An open randomized active-controlled clinical trial with low-dose SKA cytokines versus DMARDs evaluating low disease activity maintenance in patients with rheumatoid arthritis

BackgroundPrevious studies have shown beneficial effects of therapeutic fasting and plant-based dietary interventions on disease activity in patients with rheumatoid arthritis (RA) for a duration of up to 1 year. To date, the effects of such interventions on the gut microbiome and on modern diagnostic markers in patients with RA have not been studied. This trial aims to investigate the clinical effects of therapeutic fasting and a plant-based diet in patients with RA, additionally considering current immunological diagnostic tools and microbiome analyses.Methods/designThis trial is an open-label, single-centre, randomised, controlled, parallel-group clinical trial. We will randomly assign 84 patients with RA under a stable standard therapy to either (1) therapeutic fasting followed by a plant-based dietary intervention or (2) to a conventional nutritional counselling focusing on an anti-inflammatory dietary pattern according to the recommendations of the Deutsche Gesellschaft für Ernährung (German society for nutrition). Primary outcome parameter is the group difference from baseline to 12 weeks on the Health Assessment Questionnaire (HAQ). Other secondary outcomes include established clinical criteria for disease activity and treatment response in RA (Disease Activity Score 28, Simple Disease Activity Index, ACR-Response Criteria), changes in self-reported health and physical functional ability, mood, stress, quality of life, dietary behaviour via 3-day food records and a modified Food Frequency Questionnaire, body composition, changes in the gut microbiome, metabolomics and cytometric parameters. Outcomes will be assessed at baseline and day 7, after 6 weeks, 12 weeks and after 6 months.Ethics and disseminationEthical approval to process and analyse data, and to publish the results was obtained through the institutional review board of Charité-Universitätsmedizin Berlin. Results of this trial will be disseminated through peer-reviewed publications and scientific presentations.Trial registration numberNCT03856190.

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Low-dose methotrexate compared with azathioprine in the treatment of rheumatoid arthritis. a twenty-four—week controlled clinical trial

Arthritis & Rheumatism ◽

10.1002/art.1780300401 ◽

1987 ◽

Vol 30 (4) ◽

pp. 361-368 ◽

Cited By ~ 69

Author(s):

H. Hamdy ◽

R. J. R. McKendry ◽

E. Mierins ◽

J. A. Liver

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trial ◽

Low Dose ◽

Controlled Clinical Trial ◽

Dose Methotrexate

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Low-Dose Prednisone Therapy for Patients with Early Active Rheumatoid Arthritis: Clinical Efficacy, Disease-Modifying Properties, and Side Effects: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Annals of Internal Medicine ◽

10.7326/0003-4819-136-1-200201010-00006 ◽

2002 ◽

Vol 136 (1) ◽

pp. 1 ◽

Cited By ~ 287

Author(s):

Amalia A. van Everdingen ◽

Johannes W.G. Jacobs ◽

Dirk R. Siewertsz van Reesema ◽

Johannes W.J. Bijlsma

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trial ◽

Side Effects ◽

Active Rheumatoid Arthritis ◽

Low Dose ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Disease Modifying ◽

Dose Prednisone

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FRI0244 Low dose of rituximab is effective for maintenance of clinical remission or low disease activity in patients with rheumatoid arthritis

10.1136/annrheumdis-2017-eular.4958 ◽

2017 ◽

Author(s):

N Avgoustidis ◽

I Flouri ◽

C Adamichou ◽

E Kabouraki ◽

A Eskitzis ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Clinical Remission ◽

Low Dose ◽

Low Disease Activity

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Economic evaluation of low-dose SKA cytokines in patients with rheumatoid arthritis in maintaining low disease activity or remission

ABOUTOPEN ◽

10.33393/abtpn.2020.2153 ◽

2020 ◽

Vol 7 (1) ◽

pp. 67-73

Author(s):

Roberto Ravasio ◽

Alberto Migliore

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Annual Cost ◽

Low Dose ◽

Sensitivity Analyses ◽

Base Case ◽

Second Line ◽

First Line ◽

Low Disease Activity ◽

Tnf Α

Introduction. The administration of low-dose SKA cytokines allows to maintain remission or low disease activity in patients with rheumatoid arthritis. This analysis aims to estimate the maintenance treatment cost of low-dose SKA cytokines versus DMARDs in patients with rheumatoid arthritis. Methods and Results. Rather than evaluating the cost-effectiveness of individual therapeutic agents, it becomes recommendable for decision-makers to identify an optimal sequencing of such agents. A one-year cost consequence analysis (CCA) was conducted, comparing two alternative strategies to maintain remission or low disease activity in patients with rheumatoid arthritis: i) first line with low-dose SKA cytokines and second line with antitumor necrosis factor-α (TNF-α), ii) first line with DMARDs and second line with TNF-α. The CCA was conducted from the perspective of the Italian National Health Service (iNHS). Only direct medical costs (drugs cost) were considered. We performed a sensitivity analysis to test the robustness of the results. The sequence using cytokines in first line showed the lower mean annual cost of treatment: the mean annual cost per patient was €1,280.96 with cytokines and €1,987.21 with DMARDs. Sensitivity analyses confirmed the base case result. Conclusion. From the iNHS’s perspective low-dose, SKA cytokines, as first line treatment appears a cost-saving strategy to maintain remission or low disease activity in patients with rheumatoid arthritis.

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