Scandinavian Journal of Rheumatology
ISSN: 0300-9742 (Print) 1502-7732 (Online) Journal homepage: http://www.tandfonline.com/loi/irhe20
Intravenous Methylprednisolone Therapy in Rheumatoid Arthritis: A Comparative Dose Study M. B. Ferraz, R. A. Visioni, L. M. Oliveira, R. M. Ciconelli & E. Atra To cite this article: M. B. Ferraz, R. A. Visioni, L. M. Oliveira, R. M. Ciconelli & E. Atra (1992) Intravenous Methylprednisolone Therapy in Rheumatoid Arthritis: A Comparative Dose Study, Scandinavian Journal of Rheumatology, 21:5, 260-261, DOI: 10.3109/03009749209099236 To link to this article: http://dx.doi.org/10.3109/03009749209099236
Published online: 12 Jul 2009.
Submit your article to this journal
Article views: 6
View related articles
Citing articles: 1 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=irhe20 Download by: [McMaster University]
Date: 26 April 2016, At: 07:10
LETTERS TO THE EDITOR
Intravenous Methylprednisolone Therapy in Rheumatoid Arthritis:
Downloaded by [McMaster University] at 07:10 26 April 2016
A Comparative Dose Study
Sir, It has been suggested that patients with Rheumatoid Arthritis (RA) should be treated early in the course of their disease with a combination of medications to control inflammatory synovitis and prevent joint destruction (1). The pulse treatment with Methylprednisolone (MP) may be used for a limited period in combination with disease modifying antirheumatic drugs (DMARD), thereby accelerating the clinical improvement until the sustained benefit due to DMARD is achieved (2, 3, 4). This 6-week double blind randomised controlled trial compared 5 mg/Kg intravenous (IV) MP with 10 mg/Kg IV MP, given as a single pulse during a 2 hour period, in the treatment of R A patients. Thirty-nine patients with R A diagnosed according to the 1987 American Rheumatism Association criteria (9,in an active phase of the disease, were randomly selected from the rheumatology outpatient clinic at Escola Paulista de Medicina. Patients taking nonsteroidal antiinflammatory drugs or maintenance corticosteroids were taking stable doses for at least 1 month, and remained on the same regimen throughout the study. The following outcome measures were evaluated immediately prior to and at 1 , 3 and 6 weeks after the infusion: number of swollen joints (SJ), grip strength (GS), morning stiffness (MS), pain (0-lo), Health Assessment Questionnaire (HAQ) (6) and erythrocyte sedimentation rate (ESR). The Student’s t test was used to evaluate the significance of differences in efficacy measures.
At the start of the study both groups were comparable for demographic variables and outcome measures. Table 1 presents the outcome measures for each treatment group over time. After 7 days there was a marked and statistically significant improvement in clinical state, as measured by SJ, MS, pain and HAQ. This improvement persisted stable for at least 2 more weeks, in both treatment groups. In both groups, despite the initial response, most outcome measures returned to baseline values at 6 weeks later. No statistically significant difference between groups were found at any time for any outcome measure. The possibility of a type I1 statistical error in view of the relatively small sample size should, however, be mentioned. Furthermore, no clinically evident adverse effects were reported. This trial shows no major differences between 5 mg/Kg and 10 mg/Kg IV MP given once in the short term therapy of RA. Five mg/Kg IV MP can be used monthly as an inducation agent of secondline therapy in RA. M. B. Ferraz, R. A. Visioni, L. M. Oliveira, R. M. Ciconelli and E. Atra
Corr. : Marcos Bosi Ferraz, Division of Rheumatology, Escola Paulista de Medicina, Rua Botucatu 740, Sao Paulo, Brazil, CEP 04023 Received 18 May 1992 Accepted 2 August 1992
Table I: Mean values of outcome measures evaluated in each treatment group over time. Week Outcomes
5 mglKg (n = 21)
0 SJ (C-W MS (min) GS mmHg) Pain (0-10) HAQ (0-3) ESR immlh)
19 (6) 116 (97) 72 (28) 6.3 (1.9) 1.7 (0.6) 40 (20)
1 13 47 83 4.5 1.2 36
6
3 (5) (52 (28) 2.2 (0.7) (231
13 46 69 4.7 1.0 43
10 mg/Kg (n = 18)
(7) (62) (25) (2.3) (0.7) 127)
14 (6) 55 (68) 68 (25) 5.8 (2.7) 1.3 (0.7) 34 (291
0 17 (9) 102 (95) 64 (25) 5.9 (1.8) 1.6 (0.7) 52 (22)
1 10 39 68 3.8 1.0 49
3
(6) (46) (31) (2.5) (0.6) (21)
9 58 62 3.8 1.0 52
Group Difference at 6 weeks
6 (5) (57) (23) (1.9) (0.5) (23)
12 76 62 5.9 1.2 46
(9) (88) (27) (2.6) (0.7) (23)
NS NS NS NS NS
NS
SJ = number of swollen Joints, MS = morning stiffness, GS = grip strength, HA0 = Health Assessment Questionnaire, ESR = Erythrocyte sedimentation rate, NS = not significant.
