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4CPS-079 Indirect comparison of il-13 inhibitors plus topical corticosteroids in moderate to severe atopic dermatitis
  1. FJ Salmerón-Navas,
  2. M Dominguez-Cantero,
  3. MA Blanco-Castaño,
  4. J Diaz-Navarro
  1. Hospital Universitario Puerto Real, Hospital Pharmacy, Puerto Real Cádiz, Spain


Background and Importance Lebrikizumab, tralokinumab and dupilumab are anti-interleukin-13 monoclonal antibody used as therapy in patients with moderate to severe atopic dermatitis (msAD). There are no direct comparisons among them.

Aim and Objectives To establish whether lebrikizumab plus topical corticosteroids (L-TC), tralokinumab plus topical corticosteroids (T-TC) and dupilumab plus topical corticosteroids (D-TC) can be declared equivalent therapeutic alternatives (ETA) in patients with msAD through an adjusted indirect treatment comparison (ITC) using a common comparator.

Material and Methods A bibliographic search was conducted to identify phase III clinical trial (CTs) with L-TC or T-TC or D-TC with similar populations, duration and endpoints. Inclusion criteria were: phase III, randomised, double-blinded, placebo controlled and in patients with msAD. The 90% improvement in Eczema Area and Severity Index (EASI90) at week 16 was used as the main variable. An ITC of L-TC versus T-TC and L-TC vs D-TC was performed using the Bucher method, using the Indirect Treatment Comparisons calculator from the Canadian Agency for Health Technology. Delta value (Δ, maximum difference as a clinical criterion of equivalence) was calculated using half of the ARR in EASI90 obtained in the pivotal CT of dupilumab (pooled ARR=29%; Δ =15%). The results were analysed graphically and the relative position of the 95% CI and the equivalence margin were observed. Positioning was established following the ETA Guide.

Results Included three CTs in the ITC between L-TC (Adhere), T-TC (ECZTRA 3) and D-TC (Liberty ad Chronos). The difference in EASI90 expressed as ARR (IC95%) of L-TC versus T-TC, and L-TC versus D-TC, was: 6.6 (-9–22.2) y -11 (-27– 5). Applying the ETA Guide, L-TC, T-TC and D-TC could be considered ETA, being the probability of clinically relevant difference <50% (most of the 95% CI is in the equivalence range), and the failure does not involve serious/irreversible damage.

Conclusion and Relevance The ITC showed no statistically significant and clinically relevant differences in EASI90 between anti-interleukin-13 plus topical corticosteroids. These drugs could be considered ETA in most patients with msDA.

Conflict of Interest No conflict of interest.

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