Background/Purpose: Several clinical trials have reported bio-free remission or discontinuation of biologic DMARDs; however, these findings have not been confirmed in a real-world setting. The aim of this study is to evaluate the discontinuation of biologics after achieving low -activity disease status among patients with rheumatoid arthritis (RA) undergoing treatment in daily practice.

Methods: Among 1,775 patients (infliximab [IFX], 418 patients; etanercept [ETN], 690 patients; adalimumab [ADA], 267 patients; tocilizumab [TCZ], 318 patients; and abatacept [ABT], 82 patients) who had been treated with biologics in our clinic between 2003 and 2012, we extracted data on 43 patients with RA (IFX, 26 patients; ETN, 9 patients; ADA, 4 patients; TCZ, 2 patients; and ABT, 2 patients) who discontinued biologics since their disease activity were well controlled. In these patients, DAS28 scores were < 3.2 at the time of biologics discontinuation. Those 43 patients were divided into two groups (bio-free or bio-reuse) on the basis of biologic usage 1 year after discontinuation. Those 43 patients were also divided into bio-free success and bio-free failure groups on the basis of disease activity (DAS28 < 3.2 or DAS28 ≧ 3.2, respectively) 1 year after discontinuation. The clinical features of the patients at the time of initiation and discontinuation of biologics were compared between the bio-free and bio-reuse groups and between the bio-free success and bio-free failure groups. 

Results: The percentages of patients who discontinued biologics due to well-controlled disease activity and in the bio-free success group among biologics users in our clinic were 2.4% (43/1775) and 1.4% (25/1775), respectively. The number of patients in the bio-free and bio-reuse groups was 34/43 (79.1% [IFX, n = 20; ETN, n = 8; ADA, n = 3; TCZ, n = 1; and ABT, n = 2) and 9/43 (20.9%), respectively. There were no significant differences between the two groups with respect to age (bio-free vs. bio-reuse [47.5 vs. 39.0 years]), disease duration (3.0 vs. 2.0 years), DAS28 (4.17 vs. 5.10), J-HAQ (0.75 vs. 0.56), dose of MTX (8.0 vs. 8.0 mg/week), and dose of glucocorticoids (4.0 vs. 0 mg/day) at initiation of biologics, or DAS28 at discontinuation of biologics (2.09 vs. 1.80), or duration of biologics use (591.5 vs. 851.0 days). In addition, most clinical features did not differ significantly between the bio-free success (n=25 [58.1%]; IFX, n = 13; ETN, n = 6; ADA, n = 3; TCZ, n = 1; and ABT, n = 2) and bio-free failure groups (n=18 [41.9%]). The median DAS28 at initiation of biologics was significantly lower in the bio-free success group than the bio-free failure group (3.95 vs. 5.04, p=0.04). The bio-free success group was significantly decreased the average dosage of glucocorticoid during the biologics use than that in the bio-free failure group (-3.0 vs 0 mg/day, p=0.01).

Conclusion: We showed that the 1-year discontinuation rate of biologics after achieving low-activity disease status was high (79.1%) in patients with RA being treated in an outpatient setting. A lower DAS28 score at initiation of biologics and decreasing the dose of glucocorticoid before discontinuation of biologics were important factors leading to bio-free success in patients with RA irrespective of biologic type.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/discontinuation-of-biologics-in-patients-with-rheumatoid-arthritis-after-achieving-low-activity-disease-status/