Background Spondyloarthritides are associated with pain and increasing disability over time, thus leading to a high socioeconomic burden. If non-steroidal anti-inflammatory drugs (NSAIDs) fail to achieve pain reduction, agents targeting tumor-necrosis factor (TNF-)α such as etanercept (ETA) are considered. Anti-TNF therapy is costly and until now no significant effect on new bone formation was observed. Hence, physical therapy is still crucial to prevent progressive disability.
Objectives This study was conducted to prove feasibility and efficacy of low-dose ETA combined with intensive physical therapy, a concept that aims both, pain relief and maintenance of functionality in a cost effective way.
Methods Patients with spondyloarthritides and active disease assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of greater than 4 were included if anti-TNF therapy according to the guidelines of the Assessment of SpondyloArthritis International Society (ASAS) was indicated. Patients were treated with ETA (25mg per week) and intensive physical therapy (3 sessions of 45 minutes per week) over 4 months. TNF-therapy was continued and followed-up for another 2 months. Physical examinations and assessments were once a month including BASDAI, Bath Ankylosing Disease Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Metrology Index (BASMI), a visual analogue scale for pain and patient’s global, as well as ‘Funktionsfragebogen Hanover’, a German questionnaire comparable to the Health Assessment Questionnaire (HAQ).
Results Over a period of 10 months 20 patients, 75% male, were included with a mean age of 46.2 ± 7.3 years and a BASMI of 2.5 (median; IQR 1-5). Three patients dropped-out due to side effects (2x) and loss of efficacy (1x). The results show a decrease of BASDAI from 5.98 (median; IQR 4.93-6.85; n=17) to 3.43 (IQR 2.28-4.69; n=17; p<0.0001) after 8 weeks and to 2.99 (IQR 1.73-4.71; n=16; p<0.0001) after 16 weeks. Subsequent to termination of physical therapy, a significant increase of BASDAI was not observed at week 24 (3.64; IQR 1.35-4.61; n=9; p=0.884). At week 8, week 16, and week 24 the response rate was 41.2%, 50.0%, 55.6% (ASAS20), 23.5%, 43.8%, 33.3% (ASAS40), and 23.5%, 50.0%, 33.3% (BASDAI50), respectively. Pain assessed by visual analogue scale was reduced from 6.5 (median; IQR 6-8) to 4 (IQR 3-5.25; p<0.0001) after 8 weeks, to 3 (IQR 1.5-5; p<0.0001) after 16 weeks and to 4 (IQR 1-5.5; p=0.015) after 24 weeks. 9 out of 17 patients who completed the study continued low-dose ETA. Fifteen patients substantially reduced the intake of NSAIDs. During the observed period, the total saving compared to the regular ETA dose was approximately 76,000 €.
Conclusions In this pilot-study, the concept of combining intensive physical therapy with low-dose administration of ETA was effective and therefore resembles a useful alternative, especially in terms of cost savings. The results need to be confirmed by a controlled, multicentric, non-inferiority study that includes a control arm of patients receiving regular doses of ETA, but no physical therapy.
Disclosure of Interest F. Meier Grant/research support from: Pfizer, S. Nesterov: None Declared, K. Fischer: None Declared, U. Müller-Ladner Consultant for: Pfizer, U. Lange Consultant for: Pfizer
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