Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol: a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial

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Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol : a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial. / Jones, Alexis; Muller, Patrick; Dore, Caroline; Ikeji, Felicia; Caverly, Emilia; Chowdhury, Kashfia; Isenberg, David; Gordon, Caroline; Ehrenstein, Michael.

In: BMJ open, Vol. 9, No. 12, e032569, 16.12.2019, p. 1-9.

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Jones, Alexis ; Muller, Patrick ; Dore, Caroline ; Ikeji, Felicia ; Caverly, Emilia ; Chowdhury, Kashfia ; Isenberg, David ; Gordon, Caroline ; Ehrenstein, Michael. / Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol : a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial. In: BMJ open. 2019 ; Vol. 9, No. 12. pp. 1-9.

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@article{6b11ccd3abd54535b57b06a5d2f1d192,
title = "Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol: a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial",
abstract = "Introduction: Few treatment options exist for patients with systemic lupus erythematosus (SLE) who fail conventional therapy. Although widely used to treat lupus, the efficacy of B cell depletion therapy using rituximab has not been demonstrated in randomised clinical trials. Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse. The administration of belimumab, a monoclonal antibody specific for BAFF and approved for lupus therapy, could potentiate the efficacy of rituximab and enable longer periods of disease remission. The aim of this trial is to assess the safety and efficacy of belimumab following rituximab in patients with SLE.Methods and analysis: BEAT Lupus is a double-blind, randomised, placebo controlled, phase II clinical trial. Patients with SLE commencing a treatment cycle of rituximab (two 1g infusions, 2 weeks apart) as standard of care will be randomised to receive belimumab or placebo, 4 to 8 weeks following the first rituximab infusion. Belimumab or placebo infusions are administered for 52 weeks. The primary outcome measure is anti-double stranded DNA (anti-dsDNA) antibody levels at 52 weeks. Secondary outcomes include measures of adverse events, lupus disease activity and cumulative steroid dose. The kinetics of B cell repopulation will be assessed in a subgroup of participants. Belimumab administration after rituximab may provide a novel therapeutic pathway for patients with active lupus if safety is demonstrated in this proof of concept study, and lower anti-dsDNA antibodies levels are achieved in those patients treated with belimumab compared with placebo.Ethics and dissemination: The protocol has been reviewed and approved by the Hampstead Research Ethics Committee - London (reference 16/LO/1024). Trial information is available at https://www.isrctn.com/ISRCTN47873003, and the results of this trial will be submitted for publication in relevant peer-reviewed journals. Key findings will also be presented at national and international conferences.Trial registration number: ISRCTN47873; date assigned to the registry: 28 November 2016. The stage is pre-results.",
keywords = "systemic lupus erythematosus, B cell depletion, rituximab, belimumab, randomised clinical trial",
author = "Alexis Jones and Patrick Muller and Caroline Dore and Felicia Ikeji and Emilia Caverly and Kashfia Chowdhury and David Isenberg and Caroline Gordon and Michael Ehrenstein",
year = "2019",
month = dec
day = "16",
doi = "10.1136/bmjopen-2019-032569",
language = "English",
volume = "9",
pages = "1--9",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "12",

}

RIS

TY - JOUR

T1 - Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol

T2 - a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial

AU - Jones, Alexis

AU - Muller, Patrick

AU - Dore, Caroline

AU - Ikeji, Felicia

AU - Caverly, Emilia

AU - Chowdhury, Kashfia

AU - Isenberg, David

AU - Gordon, Caroline

AU - Ehrenstein, Michael

PY - 2019/12/16

Y1 - 2019/12/16

N2 - Introduction: Few treatment options exist for patients with systemic lupus erythematosus (SLE) who fail conventional therapy. Although widely used to treat lupus, the efficacy of B cell depletion therapy using rituximab has not been demonstrated in randomised clinical trials. Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse. The administration of belimumab, a monoclonal antibody specific for BAFF and approved for lupus therapy, could potentiate the efficacy of rituximab and enable longer periods of disease remission. The aim of this trial is to assess the safety and efficacy of belimumab following rituximab in patients with SLE.Methods and analysis: BEAT Lupus is a double-blind, randomised, placebo controlled, phase II clinical trial. Patients with SLE commencing a treatment cycle of rituximab (two 1g infusions, 2 weeks apart) as standard of care will be randomised to receive belimumab or placebo, 4 to 8 weeks following the first rituximab infusion. Belimumab or placebo infusions are administered for 52 weeks. The primary outcome measure is anti-double stranded DNA (anti-dsDNA) antibody levels at 52 weeks. Secondary outcomes include measures of adverse events, lupus disease activity and cumulative steroid dose. The kinetics of B cell repopulation will be assessed in a subgroup of participants. Belimumab administration after rituximab may provide a novel therapeutic pathway for patients with active lupus if safety is demonstrated in this proof of concept study, and lower anti-dsDNA antibodies levels are achieved in those patients treated with belimumab compared with placebo.Ethics and dissemination: The protocol has been reviewed and approved by the Hampstead Research Ethics Committee - London (reference 16/LO/1024). Trial information is available at https://www.isrctn.com/ISRCTN47873003, and the results of this trial will be submitted for publication in relevant peer-reviewed journals. Key findings will also be presented at national and international conferences.Trial registration number: ISRCTN47873; date assigned to the registry: 28 November 2016. The stage is pre-results.

AB - Introduction: Few treatment options exist for patients with systemic lupus erythematosus (SLE) who fail conventional therapy. Although widely used to treat lupus, the efficacy of B cell depletion therapy using rituximab has not been demonstrated in randomised clinical trials. Following rituximab, elevated levels of serum B cell activating factor (BAFF) have been associated with failure to remit or subsequent lupus relapse. The administration of belimumab, a monoclonal antibody specific for BAFF and approved for lupus therapy, could potentiate the efficacy of rituximab and enable longer periods of disease remission. The aim of this trial is to assess the safety and efficacy of belimumab following rituximab in patients with SLE.Methods and analysis: BEAT Lupus is a double-blind, randomised, placebo controlled, phase II clinical trial. Patients with SLE commencing a treatment cycle of rituximab (two 1g infusions, 2 weeks apart) as standard of care will be randomised to receive belimumab or placebo, 4 to 8 weeks following the first rituximab infusion. Belimumab or placebo infusions are administered for 52 weeks. The primary outcome measure is anti-double stranded DNA (anti-dsDNA) antibody levels at 52 weeks. Secondary outcomes include measures of adverse events, lupus disease activity and cumulative steroid dose. The kinetics of B cell repopulation will be assessed in a subgroup of participants. Belimumab administration after rituximab may provide a novel therapeutic pathway for patients with active lupus if safety is demonstrated in this proof of concept study, and lower anti-dsDNA antibodies levels are achieved in those patients treated with belimumab compared with placebo.Ethics and dissemination: The protocol has been reviewed and approved by the Hampstead Research Ethics Committee - London (reference 16/LO/1024). Trial information is available at https://www.isrctn.com/ISRCTN47873003, and the results of this trial will be submitted for publication in relevant peer-reviewed journals. Key findings will also be presented at national and international conferences.Trial registration number: ISRCTN47873; date assigned to the registry: 28 November 2016. The stage is pre-results.

KW - systemic lupus erythematosus

KW - B cell depletion

KW - rituximab

KW - belimumab

KW - randomised clinical trial

U2 - 10.1136/bmjopen-2019-032569

DO - 10.1136/bmjopen-2019-032569

M3 - Article

VL - 9

SP - 1

EP - 9

JO - BMJ open

JF - BMJ open

SN - 2044-6055

IS - 12

M1 - e032569

ER -