The following is a summary of “Predicting success with reduced dosing frequency of tralokinumab in patients with moderate-to-severe atopic dermatitis,” published in the December 2024 issue of Dermatology by Weidinger et al.
Tralokinumab maintenance dosing regimens for moderate-to-severe atopic dermatitis (AD) include 300 mg administered every 2 weeks (Q2W) or every 4 weeks (Q4W), which clinicians might consider for individuals who achieve clear or almost clear skin by Week 16 with initial Q2W dosing.
Researchers conducted a retrospective study to identify predictive factors for maintained response after switching to tralokinumab Q4W, evaluate response recapture after relapse on Q4W, and assess treatment-emergent immunogenicity with tralokinumab Q4W.
They used machine learning to identify predictive factors for maintained treatment response at Week 52, utilizing data from the Week 16 responder population (i.e., patients who fulfilled Investigator’s Global Assessment of clear/almost clear skin [IGA 0/1] and/or ≥75% improvement in Eczema Area and Severity Index [EASI-75] at Week 16 with tralokinumab Q2W monotherapy) from the phase 3 ECZTRA 1 and 2 trials. The top-ranked factors were evaluated individually and together to identify those associated with similar maintained efficacy at Week 52 in patients re-randomized to tralokinumab Q2W or Q4W monotherapy at Week 16. Additionally, the probability of achieving IGA 0/1 and/or EASI-75 response after relapse was assessed in individuals receiving tralokinumab Q4W who were transferred to the open-label arm.
The results showed the 2 top-ranked predictive factors for maintained response at Week 52 were the IGA score at Week 16 (76.1%) and the worst daily pruritus numeric rating scale (NRS) <3 at Week 16 (56.5%). Among patients with stable IGA 0/1 and worst daily pruritus NRS <3 from Weeks 12-16 on tralokinumab Q2W, similar high-maintained IGA 0/1 responses at Week 52 were observed regardless of the dosing regimen after Week 16 (Q2W: 72.0%; Q4W: 72.2%), of patients who relapsed on Q4W, 94.6% recaptured treatment response after switching back to Q2W dosing. The immunogenicity of tralokinumab was low, and patients with positive antidrug antibodies did not experience loss of efficacy or increased adverse events.
Investigators concluded a Q4W of tralokinumab might be effective for most patients who achieved stable disease control on a Q2W, as evidenced by clear or almost clear skin and no-to-mild itch for at least 4 consecutive weeks.
Source: academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljae439/7917393
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