ArticleRMD open2015
Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study.
Article in RMD open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01202773 (A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Current status of BAFF targeting immunotherapy in B-cell neoplasm.International journal of clinical oncology · 2024Review
- Skeletal muscle fibers produce B-cell stimulatory factors in chronic myositis.Frontiers in immunology · 2023Article
- Synergistic effect of Bruton's tyrosine kinase and TNF-α in the regulation of rheumatoid arthritis and underlying mechanisms.Experimental and therapeutic medicine · 2022Article
- Drug repurposing to improve treatment of rheumatic autoimmune inflammatory diseases.Nature reviews. Rheumatology · 2020Review
- Review
- B cell therapy in ANCA-associated vasculitis: current and emerging treatment options.Nature reviews. Rheumatology · 2018Review
- Treating primary-progressive multiple sclerosis: potential of ocrelizumab and review of B-cell therapies.Degenerative neurological and neuromuscular disease · 2017Review
- B Cell-Activating Factor (BAFF)-Targeted B Cell Therapies in Inflammatory Bowel Diseases.Digestive diseases and sciences · 2016Review
- Beyond pan-B-cell-directed therapy - new avenues and insights into the pathogenesis of SLE.Nature reviews. Rheumatology · 2016Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTabalumab is a human monoclonal antibody that neutralises B-cell activating factor.
objectivesTo evaluate tabalumab efficacy and safety in patients with rheumatoid arthritis (RA).
methodsThis phase 3, randomised, double-blind, placebo-controlled study evaluated 456 patients with active RA after 24-week treatment with subcutaneous tabalumab (120 mg every 4 weeks (120/Q4W) or 90 mg every 2 weeks (90/Q2W)) versus placebo, with loading doses (240 or 180 mg) at week 0. Patients were allowed background disease-modifying antirheumatic drugs and previously discontinued ≥1 tumour necrosis factor α inhibitors for lack of efficacy/intolerance. Primary end point was American College of Rheumatology 20% (ACR20) response at 24 weeks. This study was terminated early due to futility.
resultsMost patients had moderate-to-high baseline disease activity. There was no significant difference in week 24 ACR20 responses between 120/Q4W, 90/Q2W, and placebo (17.6%, 24.3%, 20%) per non-responder imputation analysis. Mean percent changes in CD20+ B-cell count (-10.8%, -9.6%, +10.9%) demonstrated expected pharmacodynamic effects. Treatment-emergent adverse events (AEs) were similar (59.5%, 51.7%, 52.6%), as were AE discontinuations (2.6%, 2.7%, 2.6%), serious AEs (4.6%, 4.1%, 3.9%), serious infectious events (1.3%, 0, 0) and events of interest: infections (23.5%, 25.9%, 24%), injection site reactions (13.1%, 25.8%, 11%) and allergy/hypersensitivity (3.9%, 4.1%, 3.9%) reports. Incidence of treatment-emergent antidrug antibodies was similar to placebo (3.9%, 4.8%, 3.9%). No deaths or new/unexpected safety findings were reported.
conclusionsTabalumab did not demonstrate clinical efficacy in patients with RA in this phase 3 study, despite evidence of biological activity. There were no notable differences in safety parameters between tabalumab treatment groups and placebo. TRIAL REGISTRATION NUMBER: NCT01202773.
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