260
Letters to the editor References 1. Healey LA, Wilske KR. Evaluating combination drug ther-
apy in rheumatoid arthritis, J Rheumatol 1991; 18: 641-2. 2. Hansen TM, Krugger P, Elling H et al. Do,uble blind pla-
Downloaded by [McMaster University] at 07:10 26 April 2016
cebo controlled trial of pulse treatment with methylprednisolone combined with disease modifying drugs in rheumatoid arthritis. Br Med J 1990; 301: 268-70. 3 . Neumann V, Hopkins R, Dixon J , Watkins A , Bird H, Wright V. Combination therapy with pulses methylprednisolone in rheumatoid arthritis. Ann Rheum Dis 1985; 44: 747-5 1 .
4. Iglehardt IW, Sutton JD, Bender JC et al. Intravenous pulsed steroids in rheumatoid arthritis: a comuarative dose study. J Rheumatol 1990; 17: 159-62. 5 . Arnett FC, Edworth SM, Bloch D A et al. The American Rheumatism Association 1987 revised criteria for the classification of Rheumatoid Arthritis. Arthritis Rheum 1988; 31: 315-24. 6. Ferraz MB, Atra E. Rheumatiod arthritis and the measurement properties of the physical ability dismension of the Stanford Health Assessment Questionnaire. Clin Exp Rheumatol 1989; 7 : 3 4 1 4 .
The Prevalence of Fibromyalgia and Widespread Chronic Musculoskeletal Pain in the General Population
Sir, Much attention has lately been drawn towards diffuse chronic nonarticular pain under the description of fibromyalgia. The prevalence of fibromyalgia in primary care patients was shown to be 2% (1). In rheumatologic settings the prevalence has been estimated to be about 5% (2). Recently an epidemiologic study on fibromyalgia in the general population was presented in this journal (3) where the prevalence of, fibromyalgia among women aged 20-49 years was found to be 10.5% using the classification criteria set out by The American College of Rheumatology in 1990 (ACR-90) (4).The ACR-90 criteria consist of two parts; the first part includes criteria for widespread pain and the second part includes a tender point count, where 11 out of 18 locations have to be painful at palpation. A prevalence of 10.5% is amazingly high as the authors also point out themselves. Having seen many fibromyalgia patients one may ask if the general population really is that ill or if there could be any methodological explanations for the finding of such a high prevalence. How was fibromyalgia actually classified in the study? The authors describe that diagnosis was based on the examination of subjects complaining of continous pain and/or stiffness for at least three months in the joints, muscles, back or all over, followed by a clinical demonstration of the prerequisite number of tender points. This implies that subjects with longstanding pain or stiffness in a single region were candidates for further fibromyalgia examination. The part of the examination during which subjects
were asked for widespread pain as defined by the ACR-90 has not been described in the paper. One might thus expect the first part of the ACR-90 criteria not to be satisfied in all subjects identified as having fibromyalgia. To give some additional perspectives on the prevalence of widespread chronic musculoskeletal pain (WCMP), a retrospective analysis on data from a health survey from 1986/87 was carried out. Six-thousand randomly selected danish citizens, living in Denmark and who were more than 15 years of age were invited to participate by the Danish Institute for Clinical Epidemiology (5). 4753 (80%) subjects agreed to participate and were representative of the overall Danish adult population with regard to gender, age, social status and geography. The occurrence of widespread pain in the musculoskeletal apparatus was investigated by analysing if subjects had stated chronic pain in the following three regions; 1) shoulderheck girdle, 2) back and low back, and 3) arms, hands, legs, knees, hips or other joints. Known specific medical conditions associated with musculoskeletal pain were also extracted. Less bothersome WCMP was indicated by 4.8% of the participants and 2.6% of the participants indicated severe WCMP. Eighty percent of those with severe WCMP related their symptoms to specific medical conditions, which were osteoarthritis (35%), back disease (25%), rheumatoid arhritis (6%), other specified musculoskeletal conditions (12%) and other specified medical conditions (22%). Thus, 0.5% of the participants stated se261
ISSN: 0300-9742 (Print) 1502-7732 (Online) Journal homepage: http://www.tandfonline.com/loi/irhe20
Intravenous Methylprednisolone Therapy in Rheumatoid Arthritis: A Comparative Dose Study M. B. Ferraz, R. A. Visioni, L. M. Oliveira, R. M. Ciconelli & E. Atra To cite this article: M. B. Ferraz, R. A. Visioni, L. M. Oliveira, R. M. Ciconelli & E. Atra (1992) Intravenous Methylprednisolone Therapy in Rheumatoid Arthritis: A Comparative Dose Study, Scandinavian Journal of Rheumatology, 21:5, 260-261, DOI: 10.3109/03009749209099236 To link to this article: http://dx.doi.org/10.3109/03009749209099236
Published online: 12 Jul 2009.
