Major Finding: Early rheumatoid arthritis patients who had an initial clinical response to methotrexate and had a 72% remission rate after 2 years on treatment continued to develop radiographic progression of joint damage, with an average rise of four points in their van der Heijde-modified Sharp score over 2 years.
Data Source: A total of 114 patients who initially had clinical responses to methotrexate monotherapy and had full radiographic follow-up after 1 and 2 years on treatment enrolled in the SWEFOT trial.
Disclosures: Mr. Rezaei said that he had no disclosures. Dr. van Vollenhoven said that he has been a consultant to Abbott, Bristol-Myers Squibb, Pfizer/Wyeth, Roche, Shering Plough, and UCB, and that he has received grant support from Abbott, Pfizer/Wyeth, Roche, and Schering-Plough. The SWEFOT study was funded in part by Schering-Plough. Dr. Gossec had no disclosures.
ROME — Rheumatoid arthritis patients with a sustained clinical response to methotrexate therapy can still have radio-graphic progression of the disease in the joints of their hands and feet, even when in remission, based on follow-up of 114 patients.
“A good clinical response to methotrexate does not preclude radiographic progression,” Hamed Rezaei said at the annual European Congress of Rheumatology.
“If you choose to use methotrexate [monotherapy] you need to monitor patients both clinically and radiologically. Even when patients are doing well clinically, you can't stop there. You need to also look at their x-rays,” said Dr. Ronald F. van Vollenhoven, senior physician at the Karolinska Institute in Stockholm and senior researcher for the new report.
“A possible driver of radio-graphic progression is synovitis, so aim for a low level or absence of synovitis” with rheumatoid arthritis (RA) treatment, commented Dr. Laure Gossec, a rheumatologist at Cochin Hospital, Paris.
The new analysis reported by Mr. Rezaei focused on 147 of 487 early RA patients enrolled in the Swedish Pharmacotherapy (SWEFOT) trial who had significant clinical responses to methotrexate monotherapy when treatment began at the start of the study, with their disease activity score (DAS)28 falling to 3.2 or less. The main portion of the SWEFOT trial focused on the 340 patients who did not respond adequately to methotrexate monotherapy and then underwent randomization to additional treatment (Lancet 2009;374:459-66).
The report from Mr. Rezaei reviewed the x-ray scans obtained from 114 of the 147 initial methotrexate responders at 1 year and 2 years after initiation of their treatment. During these 2 years of ongoing treatment with methotrexate, at dosages of at least 20 mg/week, 61% of the initial responders were in full remission after 1 year and 72% reached full remission after 2 years of treatment. Also at 2 years, 88% of patients had low disease activity. Despite this good level of clinical response, radiologic assessments showed a different situation. The average van der Heijde-modified Sharp score at baseline was 3.8, which rose to 6.0 after 1 year and 7.9 after 2 years. The percent of the 114 patients followed radiologically who had a 10-point or greater increase in their van der Heijde-modified Sharp score after 2 years on treatment was 15%, with an additional 15% having an increase of 5-9 points. A 10-point or greater rise in the score is clinically significant, the Karolinska researchers said.
The average joint erosion score and joint narrowing score for all 114 patients also showed increases from baseline to year 1 and year 2.
The percent of patients showing no joint damage at all on their x-rays was 48% at baseline, 27% after 1 year, and 20% after 2 years, said Mr. Rezaei, a doctoral student and researcher in the rheumatology unit at the Karolinska Institute.
Additional analysis showed that patients who were positive for rheumatoid factor had a higher average van der Heijde-modified Sharp score after 2 years compared with patients negative for rheumatoid factor, but the link was not statistically significant. Patients who were positive for anti-citrullinated protein antibody (ACPA) had no significant difference in their average score compared with ACPA-negative patients, and gender also did not have a significant link to radiologic progression.
Based on these findings, “we need to have more frequent x-ray examinations over the first 2 years of treatment in patients who clinically respond to methotrexate,” Mr. Rezaei said. He declined to suggest what additional treatment should be added to slow or prevent further joint damage in patients on methotrexate monotherapy.
'Even when patients are doing well … you can't stop there. You need to also look at their x-rays.'
Source DR. VAN VOLLENHOVEN