Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis

Merete Hetland; Kristian Stengaard-Pedersen; Peter Junker; Tine Lottenburger; T. Ellingsen; L.S. Andersen; Henrik Skjødt; J.K. Pedersen; Ulrik Birk Lauridsen; A. Svendsen; Ulrik Tarp; Jan Pødenphant; Gert Hansen; H. Limdegaard; A. de Carvallo; Mikkel Østergaard; Kim Hørslev-Petersen; Merete Lund Hetland

Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis

Merete Hetland, Kristian Stengaard-Pedersen, Peter Junker, Tine Lottenburger, T. Ellingsen, L.S. Andersen, Henrik Skjødt, J.K. Pedersen, Ulrik Birk Lauridsen, A. Svendsen, Ulrik Tarp, Jan Pødenphant, Gert Hansen, H. Limdegaard, A. de Carvallo, Mikkel Østergaard, Kim Hørslev-Petersen, Merete Lund Hetland

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Abstract

OBJECTIVE: To investigate whether disease control can be achieved in early active rheumatoid arthritis (RA) by treatment with methotrexate and intraarticular betamethasone, and whether the addition of cyclosporine to the regimen has any additional effect. METHODS: Patients (n = 160) were randomized to receive methotrexate 7.5 mg/week plus cyclosporine 2.5 mg/kg of body weight/day (combination therapy) or methotrexate plus placebo-cyclosporine (monotherapy). At weeks 0, 2, 4, 6, and 8 and every 4 weeks thereafter, betamethasone was injected into swollen joints (maximum 4 joints or 4 ml per visit). Beginning at week 8, if synovitis was present, the methotrexate dosage was increased stepwise up to 20 mg/week, with a subsequent stepwise increase in the cyclosporine or placebo-cyclosporine dosage up to 4 mg/kg. RESULTS: At 52 weeks, 20% improvement according to the American College of Rheumatology criteria (ACR20) was achieved in 85% of the combination therapy group versus 68% of the monotherapy group (P = 0.02). The median individual overall ACR response (ACR-N) in the 2 groups was 80.0% (interquartile range 40.1-91.8%) and 54.5% (interquartile range 2.4-87.8%), respectively (P = 0.025). At 48 and 52 weeks, ACR remission criteria were met in 35% of the combination therapy group and 28% of the monotherapy group. Progression in the Larsen score at 52 weeks was -0.2 +/- 6.5 and 0.4 +/- 6.9 (mean +/- SD) in the combination therapy and monotherapy groups, respectively. Serum creatinine levels increased by 7%, and hypertrichosis was more prevalent, in the combination therapy group. CONCLUSION: Combined treatment with methotrexate and intraarticular glucocorticoid showed excellent disease control and stopped the progression of erosions in patients with early active RA, who had a poor prognosis. Addition of cyclosporine improved the ACR20 and ACR-N responses, whereas the ACR50 and ACR70 responses, remission rates, and radiographic changes did not differ between the 2 study groups.

Original language	English
Journal	Arthritis & Rheumatism
Volume	54
Issue number	5
Pages (from-to)	1401-9
ISSN	0004-3591
Publication status	Published - 2006

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Hetland, M., Stengaard-Pedersen, K., Junker, P., Lottenburger, T., Ellingsen, T., Andersen, L. S., Skjødt, H., Pedersen, J. K., Lauridsen, U. B., Svendsen, A., Tarp, U., Pødenphant, J., Hansen, G., Limdegaard, H., de Carvallo, A., Østergaard, M., Hørslev-Petersen, K., & Hetland, M. L. (2006). Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis. Arthritis & Rheumatism, 54(5), 1401-9. http://www3.interscience.wiley.com/cgi-bin/abstract/112598659/ABSTRACT?CRETRY=1&SRETRY=0

Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis. / Hetland, Merete; Stengaard-Pedersen, Kristian; Junker, Peter et al.

In: Arthritis & Rheumatism, Vol. 54, No. 5, 2006, p. 1401-9.

