Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus

results from the British Isles Lupus Assessment Group Biologics Register

Eoghan M McCarthy, Emily Sutton, Stephanie Nesbit, James White, Ben Parker, David Jayne, Bridget Griffiths, David A Isenberg, Anisur Rahman, Caroline Gordon, David P D'Cruz, Benjamin Rhodes, Peter Lanyon, Edward M Vital, Chee-Seng Yee, Christopher J Edwards, Lee-Suan Teh, Mohammed Akil, Neil J McHugh, Asad Zoma & 1 others Ian N Bruce

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)470-479
Number of pages10
JournalRheumatology
Volume57
Issue number3
Early online date5 Dec 2017
DOIs
Publication statusPublished - 1 Mar 2018

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Biological Products
Systemic Lupus Erythematosus
Safety
Biological Therapy
Glucocorticoids
Infection
Therapeutics
Rituximab
Odds Ratio

Keywords

  • Adult
  • Antirheumatic Agents/administration & dosage
  • Biological Products/administration & dosage
  • Case-Control Studies
  • Female
  • Glucocorticoids/therapeutic use
  • Humans
  • Infection/chemically induced
  • Lupus Erythematosus, Systemic/drug therapy
  • Male
  • Middle Aged
  • Rituximab/administration & dosage
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • United Kingdom

Cite this

Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus : results from the British Isles Lupus Assessment Group Biologics Register. / McCarthy, Eoghan M; Sutton, Emily; Nesbit, Stephanie; White, James; Parker, Ben; Jayne, David; Griffiths, Bridget; Isenberg, David 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.

In: Rheumatology, Vol. 57, No. 3, 01.03.2018, p. 470-479.

Research output: Contribution to journalArticle

McCarthy, EM, Sutton, E, Nesbit, S, White, J, Parker, B, Jayne, D, Griffiths, B, Isenberg, DA, Rahman, A, Gordon, C, D'Cruz, DP, Rhodes, B, Lanyon, P, Vital, EM, Yee, C-S, Edwards, CJ, Teh, L-S, Akil, M, McHugh, NJ, Zoma, A & Bruce, IN 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, vol. 57, no. 3, pp. 470-479. https://doi.org/10.1093/rheumatology/kex395
McCarthy, Eoghan M ; Sutton, Emily ; Nesbit, Stephanie ; White, James ; Parker, Ben ; Jayne, David ; Griffiths, Bridget ; Isenberg, David 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. / Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus : results from the British Isles Lupus Assessment Group Biologics Register. In: Rheumatology. 2018 ; Vol. 57, No. 3. pp. 470-479.
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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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T1 - Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus

T2 - results from the British Isles Lupus Assessment Group Biologics Register

AU - McCarthy, Eoghan M

AU - Sutton, Emily

AU - Nesbit, Stephanie

AU - White, James

AU - Parker, Ben

AU - Jayne, David

AU - Griffiths, Bridget

AU - Isenberg, David A

AU - Rahman, Anisur

AU - Gordon, Caroline

AU - D'Cruz, David P

AU - Rhodes, Benjamin

AU - Lanyon, Peter

AU - Vital, Edward M

AU - Yee, Chee-Seng

AU - Edwards, Christopher J

AU - Teh, Lee-Suan

AU - Akil, Mohammed

AU - McHugh, Neil J

AU - Zoma, Asad

AU - Bruce, Ian N

N1 - © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

PY - 2018/3/1

Y1 - 2018/3/1

N2 - 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.

AB - 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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KW - Antirheumatic Agents/administration & dosage

KW - Biological Products/administration & dosage

KW - Case-Control Studies

KW - Female

KW - Glucocorticoids/therapeutic use

KW - Humans

KW - Infection/chemically induced

KW - Lupus Erythematosus, Systemic/drug therapy

KW - Male

KW - Middle Aged

KW - Rituximab/administration & dosage

KW - Severity of Illness Index

KW - Time Factors

KW - Treatment Outcome

KW - United Kingdom

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U2 - 10.1093/rheumatology/kex395

DO - 10.1093/rheumatology/kex395

M3 - Article

VL - 57

SP - 470

EP - 479

JO - Rheumatology

JF - Rheumatology

SN - 1462-0324

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