Articular indices of joint inflammation in rheumatoid arthritis. Correlation with the acute‐phase response

Objective. To determine the effects of drug therapy (methotrexate [MTX] versus auranofin [AUR]) onradiographic progression in patients with active rheumatoid arthritis (RA).Methods. We conducted a 9-month randomized, multicenter, double-blind trial comparing MTX and AUR. Standardized radiographs of the hands and wrists were obtained at baseline and at completion of the study. Four experienced bone radiologists graded the radiographs for erosions, joint space narrowing, erosion healing, and reparative bone formation. Conclusion. The rate of radiographic progression in patients with RA, as measured by erosion score and joint space narrowing score, was demonstrated to be lower in those treated with MTX, as compared with AUR, over a 36-week period.The rate of radiographic progression is considered to be an important parameter of the efficacy of second-line therapy in rheumatoid arthritis (RA). Whether any second-line therapy in current use, including methotrexate (MTX), slows radiographic progression is uncertain (1,2). The clinical efficacy profile of MTX is, however, favorable, based on data from short-term randomized placebo-controlled trials (3-3, comparative studies with other second-line therapies ( 6 4 , and long-term prospective studies (9,lO). In a previously published report we described the clinical results of a 36-week multicenter study comparing MTX and auranofin (AUR) (11). The effect of treatment on radiographic activity has now been evaluated PATIENTS AND METHODSPatients. Two hundred eighty-one patients with active RA were enrolled in a multicenter double-blind trial comparing MTX and AUR (1 1). All patients had had inadequate disease response to at least 2 nonsteroidal antiinflammatory drugs (NSAIDs). Patients who had received prior treatment, of any duration, with gold salts, MTX, D-penicillamine, or cytotoxic agents were excluded from the study.Patients were randomized to receive either AUR (n = 143) or MTX (n = 138) for 9 months. (At 1 of the sites, only 1 patient was enrolled in the AUR group, and that patient was excluded from the efficacy analysis.) The initial dosage of AUR was 6 mg/day; this could be increased to 9 mg/day after 24 weeks of treatment, if there was a lack of a beneficial response with the lower dosage. The initial dosage of MTX was 7.5 mg/week, which could be increased to 15 mg/week between weeks 6 and 12 in patients who had not shown a clinical response. Patients were allowed to continue taking stable maintenance doses of background NSAIDs and/or prednisone (at a maximum dosage of 10 mg/day). Standard clinical assessments of arthritis activity were performed during the trial.Radiographic evaluation. Radiographs of the hands and wrists were obtained at baseline and at completion of the 9-month trial. A standardized protocol was used for obtaining these radiographs. All radiographs were taken on a single 30 X 35-cm cassette, with the patient in a posteroanterior position with the fingers slightly separated and the forearms flat. Each study center was provided with a Kodak (Ea...

Section: Discussionmentioning

confidence: 98%

The effects of drug therapy on radiographic progression of rheumatoid arthritis. results of a 36‐week randomized trial comparing methotrexate and auranofin

Weinblatt

Polisson

Blotner

et al. 1993

“…In spite of overall general consensus, one major unresolved issue (5)(6)(7) relates to the question of whether extended or reduced joint counts would be superior in clinical studies. Satisfactory correlation with extended joint counts has been previously shown for reduced joint counts (8)(9)(10)(11)(12). A 28-joint count has been developed as a simplified joint score and as a compromise between comprehensiveness and feasibility (8).…”

mentioning

confidence: 76%

Validity and reliability of the twenty-eight-joint count for the assessment of rheumatoid arthritis activity

Smolen

Breedveld

Eberl

et al. 1995

243

119

Objective. To investigate the validity of the 28-joint count for assessment of joint involvement in patients with rheumatoid arthritis (RA).Methods. Joint involvement as determined by the 28-and the 66/68-joint count was compared using data from 735 prospectively studied RA patients.Results. The joints included in the 28-joint count were more commonly involved than other joints, and findings from the 28-joint count correlated highly with those from the 66/68-joint count in all analyses.Conclusion. The 28-joint count is a reliable and valid measure for joint assessment. It is easier to perform than the 66/68-joint count, and it addresses the joints that are critically involved.

“…The observer may record tenderness, swelling, pain on motion, deformity, and limitation of motion quantitatively or as normal/abnormal (1). In clinical trials, emphasis is placed on tenderness and swelling, findings which represent inflammation and are amenable to short-term improvement or decline (2). Pain on motion is highly correlated with tenderness (3) and has been used as a surrogate measure for tenderness in joints in which tenderness is difficult to assess, such as the shoulder, hips, and cervical spine (4).…”

mentioning

confidence: 99%

Reduced joint counts in controlled clinical trials in rheumatoid arthritis

Fuchs

Pincus

1994

101

Objective. To determine if quantitative assessment of a reduced number of joints provides information equivalent to that obtained by the traditional 60-joint evaluation in detecting changes in patients participating in clinical trials of rheumatoid arthritis (RA).Methods. The changes in quantitative joint scores of patients from 3 previously reported clinical trials were compiled and compared with changes in quantitative scores derived using a reduced number of joints. Effect sizes were calculated (mean change in joint score/ standard deviation of joint score) and compared for the different joint indices.Results. The effect sizes of the joint scores derived using a reduced number of joints were similar to those of the original 60-joint score. The reduced joint count scores revealed significant changes for clinical trials involving as few as 15 patients.Conclusion. Reduced joint count scores may be used to evaluate the results of clinical trials without decreasing the ability to detect change over time. Quantitative assessment of a reduced number of joints may also facilitate assessment of responses to treatment in the routine care of patients with RA.