Submit your article to this journal
Article views: 6
View related articles
Citing articles: 1 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=irhe20 Download by: [McMaster University]
Date: 26 April 2016, At: 07:10
LETTERS TO THE EDITOR
Intravenous Methylprednisolone Therapy in Rheumatoid Arthritis:
Downloaded by [McMaster University] at 07:10 26 April 2016
A Comparative Dose Study
Sir, It has been suggested that patients with Rheumatoid Arthritis (RA) should be treated early in the course of their disease with a combination of medications to control inflammatory synovitis and prevent joint destruction (1). The pulse treatment with Methylprednisolone (MP) may be used for a limited period in combination with disease modifying antirheumatic drugs (DMARD), thereby accelerating the clinical improvement until the sustained benefit due to DMARD is achieved (2, 3, 4). This 6-week double blind randomised controlled trial compared 5 mg/Kg intravenous (IV) MP with 10 mg/Kg IV MP, given as a single pulse during a 2 hour period, in the treatment of R A patients. Thirty-nine patients with R A diagnosed according to the 1987 American Rheumatism Association criteria (9,in an active phase of the disease, were randomly selected from the rheumatology outpatient clinic at Escola Paulista de Medicina. Patients taking nonsteroidal antiinflammatory drugs or maintenance corticosteroids were taking stable doses for at least 1 month, and remained on the same regimen throughout the study. The following outcome measures were evaluated immediately prior to and at 1 , 3 and 6 weeks after the infusion: number of swollen joints (SJ), grip strength (GS), morning stiffness (MS), pain (0-lo), Health Assessment Questionnaire (HAQ) (6) and erythrocyte sedimentation rate (ESR). The Student’s t test was used to evaluate the significance of differences in efficacy measures.
At the start of the study both groups were comparable for demographic variables and outcome measures. Table 1 presents the outcome measures for each treatment group over time. After 7 days there was a marked and statistically significant improvement in clinical state, as measured by SJ, MS, pain and HAQ. This improvement persisted stable for at least 2 more weeks, in both treatment groups. In both groups, despite the initial response, most outcome measures returned to baseline values at 6 weeks later. No statistically significant difference between groups were found at any time for any outcome measure. The possibility of a type I1 statistical error in view of the relatively small sample size should, however, be mentioned. Furthermore, no clinically evident adverse effects were reported. This trial shows no major differences between 5 mg/Kg and 10 mg/Kg IV MP given once in the short term therapy of RA. Five mg/Kg IV MP can be used monthly as an inducation agent of secondline therapy in RA. M. B. Ferraz, R. A. Visioni, L. M. Oliveira, R. M. Ciconelli and E. Atra
Corr. : Marcos Bosi Ferraz, Division of Rheumatology, Escola Paulista de Medicina, Rua Botucatu 740, Sao Paulo, Brazil, CEP 04023 Received 18 May 1992 Accepted 2 August 1992
Table I: Mean values of outcome measures evaluated in each treatment group over time. Week Outcomes
5 mglKg (n = 21)
0 SJ (C-W MS (min) GS mmHg) Pain (0-10) HAQ (0-3) ESR immlh)
19 (6) 116 (97) 72 (28) 6.3 (1.9) 1.7 (0.6) 40 (20)
1 13 47 83 4.5 1.2 36
6
3 (5) (52 (28) 2.2 (0.7) (231
13 46 69 4.7 1.0 43
10 mg/Kg (n = 18)
(7) (62) (25) (2.3) (0.7) 127)
14 (6) 55 (68) 68 (25) 5.8 (2.7) 1.3 (0.7) 34 (291
0 17 (9) 102 (95) 64 (25) 5.9 (1.8) 1.6 (0.7) 52 (22)
1 10 39 68 3.8 1.0 49
3
(6) (46) (31) (2.5) (0.6) (21)
9 58 62 3.8 1.0 52
Group Difference at 6 weeks
6 (5) (57) (23) (1.9) (0.5) (23)
12 76 62 5.9 1.2 46
(9) (88) (27) (2.6) (0.7) (23)
NS NS NS NS NS
NS
SJ = number of swollen Joints, MS = morning stiffness, GS = grip strength, HA0 = Health Assessment Questionnaire, ESR = Erythrocyte sedimentation rate, NS = not significant.
