dc.contributor.author | Little, Mark | |
dc.contributor.author | Jayne, David | |
dc.contributor.author | Blockmans, Daniel | |
dc.contributor.author | Luqmani, Raashid | |
dc.contributor.author | Moiseev, Sergey | |
dc.contributor.author | Ji, Beulah | |
dc.contributor.author | Green, Yulia | |
dc.contributor.author | Hall, Leanne | |
dc.contributor.author | Roth, David | |
dc.contributor.author | Henderson, Robert B. | |
dc.contributor.author | Merkel, Peter A. | |
dc.date.accessioned | 2020-01-27T16:05:58Z | |
dc.date.available | 2020-01-27T16:05:58Z | |
dc.date.issued | 2019 | |
dc.date.submitted | 2019 | en |
dc.identifier.citation | Jayne, D., Blockmans, D., Luqmani, R., Moiseev, S., Ji, B., Green, Y., Hall, L., Roth, D., Henderson, R.B. & Merkel, P.A., Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study., Arthritis & rheumatology (Hoboken, N.J.), 2019 | en |
dc.identifier.other | Y | |
dc.identifier.uri | http://hdl.handle.net/2262/91393 | |
dc.description | PUBLISHED | en |
dc.description.abstract | Objective:
To evaluate the safety and efficacy of belimumab as adjunctive therapy to maintain remission in antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis (AAV).
Methods:
In this multicenter, double‐blind, placebo‐controlled study, patients with AAV (ages ≥18 years) were randomized 1:1 to receive azathioprine (2 mg/kg/day), low‐dose oral glucocorticoids (≤10 mg/day), and either intravenous belimumab (10 mg/kg) or placebo, following remission induction with rituximab or cyclophosphamide along with glucocorticoids. The primary end point was time to first protocol‐specified event (PSE), with first PSE defined as a Birmingham Vasculitis Activity Score (BVAS) of ≥6, presence of ≥1 major BVAS item, or receipt of prohibited medications for any reason, resulting in treatment failure (adjusted for ANCA type [proteinase 3 (PR3) or myeloperoxidase (MPO)], disease stage at induction, and induction regimen). Vasculitis relapse was defined as the PSE of either a BVAS activity score of ≥6 or receipt of prohibited medications for vasculitis. Changes in treatment practice led to truncation of the study population from ~300 patients to ~100 patients.
Results:
The intent‐to‐treat population totaled 105 patients with AAV, of whom 52 (40 with PR3‐ANCAs, 12 with MPO‐ANCAs) received placebo and 53 (41 with PR3‐ANCAs, 12 with MPO‐ANCAs) received belimumab; 27 of the patients were in rituximab‐induced disease remission, while 78 were in cyclophosphamide‐induced disease remission at baseline. Compared with placebo, treatment with belimumab did not reduce the risk of a PSE (adjusted hazard ratio [HR] 1.07, 95% confidence interval [95% CI] 0.44–2.59; P = 0.884) or vasculitis relapse (adjusted HR 0.88, 95% CI 0.29–2.65; P = 0.821). The overall rate of PSEs was low (11 [21.2%] of 52 patients receiving placebo, 10 [18.9%] of 53 patients receiving belimumab). Vasculitis relapse in the placebo group (n = 8) occurred independent of the induction regimen, disease stage, or ANCA type. All vasculitis relapses in the belimumab group (n = 6) occurred in patients who had PR3‐ANCA–associated vasculitis with cyclophosphamide‐induced disease remission. Adverse events occurred in 49 (92.5%) of 53 patients receiving belimumab and 43 (82.7%) of 52 patients receiving placebo, with no new safety concerns.
Conclusion:
Belimumab plus azathioprine and glucocorticoids for the maintenance of remission in AAV did not reduce the risk of relapse. | en |
dc.language.iso | en | en |
dc.relation.ispartofseries | Arthritis & rheumatology (Hoboken, N.J.); | |
dc.rights | Y | en |
dc.subject | ANCA-associated vasculitis | en |
dc.subject | B-Lymphocyte | en |
dc.subject | Randomised trial | en |
dc.subject | Vasculitis | en |
dc.title | Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study | en |
dc.type | Journal Article | en |
dc.type.supercollection | scholarly_publications | en |
dc.type.supercollection | refereed_publications | en |
dc.identifier.peoplefinderurl | http://people.tcd.ie/mlittle | |
dc.identifier.rssinternalid | 210896 | |
dc.identifier.doi | https://doi.org/10.1002/art.40802 | |
dc.rights.ecaccessrights | openAccess | |
dc.subject.TCDTheme | Immunology, Inflammation & Infection | en |
dc.identifier.rssuri | https://onlinelibrary.wiley.com/doi/full/10.1002/art.40802 | |
dc.identifier.orcid_id | 0000-0001-6003-397X | |