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Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: Results from the british isles lupus assessment group biologics register

Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: Results from the british isles lupus assessment group biologics register
Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: Results from the british isles lupus assessment group biologics register

Objectives. To describe the baseline characteristics of SLE patients requiring biologic therapy in the UK and to explore short term efficacy and infection rates associated with rituximab (RTX) use. Methods. Patients commencing biologic therapy for refractory SLE and who consented to join BILAG-BR were analysed. Baseline characteristics, disease activity (BILAG 2004/SLEDAI-2K) and rates of infection over follow-up were analysed. Response was defined as loss of all A and B BILAG scores to41 B score with no new A/B scores in other organ systems at 6 months. Results. Two hundred and seventy SLE patients commenced biologic therapy from September 2010 to September 2015, most commonly RTX (n = 261). Two hundred and fifty (93%) patients were taking glucocorticoids at baseline at a median [interquartile range (IQR)] oral dose of 10mg (5-20 mg) daily. Response rates at 6 months were available for 68% of patients. The median (IQR) BILAG score was 15 (10-23) at baseline and 3 (2-12) at 6 months (P<0.0001). The median (IQR) SLEDAI-2K reduced from 8 (5-12) to 4 (0-7) (P<0.001). Response was achieved in 49% of patients. There was also a reduction in glucocorticoid use to a median (IQR) dose of 7.5mg (5-12 mg) at 6 months (P< 0.001). Serious infections occurred in 26 (10%) patients, being more frequent in the first 3 months post-RTX therapy. A higher proportion of early infections were non-respiratory (odds ratio = 1.98, 95% CI: 0.99, 3.9; P = 0.049). Conclusion. RTX is safe and is associated with improvement in disease activity in refractory SLE patients with concomitant reductions in glucocorticoid use. Early vigilance for infection post-infusion is important to further improve treatment risks and benefits.

Biologic therapy, Register, Rituximab, Systemic lupus erythematosus
1462-0324
470-479
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McCarthy, Eoghan M., Sutton, Emily, Nesbit, Stephanie, White, James, Parker, Ben, Jayne, David, Griffiths, Bridget, Isenberg, WDavid A., Rahman, Anisur, Gordon, Caroline, D'Cruz, David P., Rhodes, Benjamin, Lanyon, Peter, Vital, Edward M., Yee, Chee Seng, Edwards, Christopher J., Teh, Lee Suan, Akil, Mohammed, McHugh, Neil J., Zoma, Asad, Bruce, Ian N., Gordon, Patrick, Young-Min, Steven, Stevens, Robert, Prabu, Athiveer, Batley, Mike, Gendi, Nagui, Dasgupta, Bhaskar, Khamashta, Munther, Hewins, Peter, Stratton, Richard J., Chan, Antoni, De Lord, Denise, King, Jon, Dubey, Shirish, O'Riordan, Edmond, Shaffu, Shireen, Laversuch, Cathy, Sheeran, Thomas P., Vermaak, Erin, Erb, Nicola, Pyne, Debasish, Jeffrey, Rachel, Youssef, Hazem, Al-Allaf, Wahab, Regan, Marian and Kaul, Arvind , On behalf of the British Isles Lupus Assessment Group Biologics Register (2018) Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: Results from the british isles lupus assessment group biologics register. Rheumatology (United Kingdom), 57 (3), 470-479. (doi:10.1093/rheumatology/kex395).

Record type: Article

Abstract

Objectives. To describe the baseline characteristics of SLE patients requiring biologic therapy in the UK and to explore short term efficacy and infection rates associated with rituximab (RTX) use. Methods. Patients commencing biologic therapy for refractory SLE and who consented to join BILAG-BR were analysed. Baseline characteristics, disease activity (BILAG 2004/SLEDAI-2K) and rates of infection over follow-up were analysed. Response was defined as loss of all A and B BILAG scores to41 B score with no new A/B scores in other organ systems at 6 months. Results. Two hundred and seventy SLE patients commenced biologic therapy from September 2010 to September 2015, most commonly RTX (n = 261). Two hundred and fifty (93%) patients were taking glucocorticoids at baseline at a median [interquartile range (IQR)] oral dose of 10mg (5-20 mg) daily. Response rates at 6 months were available for 68% of patients. The median (IQR) BILAG score was 15 (10-23) at baseline and 3 (2-12) at 6 months (P<0.0001). The median (IQR) SLEDAI-2K reduced from 8 (5-12) to 4 (0-7) (P<0.001). Response was achieved in 49% of patients. There was also a reduction in glucocorticoid use to a median (IQR) dose of 7.5mg (5-12 mg) at 6 months (P< 0.001). Serious infections occurred in 26 (10%) patients, being more frequent in the first 3 months post-RTX therapy. A higher proportion of early infections were non-respiratory (odds ratio = 1.98, 95% CI: 0.99, 3.9; P = 0.049). Conclusion. RTX is safe and is associated with improvement in disease activity in refractory SLE patients with concomitant reductions in glucocorticoid use. Early vigilance for infection post-infusion is important to further improve treatment risks and benefits.

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Accepted/In Press date: 27 September 2017
e-pub ahead of print date: 5 December 2017
Published date: 1 March 2018
Keywords: Biologic therapy, Register, Rituximab, Systemic lupus erythematosus

Identifiers

Local EPrints ID: 418716
URI: http://eprints.soton.ac.uk/id/eprint/418716
ISSN: 1462-0324
PURE UUID: 1c681ba3-e21a-4540-a3c5-60404ca8637e

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Date deposited: 20 Mar 2018 17:30
Last modified: 25 Nov 2021 17:58

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Contributors

Author: Eoghan M. McCarthy
Author: Emily Sutton
Author: Stephanie Nesbit
Author: James White
Author: Ben Parker
Author: David Jayne
Author: Bridget Griffiths
Author: WDavid A. Isenberg
Author: Anisur Rahman
Author: Caroline Gordon
Author: David P. D'Cruz
Author: Benjamin Rhodes
Author: Peter Lanyon
Author: Edward M. Vital
Author: Chee Seng Yee
Author: Lee Suan Teh
Author: Mohammed Akil
Author: Neil J. McHugh
Author: Asad Zoma
Author: Ian N. Bruce
Author: Patrick Gordon
Author: Steven Young-Min
Author: Robert Stevens
Author: Athiveer Prabu
Author: Mike Batley
Author: Nagui Gendi
Author: Bhaskar Dasgupta
Author: Munther Khamashta
Author: Peter Hewins
Author: Richard J. Stratton
Author: Antoni Chan
Author: Denise De Lord
Author: Jon King
Author: Shirish Dubey
Author: Edmond O'Riordan
Author: Shireen Shaffu
Author: Cathy Laversuch
Author: Thomas P. Sheeran
Author: Erin Vermaak
Author: Nicola Erb
Author: Debasish Pyne
Author: Rachel Jeffrey
Author: Hazem Youssef
Author: Wahab Al-Allaf
Author: Marian Regan
Author: Arvind Kaul
Corporate Author: On behalf of the British Isles Lupus Assessment Group Biologics Register

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