ArticleLupus science & medicine2018
Safety, tolerability and pharmacokinetics of subcutaneous and intravenous anifrolumab in healthy volunteers.
Article in Lupus science & medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non-Japanese Individuals.Journal of clinical pharmacology · 2026Review
- Anifrolumab-A Potential New Systemic Sclerosis Treatment.Journal of clinical medicine · 2026Review
- What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond.The Journal of clinical and aesthetic dermatology · 2026Review
- Atypical infections during combination therapy with anifrolumab and other immunosuppressives in patients with lupus erythematosus: A case series.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025Article
- Post-marketing safety signals of anifrolumab in systemic lupus erythematosus: a pharmacovigilance study based on FAERS.BMC rheumatology · 2025Article
- Virtual patients inspired by multiomics predict the efficacy of an anti-IFNα mAb in cutaneous lupus.iScience · 2025Article
- Physiology-based pharmacokinetic model with relative transcriptomics to evaluate tissue distribution and receptor occupancy of anifrolumab.CPT: pharmacometrics & systems pharmacology · 2025Article
- Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anifrolumab.Clinical pharmacokinetics · 2023Review
- Nonlinear Population Pharmacokinetics of Anifrolumab in Healthy Volunteers and Patients With Systemic Lupus Erythematosus.Journal of clinical pharmacology · 2022Article
- [Innovations in the pharmaceutical treatment of systemic lupus erythematosus].Der Internist · 2022Review
- Type I Interferons in Systemic Lupus Erythematosus: A Journey from Bench to Bedside.International journal of molecular sciences · 2022Review
- Anifrolumab: First Approval.Drugs · 2021Review
- Type I interferon antagonists in clinical development for lupus.Expert opinion on investigational drugs · 2020Review
- Pathogenic Role of Type I Interferons in HIV-Induced Immune Impairments in Humanized Mice.Current HIV/AIDS reports · 2019Review
- Spotlight on anifrolumab and its potential for the treatment of moderate-to-severe systemic lupus erythematosus: evidence to date.Drug design, development and therapy · 2019Review
- Understanding the Monoclonal Antibody Disposition after Subcutaneous Administration using a Minimal Physiologically based Pharmacokinetic Model.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2018Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo compare the pharmacokinetics (PK), safety and tolerability of subcutaneous (SC) and intravenous anifrolumab, an anti-type I interferon receptor monoclonal antibody in development for SLE, in healthy volunteers.
methodsIn this Phase I randomised, placebo-controlled study, 30 adults were assigned to three treatment cohorts (anifrolumab 300 mg SC (n=6), anifrolumab 300 mg intravenous (n=6), anifrolumab 600 mg SC (n=6)) and placebo (n=4/cohort). Serial blood samples were collected up to Day 84 to measure anifrolumab concentrations and antidrug antibodies (ADAs). PK parameters were estimated by noncompartmental analysis.
resultsMaximum serum concentrations in SC cohorts occurred after 4-7 days. Anifrolumab serum concentrations were below the limit of detection in all individuals by Day 84. Exposure to SC anifrolumab increased dose proportionally from 300 mg to 600 mg based on area under the serum concentration-time curve. Anifrolumab 300 mg SC exposure reached 87% of the intravenous exposure. Anifrolumab 300 mg SC and placebo administration elicited minimal injection-site reactions. Transient injection-site induration occurred in five of six individuals after anifrolumab 600 mg SC and two of four individuals after placebo. Transient, mild to moderate injection-site induration and pruritus occurred simultaneously in two of six individuals after anifrolumab 600 mg SC. Adverse events were reported by 50% (n=9) of anifrolumab-treated individuals and 33% (n=4) of placebo-treated individuals. ADAs were detected in only one individual in the anifrolumab 300-mg intravenous group at the Day 84 assessment.
conclusionAnifrolumab 300-mg SC exposure was 87% of intravenous administration, with single SC anifrolumab administrations well tolerated in healthy volunteers.
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