Research output: Contribution to journal › Journal article › Research › peer-review

Hetland, M, Stengaard-Pedersen, K, Junker, P, Lottenburger, T, Ellingsen, T, Andersen, LS, Skjødt, H, Pedersen, JK, Lauridsen, UB, Svendsen, A, Tarp, U, Pødenphant, J, Hansen, G, Limdegaard, H, de Carvallo, A, Østergaard, M, Hørslev-Petersen, K & Hetland, ML 2006, 'Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis', Arthritis & Rheumatism, vol. 54, no. 5, pp. 1401-9. <http://www3.interscience.wiley.com/cgi-bin/abstract/112598659/ABSTRACT?CRETRY=1&SRETRY=0>

@article{f0327fbbf8c04aada68d9cc24d3e0fb1,

title = "Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis",

abstract = "OBJECTIVE: To investigate whether disease control can be achieved in early active rheumatoid arthritis (RA) by treatment with methotrexate and intraarticular betamethasone, and whether the addition of cyclosporine to the regimen has any additional effect. METHODS: Patients (n = 160) were randomized to receive methotrexate 7.5 mg/week plus cyclosporine 2.5 mg/kg of body weight/day (combination therapy) or methotrexate plus placebo-cyclosporine (monotherapy). At weeks 0, 2, 4, 6, and 8 and every 4 weeks thereafter, betamethasone was injected into swollen joints (maximum 4 joints or 4 ml per visit). Beginning at week 8, if synovitis was present, the methotrexate dosage was increased stepwise up to 20 mg/week, with a subsequent stepwise increase in the cyclosporine or placebo-cyclosporine dosage up to 4 mg/kg. RESULTS: At 52 weeks, 20% improvement according to the American College of Rheumatology criteria (ACR20) was achieved in 85% of the combination therapy group versus 68% of the monotherapy group (P = 0.02). The median individual overall ACR response (ACR-N) in the 2 groups was 80.0% (interquartile range 40.1-91.8%) and 54.5% (interquartile range 2.4-87.8%), respectively (P = 0.025). At 48 and 52 weeks, ACR remission criteria were met in 35% of the combination therapy group and 28% of the monotherapy group. Progression in the Larsen score at 52 weeks was -0.2 +/- 6.5 and 0.4 +/- 6.9 (mean +/- SD) in the combination therapy and monotherapy groups, respectively. Serum creatinine levels increased by 7%, and hypertrichosis was more prevalent, in the combination therapy group. CONCLUSION: Combined treatment with methotrexate and intraarticular glucocorticoid showed excellent disease control and stopped the progression of erosions in patients with early active RA, who had a poor prognosis. Addition of cyclosporine improved the ACR20 and ACR-N responses, whereas the ACR50 and ACR70 responses, remission rates, and radiographic changes did not differ between the 2 study groups.",

author = "Merete Hetland and Kristian Stengaard-Pedersen and Peter Junker and Tine Lottenburger and T. Ellingsen and L.S. Andersen and Henrik Skj{\o}dt and J.K. Pedersen and Lauridsen, {Ulrik Birk} and A. Svendsen and Ulrik Tarp and Jan P{\o}denphant and Gert Hansen and H. Limdegaard and {de Carvallo}, A. and Mikkel {\O}stergaard and Kim H{\o}rslev-Petersen and Hetland, {Merete Lund}",

year = "2006",

language = "English",

volume = "54",

pages = "1401--9",

journal = "Arthritis & Rheumatology",

issn = "2326-5205",

publisher = "Wiley",

number = "5",

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TY - JOUR

T1 - Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis

AU - Hetland, Merete

AU - Stengaard-Pedersen, Kristian

AU - Junker, Peter

AU - Lottenburger, Tine

AU - Ellingsen, T.

AU - Andersen, L.S.

AU - Skjødt, Henrik

AU - Pedersen, J.K.

AU - Lauridsen, Ulrik Birk

AU - Svendsen, A.

AU - Tarp, Ulrik

AU - Pødenphant, Jan

AU - Hansen, Gert

AU - Limdegaard, H.

AU - de Carvallo, A.

