gms | German Medical Science

Background: To assess demographics and baseline characteristics of patients with RA (rheumatoid arthritis), AS (ankylosing spondylitis), or PsA (psoriatic arthritis), receiving SDZ ETN (GP2015) under real-world conditions.

Methods: COMPACT is an ongoing, observational study in patients aged ≥ 18 years with RA/AS/PsA for whom treatment with SDZ ETN was initiated. Patients are categorised based on prior treatment status: (i) switched from reference etanercept (ref ETN; ie., stable, in remission or low disease activity); (ii) switched from other anti-TNFs (uncontrolled, progressive, high disease activity); (iii) biologic-naïve (failed treatment with csDMARD–MTX); (iv) DMARD-naïve (recently diagnosed with severe, active disease).

Results: 244 patients were recruited until the interim analysis cut-off date of 12 October, 2018 (Germany [n=182], UK [n=58], and Poland [n=4]). Of these, 45.5% patients were switched from ref ETN; 6.1% were switched from other anti-TNFs; 41% were biologic-naïve; and 7.4% were DMARD-naïve. Most patients had RA (n=142), followed by AS (n=54) and PsA (n=48). Comorbidities were more frequent in the RA group (82.4%) than PsA (72.9%) or AS (61.1%) groups and the use of non-rheumatic comedication was high (Table 1 [Tab. 1]). Systemic corticosteroids use was highest in patients with RA (43.7%). By pre-treatment status, it was lowest in patients with a stable response to ref ETN (15.3%) (Table 1 [Tab. 1]).

Conclusion: The baseline characteristics of patients enrolled in this real-world study match with the expected demographic profiles for the three rheumatic diseases and four defined groups. Corticosteroid use is low in stable disease control with reference ETN. The study captures a real-world cohort of patients which is characterised by frequent co-morbidities, particularly in RA patients, and frequent use of non-rheumatic comedications. First effectiveness and safety data are expected by end of 2019.