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Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study).

Takeuchi T, Tanaka Y, Kaneko Y, Tanaka E, Hirata S, Kurasawa T, Kubo S, Saito K, Shidara K, Kimura N, Nagasawa H, Kameda H, Amano K, Yamanaka H - Mod Rheumatol (2011)

Bottom Line: Clinical and functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment.Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years).It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan. tsutake@z5.keio.jp

ABSTRACT
We retrospectively investigated the ability of adalimumab (ADA) to reduce disease activity, improve physical function, and retard the progression of structural damage in 167 patients with rheumatoid arthritis. Clinical and functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment. At week 52, 38.3% achieved clinical remission: 42.4 and 28.6% of patients achieved remission in those without and with previous biologics, respectively, while 42.7 and 12.5% of patients achieved remission in those with and without concomitant MTX, respectively. ADA treatment significantly reduced the rate of radiographic progression from 27.1 ± 46.0 (median 13.6; 25th-75th percentiles 8.3 to 28.9) at baseline to 0.8 ± 5.0 (median 0.0; 25th-75th percentiles -0.9 to 2.0) at week 52 (P < 0.0001). Radiographic progression was absent in 59.8% of patients. Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years). ADA therapy is highly effective for reducing disease activity, improving physical function, and limiting radiographic progression. It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.

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Time course of Health Assessment Questionnaire—Disability Index (HAQ-DI) over 52 weeks following the initiation of adalimumab treatment. Data were analyzed by the last observation carried forward (LOCF) method. Points and bars represent the mean and standard deviation, respectively. a All patients (n = 149), b previous biologics (+) (n = 41) and (−) (n = 108), c concomitant MTX (+) (n = 131) and (−) (n = 18). **P < 0.0001 versus baseline by the Wilcoxon signed rank test
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Fig3: Time course of Health Assessment Questionnaire—Disability Index (HAQ-DI) over 52 weeks following the initiation of adalimumab treatment. Data were analyzed by the last observation carried forward (LOCF) method. Points and bars represent the mean and standard deviation, respectively. a All patients (n = 149), b previous biologics (+) (n = 41) and (−) (n = 108), c concomitant MTX (+) (n = 131) and (−) (n = 18). **P < 0.0001 versus baseline by the Wilcoxon signed rank test

Mentions: The mean HAQ score of 1.24 ± 0.78 at baseline decreased to 0.92 ± 0.77 at week 52 (Fig. 3). The improvement was moderate but significant (P < 0.0001 vs. baseline). At week 4, the mean change was −0.22, which has been associated with meaningful clinical improvements and can be considered to represent the minimum clinically important difference (MCID) [24]. Although the baseline HAQ scores were comparable between the previous biologics (+) and (−) groups on average (1.24 ± 0.85 vs. 1.25 ± 0.76), patients without previous biologic therapy (−) showed a greater improvement than those with previous biologic treatment (+) (0.83 ± 0.72 vs. 1.16 ± 0.86) at week 52. In addition, the difference at week 52 was even more striking between the concomitant MTX treatment (+) and (−) groups (0.87 ± 0.75 vs. 1.29 ± 0.85). A significant improvement in the HAQ score as compared to baseline was detected only in the previous biologics (−) and concomitant MTX (+) groups (P < 0.0001 for both groups).Fig. 3


Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study).

Takeuchi T, Tanaka Y, Kaneko Y, Tanaka E, Hirata S, Kurasawa T, Kubo S, Saito K, Shidara K, Kimura N, Nagasawa H, Kameda H, Amano K, Yamanaka H - Mod Rheumatol (2011)

Time course of Health Assessment Questionnaire—Disability Index (HAQ-DI) over 52 weeks following the initiation of adalimumab treatment. Data were analyzed by the last observation carried forward (LOCF) method. Points and bars represent the mean and standard deviation, respectively. a All patients (n = 149), b previous biologics (+) (n = 41) and (−) (n = 108), c concomitant MTX (+) (n = 131) and (−) (n = 18). **P < 0.0001 versus baseline by the Wilcoxon signed rank test
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3375429&req=5

Fig3: Time course of Health Assessment Questionnaire—Disability Index (HAQ-DI) over 52 weeks following the initiation of adalimumab treatment. Data were analyzed by the last observation carried forward (LOCF) method. Points and bars represent the mean and standard deviation, respectively. a All patients (n = 149), b previous biologics (+) (n = 41) and (−) (n = 108), c concomitant MTX (+) (n = 131) and (−) (n = 18). **P < 0.0001 versus baseline by the Wilcoxon signed rank test
Mentions: The mean HAQ score of 1.24 ± 0.78 at baseline decreased to 0.92 ± 0.77 at week 52 (Fig. 3). The improvement was moderate but significant (P < 0.0001 vs. baseline). At week 4, the mean change was −0.22, which has been associated with meaningful clinical improvements and can be considered to represent the minimum clinically important difference (MCID) [24]. Although the baseline HAQ scores were comparable between the previous biologics (+) and (−) groups on average (1.24 ± 0.85 vs. 1.25 ± 0.76), patients without previous biologic therapy (−) showed a greater improvement than those with previous biologic treatment (+) (0.83 ± 0.72 vs. 1.16 ± 0.86) at week 52. In addition, the difference at week 52 was even more striking between the concomitant MTX treatment (+) and (−) groups (0.87 ± 0.75 vs. 1.29 ± 0.85). A significant improvement in the HAQ score as compared to baseline was detected only in the previous biologics (−) and concomitant MTX (+) groups (P < 0.0001 for both groups).Fig. 3

Bottom Line: Clinical and functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment.Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years).It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan. tsutake@z5.keio.jp

ABSTRACT
We retrospectively investigated the ability of adalimumab (ADA) to reduce disease activity, improve physical function, and retard the progression of structural damage in 167 patients with rheumatoid arthritis. Clinical and functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment. At week 52, 38.3% achieved clinical remission: 42.4 and 28.6% of patients achieved remission in those without and with previous biologics, respectively, while 42.7 and 12.5% of patients achieved remission in those with and without concomitant MTX, respectively. ADA treatment significantly reduced the rate of radiographic progression from 27.1 ± 46.0 (median 13.6; 25th-75th percentiles 8.3 to 28.9) at baseline to 0.8 ± 5.0 (median 0.0; 25th-75th percentiles -0.9 to 2.0) at week 52 (P < 0.0001). Radiographic progression was absent in 59.8% of patients. Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years). ADA therapy is highly effective for reducing disease activity, improving physical function, and limiting radiographic progression. It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.

Show MeSH
Related in: MedlinePlus