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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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Related in: MedlinePlus

Correlation between improvement in SS and RA. Correlation between (A) increase in saliva volume (assessed by Saxon's test) and fall in SDAI (n = 29 patients). Spearman's rank correlation coefficient = 0.211, not significant, and (B) between increase of tear volume (assessed by Schirmer's test) and fall in SDAI (n = 25 patients). Data deficit was compensated by the LOCF method. Spearman's rank correlation coefficient = 0.333, not significant.
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Figure 6: Correlation between improvement in SS and RA. Correlation between (A) increase in saliva volume (assessed by Saxon's test) and fall in SDAI (n = 29 patients). Spearman's rank correlation coefficient = 0.211, not significant, and (B) between increase of tear volume (assessed by Schirmer's test) and fall in SDAI (n = 25 patients). Data deficit was compensated by the LOCF method. Spearman's rank correlation coefficient = 0.333, not significant.

Mentions: We analyzed the correlation between the increase in saliva volume by Saxon's test and tear volume by Schirmer's test, and the fall in SDAI. There was no significant correlation between the increase in saliva volume and reduction of SDAI (Spearman's rank correlation coefficient = 0.221; Figure 6A), as well as between the increase in tear volume and reduction of SDAI (Spearman's rank correlation coefficient = 0.333; Figure 6B). However, saliva volume and SDAI improved simultaneously in 13 of 29 (44.8%) patients, and tear volume and SDAI in 13 of 25 (52.0%) patients, respectively.


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)

Correlation between improvement in SS and RA. Correlation between (A) increase in saliva volume (assessed by Saxon's test) and fall in SDAI (n = 29 patients). Spearman's rank correlation coefficient = 0.211, not significant, and (B) between increase of tear volume (assessed by Schirmer's test) and fall in SDAI (n = 25 patients). Data deficit was compensated by the LOCF method. Spearman's rank correlation coefficient = 0.333, not significant.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 6: Correlation between improvement in SS and RA. Correlation between (A) increase in saliva volume (assessed by Saxon's test) and fall in SDAI (n = 29 patients). Spearman's rank correlation coefficient = 0.211, not significant, and (B) between increase of tear volume (assessed by Schirmer's test) and fall in SDAI (n = 25 patients). Data deficit was compensated by the LOCF method. Spearman's rank correlation coefficient = 0.333, not significant.
Mentions: We analyzed the correlation between the increase in saliva volume by Saxon's test and tear volume by Schirmer's test, and the fall in SDAI. There was no significant correlation between the increase in saliva volume and reduction of SDAI (Spearman's rank correlation coefficient = 0.221; Figure 6A), as well as between the increase in tear volume and reduction of SDAI (Spearman's rank correlation coefficient = 0.333; Figure 6B). However, saliva volume and SDAI improved simultaneously in 13 of 29 (44.8%) patients, and tear volume and SDAI in 13 of 25 (52.0%) patients, respectively.

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