AU - Østergaard, Mikkel

AU - Hørslev-Petersen, Kim

AU - Hetland, Merete Lund

PY - 2006

Y1 - 2006

N2 - OBJECTIVE: To investigate whether disease control can be achieved in early active rheumatoid arthritis (RA) by treatment with methotrexate and intraarticular betamethasone, and whether the addition of cyclosporine to the regimen has any additional effect. METHODS: Patients (n = 160) were randomized to receive methotrexate 7.5 mg/week plus cyclosporine 2.5 mg/kg of body weight/day (combination therapy) or methotrexate plus placebo-cyclosporine (monotherapy). At weeks 0, 2, 4, 6, and 8 and every 4 weeks thereafter, betamethasone was injected into swollen joints (maximum 4 joints or 4 ml per visit). Beginning at week 8, if synovitis was present, the methotrexate dosage was increased stepwise up to 20 mg/week, with a subsequent stepwise increase in the cyclosporine or placebo-cyclosporine dosage up to 4 mg/kg. RESULTS: At 52 weeks, 20% improvement according to the American College of Rheumatology criteria (ACR20) was achieved in 85% of the combination therapy group versus 68% of the monotherapy group (P = 0.02). The median individual overall ACR response (ACR-N) in the 2 groups was 80.0% (interquartile range 40.1-91.8%) and 54.5% (interquartile range 2.4-87.8%), respectively (P = 0.025). At 48 and 52 weeks, ACR remission criteria were met in 35% of the combination therapy group and 28% of the monotherapy group. Progression in the Larsen score at 52 weeks was -0.2 +/- 6.5 and 0.4 +/- 6.9 (mean +/- SD) in the combination therapy and monotherapy groups, respectively. Serum creatinine levels increased by 7%, and hypertrichosis was more prevalent, in the combination therapy group. CONCLUSION: Combined treatment with methotrexate and intraarticular glucocorticoid showed excellent disease control and stopped the progression of erosions in patients with early active RA, who had a poor prognosis. Addition of cyclosporine improved the ACR20 and ACR-N responses, whereas the ACR50 and ACR70 responses, remission rates, and radiographic changes did not differ between the 2 study groups.

AB - OBJECTIVE: To investigate whether disease control can be achieved in early active rheumatoid arthritis (RA) by treatment with methotrexate and intraarticular betamethasone, and whether the addition of cyclosporine to the regimen has any additional effect. METHODS: Patients (n = 160) were randomized to receive methotrexate 7.5 mg/week plus cyclosporine 2.5 mg/kg of body weight/day (combination therapy) or methotrexate plus placebo-cyclosporine (monotherapy). At weeks 0, 2, 4, 6, and 8 and every 4 weeks thereafter, betamethasone was injected into swollen joints (maximum 4 joints or 4 ml per visit). Beginning at week 8, if synovitis was present, the methotrexate dosage was increased stepwise up to 20 mg/week, with a subsequent stepwise increase in the cyclosporine or placebo-cyclosporine dosage up to 4 mg/kg. RESULTS: At 52 weeks, 20% improvement according to the American College of Rheumatology criteria (ACR20) was achieved in 85% of the combination therapy group versus 68% of the monotherapy group (P = 0.02). The median individual overall ACR response (ACR-N) in the 2 groups was 80.0% (interquartile range 40.1-91.8%) and 54.5% (interquartile range 2.4-87.8%), respectively (P = 0.025). At 48 and 52 weeks, ACR remission criteria were met in 35% of the combination therapy group and 28% of the monotherapy group. Progression in the Larsen score at 52 weeks was -0.2 +/- 6.5 and 0.4 +/- 6.9 (mean +/- SD) in the combination therapy and monotherapy groups, respectively. Serum creatinine levels increased by 7%, and hypertrichosis was more prevalent, in the combination therapy group. CONCLUSION: Combined treatment with methotrexate and intraarticular glucocorticoid showed excellent disease control and stopped the progression of erosions in patients with early active RA, who had a poor prognosis. Addition of cyclosporine improved the ACR20 and ACR-N responses, whereas the ACR50 and ACR70 responses, remission rates, and radiographic changes did not differ between the 2 study groups.

M3 - Journal article

SN - 2326-5205

VL - 54

SP - 1401

EP - 1409

JO - Arthritis & Rheumatology

JF - Arthritis & Rheumatology

IS - 5

ER -

Combination treatment with metrotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis

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