{"title":"The Swedish version of the Bath ankylosing spondylitis disease activity index. Reliability and validity.","authors":"A. Waldner, H. Cronstedt, C. Stenström","doi":"10.1080/03009749950155724-1","DOIUrl":"https://doi.org/10.1080/03009749950155724-1","url":null,"abstract":"The aim of the study was to investigate the reliability and the validity of the Swedish version of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). A total of 113 patients with ankylosing spondylitis were assessed with the BASDAI, the Swedish version of the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), the Bath Ankylosing Spondylitis Patient Global Score (BAS-G), and a questionnaire on their opinions of the relevance of the BASDAI. The test-retest stability investigation of the BASDAI over 24 hours did not show any difference between the two occasions (md 4.4, range 0.80-8.43 vs md 4.0, range 0-7.80, p > 0.05). The correlation coefficient between the BASDAI and the BASMI was r(s) = 0.07, between the BASDAI and the BASFI r(s) = 0.64, and between the BASDAI and the BAS-G r(s) = 0.80. Eighty percent of the patients considered the contents of the BASDAI to be relevant. The BASDAI, the BAS-G and the BASMI showed significant improvements after an intensive rehabilitation period. In conclusion the results of the present study indicate that the Swedish BASDAI is reliable and valid.","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"572 1","pages":"10-6"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84563994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and safety of the new DMARD leflunomide: comparison to placebo and sulfasalazine in active rheumatoid arthritis.","authors":"J S Smolen","doi":"10.1080/030097499750042245-1","DOIUrl":"https://doi.org/10.1080/030097499750042245-1","url":null,"abstract":"<p><p>The efficacy and safety of the novel DMARD leflunomide was compared to placebo and sulfasalazine in a randomized, double-blind study. At Week 24, leflunomide significantly reduced tender and swollen joint counts and physician and patient assessment scores compared to placebo (P < 0.001). Response rates with leflunomide were significantly greater than placebo: ACR 20% (55% vs 29%, P = 0.0001). Comparable response rates were observed with sulfasalazine (ACR 20%: 56%). Leflunomide significantly improved HAQ scores compared to placebo or sulfasalazine (P < 0.009). The onset of action with leflunomide was rapid and was seen as early as Week 2. Radiographic disease progression was significantly slower with leflunomide than placebo (P < 0.01). Leflunomide was well tolerated. No long-term safety issues were reported with leflunomide in patients who opted to continue treatment for up to 2 years. Efficacy of leflunomide in the treatment of RA was maintained at 2 years.</p>","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"112 ","pages":"15-21"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/030097499750042245-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21522711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Leflunomide versus methotrexate: a comparison of the European and American experience.","authors":"M H Schiff","doi":"10.1080/030097499750042263","DOIUrl":"https://doi.org/10.1080/030097499750042263","url":null,"abstract":"<p><p>This paper compares and contrasts the results of two major Phase III clinical trials that compared the efficacy and safety of leflunomide, a new disease-modifying antirheumatic drug (DMARD), and methotrexate. In both the American trial (US301) and the multinational trial (MN302), patients with active rheumatoid arthritis (RA) were given either leflunomide (20 mg/day after a loading dose of 100 mg/day for 3 days) or methotrexate (7.5-15 mg/week) for 52 weeks. US301 was also placebo-controlled. Folate supplementation was mandatory in US301 but was given to < 10% of the patients in MN302. In US301, American College of Rheumatology (ACR) 20% response rates and improvement in tender and swollen joints were significantly better than placebo in both treatment groups, but were not significantly different from each other. Both treatments significantly retarded radiographically assessed progression of RA compared to placebo, but the degree of retardation was significantly greater with leflunomide. In MN302, the ACR response rate and improvement in tender and swollen joints with leflunomide were similar to those seen in US301. The ACR response rate and improvements in all efficacy variables with methotrexate were significantly greater than with leflunomide, however. Radiographically assessed disease progression was not statistically different with the two treatments. Use of methotrexate without folate in MN302 was associated with a higher incidence of clinically significant elevations of liver enzyme levels. These results indicate that both leflunomide and methotrexate are effective DMARDs. The symptomatic relief provided by both drugs is similar when they are given with folate supplementation.</p>","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"112 ","pages":"31-5"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/030097499750042263","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21522713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"COX-2: separating myth from reality.","authors":"F McKenna","doi":"10.1080/030097499750042399","DOIUrl":"https://doi.org/10.1080/030097499750042399","url":null,"abstract":"<p><p>Several currently available nonsteroidal anti-inflammatory drugs (NSAIDs) have been evaluated for their relative selectivity in inhibiting the two cyclooxygenase (COX) isozymes, COX-1 and COX-2. Arguments have been made that more selective inhibitors of COX-2 will be safer than less selective ones. Rankings of the COX-2/COX-1 inhibition ratios of various NSAIDs as they relate to the agents' toxicities have been used as evidence that COX-2 selectivity is an important factor in the upper gastrointestinal (GI) safety of some NSAIDs. Unfortunately, none of these claims has been supported by endoscopy studies in treated patients. Since all NSAIDs inhibit COX-1, they all cause upper GI mucosal damage. What is needed are specific COX-2 inhibitors that do not inhibit COX-1. Such agents are currently under development. Ongoing clinical trials will determine the potential role for specific COX-2 inhibitors in the treatment of arthritis and pain. If specific COX-2 inhibitors are shown to be both safe and effective, the treatment of rheumatic diseases will be revolutionized.