260
Letters to the editor References 1. Healey LA, Wilske KR. Evaluating combination drug ther-
apy in rheumatoid arthritis, J Rheumatol 1991; 18: 641-2. 2. Hansen TM, Krugger P, Elling H et al. Do,uble blind pla-
Downloaded by [McMaster University] at 07:10 26 April 2016
cebo controlled trial of pulse treatment with methylprednisolone combined with disease modifying drugs in rheumatoid arthritis. Br Med J 1990; 301: 268-70. 3 . Neumann V, Hopkins R, Dixon J , Watkins A , Bird H, Wright V. Combination therapy with pulses methylprednisolone in rheumatoid arthritis. Ann Rheum Dis 1985; 44: 747-5 1 .
4. Iglehardt IW, Sutton JD, Bender JC et al. Intravenous pulsed steroids in rheumatoid arthritis: a comuarative dose study. J Rheumatol 1990; 17: 159-62. 5 . Arnett FC, Edworth SM, Bloch D A et al. The American Rheumatism Association 1987 revised criteria for the classification of Rheumatoid Arthritis. Arthritis Rheum 1988; 31: 315-24. 6. Ferraz MB, Atra E. Rheumatiod arthritis and the measurement properties of the physical ability dismension of the Stanford Health Assessment Questionnaire. Clin Exp Rheumatol 1989; 7 : 3 4 1 4 .
The Prevalence of Fibromyalgia and Widespread Chronic Musculoskeletal Pain in the General Population
Sir, Much attention has lately been drawn towards diffuse chronic nonarticular pain under the description of fibromyalgia. The prevalence of fibromyalgia in primary care patients was shown to be 2% (1). In rheumatologic settings the prevalence has been estimated to be about 5% (2). Recently an epidemiologic study on fibromyalgia in the general population was presented in this journal (3) where the prevalence of, fibromyalgia among women aged 20-49 years was found to be 10.5% using the classification criteria set out by The American College of Rheumatology in 1990 (ACR-90) (4).The ACR-90 criteria consist of two parts; the first part includes criteria for widespread pain and the second part includes a tender point count, where 11 out of 18 locations have to be painful at palpation. A prevalence of 10.5% is amazingly high as the authors also point out themselves. Having seen many fibromyalgia patients one may ask if the general population really is that ill or if there could be any methodological explanations for the finding of such a high prevalence. How was fibromyalgia actually classified in the study? The authors describe that diagnosis was based on the examination of subjects complaining of continous pain and/or stiffness for at least three months in the joints, muscles, back or all over, followed by a clinical demonstration of the prerequisite number of tender points. This implies that subjects with longstanding pain or stiffness in a single region were candidates for further fibromyalgia examination. The part of the examination during which subjects
were asked for widespread pain as defined by the ACR-90 has not been described in the paper. One might thus expect the first part of the ACR-90 criteria not to be satisfied in all subjects identified as having fibromyalgia. To give some additional perspectives on the prevalence of widespread chronic musculoskeletal pain (WCMP), a retrospective analysis on data from a health survey from 1986/87 was carried out. Six-thousand randomly selected danish citizens, living in Denmark and who were more than 15 years of age were invited to participate by the Danish Institute for Clinical Epidemiology (5). 4753 (80%) subjects agreed to participate and were representative of the overall Danish adult population with regard to gender, age, social status and geography. The occurrence of widespread pain in the musculoskeletal apparatus was investigated by analysing if subjects had stated chronic pain in the following three regions; 1) shoulderheck girdle, 2) back and low back, and 3) arms, hands, legs, knees, hips or other joints. Known specific medical conditions associated with musculoskeletal pain were also extracted. Less bothersome WCMP was indicated by 4.8% of the participants and 2.6% of the participants indicated severe WCMP. Eighty percent of those with severe WCMP related their symptoms to specific medical conditions, which were osteoarthritis (35%), back disease (25%), rheumatoid arhritis (6%), other specified musculoskeletal conditions (12%) and other specified medical conditions (22%). Thus, 0.5% of the participants stated se261
