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Biomedical subjects

P van Riel

Publications and source records attributed to P van Riel.

9 recordsLinked to original sources

When a DMARD fails, should patients switch to sulfasalazine or add sulfasalazine to continuing leflunomide?

OBJECTIVE: To evaluate the efficacy and safety of adding sulfasalazine to leflunomide treatment compared with switching to sulfasalazine alone in patients with RA with an inadequate response to leflunomide monotherapy. METHODS: Patients with active RA ((DAS28) >3.2) who were enrolled in the first open label phase of the RELIEF study received leflunomide for 24 weeks. Inadequate responders then entered the double blind phase and received a further 24 weeks' treatment with leflunomide (20 mg once daily) plus sulfasalazine (final dose 2 g once daily), or placebo plus sulfasalazine (dose as above). The primary efficacy variable was the DAS28 response rate, and secondary efficacy outcomes were ACR 20%, 50%, and 70% response rates. Adverse events, including standard laboratory tests, were recorded. RESULTS: 106 inadequate responders entered the double blind phase; 56 received leflunomide plus sulfasalazine, and 50 placebo plus sulfasalazine. In the intention to treat population, more patients receiving leflunomide plus sulfasalazine (25/56 (45%)) achieved a DAS28 response than those receiving placebo plus sulfasalazine (17/50 (34%)) (p = 0.179). In week 24 completers, more patients receiving leflunomide plus sulfasalazine (17/56 (30%)) were DAS28 responders than those receiving placebo plus sulfasalazine (10/50 (20%)) (p = 0.081). Comparable numbers in each group were ACR 20% responders; the ACR 50% response rate was significantly higher in the leflunomide plus sulfasalazine group (8.9%) than in the placebo plus sulfasalazine group (0%) (p = 0.038). The safety profiles of both groups were comparable. CONCLUSION: Patient numbers are small and firm conclusions cannot be reached, but a non-significant benefit is indicated for combining leflunomide with sulfasalazine compared with switching to sulfasalazine alone in patients inadequately responding to leflunomide.

Adolescent↗

Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology.

Observational and longitudinal observational studies (LOS) provide essential information about the course and outcome of rheumatic disorders that cannot be provided by randomized controlled trials, and they constitute the major clinical scientific communication in rheumatology. There has been no consensus as to the full and appropriate content of LOS. This report defines a core set of domains and reporting requirements for LOS. At the 1998 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs, variables, and outcomes of rheumatology by using introductory lectures, nominal groups, and plenary sessions. The result of this process was to identify 5 "core" domains that should be included in every LOS: Health Status, Disease Process, Damage, Mortality, and Toxicity/Adverse Reactions. Two additional domains, Work Disability and Costs, were recognized as important, but need not be used in all LOS. Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units. A set of reporting requirements was also determined. The core recommendations, which follow on the WHO ICIDH-2 outline, are not disease-specific; the substitution of different "disease process" and "damage" measures make them suitable for many rheumatic disorders. The core set is intended to serve as a core for LOS in almost all rheumatic conditions.

Decision Making↗

Mucocutaneous reactions to gold: a prospective study of 74 patients with rheumatoid arthritis.

OBJECTIVE: To describe causality, morphology, course, and risk factors of mucocutaneous reactions to gold. METHODS: A prospective study of 74 patients with rheumatoid arthritis starting with gold thioglucose. RESULTS: Thirty-nine patients experienced an episode of gold dermatitis. Sixteen patients continued gold treatment. The estimated treatment withdrawal at 1 year was 26%. The clinical picture was variable and nonspecific. Gold dermatitis was associated with HLA-B35 and disease duration. CONCLUSION: Mucocutaneous reactions to gold are nonspecific, therefore a causality assessment is necessary. Incidence is high, but treatment can often be continued with dose reduction and local steroids. The predictive value of risk factors is low.

Adolescent↗

Longterm treatment with nonsteroidal antiinflammatory drugs in rheumatoid arthritis: a prospective drug survival study.

The longterm use of nonsteroidal antiinflammatory drugs (NSAID) was studied in a consecutive sample of 148 patients with recently diagnosed rheumatoid arthritis. A survival analysis was done in which treatment terminations due to side effects and to insufficient therapeutic effect were used as index causes. Cumulative drug 'survival' of indomethacin with treatment terminations due to untoward reactions as endpoints was significantly less compared to naproxen and diclofenac (p less than 0.001). No significant difference with termination due to lack of efficacy as index cause was observed (p greater than 0.90). No influence of sex or age on the drug survival with the different endpoints mentioned above could be established.

Adult↗

Sequential occupational dexterity assessment (SODA): a new test to measure hand disability.

Measuring hand-related disability poses a problem due to a lack of validated tests. This report introduces the sequential occupational dexterity assessment (SODA), a test that measures bimanual dexterity in daily life. The design of the SODA is described. Validity and reliability of the SODA are demonstrated in a sample of patients with rheumatoid arthritis (RA), in whom impairment of the hands may cause serious disability in daily life. Good reliability was found, as measured by internal consistency, test-retest correlation, and interrater stability. Validity was established by relating the SODA to a number of other variables. Current disease activity was only weakly related to the SODA score. Impairment of the hands is more strongly related to dexterity than to current disease activity. However, dexterity could vary considerably in patients with similar degrees of impairment. Pain during the SODA proved to be more important for dexterity than general level of pain. Considerable variation was found in self-reported and observed dexterity. It was concluded that the SODA may guide the therapist in making decisions about hand therapy. The use of the SODA allows standardized evaluation of the effects of hand surgery on bimanual dexterity.

Activities of Daily Living↗