Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study
Objective To characterise disease control and remission in patients with SLE receiving belimumab for up to 12 months in the real world.Methods This post hoc analysis (GSK Study 213502) used data from the US evaluation Of use of Belimumab in clinical practice SEttings (OBSErve) study (GSK Study 11729...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-07-01
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| Series: | Lupus Science and Medicine |
| Online Access: | https://lupus.bmj.com/content/9/1/e000710.full |
| _version_ | 1827902612650852352 |
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| author | Holly Quasny Anna Richards Jacob N Hunnicutt Jolyon Fairburn-Beech Mary Elizabeth Georgiou Yun Irene Gregan Deven Chauhan |
| author_facet | Holly Quasny Anna Richards Jacob N Hunnicutt Jolyon Fairburn-Beech Mary Elizabeth Georgiou Yun Irene Gregan Deven Chauhan |
| author_sort | Holly Quasny |
| collection | DOAJ |
| description | Objective To characterise disease control and remission in patients with SLE receiving belimumab for up to 12 months in the real world.Methods This post hoc analysis (GSK Study 213502) used data from the US evaluation Of use of Belimumab in clinical practice SEttings (OBSErve) study (GSK Study 117295), an observational cohort study of adults with SLE initiating and continuing belimumab for ≥6 months. Data were collected every 6 months by physician chart review; details of disease activity using the Safety of Estrogens in Lupus Erythematosus National Assessment–SLE Disease Activity Index (SELENA-SLEDAI) score were collected if routinely used by physicians. Disease control definitions evaluated were SELENA-SLEDAI score of ≤2 at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid (prednisone equivalent) dose of ≤5 mg/day at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months. Disease remission definition was SELENA-SLEDAI score=0 at 12 months. Glucocorticoid dose during follow-up was quantified.Results US OBSErve enrolled 501 patients, 90 of whom had eligible SELENA-SLEDAI scores for inclusion in this analysis. Mean (SD) SELENA-SLEDAI scores were 13.1 (3.0) at baseline and 4.9 (3.4) at 12 months. Disease control at 12 months was achieved by 31.1% of patients when defined as a SELENA-SLEDAI score of ≤2 (95% CI 21.8 to 41.7); this decreased to 25.6% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day (95% CI 16.9 to 35.8) and 17.8% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months (95% CI 10.5 to 27.3). No patient achieved remission at 12 months. Glucocorticoids decreased from a baseline median of 20.0 mg/day (IQR 15.0–30.0) to 5.0 mg/day (IQR 0–10.0) at 12 months.Conclusion Improved disease control and reduced glucocorticoid use was achieved for a proportion of patients following up to 12 months of belimumab treatment in a US real-world setting. |
| first_indexed | 2024-03-13T00:01:42Z |
| format | Article |
| id | doaj.art-303ee4aa6c3549a285688637e6c39a4a |
| institution | Directory Open Access Journal |
| issn | 2053-8790 |
| language | English |
| last_indexed | 2024-03-13T00:01:42Z |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Lupus Science and Medicine |
| spelling | doaj.art-303ee4aa6c3549a285688637e6c39a4a2023-07-13T08:00:07ZengBMJ Publishing GroupLupus Science and Medicine2053-87902022-07-019110.1136/lupus-2022-000710Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve studyHolly Quasny0Anna Richards1Jacob N Hunnicutt2Jolyon Fairburn-Beech3Mary Elizabeth Georgiou4Yun Irene Gregan5Deven Chauhan618 Clinical Sciences, GSK, Research Triangle Park, North Carolina, USAValue Evidence and Outcomes, GSK, Brentford, UKValue Evidence and Outcomes, GSK, Collegeville, Pennsylvania, USAValue Evidence and Outcomes, GSK, Brentford, UKValue Evidence and Outcomes, GSK, Brentford, UKClinical Science Immunology, GSK, Collegeville, Pennsylvania, USAValue Evidence and Outcomes, GSK, Brentford, UKObjective To characterise disease control and remission in patients with SLE receiving belimumab for up to 12 months in the real world.Methods This post hoc analysis (GSK Study 213502) used data from the US evaluation Of use of Belimumab in clinical practice SEttings (OBSErve) study (GSK Study 117295), an observational cohort study of adults with SLE initiating and continuing belimumab for ≥6 months. Data were collected every 6 months by physician chart review; details of disease activity using the Safety of Estrogens in Lupus Erythematosus National Assessment–SLE Disease Activity Index (SELENA-SLEDAI) score were collected if routinely used by physicians. Disease control definitions evaluated were SELENA-SLEDAI score of ≤2 at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid (prednisone equivalent) dose of ≤5 mg/day at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months. Disease remission definition was SELENA-SLEDAI score=0 at 12 months. Glucocorticoid dose during follow-up was quantified.Results US OBSErve enrolled 501 patients, 90 of whom had eligible SELENA-SLEDAI scores for inclusion in this analysis. Mean (SD) SELENA-SLEDAI scores were 13.1 (3.0) at baseline and 4.9 (3.4) at 12 months. Disease control at 12 months was achieved by 31.1% of patients when defined as a SELENA-SLEDAI score of ≤2 (95% CI 21.8 to 41.7); this decreased to 25.6% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day (95% CI 16.9 to 35.8) and 17.8% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months (95% CI 10.5 to 27.3). No patient achieved remission at 12 months. Glucocorticoids decreased from a baseline median of 20.0 mg/day (IQR 15.0–30.0) to 5.0 mg/day (IQR 0–10.0) at 12 months.Conclusion Improved disease control and reduced glucocorticoid use was achieved for a proportion of patients following up to 12 months of belimumab treatment in a US real-world setting.https://lupus.bmj.com/content/9/1/e000710.full |
| spellingShingle | Holly Quasny Anna Richards Jacob N Hunnicutt Jolyon Fairburn-Beech Mary Elizabeth Georgiou Yun Irene Gregan Deven Chauhan Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study Lupus Science and Medicine |
| title | Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study |
| title_full | Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study |
| title_fullStr | Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study |
| title_full_unstemmed | Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study |
| title_short | Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study |
| title_sort | evaluating disease control following belimumab treatment in patients with sle enrolled in the us observe study |
| url | https://lupus.bmj.com/content/9/1/e000710.full |
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