</p>","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"109 ","pages":"19-29"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/030097499750042399","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21288262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Swedish version of the Bath ankylosing spondylitis functional index. Reliability and validity.","authors":"H Cronstedt, A Waldner, C H Stenström","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The aim of the study was to investigate the reliability and the validity of the Swedish version of the Bath Ankylosing Spondylitis Functional Index (BASFI). A total of 113 patients were assessed with the BASFI, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), and the Bath Ankylosing Spondylitis Patient Global Score (BAS-G). The median BASFI scores on two occasions within 24 hours were 3.6 versus 3.7 (p>0.05). The patients found the BASFI items relevant. The median self-reported and physiotherapist-observed BASFI scores were 3.4 and 2.8 respectively (p>0.05). The correlation coefficient between the BASFI and the BASMI was r(s)=0.55, between the BASFI and the BASDAI r(s)=0.68, and between the BASFI and the BAS-G r(s)=0.67. Significant improvements between the pre- and post-training results for both the BASFI (3.1 vs 2.0, p<0.001) and the BASMI (3.0 vs 1.0, p<0.001) were found after three weeks' inpatient rehabilitation. The results indicated that the Swedish BASFI is reliable and valid.</p>","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"111 ","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21366102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Disease modification in rheumatoid arthritis with leflunomide.","authors":"P Emery","doi":"10.1080/030097499750042236","DOIUrl":"https://doi.org/10.1080/030097499750042236","url":null,"abstract":"<p><p>Rheumatoid arthritis (RA) is characterized by chronic inflammation and irreversible destruction of articular cartilage and bone. Disease progression as assessed by radiographic imaging of structural joint damage is a key outcome measure in RA. Joint damage is especially rapid during early phases of RA, thus the current trend of early aggressive therapy with disease-modifying antirheumatic drugs (DMARDs). Radiographic analysis of disease progression with the novel DMARD leflunomide was compared to methotrexate and sulfasalazine in two large, placebo-controlled, randomized Phase III studies (N = 580). The results as indicated by changes in x-ray scores indicate that leflunomide and both active comparators slow disease progression significantly better than placebo (P < or = 0.01). Slowing of disease progression with leflunomide was similar to sulfasalazine at 6 months but better than methotrexate (P < or = 0.049) at 12 months. These data verify the ability of leflunomide to slow disease progression and confirm its disease-modifying potential.</p>","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"112 ","pages":"9-14"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/030097499750042236","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21522710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Changing the course of rheumatoid arthritis. Introduction.","authors":"J R Kalden","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"112 ","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21564134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Update on clinical developments with celecoxib, a new specific COX-2 inhibitor: what can we expect?","authors":"G. Geis","doi":"10.1080/030097499750042407","DOIUrl":"https://doi.org/10.1080/030097499750042407","url":null,"abstract":"Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective for the relief of pain and inflammation, yet their use is tempered by the development of side effects, primarily in the gastrointestinal (GI) tract. It is now known that inhibition of the enzyme cyclooxygenase (COX) is the principal mechanism for both the efficacy and the toxicity of NSAIDs. Recent research has shown that COX exists as at least two isoenzymes, COX-1 and COX-2. Compelling evidence suggests that COX-1 synthesizes prostaglandins that are involved in the regulation of normal cell activity (including GI cytoprotection), whereas COX-2 appears to produce prostaglandins mainly at sites of inflammation. These findings led to the search for compounds that would inhibit COX-2 without affecting COX-1. Several agents are under investigation in this new therapeutic category, including celecoxib (SC-58635). Celecoxib was developed as an anti-inflammatory and analgesic agent, and has been studied in preclinical studies and in clinical trials. This paper focuses on the results of five key clinical trials of celecoxib: an efficacy trial in dental pain, a 2-week osteoarthritis (OA) efficacy trial, a 4-week rheumatoid arthritis (RA) efficacy trial, a 1-week endoscopic study of GI mucosal effects, and a 10-day study of effects on platelet function. The arthritis trials identified celecoxib doses that were effective in treating OA and RA and that were distinguished from placebo on standard arthritis scales. In the upper GI endoscopy study, no ulcers occurred in subjects receiving celecoxib or placebo, whereas 19% of subjects receiving naproxen developed gastric ulcers. In the platelet effects trial, no statistically significant difference from placebo was seen in the effect of celecoxib on platelet aggregation or bleeding time. In contrast, naproxen caused statistically significant reductions in platelet aggregation and a statistically significant increase in bleeding time. These preliminary trials show that celecoxib achieves analgesic and anti-inflammatory efficacy in arthritis through specific COX-2 inhibition without showing evidence of two of the toxic effects of COX-1 inhibition associated with NSAIDs.","PeriodicalId":21501,"journal":{"name":"Scandinavian journal of rheumatology. Supplement","volume":"9 1","pages":"31-7"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74105098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}