Objective. To evaluate treatment with methotrexate (MTX) in patients with newly diagnosed giant cell arteritis (GCA) to determine if MTX reduces GCA relapses and cumulative corticosteroid (CS) requirements and diminishes disease-and treatment-related morbidity.Methods. This was a multicenter, randomized, double-blind study. Over 4 years, 16 centers from the International Network for the Study of Systemic Vasculitides enrolled patients with unequivocal GCA. The initial treatment was 1 mg/kg/day (<60 mg every day) prednisone, plus either 0.15 mg/kg/week MTX (increased to 0.25 mg/kg/week, for a maximum weekly dosage of 15 mg) or placebo. Two physicians, both blinded to treatment allocation, evaluated each patient at every trial visit. One physician was responsible for providing global medical care. The other assessed GCA status according to a standard protocol. Treatment
DeQuervain tenosynovitis, which involves the abductor pollicis longus and extensor pollicis brevis tendons, is much more common in women than men and is due to repetitive movements of the hand such as grasping and twisting. Housewives and persons involved in manual occupations using the hands and wrists account for most cases in previous series. In this series, six of 24 female patients (25%) were pregnant or postpartum at the time of onset. In five of the six, activities of infant care aggravated symptoms. Both pregnancy, per se, and mechanical factors appear to play a role in causing this condition.
ReplySchned and coworkers raise an important issue. Can research done in academic settings be generalized to community practice? This is a pervasive issue in the medical literature since most clinical research is undertaken in academic settings.Indeed, the clinicians involved in the development of the SLEDAI were from teaching and research settings. The patients' profiles were generated from a center with a mix of primary, secondary, and tertiary care patients. However, primary care patients were well represented; 70% of the patients came to the clinic within 1 year of diagnosis and 50% of the patients were first diagnosed at the clinic. We believe that a significant portion of patients can be considered "primary care patients." Nonetheless, as Schned et a1 propose, the index needs to be validated in various settings to test its generalizability. We have already undertaken this process. The SLEDAI has recently been tested internationally (1-4). It was compared in 8 European and 6 American centers (on their own local patients) against two other indices, the BILAG (British Isles Lupus Assessment Group) ( 5 ) and the SLAM (Systemic Lupus Activity Measure) (6). It was also assessed by 8 rheumatologists from 4 countries who examined and evaluated the same patients. The results showed that these indices were comparable and reproducible for evaluating disease activity in SLE.The 3 instruments (SLEDAI, BILAG, and SLAM) were recently tested for their sensitivity to change in disease activity, by 8 rheumatologists from 4 countries (7). Also, the usefulness of the SLEDAI has been demonstrated not only by the expert clinicians who participated in its generation, but also by other rheumatologists who treat lupus patients as well as by less experienced clinicians such as rheumatology fellows (8).Schned and colleagues' question can only be answered by continuing the process of evaluating the SLE-DAI's feasibility and practicability in various settings. Derivation of the SLEDAI To the Editor:We enjoyed reading the recent article by Bombardier et a1 in which a nominal group technique was used to develop an index of disease activity in systemic lupus erythematosus (SLE) (Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH, and the Committee on Prognosis Studies in SLE: Derivation of the SLEDAI: a disease activity index for lupus patients. Arthritis Rheum 35:630-640, 1992). In conjunction with indices for assessing damage from disease and health status, which hopefully will be developed, the SLEDAI promises to be an important tool for outcomes assessment in clinical and research settings.As the authors explain, this index relies on a "judgmental, rather than an empirical, approach." It should be emphasized, then, that it reflects the collective clinical judgment of this particular group of academic-based rheumatologists and methodologists. The raters were described as "experienced 'lupologists' . . . engaged in the study of methods for assessing disease activity at their own institutions. " There is no question about the ex...
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