Registries – an important research tool in biologics

Registry data on the use of biologics give important additional information on how the drug is behaving in daily practice.

As Prof. Bruce E. Strober (UConn Health, USA) pointed out, randomised controlled clinical trials (RCT) lasting up to 1 year now exist for all biologics and present the “gold standard” of evidence-based medicine [1]. However, they have several important limitations: they allow no long-term (>1 year) comparative efficacy assessments; milder patients are often excluded as only more severe patients are enrolled; and due to strict inclusion criteria, patients are generally healthier than in daily practice and have fewer comorbidities. No combination therapy is evaluated in these trials, even though combinations are very common in daily practice.

“To get a thorough picture of a drug, registries are required to establish comparative long-term effectiveness,” said Prof. Strober. They allow longer term cross comparisons, often beyond 1 year, and are a valuable tool to assess efficacy and safety in daily practice [1]. Questions that can be uniquely addressed with registries are real-world durability of response, effectiveness and safety in patients with major comorbidities, and the important question of whether treat-to-target is being practiced.

An example of a real-life assessment of systemic treatment and durability of response comes from the BIOBADADERM registry [2]. In this registry, the durability of response was compared between classic systemic therapies and biologics (i.e. TNF inhibitors and ustekinumab) prescribed from 2008-2013 in hospitals in Spain in 1,956 patients with moderate-to-severe psoriasis. Median follow-up time was 3.3 years. In this analysis, biologics showed a higher drug survival than classics. The main reason for discontinuation was lack of efficacy (36.4%) and remission (27.2%).

Despite the large amount of data available on biologics, analyses from registries and RCTs that incorporate analyses of the newer therapies, such as selective IL-23 inhibitors, IL-17 inhibitors, and apremilast, are still lacking. One study published this year that tried to fill this gap is an analysis of the Danish DERMBIO registry, which compared the drug survival of the IL-17 blockers secukinumab and ixekizumab over 12 months [3]. Drug survival of ixekizumab was significantly higher compared with secukinumab. After a year 23.5% vs 0.0% of bio-naïve secukinumab and ixekizumab treated patients with moderate-to-severe psoriasis discontinued therapy. Surprisingly, drug survival was higher for ixekizumab even though secukinumab-treated patients had been treated with significantly fewer biologics before starting this drug.

1. 
   
   1. Strober BE. 24th World Congress of Dermatology, 10-15 June 2019, Milan, Italy.
   2. Dávila-Seijo P, et al. J Eur Acad Dermatol Venereol 2016;30(11):1942-1950.
   3. Egeberg A, et al. J Am Acad Dermatol 2019;81(1):173-178.

Posted on 26 August, 201918 March, 2021