Evidence map›Paper›PMID 33597205›Full record

Trial reportLupus science & medicine2021

Safety profile of anifrolumab in patients with active SLE: an integrated analysis of phase II and III trials.

Raj Tummala, Gabriel Abreu, Lilia Pineda, M Alex Michaels, Rubana N Kalyani, Richard A Furie, Eric F Morand

Open access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lupus science & medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
11.7field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Vaccination in systemic lupus erythematosus.Human vaccines & immunotherapeutics · 2026
    Review
  12. Article
  13. Tenofovir, Interferon Pathways, and Mucosal Immunity: Implications for People Living With HIV.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
  14. Observational
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 3 countries.

Raj TummalaBiopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA Raj.Tummala@astrazeneca.com.
Gabriel AbreuBioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Lilia PinedaBiopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
M Alex MichaelsBiopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Rubana N KalyaniBiopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Richard A FurieDivision of Rheumatology, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, USA.
Eric F MorandCentre for Inflammatory Disease, Monash University, Melbourne, Victoria, Australia.
AstraZeneca (United States) · USAstraZeneca (Sweden) · SEHofstra University · USMonash University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn phase II and III trials, anifrolumab, a human monoclonal antibody that binds type I interferon receptor subunit 1, has shown efficacy in adults with moderate to severe SLE. We evaluated the safety and tolerability of anifrolumab using data pooled from these trials to more precisely estimate the rate and severity of adverse events (AEs).

methodsData were pooled from patients receiving monthly intravenous anifrolumab 300 mg or placebo in MUSE, TULIP-1 and TULIP-2. Key safety endpoints included percentages and exposure-adjusted incidence rates (EAIRs) of patients who experienced AEs, serious AEs (SAEs), AEs leading to discontinuation and AEs of special interest.

resultsDuring treatment, 86.9% of patients receiving anifrolumab 300 mg (n=459) experienced AEs (≥1) versus 79.4% receiving placebo (n=466), and 4.1% versus 5.2% experienced an AE leading to discontinuation of investigational product. SAEs (≥1) were experienced by 11.8% and 16.7% of patients receiving anifrolumab and placebo, respectively (EAIR risk difference (95% CI) -7.2 (-12.5 to -1.9)), including lupus exacerbations classified as SAEs (1.5% and 3%, respectively). Infections occurred in 69.7% and 55.4% of patients receiving anifrolumab and placebo, respectively; difference in reported rates was driven by herpes zoster (HZ) and mild and moderate respiratory (excluding pneumonia) infections. The risk of HZ was increased with anifrolumab versus placebo (6.1% vs 1.3%, respectively; EAIR risk difference (95% CI) 5.4 (2.8 to 8.4)); most HZ events were mild or moderate, cutaneous and resolved without treatment discontinuation. Serious infections occurred in 4.8% and 5.6% of patients receiving anifrolumab and placebo, respectively.

conclusionsIn this pooled analysis of 925 patients with moderate to severe SLE, monthly intravenous anifrolumab 300 mg was generally well tolerated over 52 weeks with an acceptable safety profile. Anifrolumab was associated with an increased incidence of HZ and respiratory tract infections and lower reported rate of SLE worsening as SAEs.

Indexed as

Lupus Erythematosus, SystemicAntibodies, Monoclonal, HumanizedHumansRespiratory Tract InfectionsanifrolumabAntibodies, Monoclonal, Humanizedbiological productshealth careinterferon type Ilupus erythematosusoutcome assessmentsystemictherapeutics

Identifiers

PMID33597205
PMCPMC7893670
OpenAlexW3130819905

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.