Background/Purpose: Clinical trials showed that Etanercept (ETN) is highly effective in reducing clinical disease activity and often leading to remission and radiographic non-progression in patients with Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA). However, the course of radiographic progression in everyday clinical practice is not known. This German non-interventional study (NIS) assessed radiographic progression in patients with RA or PsA managed in routine outpatient care in private practices with a time interval up to 36 months.

Methods: Throughout the study up to 10 visits (V) were performed (V1 at baseline, V2-7 every 3 months until month 18 – phase 1, V8-10 every 6 months until month 36 – phase 2). Radiographs of hands and feet were taken at baseline (±3 months start of ETN treatment), at month 12 to 18 and/or at months 30-36. All radiographs were scored by 2 blinded readers by the ‘van der Heijde modified Total Sharp Score’ (mTSS^RA) for RA patients and the ‘van der Heijde modified Total Sharp Score adapted’ (mTSS^PsA) for PsA patients. Additional parameters such as Disease Activity Score (DAS28) and (serious) adverse events were documented.

Results: 1,821 patients were available for the final analysis, 75.7% (N=1,378) were diagnosed as RA and 24.2% (N=440) as PsA patients. The median disease duration at baseline was 4.9 years (range: 0;54 RA) and 8.9 years (0;38 PsA). In RA patients the mean mTSS^RA increased from 25.1±42.4 (n=504) at baseline to 26.2±43.6 (n=284) at the end of phase 1 (12-18 months) and to 29.8±48.6 (n=74) at the end of phase 2 (30-36 months). In PsA patients the mean mTSS^PsA was 14.7±25.7 (n=166) at baseline, 14.6±23.5 (n=80) at the end of phase 1 and 12.6±23.2 (n=35) at the end of phase 2. Median changes compared to baseline at the end of phase 1 and phase 2 were 0.0, suggesting no radiographic progression on the group level. Calculating normalized progression with yearly intervals about two thirds of the patients showed no radiographic progression after 24 months, i.e. radiographic non-progression defined as a change of mTSS^RA/PsA≤0.5 was observed in 64.2% of RA- and 68.9% of PsA patients after 24 months. The DAS28 decreased from a mean baseline value of 4.6±1.2 (n=1,014) in RA and 4.2±1.1 (n=327) in PsA patients, respectively, to 2.6±1.2 (RA, n=190) and 2.5±1.1 (PsA, n=88) at month 36 indicating an important decrease of disease activity under ETN treatment. Moreover, at month 36, 61.6% of RA and 64.8% of PsA patients were considered to be in remission (DAS< 2.6). A total of 1,993 Treatment Emergent Adverse Events (TEAE) occurred in 849 (46.6%) patients. Most of the AEs were of ‘mild’ (768 events in 377 patients, 20.7%) or ‘moderate’ (825 events in 481 patients, 26.4%) severity. 446 patients (24.5%) experienced a total of 753 AEs which were assessed as ‘treatment related’ to Etanercept (i.e. as adverse drug reactions). 62 out of them in 47 patients (2.6%) were considered to be serious adverse drug reactions.

Conclusion: The final results of this NIS demonstrated that treatment with ETN slows or even stops radiographic progression and reduces disease activity in RA and PsA patients in routine clinical care. The treatment with ETN was well tolerated and no new safety signals were observed.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-etanercept-on-radiographic-progression-in-adult-patients-with-rheumatoid-arthritis-or-psoriatic-arthritis-final-results-from-a-german-non-interventional-prospective-multi-center-study/