By Chris Berrie
BARCELONA, SPAIN -- June 18, 2007 -- For patients with early rheumatoid arthritis (RA), there's a stark contrast in disease control achieved in routine clinical practices compared with that in clinical trials, according to research presented here at the Annual European Congress of Rheumatology (EULAR).
This underscores the need for targets to be set for tight disease control in the treatment of these patients in routine clinical practice, researchers say.
The analysis of the Early Rheumatoid Arthritis Network (ERAN) prospective database was presented by Richard Williams, MD, chairman, Audit Subcommittee for ERAN, and consultant rheumatologist, rheumatology department, Hereford Hospitals NHS Trust, Hereford, UK.
While EULAR, the British Society of Rheumatology, and the American College of Rheumatology all recommend early aggressive treatment of patients with early RA, there have been no specific disease suppression targets set. So ERAN was established in 2002 to provide a national resource for the collection of prospective data on patients with early RA.
The aim of the researchers was to mine the data from the ERAN database to determine treatment modalities, remission rates, and maintenance of disease activity up to 36 months from baseline by measuring patient Disease Activity Scores (DAS)28.
The 712 patients with early RA enrolled in the ERAN database to January 2007 were included in the baseline analyses. Their mean age of disease onset was 55 years (males, 59.5 years; females, 53.3 years), with 68% female, 59% positive for rheumatic factor, and 29% with erosive disease.
The treatment modalities at 12 months show 56% on monotherapy, 15% with sequential monotherapy, 12% with step-up therapy, 6% on combination therapy, and 11% without disease-modifying antirheumatic drugs (DMARDs). Thus, DMARDs had been started in 89% of the ERAN population at a mean of 1 month from the first rheumatological consultation.
The first DMARD chosen was often methotrexate (48%) and sulfasalazine, but also oral steroids (6%), hydroxychloroquine (5%), and leflunomide (2%).
A DAS28 of <2.6 was considered remission, 2.6 to 3.2 was low disease activity, 3.3 to 5.1 was moderate, and >5.1 was high. At baseline, most patients fell into the higher two score groups, as ~40% and ~ 45%, respectively, with around 10% in each of the lower groups. By 12 months (n = 255), while the distribution was indeed biased towards the lower two scores groups (~25%, ~10%), the proportions with DAS28 >3.3 remained relatively high (~40%, ~20%).
At 24 months (n = 162), further improvements were seen in the lower DAS28 scores, with no changes in the higher ones, indicating some continued improvement in the patients with low disease levels. Despite reduced numbers with 36 months of follow-up (n = 66), benefits for the DAS28 3.3-to-5.1 group were indicated, although ~20% of these patients still remained with DAS28 >5.1, indicating no change in these levels from 12 months.
The data demonstrate that in the routine clinical practices, over the first 2 years of treatment, only 37% of these patients reach remission or low disease activity. Although this improves to 50% after 3 years, the levels remain low overall. As has been seen in the clinical trial setting, where patient monitoring and treatment are more intensive, levels of over 65% should be reached at this time.
Dr. Williams said, "The data that we've got here [are] showing that we don't use much combination therapy, even though we know it works, and that will be a trigger to us to use more combination therapy so that we hope to see progressive increases in the percentages of patients achieving remission or low disease activity."
So while the ERAN database at present includes a relatively small cross-section of the total relevant centers in the UK, as Dr. Williams indicated, the hope is to continue to recruit centers and patients, and promote optimal treatment for the patient with early RA.
"The patient benefit for the future is that we will use the best available evidence from whatever source to look at driving the standards up, so we improve the likelihood of any particular patient getting very good disease control or going into remission," he added.
[Presentation title: Early Rheumatoid Arthritis Network (ERAN) Audit of Disease Control in Early RA and Recommendations for Realistic Targets for Routine Clinical Practice. Abstract FRI0306]
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