Evidence map›Paper›PMID 33867740›Full record

ArticleIndian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion2021

Efficacy, safety, and quality of life of generic and innovator ibrutinib in Indian CLL patients.

Charanpreet Singh, Nishant Jindal, Padma Youron, Pankaj Malhotra, Gaurav Prakash, Alka Khadwal, Arihant Jain, Sreejesh Sreedharanunni, Man Updesh Singh Sachdeva, Shano Naseem and 3 more

Abstract read
In one paragraph

Article in Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Comprehensive bibliographic study of the framework of complex generic drugs.Journal of Taibah University Medical Sciences · 2025
    Article
  4. Article
  5. 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

13 authors.

Charanpreet SinghDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Nishant JindalDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Padma YouronDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Pankaj MalhotraDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Gaurav PrakashDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Alka KhadwalDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Arihant JainDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Sreejesh SreedharanunniDepartment of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Man Updesh Singh SachdevaDepartment of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Shano NaseemDepartment of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Neelam VarmaDepartment of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Subhash VarmaDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Deepesh P LadDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.ORCID 0000-0003-3754-7774

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To report the efficacy, safety, and quality of life (QoL) on generic and innovator ibrutinib in Indian CLL patients. This was a single centre, prospective study of treatment-naive (TN), and relapsed/refractory (R/R) CLL patients receiving ibrutinib in India. The choice of innovator or generic ibrutinib was as per patient discretion. Response and adverse events were recorded as per the 2018 iwCLL guidelines and CTCAEv4.0. QoL was assessed using the EORTC QLQ-C30 and CLL17 questionnaires. A total of 32 CLL patients (TN, n = 7 and R/R, n = 25) received ibrutinib from 2016-2019. The median age was 60 years (37-84). All TN patients attained partial response without any grade 3/4 adverse events (AE). Ibrutinib was less tolerated in the R/R setting, with 52% patients developing grade 3/4 AE and required dose reduction. Eleven patients (44%) died during follow-up. Grade 3-5 infections were seen in 44% of R/R CLL patients. Generic ibrutinib (n = 8) was comparable to innovator ibrutinib (n = 17) in terms of efficacy, safety, and QoL. Ibrutinib is less well tolerated in Indian R/R CLL patients. Infections are a common cause of morbidity and mortality. This study affirms the safety and efficacy of generic ibrutinib.

Indexed as

CLLGenericIbrutinibInnovator

Identifiers

PMID33867740
PMCPMC8012457

What OpenQuestion holds

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Registered trials

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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.