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Daniel O. Clegg MD,
Domenic J. Reda MS,
Michael H. Weisman MD,
Warren D. Blackburn MD,
John J. Cush MD,
Grant W. Cannon MD,
Maren L. Mahowald MD,
H. Ralph Schumacher Jr. MD,
Thomas Taylor MD,
Elly Budiman-Mak MD, [......],
Stuart L. Silverman MD,
Rama Makkena MD,
F. Paul Alepa MD,
Joel Buxbaum MD,
MS Clair M. Haakenson RPH,
Richard H. Ward PhD,
B. J. Manaster MD,
Robert J. Anderson PhD, John R. Ward MD,
William G. Henderson PhD
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ABSTRACT: Objective. To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective for the treatment of active ankylosing spondylitis (AS) that is not controlled with nonsteroidal antiinflammatory drug therapy.Methods. Two hundred sixty-four patients with AS were recruited from 15 clinics, randomized (double-blind) to SSZ or placebo treatment, and followed up for 36 weeks. Treatment response was based on morning stiffness, back pain, and physician and patient global assessments.Results. While longitudinal analysis revealed a trend favoring SSZ in the middle of treatment, no difference was seen at the end of treatment. Response rates were 38.2% for SSZ and 36.1% for placebo (P = 0.73). The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). AS patients with associated peripheral arthritis showed improvement that favored SSZ (P = 0.02). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints.Conclusion. SSZ at a dosage of 2,000 mg/day does not seem to be more effective than placebo in the treatment of AS patients with chronic, longstanding disease. SSZ is well tolerated and may be more effective than placebo in the treatment of AS patients with peripheral joint involvement. This effect is more pronounced in treatment of the peripheral arthritis in this subgroup of AS patients.
Arthritis & Rheumatism 12/2005; 39(12):2004 - 2012. · 7.87 Impact Factor
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ABSTRACT: In a sample of 107 patients with classic or definite rheumatoid arthritis (RA), we examined the convergent and divergent validity of measures of disability and depression. Scores on the self-report Disability index of the Health Assessment Questionnaire were highly correlated with physical therapist and spouse ratings of disability. Although Health Assessment Questionnaire disability scores were significantly correlated with self-reported and interviewer-assessed ratings of depression, these correlations were significantly smaller. Factor analyses of the Beck Depression Inventory (BDI) and rheumatologist ratings of BDI items indicated that this measure is highly contaminated by the inclusion of items reflecting RA disease severity. A dysphoric mood subcomponent of the BDI may be a more valid measure of depression in RA populations. Although depression and disability are clearly positively correlated in RA patients, depression scales that include somatic items are likely to yield an overestimate of the association. Finally, self-reported pain intensity was more clearly related to disability and reported recent disease activity than to depression.
Arthritis & Rheumatism 12/2005; 32(9):1100 - 1106. · 7.87 Impact Factor
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Daniel O. Clegg MD,
Domenic J. Reda MD,
Edwin Mejias MD,
Grant W. Cannon MD,
Michael H. Weisman MD,
Thomas Taylor MD,
Elly Budiman-Mak MD,
Warren D. Blackburn MD,
Frank B. Vasey MD,
Maren L. Mahowald MD, [......],
F. Paul Alepa,
Michael E. Luggen,
Miriam R. Cohen,
Rama Makkena,
Clair M. Haakenson,
Richard H. Ward,
B. J. Manaster,
Robert J. Anderson,
John R. Ward,
William G. Henderson
[show abstract]
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ABSTRACT: Objective. To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective for the treatment of active psoriatic arthritis (PsA) resistant to nonsteroidal antiinflammatory drug therapy.Methods. Two hundred twenty-one patients with PsA were recruited from 15 clinics, randomized (double-blind) to SSZ or placebo treatment, and followed up for 36 weeks. Treatment response was based on joint pain/tenderness and swelling scores and physician and patient global assessments.Results. Longitudinal analysis revealed a trend favoring SSZ treatment (P = 0.13). At the end of treatment, response rates were 57.8% for SSZ compared with 44.6% for placebo (P = 0.05). The Westergren erythrocyte sedimentation rate declined more in the PsA patients taking SSZ than in those taking placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints, including dyspepsia, nausea, vomiting, and diarrhea.Conclusion. SSZ at a dosage of 2,000 mg/day is well tolerated and may be more effective than placebo in the treatment of patients with PsA.
