both doses, he added.

Symptoms “are key for patients with chronic hand eczema, specifically pain and pruritus,” Bissonnette said. The change from baseline in pain was an 80% decrease with 200 mg and a 90% decrease with 100 mg abrocitinib vs 7% with placebo.

In addition, pruritus decreased by 66%-77% with treatment vs 9% with placebo. “Again, this was a highly statistically significant finding,” he added.

A meeting attendee asked if patients were allowed to moisturize their hands during the study, and if that could partially explain the “quite high placebo effect.” Bissonnette replied, “What we decided to do in this trial was to ask patients not to change anything related to their use of moisturizers. People…using moisturizers once a day or 10 times a day had to continue at the same pace, and people were not using any moisturizers could not start a moisturizer.”

Bissonnette acknowledged that the placebo response “was likely higher than what has been reported in other trials” regarding changes in mTLSS scores. “But when you look at all of our other endpoints, the change from baseline HECSI, the PGA, the change in pain or pruritus, it’s either similar to other trials or lower.”

“My take on this is that it’s an issue of the endpoint,” he added. “Some of our sites were experienced doing mTLSS and others were not. Is there a learning curve? I’m not sure.”

One Serious Adverse Event Reported

In terms of safety, “with the sample size like this, the conclusions that we can draw on safety are fairly limited,” Bissonnette said. He noted, however, that abrocitinib has been on the market for atopic dermatitis for years.

One serious adverse event was a case of breast cancer in the abrocitinib 200 mg group. “If we look at the other adverse events, in my opinion, there’s no major change or major difference,” Bissonnette said. He said the safety profile of abrocitinib is in line with the overall safety profile for this agent.

Study discontinuation occurred in 10% and 11% of the abrocitinib groups and 22% in the placebo group.

The trial is ongoing. Part B of the study will assess treatment response vs placebo from week 16 to week 32.

A ‘Well Done Study’

“This is a well-done study looking at abrocitinib in CHE,” said JiaDe “Jeff” Yu, MD, a dermatologist at Massachusetts General Hospital in Boston, who was not affiliated with the research and was asked to comment on the findings. “This echoes the other oral JAK inhibitor data available on Rinvoq and CHE, which is also quite impressive.”

“I think this adds another potential tool in the toolbox to treat CHE for our patients,” Yu added in an interview.

This study was funded by Pfizer. Bissonnette reported being a consultant and investigator for AbbVie, Amgen, BMS, Janssen Scientific Affairs, Merck, Organon, Pfizer Inc., Sanofi Genzyme, and UCB. He reported being a consultant only for Almirall, Apogee Therapeutics, GSK, Organon, Sitryx, T-Rex BioPharma, Takeda Pharmaceuticals USA, and TARGET Pharma. He reported serving on the advisory board and being an investigator for Eli Lilly and Company, Leo Pharma Inc. He reported being an investigator for Aclaris Therapeutics, Alumis, Opsidio, Sun Pharmaceutical Industries, Takeda Development Center Americas, TARGET Pharma, and Zai Lab. He also reported receiving grants/research funding from Aclaris Therapeutics, Aldena Therapeutics, Almirall, Apogee Therapeutics, Arcutis., Arena Pharmaceuticals, Areteia Therapeutics, Artax Biopharma, Attovia Therapeutics, BioMimetix JV LLC, Bluefin Biomedicine, Brickell Biotech., Cara Therapeutics, GSK, Horizon Therapeutics Ireland DAC, Incyte Corporation, Inmagene Biopharmaceuticals, Nektar Therapeutics, Organon, Pelage Pharmaceuticals, Q32 Bio Inc., Sanofi, Triveni Bio, VYNE Therapeutics, Xencor, and Zura Bio. He reported being an Indero stockholder. Yu had no relevant disclosures.

Damian McNamara is a freelance contributor to Medscape Medical News. He worked full-time for Medscape and WebMD from 2018 to 2024. Damian has a BA in chemistry and an MA in science, health, and environmental reporting/journalism.