Background/Purpose

Although a combination with MTX is recommended for all biologics, data from different registries around the world show that in real life around 30% of all RA patients are treated in mono therapy. However, data on safety and efficacy of Etanercept (ETN) as mono therapy in dally practice are rare.

Methods

Adults with RA newly initiating ETN have been included into this non-interventional study.

Due to the non-interventional nature of the study, no specific requirements were specified with regard to the management of treatment. The physician could decide on dosing and the duration of treatment according to the treatment needs of each individual patient. At seven data collection points the course of the disease was documented for up to 52 weeks. Safety, efficacy as well as health outcome parameters have been assessed.

Results

4871 patients have been included into this study. 1090 of these have continuously been  treated with ETN and 1441 with ETN + MTX. There have been no statistically differences regarding all baseline characteristics. The mean disease duration was 10.6±10.3 years in the ETN and  9.7±8.9 years in the ETN + MTX group. They have been pretreated with 2.9±1.6 and 2.7±1.2 DMARDs respectively. From a mean baseline value of 5.5±1.3 and 5.3±1.3 score points, the DAS28 continually decreased to 3.4±1.4 and 3.2±1.3 at visit 7. At week 52 slightly less patients with ETN reached DAS28 remission (DAS28<2,6) as with ETN+MTX (32.5% [29.0-36.1%] vs. 35.4% [32.5-38.3%]). Concurrently with the DAS28 also the mean disease activity (patient global assessment, visual analogue scale VAS), pain (VAS) and fatigue (VAS) improved in both treatment groups. Duration of morning stiffness decreased in the ETN group from 78.7±88.1 to 26.2±50.6 min and in the ETN + MTX group from 72.6±81.1 to 21.8±50.6 min.  38.4 % [35.1 – 41.7%] of patients with ETN reached a functional remission (FFbH) at week 52 (vs. 44.3 % [41.5 – 47.2%] under ETN+MTX therapy). In both groups the treatment was well tolerated and no new safety signals have been observed.

Conclusion

Etanercept rapidly reduces diseases activity in combination with MTX as well as in mono therapy . Abaout half of the patients stay on their initial  treatment regime (mono or combination with MTX) in daily practice over 52 weeks. Within this study no new safety signals occurred and Etanercept was well tolerated in mono and combination therapy.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/etanercept-in-mono-therapy-or-in-combination-with-mtx-results-from-a-sub-analysis-of-a-german-non-interventional-study/