New publications summer 2018

Between May ans August 2018, five new articles have been published using SCQM data.

Subjects covered this time:

  • Analysis of serological biomarkers in RA
  • Comparative effectiveness of tocilizumab and TNF inhibitors in mono and combo therapy
  • Prediction of real-world effectiveness of new drugs pre-launch
  • Incidence and progression of osteoarthritis in interphalangeal in RA
  • Radiographic progression in early undifferentiated arthritis.

Analysis of serological biomarkers in RA

The goal of this study by Laura Martinez-Prat, Michael Nissen and others was to evaluate the clinical performance of several RF and ACPA immunoassays for the diagnosis of RA, as well as the diagnostic value of a combinatory approach with these markers. For this, biosamples from patients from all SCQM cohorts were analyzed. Samples from axSpA and PsA were used as diseased controls. All three ACPA assays showed good discrimination between RA patients and controls. Overall, the performance of CCP3 was superior to CCP2. The combination of these biomarkers in an interval model represents a potential tool for the diagnosis of RA patients.

Comparative effectiveness of tocilizumab and TNF inhibitors in mono and combo therapy

Kim Lauper, Cem Gabay and colleagues performed this study within the European collaborative TOCERRA register. The objective was to compare the real-world effectiveness of tocilizumab and TNF-inhibitors as monotherapy (mono) or in combination with csDMARDs (combo) in bio-experienced RA patients. Adjusted hazards of discontinuation were significantly lower among patients on tocilizumab compared with patients with TNF inhibitors, either mono or combo. Average adjusted CDAI change and CDAI remission and LDA rates were comparable between groups. With similar effectivenessx to TNF inhibitors combo, TCZ mono or combo seems thus to be reasonable therapeutic options in patients with inadequate response to at least one bDMARD.

Prediction of real-world effectiveness of new drugs pre-launch

This study is part of the getREAL project (http://www.imi-getreal.eu/). From the SCQM side, Axel Finckh supported this project with rheumatological / rheumatology research know-how. The aims of getREAL are to better understand the potential gap between ‘efficacy’ of drugs in clinical trials compared to the ‘effectiveness’ later observed in real-world use of that drug. This particular study aimed to develop a method to predict real-world effectiveness of a new biologic substance based on the efficacy observed for that substance in its clinical trial program. For this, RCT data from two tocilizumab clinical trials and observational data from the British Society for Rheumatology Biologics Registry in RA (BSRBR-RA) and the SCQM were used. The case study concluded that their model performed quite well in predicting the change in DAS28 in real-world data from RCT data after six months.

Incidence and progression of osteoarthritis in interphalangeal in RA

Christoan Lechtenboehmer and Thomas Huegle analyzed SCQM radiographic data is analyzed with the focus on osteoarthritis. Lechtenboehmer scored 1988 RA patients with suitable radiographic information with the modified Kellgren–Lawrence osteoarthritis score and evaluated the radiographic prevalence, incidence and progression of DIP-OA in these patients. 60% of patients had DIP-OA at baseline. Older age, female sex and greater BMI were associated with higher prevalence of DIP-OA at baseline. Disease activity and baseline erosions were not associated with higher levels of DIP-OA progression. The lack of a clear association between RA disease activity, autoantibody status, and MCP erosions at baseline with the prevalence or progression of DIP-OA led the authors to suggest distinct types of inflammation in the pathogenesis of RA and DIP-OA.

Radiographic progression in early undifferentiated arthritis

In this study by Ruediger Mueller, Johannes von Kempis and colleagues, 183 patients with early undifferentiated arthritis (disease duration ≤1 year, no previous disease-modifying anti-rheumatic drugs (DMARDs) and 2010 ACR/EULAR criteria negative) were separated into two groups (radiographic vs non-radiographic arthritis) depending on whether or not they had radiographic changes (≥3 joints
with erosions) at time of diagnosis (= baseline). Radiographic progression was observed mainly in patients who had non-radiographic arthritis at baseline.