‘Don’t give up’: Long-term lebrikizumab for AD may benefit initial nonresponders

Key takeaways:

• Of the 147 lebrikizumab-treated patients that did not achieve protocol-defined responses by week 16, 36.1% achieved IGA 0 or 1 by week 52.
• 75.5% and 44.2% also achieved EASI 75 and EASI 90.

Long-term treatment with lebrikizumab may be beneficial for patients with atopic dermatitis that were not initially responders to the treatment, according to a study.

Patients with atopic dermatitis that do not respond to topical interventions may be moved to a biologic regimen. Lebrikizumab, a monoclonal antibody that inhibits interleukin-13, is one such biologic that has shown long-term efficacy in this population group as demonstrated in the phase 3 clinical trial program ADvocate.

One aspect of the ADvocate trials showed that patients who achieved the protocol-defined response criteria by week 16 maintained a durable response through the rest of the 52-week program. The current study at hand, led by Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology and director of the Center of Excellence in Eczema and the Laboratory of Inflammatory Skin Diseases at the Icahn School of Medicine at Mount Sinai, reported the results of patients in the ADvocate trial who did not achieve initial response in the first 16 weeks, but continued lebrikizumab therapy once every 2 weeks for another 36 weeks.

The study ended up finding that patients without an initial response can still benefit from continuation of long-term lebrikizumab therapy.

“This study actually showed the importance for nonresponders to just keep going,” Guttman-Yassky, who is also a member of Healio Dermatology’s Peer Perspective Board, told Healio. “Each patient with atopic dermatitis is different and some need continuous treatment until they become responders.”

Of the 147 lebrikizumab-treated patients that did not achieve protocol-defined responses by week 16, 36.1% achieved IGA 0 or 1 with a 2-point or more improvement by week 52. Additionally, 75.5% achieved EASI 75 and 44.2% reached EASI 90 in the same period. A 4-point or higher improvement on the Pruritus Numeric Rating Scale was also achieved by 66.4% of these patients.

According to the study, the proportion of patients using rescue medication in this population was higher compared with per protocol lebrikizumab responders at week 16, but was still relatively low at under 30%, suggesting that the use of rescue medication was not the primary driver of efficacy response in initial nonresponders. Nevertheless, a topical medication is certainly recommended if the patient needs relief.

“If you have reason to believe that the patient is trending in the right direction, but he is not there yet, just use some topicals to get them better in the meantime and tell them that at some point they will be able to stop the topicals if they continue treatment,” Guttman-Yassky said. “Just remember to set a goal of a certain time that you and your patient will reconvene to decide if this drug is right.”

In the study, 58.1% of the lebrikizumab patients that did not meet the initial response criteria by week 16 but went on to achieve IGA 0 or 1 by week 52 did see at least see a 50% improvement in EASI by week 16.

As a result, Guttman-Yassky recommends that patients remain on lebrikizumab at least 6 months before judging whether the medication is working.

“There are some drugs that are not right for patients and may need to be switched,” she said. “If the patient really doesn’t see anything or sees very, very little at week 16, then I would suggest looking elsewhere. But if they are not quite 75% improved but are 50% improved, then don’t give up.”