The primary endpoint of the trial was defined by the proportion of participants who achieved a 75 percent or greater change from baseline in their eczema area and severity index (EASI-75) at week 16. An EASI score is a standardized way that doctors evaluate atopic dermatitis, dividing the skin into four regions and then rating the intensity of redness, thickness, scratching, and lichenification (meaning lined skin, furrowing, and prurigo nodules). Olumiant is part of a class of drugs known as JAK inhibitors, which belong to a category of drugs called disease-modifying antirheumatic drugs (DMARDs). Currently, Olumiant is approved to treat RA but not atopic dermatitis, the most common type of eczema. Dupixent (dupilumab) is the only JAK inhibitor that’s been approved for treating atopic dermatitis, but there are several other drugs in the pipeline. Those include abrocitinib, and lebrikizumab, an anti-IL-13 antibody medication, which could be available in the future if they have successful trials. “I have an atopic dermatitis and itch specialty clinic here at Johns Hopkins, and so I treat a lot of people with atopic dermatitis, and this is really an exciting time,” says Shawn Kwatra, MD, an assistant professor of dermatology at Johns Hopkins Medicine in Baltimore. “For many years we didn’t have good treatment options for these patients.” RELATED: A Complete Guide to Treating Eczema
More Options May Mean Fewer Side Effects for People With Atopic Dermatitis
Atopic dermatitis is a chronic inflammatory skin disease that causes rashes and areas of itchy skin. Close to 16.5 million adults have atopic dermatitis, with 6.6 million reporting moderate to severe symptoms, according to the Asthma and Allergy Foundation of America. Many people with the condition who didn’t do well or find relief with topical steroids have had to use therapies with significant comorbidities, such as Sterapred (oral prednisone) or intramuscular prednisone, and immunomodulators such as Trexall (methotrexate) or cyclosporin, says Dr. Kwatra. “Patients had to use these therapies that had many side effects and lacked proper trials,” he says. “Medications like dupilumab, baricitinib, and other drugs in various stages of development and approval represent a new era in treating atopic dermatitis,” he adds. Baricitinib also showed efficacy in improving itch, which is a critically important measure, according to Kwatra. “Both the 1 milligram (mg) and 2 mg doses showed a four-point improvement in the itch rating scale,” he says. Baricitinib provided a four-point improvement in close to 16 percent of subjects with the 1 mg dose and in 25 percent with the 2 mg dose. The itch rating scale runs from 0 to 10, with 10 being the worst itch and 0 being no itch, explains Kwatra. “This is a very important measure, because in atopic dermatitis, itch is a driver of patient symptoms, decreased quality of life, and difficult sleeping,” he says. “Having a drop in itch severity of four points is significant.” The proportion of patients with EASI-75, the primary endpoint, and reduction in inflammatory lesions is notable as well, he adds. RELATED: Your Everyday Guide to Living Well With Eczema
More Evidence That Olumiant Is Safe for People With Atopic Dermatitis
The safety findings in the BREEZE-AD5 trial was consistent with what has been reported in other trials of the drug, according to a January 30, 2020, statement released by Eli Lilly. The most common treatment emergent adverse events (TEAE) included upper respiratory tract infections, nasopharyngitis, and diarrhea. A TEAE is an undesirable event that was not present before treatment or an already existing event or condition that worsens following the treatment. Serious blood clots, some of which have resulted in death, have been observed in other Olumiant trials, though none occurred in the BREEZE-AD5 trial. “Side effect profiles will be important to consider when the full trials come out so that we can properly educate patients,” says Kwatra. Integrating all the data along with an understanding of each patient’s preferences and comorbidities will help doctors select the right agent to treat atopic dermatitis, he adds. RELATED: Bacteria Therapy for Eczema Shows Promise for More Effective, Cheaper Treatment
Can My Doctor Prescribe Olumiant for My Atopic Dermatitis Now?
Lilly has already submitted baricitinib for regulatory review in Europe as a treatment for moderate to severe atopic dermatitis and plans to submit for U.S. approval in 2020. While it is technically possible to prescribe Olumiant to patients with atopic dermatitis now, using medicines off-label is very difficult in dermatology, says Kwatra. “Off-label” is a term used when doctors decide to prescribe a U.S. Food and Drug Administration (FDA)–approved drug for an unapproved use, the FDA notes. “JAK inhibitors are being used more off-label in alopecia areata, where there’s no FDA-approved agent, but in general it’s very difficult to get off-label usage,” says Kwatra. This is because most insurance companies will not cover Olumiant for atopic dermatitis before it’s been given FDA approval for the condition, and without insurance coverage, the medication is very expensive, explains Kwatra. “I think that Olumiant will be more widely implemented for atopic dermatitis once FDA approvals are given,” he says. RELATED: A Comprehensive Glossary of Eczema Terms
When It Comes to Treating Atopic Dermatitis, It’s All About the Itch
A big cause of discomfort and decreased quality of life in people with atopic dermatitis is itch. “This agent, along with other agents in the pipeline and dupilumab, which is already approved for atopic dermatitis, have demonstrated abilities to affect itch, which can then result in less inflammation, less difficulty sleeping, less disruption in quality of life, and less depression and psychosocial comorbidities,” says Kwatra. “As someone who treats these patients, I really place a lot of emphasis on the itch-reduction data because it means so much in terms of what patients are experiencing on a day-to-day basis,” says Kwatra. “For that reason, I’m excited about this drug and the other drugs in the pipeline as well,” he says.
