Trial reportLupus2009
An exploratory dose-escalating study investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous atacicept in patients with systemic lupus erythematosus.
Trial report in Lupus, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 111 citations in OpenAlex.
- Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021Pooled it
- A Comprehensive Review of Biological Agents for Lupus: Beyond Single Target.Frontiers in immunology · 2020Pooled it
- Systematic Review of Safety and Efficacy of Atacicept in Treating Immune-Mediated Disorders.Frontiers in immunology · 2020Pooled it
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Atacicept in a Randomized Trial in Healthy Caucasian and Japanese Subjects.European journal of drug metabolism and pharmacokinetics · 2020Trial
- Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study.Arthritis & rheumatology (Hoboken, N.J.) · 2018Trial
- Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study.Arthritis & rheumatology (Hoboken, N.J.) · 2017Trial
- Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials.Arthritis research & therapy · 2015Trial
- Review
- Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials.CPT: pharmacometrics & systems pharmacology · 2023Article
- Kinetics of free and ligand-bound atacicept in human serum.Frontiers in immunology · 2022Article
- Biologic therapy in Sjögren's syndrome.Clinical rheumatology · 2021Review
- Telitacicept Following Plasma Exchange in the Treatment of Subjects With Recurrent NMOSD: Study Protocol for a Single-Center, Single-Arm, Open-Label Study.Frontiers in neurology · 2021Article
- [New treatments for systemic lupus erythematosus].Zeitschrift fur Rheumatologie · 2020Review
- Commentary: Systematic Review of Safety and Efficacy of Atacicept in Treating Immune-Mediated Disorders.Frontiers in immunology · 2020Article
- Integrated safety profile of atacicept: an analysis of pooled data from the atacicept clinical trial programme.Rheumatology advances in practice · 2019Article
- The Expanding Field of Secondary Antibody Deficiency: Causes, Diagnosis, and Management.Frontiers in immunology · 2019Review
- DNA Damage and Deficiencies in the Mechanisms of Its Repair: Implications in the Pathogenesis of Systemic Lupus Erythematosus.Journal of immunology research · 2018Review
- Recent advances in the management of systemic lupus erythematosus.F1000Research · 2018Review
- Clinical Pharmacokinetics and Pharmacodynamics of Biologic Therapeutics for Treatment of Systemic Lupus Erythematosus.Clinical pharmacokinetics · 2017Review
- Treating primary-progressive multiple sclerosis: potential of ocrelizumab and review of B-cell therapies.Degenerative neurological and neuromuscular disease · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Atacicept, a recombinant fusion protein containing the extracellular, ligand-binding portion of the transmembrane activator and calcium modulator and cyclophilin-ligand interactor receptor, and the Fc portion of human immunoglobulin (Ig) G, is designed to block the activity of B-lymphocyte stimulator and a proliferation-inducing ligand, and may have utility as a treatment for B-cell-mediated diseases, such as systemic lupus erythematosus (SLE). This Phase Ib study investigated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous (i.v.) atacicept in patients with mild-to-moderate SLE. Patients (n = 24) were randomised (5:1) to receive atacicept (single dose: 3, 9 or 18 mg/kg; or multiple dose: 2 x 9 mg/kg) or matching placebo. Patients were followed for 6 weeks after dosing (9 weeks in the 2 x 9 mg/kg cohort). Local tolerability of atacicept was comparable with that of placebo, with only mild injection-site reactions reported with atacicept. Atacicept i.v. was generally well tolerated, both systemically and locally, in patients with mild-to-moderate SLE. Atacicept displayed non-linear PK, which was predictable across doses and between single and repeat doses. The biological activity of atacicept was demonstrated by its marked effect in reducing B-cells and Ig levels in patients with SLE. This supports the utility of this therapeutic approach in the treatment of autoimmune diseases, such as SLE.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.