The aim of the EuroSpA Research Collaboration Network

The aim of the EuroSpA Research Collaboration Network (RCN) is to jointly address research questions in SpA including, but not limited to, real world effectiveness and safety profiles of biologic therapies. This is done by retrospectively and prospectively collecting real life patient data from European registers.

The collaboration promotes opportunities to identify unmet needs in the treatment of SpA patients by utilizing high-quality data from existing patient registries.

Our aims are in line with the EMA initiative for patient registries and are consistent with discussions at the EMA workshop “How to make better use of patient registries to collect high-quality data on medicines” held in London on October 28th, 2016 in London.

EuroSpA RCN Scope

Currently the collaboration consists of 16 registries (see map).

There is a recognized openness to include other interested registries and to other parties such as health authorities (EMA and local regulatory bodies) and patient organizations, although the extent of their involvement will need to be further defined.

Acknowledgments

Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration.

Registries that contribute data to the collaboration

ARC (Netherlands)

ARTIS (Sweden)

ASRI (Ireland)

ATTRA (Czech Republic)

BIOBADASER (Spain)

Biorx.si (Slovenia)

BSRBR-AS (United Kingdom)

DANBIO (Denmark)

ESTONIA (ERS Biologic Therapy Register)

GISEA (Italy)

ICEBIO (Iceland)

NOR-DMARD (Norway)

Reuma.pt (Portugal)

ROBFIN (Finland)

Romanian registry of Rheumatic Diseases

SCQM (Switzerland)

TURKBIO (Turkey)

Research Questions

Disease-level research objectives

Characterization of TNF-i exposure among patients with SpA (PsA, non-radiographic axial SpA, and AS) patients (switching rates, time to switch, reasons for switching, characterization of non-responders)

Exploration of changes in patient reported outcomes (PROs) among patients with SpA over time and by treatment (conventional DMARDs, TNF-i, etc.)

Long-term studies on incidence of relevant safety outcomes for conventional DMARDs, TNF-i and other biologics in patients with SpA, to allow the detection of rare side effects or potentially beneficial effects.

Exploration of predictors of treatment response to evaluate the possibility of individualized therapy for patients with SpA.

Remission and drug retention rates of secukinumab in patients with SpA treated in routine care