Evidence map›Paper›PMID 37304488›Full record

ArticleIndian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion2023

Efficacy and Safety of Biosimilar Romiplostim Versus Innovator Romiplostim in Patients with Chronic Immune Thrombocytopenia.

S Chandrakala, Manoj Toshniwal, Mitesh Halvawala, Namita Padwal, Neeraj Sidharthan, Pankaj Malhotra, B Prashantha, Riya Ballikar, Sandip Shah, Shashikant Apte and 6 more

Erratum issuedOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 32% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

S ChandrakalaSeth G. S. Medical College and KEM Hospital, Mumbai, India.
Manoj ToshniwalIshwar Institute of Health Care, Aurangabad, India.
Mitesh HalvawalaNirmal Hospital Pvt Ltd, Surat, India.
Namita PadwalLTMMC and General Hospital, Sion, India.
Neeraj SidharthanAmrita Institute of Medical Sciences, Kochi, India.
Pankaj MalhotraPostgraduate Institute of Medical Education and Research, Chandigarh, India.
B PrashanthaKasturba Medical College (KMC) Hospital, Mangalore, India.
Riya BallikarCriticare Hospital and Research Institute, Nagpur, India.
Sandip ShahHemato-Oncology Clinic, Ahmedabad, India.
Shashikant ApteSahyadri Super Specialty Hospital, Pune, India.
T Kasi ViswanathanMeenakshi Mission Hospital and Research Centre, Madurai, India.
Vijay RamananGrant Medical Foundation Ruby Hall Clinic, Pune, India.
Akhilesh SharmaMedical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg,Lower Parel, Mumbai, India.
Dattatray PawarMedical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg,Lower Parel, Mumbai, India.
Roshan PawarMedical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg,Lower Parel, Mumbai, India.
Vinayaka ShahaviMedical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg,Lower Parel, Mumbai, India.
Alkem (India) · INAmrita Institute of Medical Sciences and Research Centre · INKasturba Medical College, Manipal · INLokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College · INMeenakshi Mission Hospital and Research Centre · INNirma (India) · INPost Graduate Institute of Medical Education and Research · INRuby Hall Clinic · INSahyadri Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Romiplostim is a Food and Drug Administration (FDA)-approved therapy for immune thrombocytopenia (ITP). Biosimilar is a biological product that has no clinical meaningful difference from an existing FDA-approved reference product. It has a potential of lowering health-care-related cost. Biosimilar of romiplostim can be made available to patients with ITP at a low cost and can be beneficial in providing the best therapy. Thus, the efficacy and safety of biosimilar romiplostim (ENZ110) was compared with innovator romiplostim (Nplate) with respect to platelet response in patients with chronic ITP. This was a prospective, multicenter, randomized, and double-blind clinical trial. Patients with chronic ITP, aged 18-65 years, were enrolled in a study and were randomized to receive either ENZ110 or Nplate in a 3:1 ratio for a treatment period of 12 weeks, respectively. After completion of the treatment period, the patients were followed-up for one week to evaluate the platelet response and to monitor the adverse events (AEs). Over the duration of 12 weeks, platelet response of > 50 × 10

Indexed as

Adverse eventBiosimilar romiplostimEfficacy endpointImmune thrombocytopenia

Identifiers

PMID37304488
PMCPMC10247600
OpenAlexW4309070530

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.