Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Biological disease-modifying antirheumatic drugs (bDMARDs) are essential in the treatment of rheumatoid arthritis (RA). Biological DMARDs are particularly recommended for patients with active RA who may incur further joint damage. However, in daily clinical practice, some patients with RA do not accept or discontinue bDMARDs because of their high cost. Similar to use of glucocorticoids, the use of bDMARDs may be limited to periods of high disease activity to help reduce patient costs. For this option to work well, the efficacy of a bDMARD should be maintained when restarting the same bDMARDs after several periods of discontinuation, bDMARDs holiday. We conducted a prospective, nonrandomized, non-blinded study (RESUME study: UMIN000008164) to examine the sustained efficacy of etanercept (ETN) after starting and stopping ETN several times in the patients with rheumatoid arthritis.
Methods: Thirty-one bDMARD-naive patients with RA with moderate to severe disease activity (Disease Activity Score 28 [DAS28] of ≥3.2) were enrolled in this study with written consent from 1 January 2011 to 31 December 2012. Their average age was 60 years and average disease duration was 5 years. ETN was administered at 50 mg/week and discontinued when low disease activity (LDA) (DAS28 of <3.2) was achieved. Upon recurrence, the same dose of ETN was administered with observation every 2 months. This strategy was maintained for 2 years. If patients did not achieve LDA within 3 months of ETN administration, other synthetic DMARDs other than glucocorticoids and tacrolimus were administered. If LDA was not achieved within 6 months, the patients were withdrawn from the trial. Clinical measure by DAS28, blood test, radiography (mTSS) was analyzed at baseline, 1 year, and 2year visit. In order to compare the structural damage of this study population, another series of 31 patients with RA treated with fully-use of ETN were evaluated by mTSS.
Results: Thirteen of the 31 patients had an inadequate response to ETN and were withdrawn from the study. Five patients had no flare-up of disease activity after discontinuation of ETN during the observation period. In the remaining 13 patients (8 women), on-demand use of ETN was carried out to maintain LDA. The mean dose of methotrexate in these 13 patients was 10 mg/week, rheumatoid factor was positive in 11 patients, and the mean follow-up period was 20.5 months. All 13 patients achieved LDA at the final follow-up after starting and stopping the ETN several times. The cost-saving calculation was approximately 28% among the five patients who maintained LDA with no need to restart ETN. Structural remission (DmTSS =<0.5) was achieved in 82% of the 13 patients as evaluated by the total Sharp score in 1 year, and 50% in 2 years. Structural remission rate in this study population in 1 year was equivalent to that of full dose use (p=0.464, Fisher’s exact probability test).
Conclusion: On-demand use of ETN for disease flares reduced disease activity score and structural damage at low cost.
To cite this abstract in AMA style:Inui K, Koike T, Tada M, Sugioka Y, Mamoto K, Okano T, Sakawa A, Fukushima K, Nakamura H. On-Demand Use of Etanercept Only for Disease Flares Reduced the Disease Activity Score and Structural Damage Equivalent to Fully-Use of Etanercept in RA Patients [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/on-demand-use-of-etanercept-only-for-disease-flares-reduced-the-disease-activity-score-and-structural-damage-equivalent-to-fully-use-of-etanercept-in-ra-patients/. Accessed June 5, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/on-demand-use-of-etanercept-only-for-disease-flares-reduced-the-disease-activity-score-and-structural-damage-equivalent-to-fully-use-of-etanercept-in-ra-patients/