Delving into the Latest Updates on Infliximab(Nichi-Iko Pharmaceutical) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Infliximab biosimilar (Nichiiko Pharmaceutical/Aprogen)

+ [1]

Target

TNF-α

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCardiovascular Diseases+ [6]

Active Indication

Colitis, UlcerativeCrohn DiseaseErythrodermic psoriasis+ [6]

Inactive Indication-

Originator Organization

Nichi-Iko Pharmaceutical Co., Ltd.

Active Organization

Nichi-Iko Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (27 Sep 2017),

Ankylosing SpondylitisArthritis, PsoriaticBehcet's uveitis

Regulation-

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Structure/Sequence

Sequence Code 69035L

Source: *****

Sequence Code 69038H

Source: *****

OBJECTIVETo assess the relative efficacy and safety of infliximab and its biosimilars in patients with active rheumatoid arthritis (RA) who showed an inadequate response to methotrexate (MTX).METHODSWe performed a Bayesian network meta-analysis combining direct and indirect evidence from randomized controlled trials (RCTs), comparing the efficacy and safety of infliximab biosimilars versus the originator product in patients with active RA despite receiving MTX.RESULTSOverall, 7 RCTs involving 3168 patients, including 7 biologic agents, met the inclusion criteria. The NI-071 was listed at the top left of the diagonal of the league table because it was associated with the most favorable surface under the cumulative ranking curve (SUCRA) for the American College of Rheumatology 20 (ACR20) response rate. SB2 was listed at the bottom right of the diagonal of the league table because it was associated with the least favorable results. Based on SUCRA, NI-071 had the highest probability of being the best treatment agent in terms of the ACR20 response rate (SUCRA = 0.731), followed by ABP 710, CT-P13, BCD-055, infliximab, Exemptia, PF-06438179, and SB2 (SUCRA = 0.311). Although statistically non-significant differences in safety ranking were observed for serious adverse events (SAEs) among the treatment options, ABP 710 presented the highest safety probability (SUCRA = 0.739) while BCD-055 showed the lowest safety profile (SUCRA = 0.289).CONCLUSIONNo significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations.

02 Nov 2019·Modern RheumatologyQ4 · MEDICINE

A randomized double-blind parallel-group phase III study to compare the efficacy and safety of NI-071 and infliximab reference product in Japanese patients with active rheumatoid arthritis refractory to methotrexate

Q4 · MEDICINE

Article

Author: Matsuno, Hiroaki ; Matsubara, Tsukasa

Objectives: This study aimed to demonstrate the equivalence of NI-071, an infliximab biosimilar (BS), and the infliximab reference product (RP) for treating Japanese patients with active rheumatoid arthritis (RA) refractory to methotrexate.Methods: In this multicenter two-period phase III study, patients were treated with BS or RP for 30 weeks (Period I) in a randomized double-blind manner and then with BS for the following 24 weeks (Period II). The efficacy and safety of BS and RP were compared.Results: The disease activity score in 28-joint count based on erythrocyte sedimentation rate or C-reactive protein and the American College of Rheumatology 20/50/70-based efficacy profiles of BS were similar to those of RP during Period I (30 weeks) including evaluations at week 14, a critical time point. BS efficacy was maintained throughout the 54-week study period. BS efficacy profile matched the RP profile until week 54 after the drug switch from RP to BS at week 30. The safety profiles of BS and RP were comparable and the long-term safety of BS was confirmed.Conclusion: BS demonstrated equivalent efficacy and safety to RP at treatment weeks 14 and 30, and long-term safety until week 54 in Japanese RA patients.

01 May 2010·Praxis

Schweizerisches Register für TNF-α-Blocker bei Kindern und Jugendlichen mit rheumatologischen Erkrankungen

Article

Author: Sauvain ; Schalm ; Hofer ; Kaiser ; Bérthet ; Bolt ; Bolz ; Saurenmann ; Cannizzaro

100 Deals associated with Infliximab(Nichi-Iko Pharmaceutical)

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External Link

KEGG	Wiki	ATC	Drug Bank
D02598	-	L04AB02	DB00065

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Colitis, Ulcerative	JP	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Crohn Disease	JP	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Erythrodermic psoriasis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Psoriasis vulgaris	JP	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Pustular psoriasis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Rheumatoid Arthritis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	20 Jun 2018
Ankylosing Spondylitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	27 Sep 2017
Arthritis, Psoriatic	JP	Nichi-Iko Pharmaceutical Co., Ltd.	27 Sep 2017
Behcet's uveitis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	27 Sep 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	RU	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Phase 2	US	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Phase 2	GB	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Phase 1	PR	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Phase 1	PL	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Phase 1	ES	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Phase 1	UA	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017
Rheumatoid Arthritis	Phase 1	CZ	Nichi-Iko Pharmaceutical Co., Ltd.	19 Jan 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02990806 (CTgov)	Phase 3	Rheumatoid Arthritis	683	Remicade (Stage 1: Remicade-US Group)	uowreprxrs(kdsrugqrer) = aqjxdnkowf etnvmtroir (lxgzuzlapc, hawiphedet - ovwgjmhxwv) View more	-	25 Jan 2023
				Remicade (Stage 2 and Stage 3: Remicade US to Remicade-US Group)	fhytxtfvsr(idgnvfwxdx) = kismjquxom tclkpswqbd (bpylaiuhwt, kboqcayilx - teziohlftk) View more
NCT01927263 (Pubmed \| Isr Med Assoc J) Manual	Phase 3	Rheumatoid Arthritis	242	NI-071	pduezkimkw(wyiqkcmeor) = BS demonstrated equivalent efficacy to RP at treatment weeks 14 and 30, oeaqccavgj (deiyjmaunb ) View more	Positive	01 Nov 2019
				Infliximab