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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 IgG, RF, and anti-SS-A antibody in SS. Effects of abatacept treatment on (A) serum IgG level (n = 31), (B) serum RF level (n = 30 patients), (C) titer of anti-SS-A antibody (n = 20 patients). Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), N.S; not significant vs baseline, Wilcoxon signed-rank test. ABT; abatacept.
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Figure 5: Effect of abatacept on IgG, RF, and anti-SS-A antibody in SS. Effects of abatacept treatment on (A) serum IgG level (n = 31), (B) serum RF level (n = 30 patients), (C) titer of anti-SS-A antibody (n = 20 patients). Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), N.S; not significant vs baseline, Wilcoxon signed-rank test. ABT; abatacept.

Mentions: Abatacept significantly decreased serum IgG and RF levels from 1782 ± 551 mg/dl and 204 ± 286 IU/ml at 0 week to 1555 ± 379 mg/dl and 188 ± 285 IU/ml at 24 weeks, respectively (P < 0.05; Figure 5A and B). On the other hand, abatacept had no effect on anti-SS-A antibody titer (Figure 5C). These findings suggest the effectiveness of abatacept for RA-related SS, especially SS-dryness, secretory dysfunction, and production of antibodies.


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 IgG, RF, and anti-SS-A antibody in SS. Effects of abatacept treatment on (A) serum IgG level (n = 31), (B) serum RF level (n = 30 patients), (C) titer of anti-SS-A antibody (n = 20 patients). Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), N.S; not significant vs baseline, Wilcoxon signed-rank test. ABT; abatacept.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 5: Effect of abatacept on IgG, RF, and anti-SS-A antibody in SS. Effects of abatacept treatment on (A) serum IgG level (n = 31), (B) serum RF level (n = 30 patients), (C) titer of anti-SS-A antibody (n = 20 patients). Data deficit was compensated by the LOCF method (∗P < 0.05 vs 0 week [baseline]), N.S; not significant vs baseline, Wilcoxon signed-rank test. ABT; abatacept.
Mentions: Abatacept significantly decreased serum IgG and RF levels from 1782 ± 551 mg/dl and 204 ± 286 IU/ml at 0 week to 1555 ± 379 mg/dl and 188 ± 285 IU/ml at 24 weeks, respectively (P < 0.05; Figure 5A and B). On the other hand, abatacept had no effect on anti-SS-A antibody titer (Figure 5C). These findings suggest the effectiveness of abatacept for RA-related SS, especially SS-dryness, secretory dysfunction, and production of antibodies.

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