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Intravenous application of omega-3 fatty acids in patients with active rheumatoid arthritis. The ORA-1 trial. An open pilot study

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Lipids

Abstract

The objective of this work was to assess the therapeutic efficacy and to lerability of intravenously applied n-3-PUFA in patients with active rheumatoid arthritis (RA). Thirty-four patients with active RA [identified as having a DAS28 (disease activity score including a 28 joint count) >4.0] were enrolled into this 5-wk open pilot study (one group design). From the time of screening (visit 0, or V0), background therapy had to remain unchanged. Patients received 2 mL/kg(=0.1–0.2 g fish oil/kg) fish oil emulsion intravenously on 7 consecutive days (Visit 1–Visit 2, or V1–V2) in addition to their background therapy. A decrease of the DAS28>0.6 at day 8 (Visit 2) was the primary efficacy measure. Moreover, the DAS28 at day 35 (Visit 3, or V3), the modified Health Assessment Questionnaire, the American College of Rheumatology (ACR) response criteria (V2, V3) and the Short Form-36 (V3) were assessed. Thirty-three patients completed the trial. The mean DAS28 at V1 was 5.45; at V2, 4.51 (P<.001 V1–V2) and at V3, 4.73 (P<.001 V1–V3; V2–V3, not significantly different). Of the 34 patients, 56% achieved a reduction of the DAS28>0.6 at V2 (mean 1.52); 27%>1.2. At V3, 41% of the patients showed a DAS28 reduction >0.6 (mean 1.06), and 36%>1.2. ACR 20 and 50% responses at V2 were seen in 29 and 12% of patients, respectively; at V3, the comparable values were 18 and 9%, respectively. Overall tolerability was excellent. Intravenous application of n-3-PUFA (as an add-on therapy) was considerably well tolerated and led to improvement of the disease activity status in a reasonable number of RA patients. Future trials are warranted to answer whether the intravenous application of n-3-PUFA constitutes a therapeutic option in RA patients.

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Abbreviations

ACR:

American College of Rheumatology

BMI:

body mass index

CRP:

C-reactive protein

DAS28:

disease activity score including a 28-joint count

DMARD:

disease-modifying antirheumatic drug(s)

ESR:

erythrocyte sedimentation rate

EULAR:

European League Against Rheumatism

EULARC:

EULAR response criteria

ITT:

intent-to-treat

M-HAQ:

modified health assessment questionnaire

NS:

not significantly different

NSAID:

nonsteroidal antirheumatic drug(s)

RA:

rheumatoid arthritis

RF:

IgM-rheumatoid factor

SF-36:

Medical Outcomes Study Short Form 36

SJC:

swollen joint count

TJC:

tender joint count

V0:

screening visit

V1:

study entry visit

V2:

visit after 1 wk

V3:

final visit (4 wk after application of PUFA)

VAS:

visual analog scale

VAS-GH:

visual analog scale of patient's general health

VAS pain:

visual analog scale of patient's pain

VAS ph:

visual analog scale of physician's global assessment

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Authors and Affiliations

  1. Second Department of Medicine, Humanisklinikum Lower Austria, Lower Austrian Center for Rheumatology, Stockerau, Landstrasse 18, A-2000, Stockerau, Austria

    Burkhard F. Leeb, Judith Sautner, Ingrid Andel & Bernhard Rintelen

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  1. Burkhard F. Leeb
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  2. Judith Sautner
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  3. Ingrid Andel
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  4. Bernhard Rintelen
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Correspondence to Burkhard F. Leeb.

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Leeb, B.F., Sautner, J., Andel, I. et al. Intravenous application of omega-3 fatty acids in patients with active rheumatoid arthritis. The ORA-1 trial. An open pilot study. Lipids 41, 29–34 (2006). https://doi.org/10.1007/11745-006-5066-x

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  • DOI: https://doi.org/10.1007/11745-006-5066-x

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