Eric L. Simpson, MD

Research suggests lebrikizumab (LEB) in combination with low-to mid-potency topical corticosteroids (TCS) led to improved outcomes for adults and adolescents with moderate-to-severe atopic dermatitis (AD), compared with those given only TCS.

Lebrikizumab works as a novel monoclonal antibody and inhibits IL-13 signaling to address AD.

However, the study’s authors pointed out that monotherapy may not always be feasible in the clinical space.

An important facet of AD treatment is topical medication, and the study authors felt that a combined look at TCS along with lebrikizumab might improve the level of understanding of combining biologic and TCS therapy for AD patients.

The study was led by Eric L. Simpson, MD, from the Department of Dermatology at Oregon Health & Science University, Portland.

“Here, we present the results of a phase 3 combination therapy study, ADhere…which evaluated the efficacy and safety of lebrikizumab when used in combination with low-to mid-potency TCS treatment vs TCS alone in adolescents and adults with moderate-to-severe AD,” Simpson and colleagues wrote.

Study Background

Over the course of 16 weeks of treatment with lebrikizumab and TCS, the investigators conducted the phase 3, placebo-controlled, randomized clinical trial on a total of 211 study participants with moderate-to-severe AD.

The investigators randomized the participants to either receive subcutaneous LEB and TCS or a placebo in combination with TCS.

They were given 500 mg of LEB therapy beginning at baseline and week 2, later followed by 250 mg of LEB over the course of 16 weeks and at a rate of every 2 weeks.

The research teams’ primary endpoint for efficacy was decided to be the percentage of participants with an Investigator’s Global Assessment (IGA) rating of 0 or 1, and a 2 or more point improvement from baseline after 16 weeks.

The participants’ mean age was approximately 37.2 and almost 49% of participants included in the study were female.

Another endpoint was 75% or more of participants showing an improved Eczema Area and Severity Index rating (EASI-75). EASI and IGA scores were gathered every other week at a study clinic.

Study Findings

The research team found that by 16 weeks, LEB and TCS combined were associated with better outcomes than TCS and the placebo.

Specifically, they reported that 41.2% of participants (145) achieved IGA (0,1) in the LEB+TCS arm compared to about 22%) being treated with the placebop and TCS (P = .01).

The first group of AD patients had an EASI-75 percentage of 69.5% compared to the placebo and TCS group with a 42.2% percentage (P < .001).

The investigators noted that overall, the LEB and TCS combination group’s data indicated statistically significant improvements were reported for all of the major secondary endpoints in the study.

They also noted that AEs related to treatment were found to be moderate and not serious for patients.

“Lebrikizumab,a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate-to-severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies,” they wrote.

The study, “Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis,” was published online in JAMA Dermatology.