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Efficacy and safety of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis: rheumatoid arthritis with orencia trial toward Sjögren's syndrome Endocrinopathy (ROSE) trial-an open-label, one-year, prospective study-Interim analysis of 32 patients for 24 weeks.

Tsuboi H, Matsumoto I, Hagiwara S, Hirota T, Takahashi H, Ebe H, Yokosawa M, Hagiya C, Asashima H, Takai C, Miki H, Umeda N, Kondo Y, Ogishima H, Suzuki T, Hirata S, Saito K, Tanaka Y, Horai Y, Nakamura H, Kawakami A, Sumida T - Mod Rheumatol (2014)

Bottom Line: Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections.Conclusion.Abatacept seems to be effective for both RA and RA-related secondary SS.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Faculty of Medicine, University of Tsukuba , Tsukuba, Ibaraki Prefecture , Japan.

ABSTRACT
Abstract Objective. To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods. The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results. Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min (P < 0.05). Schirmer's test for tear volume showed increase from 3.6 ± 4.6 (0 week) to 5.5 ± 7.1 (24 weeks) mm/5 min (n = 25; P < 0.05). Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections. Conclusion. Abatacept seems to be effective for both RA and RA-related secondary SS.

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Effect of abatacept on RA. (A) Effects of abatacept treatment on Simplified Disease Activity Index (SDAI) in 31 patients. Data deficit was compensated by the last observation carried forward (LOCF) method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept. (B) Effects of abatacept treatment on SDAI in 7 bio-switch patients and 24 bio-naïve patients. Data deficit compensated by the LOCF method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. The difference between two groups was examined using Mann–Whitney U-test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept and methotrexate combination treatment on SDAI in 23 patients and of abatacept alone in 8 patients. Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant.
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Figure 1: Effect of abatacept on RA. (A) Effects of abatacept treatment on Simplified Disease Activity Index (SDAI) in 31 patients. Data deficit was compensated by the last observation carried forward (LOCF) method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept. (B) Effects of abatacept treatment on SDAI in 7 bio-switch patients and 24 bio-naïve patients. Data deficit compensated by the LOCF method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. The difference between two groups was examined using Mann–Whitney U-test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept and methotrexate combination treatment on SDAI in 23 patients and of abatacept alone in 8 patients. Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant.

Mentions: Analysis of data of 31 patients showed that SDAI decreased significantly after treatment with abatacept from 19.8 ± 11.0 (0 week, baseline) to 9.9 ± 9.9 (24 weeks) (P < 0.05). Significant reduction of SDAI relative to baseline (P < 0.05) was noted at 4 weeks and maintained to 24 weeks (Figure 1A). Comparison of bio-switch patients with bio-naïve patients showed significant falls in SDAI after initiation of abatacept in both groups (P < 0.05; Figure 1B). Although the disease activity by SDAI was higher in bio-switch patients than in bio-naïve patients, there was no significant difference between two groups at each time point (Figure 1B).


Efficacy and safety of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis: rheumatoid arthritis with orencia trial toward Sjögren's syndrome Endocrinopathy (ROSE) trial-an open-label, one-year, prospective study-Interim analysis of 32 patients for 24 weeks.

Tsuboi H, Matsumoto I, Hagiwara S, Hirota T, Takahashi H, Ebe H, Yokosawa M, Hagiya C, Asashima H, Takai C, Miki H, Umeda N, Kondo Y, Ogishima H, Suzuki T, Hirata S, Saito K, Tanaka Y, Horai Y, Nakamura H, Kawakami A, Sumida T - Mod Rheumatol (2014)

Effect of abatacept on RA. (A) Effects of abatacept treatment on Simplified Disease Activity Index (SDAI) in 31 patients. Data deficit was compensated by the last observation carried forward (LOCF) method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept. (B) Effects of abatacept treatment on SDAI in 7 bio-switch patients and 24 bio-naïve patients. Data deficit compensated by the LOCF method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. The difference between two groups was examined using Mann–Whitney U-test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept and methotrexate combination treatment on SDAI in 23 patients and of abatacept alone in 8 patients. Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4389760&req=5

Figure 1: Effect of abatacept on RA. (A) Effects of abatacept treatment on Simplified Disease Activity Index (SDAI) in 31 patients. Data deficit was compensated by the last observation carried forward (LOCF) method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept. (B) Effects of abatacept treatment on SDAI in 7 bio-switch patients and 24 bio-naïve patients. Data deficit compensated by the LOCF method (∗P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. The difference between two groups was examined using Mann–Whitney U-test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept and methotrexate combination treatment on SDAI in 23 patients and of abatacept alone in 8 patients. Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant.
Mentions: Analysis of data of 31 patients showed that SDAI decreased significantly after treatment with abatacept from 19.8 ± 11.0 (0 week, baseline) to 9.9 ± 9.9 (24 weeks) (P < 0.05). Significant reduction of SDAI relative to baseline (P < 0.05) was noted at 4 weeks and maintained to 24 weeks (Figure 1A). Comparison of bio-switch patients with bio-naïve patients showed significant falls in SDAI after initiation of abatacept in both groups (P < 0.05; Figure 1B). Although the disease activity by SDAI was higher in bio-switch patients than in bio-naïve patients, there was no significant difference between two groups at each time point (Figure 1B).

Bottom Line: Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections.Conclusion.Abatacept seems to be effective for both RA and RA-related secondary SS.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Faculty of Medicine, University of Tsukuba , Tsukuba, Ibaraki Prefecture , Japan.

ABSTRACT
Abstract Objective. To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods. The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results. Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min (P < 0.05). Schirmer's test for tear volume showed increase from 3.6 ± 4.6 (0 week) to 5.5 ± 7.1 (24 weeks) mm/5 min (n = 25; P < 0.05). Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections. Conclusion. Abatacept seems to be effective for both RA and RA-related secondary SS.

Show MeSH
Related in: MedlinePlus