Evidence map›Paper›PMID 32656662›Full record

ArticleClinical rheumatology2021

Experience with similar biologic rituximab in 77 patients of granulomatosis with polyangiitis-a real-life experience.

Sakshi Mittal, G S R S N K Naidu, Saket Jha, Manish Rathi, Ritambhra Nada, Ranjana W Minz, Kusum Sharma, Varun Dhir, Sanjay Jain, Aman Sharma

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Article in Clinical rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05716334 (Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT05716334 completednot on this map

Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator (BRAVO): a CanVasc Multicentre Study

TypeobservationalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2021 to 2025Enrolled201ConditionsANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Sakshi MittalDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
G S R S N K NaiduDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Saket JhaDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Manish RathiDepartment of Nephrology, PGIMER,, Chandigarh, India.
Ritambhra NadaDepartment of Histopathology, PGIMER, Chandigarh, India.
Ranjana W MinzDepartment of Immunopathology, PGIMER, Chandigarh, India.
Kusum SharmaDepartment of Medical Microbiology, PGIMER, Chandigarh, India.
Varun DhirDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Sanjay JainDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Aman SharmaDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India. amansharma74@yahoo.com.ORCID http://orcid.org/0000-0003-0813-1243

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo present single centre experience on the efficacy and safety of similar biologic of rituximab in patients with granulomatosis with polyangiitis (GPA).

methodsThis was a retrospective study of GPA patients who received similar biologic of rituximab as either remission induction or maintenance agent. Demographic parameters, Birmingham Vasculitis Activity Score (BVAS-v3), vasculitis damage index, relapse and adverse events were retrieved from patient records. Outcomes noted were remission at 6 months in remission induction group and rates of relapses, adverse events, serious infections and mortality in both remission induction and maintenance groups.

resultsSeventy-seven GPA patients were enrolled. Sixty received rituximab for induction and 57 for maintenance; 69% were anti PR-3 positive. In the induction group, median BVAS-v3 reduced from 12 (IQR 6-21.5) to 0 (0-1) at 6 months. At 6 months, 60% patients attained remission, 40% in primary induction group and 74% in re-induction group (p = 0.016%). In the maintenance group, seven (12%) patients had relapses with median time to relapse of 12 (6-22) months. Median relapse free survival was 21 (6-22) months on rituximab maintenance. There were 12 deaths (15.6%) and 18 serious infections.

conclusionSimilar biologic of rituximab was an effective agent for remission induction and remission maintenance in patients with GPA. Head to head trials with innovator molecule are needed to confirm these results. KEY POINTS: • Remission was achieved in 60% of GPA patients who received similar biologic of rituximab as remission induction therapy. • Relapse rate during maintenance phase was 12% with similar biologic of rituximab. Serious infections and mortality with similar biologic of rituximab were comparable with that reported previously in AAV trials.

Indexed as

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisBiological ProductsGranulomatosis with PolyangiitisHumansImmunosuppressive AgentsRecurrenceRemission InductionRetrospective StudiesRituximabTreatment OutcomeBiological ProductsImmunosuppressive AgentsRituximabANCA-associated vasculitisBiosimilarGranulomatosis with polyangiitisRituximabSimilar biologic

Identifiers

PMID32656662

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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.