Arthritis & Rheumatism 11/1996; 39(12):2013 - 2020. · 7.87 Impact Factor
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Daniel O. Clegg MD,
Domenic J. Reda MS,
Michael H. Weisman MD,
John J. Cush MD,
Frank B. Vasey MD,
H. Ralph Schumacher Jr. MD,
Elly Budiman-Mak MD,
Dominic J. Balestra MD,
Warren D. Blackburn MD,
Grant W. Cannon MD, [......],
Jean Higashida,
Stuart L. Silverman,
Nourollah Parhami,
Joel Buxbaum,
Clair M. Haakenson,
Richard H. Ward,
B. J. Manaster,
Robert J. Anderson,
John R. Ward,
William G. Henderson
[show abstract]
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ABSTRACT: Objective. To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective in the treatment of reactive arthritis (ReA) that has been unresponsive to nonsteroidal antiinflammatory drug (NSAID) therapy.Methods. One hundred thirty-four patients with ReA who had failed to respond to NSAIDs were recruited from 19 clinics, randomized (double-blind) to receive either SSZ or placebo, and followed up for 36 weeks. The definition of treatment response was based on joint pain/tenderness and swelling scores and physician and patient global assessments.Results. Longitudinal analysis revealed improvement in the patients taking SSZ compared with those taking placebo, which appeared at 4 weeks and continued through the trial (P = 0.02). At the end of treatment, response rates were 62.3% for SSZ treatment compared with 47.7% for placebo treatment. The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints.Conclusion. SSZ at a dosage of 2,000 mg/day is well tolerated and effective in patients with chronically active ReA.
Arthritis & Rheumatism 11/1996; 39(12):2021 - 2027. · 7.87 Impact Factor
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John R. Ward MD,
H. James Williams,
Marlene J. Egger,
James C. Reading,
Eric Boyce,
Mary Altz‐Smith,
Cecil O. Samuelson JR,
Robert F. Willkens,
Marilyn A. Solsky,
Stanley P. Hayes,
Kenneth L. Blocka,
Arthur Weinstein,
Robert F. Meenan,
Maria Guttadauria,
Stanley B. Kaplan,
John Klippel
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ABSTRACT: A prospective controlled, double-blind multi-center trial compared placebo, auranofin (an orally administered gold complex), and parenteral gold sodium thiomalate (GST) in patients with active rheumatoid arthritis (RA). Of 193 patients who received any treatment, the only important improvement identified for either auranofin or GST was for pain/tenderness scores. When 161 patients who completed 20 weeks of treatment were examined, both auranofin and GST treatments were superior to placebo as measured by improvement in number of painful and/or tender joints, joint pain/tenderness scores, physician's assessment of disease activity, and decrease in erythrocyte sedimentation rate when elevated at entry. GST was superior to placebo in improvement of joint swelling scores, anemia, thrombo-cytosis, and rheumatoid factor. No drug-related remissions were observed. The only statistically significant advantages of GST over auranofin for efficacy were an increase in hemoglobin concentration and decrease of thrombocytosis with GST. Withdrawals for adverse effects were 5 times more frequent with GST treatment. Thrombocytopenia, proteinuria, elevated liver enzymes, “nitritoid” reactions, and “gold pneumonitis” were observed only in the GST treatment group. These results confirm that both parenteral and oral gold may be effective for the treatment of RA, that GST tends to show greater efficacy than auranofin, and that auranofin has fewer significant adverse effects than GST. However, long-term benefits, tolerability, and safety cannot be inferred from this study.
Arthritis & Rheumatism 10/1983; 26(11):1303 - 1315. · 7.87 Impact Factor