Correction: Clinical response to discontinuation of anti-TNF therapy in patients with ankylosing spondylitis after 3 years of continuous treatment with infliximab

Rheumazentrum Ruhrgebiet, Herne, Germany.
Arthritis research & therapy (Impact Factor: 3.75). 03/2005; 7(3):R439-44. DOI: 10.1186/ar1693
Source: PubMed Central


We analyzed the clinical response and the time to relapse after discontinuation of continuous long-term infliximab therapy in patients with ankylosing spondylitis (AS). After 3 years of infliximab therapy, all AS patients (n = 42) discontinued treatment (time point (TP)1) and were visited regularly for 1 year in order to assess the time to relapse (TP2). Relapse was defined as an increase to a value >or= 4 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and a physician's global assessment >or= 4 according to the recommendations of the Assessments in Ankylosing Spondylitis (ASAS) working group. After 52 weeks, 41 of the 42 patients (97.6%) had to be reinfused because of relapse. The mean change in the BASDAI between TP1 and TP2 was 3.6 +/- 1.7 and that in the physician's global assessment was 4.4 +/- 1.8 (both P < 0.001). The mean time to relapse was 17.5 weeks (+/- 7.9 weeks, range 7 to 45). Ten patients (24%) showed a relapse within 12 weeks and 38 patients (90.5%), within 36 weeks. After 52 weeks, only one patient had remained in ongoing remission without further treatment with anti-tumor-necrosis factor. Patients who were in partial remission according to the ASAS criteria and those with normal C-reactive protein levels at the time point of withdrawal had longer times to relapse after discontinuation of the treatment. Retreatment with infliximab was safe and resulted in clinical improvement in all patients to a state similar to that before the treatment was stopped. Discontinuation of long-term therapy with infliximab eventually led to relapse of disease activity in all patients but one.

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    • "Withdrawal studies of TNFi agents in early axSpA and AS also suggest that the frequency of drug-free remission is higher the earlier a patient is treated. In established AS patients treated with a TNFi agent and monitored for 6 months or more after discontinuation, 91 to 100% of patients flare [12-14]. In the INFAST trial, 40 to 48% of patients who received early infliximab treatment remained in drug-free remission 6 months after stopping their infliximab [15]. "
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    ABSTRACT: The window of opportunity is a concept critical to rheumatoid arthritis treatment. Early treatment changes the outcome of rheumatoid arthritis treatment, in that response rates are higher with earlier disease-modifying anti-rheumatic drug treatment and damage is substantially reduced. Axial spondyloarthritis is an inflammatory axial disease encompassing both nonradiographic axial spondyloarthritis and established ankylosing spondylitis. In axial spondyloarthritis, studies of magnetic resonance imaging as well as tumor necrosis factor inhibitor treatment and withdrawal studies all suggest that early effective suppression of inflammation has the potential to reduce radiographic damage. This potential would suggest that the concept of a window of opportunity is relevant not only to rheumatoid arthritis but also to axial spondyloarthritis. The challenge now remains to identify high-risk patients early and to commence treatment without delay. Developments in risk stratification include new classification criteria, identification of clinical risk factors, biomarkers, genetic associations, potential antibody associations and an ankylosing spondylitis-specific microbiome signature. Further research needs to focus on the evidence for early intervention and the early identification of high-risk individuals.
    Full-text · Article · May 2014 · Arthritis Research & Therapy
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    • "And Brandt et al. (22) found that more than two-thirds of the patients with AS already had a relapse after 12 weeks and almost all patients had a relapse after 24 weeks of discontinuation of etanercept. In the case of infliximab, after 12 weeks of discontinuation 64% patients experienced a flare and after 52 weeks 97% patients had to be re-infused because of relapse (23). In our study, patients with AS had a lower flare rate compared with earlier reports and patients with RA were comparable. "
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    ABSTRACT: There is no consensus on whether it is safe to re-administer tumor necrosis factor-alpha (TNFα) inhibitors in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) flared after withdrawal of TNFα inhibitors due to active tuberculosis (TB). We evaluated the safety of restarting anti-TNFα therapy in patients with TNFα-associated TB. We used data of 1,012 patients with RA or AS treated with TNFα inhibitors at Seoul St. Mary's Hospital between January 2003 and July 2013 to identify patients who developed active TB. Demographic and clinical data including the results of tuberculin skin tests (TST) and interferon-γ releasing assays (IGRA) were collected. Fifteen patients developed active TB. Five cases were occurred in RA and 10 cases in AS. Nine of 15 patients had a negative TST or IGRA and 6 TST-positive patients had received prophylaxis prior to initiating anti-TNFα therapy. All patients discontinued TNFα inhibitors with starting the treatment of TB. Eight patients were re-administered TNFα inhibitors due to disease flares and promptly improved without recurrence of TB. TNFα inhibitors could be safely resumed after starting anti-TB regimen in patients with RA or AS.
    Full-text · Article · Mar 2014 · Journal of Korean medical science
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    • "However, their clinical response after etanercept re-administration was similar to their status prior to discontinuation. These data have been reported elsewhere [8,28] and suggest that continuous treatment with TNF-blockers is recommended for the treatment of patients with active AS, as shown also with other anti-TNF compounds [28]. However, when needed, treatment discontinuation and then the resumption of therapy are possible without loss of clinical efficacy in the long term. "
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    ABSTRACT: Data from clinical studies on the long-term efficacy and safety of anti-tumor necrosis factor (TNF)-alpha therapy in patients with ankylosing spondylitis (AS) are scarce. This is the first report on continuous treatment with the TNFalpha fusion protein etanercept over 7 years (y). Overall, 26 patients with active AS were initially treated with etanercept 2x25mg s.c./week with no concomitant disease modifying anti-rheumatic drugs (DMARDs) or steroids. The clinical response was assessed by standardized parameters. The primary outcome was the proportion of patients in spondyloarthritis international society (ASAS) partial remission at 7y. AS disease activity scores (ASDAS) for status and improvement were compared to conventional outcome measures. Overall, 21/26 patients (81%) completed 2y and 16/26 patients (62%) completed 7y. In the completer analysis, 31% patients were in ASAS partial remission at 7y, while 44% patients showed ASDAS inactive disease status. Mean Bath AS activity index (BASDAI) scores which were elevated at baseline (6.3(plus/minus)0.9) showed constant improvement and remained low: 3.1(plus/minus)2.5 at 2y and 2.5(plus/minus)2.2 at 7y, while ASDAS also improved (3.9(plus/minus)0.7 at baseline, 1.8(plus/minus)0.9 at 2y, 1.6(plus/minus)0.8 at 7y), all p<0.001. From the 10 dropouts, only 5 patients discontinued treatment due to adverse events. Patients who completed the study had lower baseline Bath AS function index (BASFI) scores vs. patients who discontinued. No other clinical parameter at baseline could predict any long-term outcome. This study confirms the clinical efficacy and safety of etanercept in patients with active AS over 7y of continuous treatment. After 7y, more than half of the initially treated patients remained on anti-TNF therapy, and 1/3 were in partial remission.
    Full-text · Article · Jun 2013 · Arthritis research & therapy
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