MTX + Prednisone Regimen Improves Outcomes for Early RA

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.