Delving into the Latest Updates on Peginterferon alfa-2a(Rhein-Minapharm) with Synapse

Overview

Basic Info

Drug Type

Interferons, Biosimilar

Synonyms

Hansenula-derived peginterferon alpha-2a (Rhein-Minapharm), PEG-IFN alpha-2a (Rhein-Minapharm), PEG-interferon alpha-2a (Rhein-Minapharm)

+ [3]

Target

IFNAR

Action

agonists

Mechanism

IFNAR agonists(Interferon alpha/beta receptor agonists)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis C

Inactive Indication-

Originator Organization

Rhein-Minapharm

Active Organization

Rhein-Minapharm

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Egypt (01 Jan 2015),

Hepatitis C

Regulation-

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Structure/Sequence

Sequence Code 32821

The sequence is quoted from: *****

Efficacy of preceding administration of Entecavir with PEG-IFN-alfa2a for patients with chronic hepatitis B, positive with HBe antigen in young aged populations - Efficacy of preceding administration of Entecavir with PEG-IFN-alfa2a for patients with chronic hepatitis B, positive with HBe antigen in young aged populations

Start Date01 Mar 2014

Sponsor / Collaborator-

100 Clinical Results associated with Peginterferon alfa-2a(Rhein-Minapharm)

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100 Translational Medicine associated with Peginterferon alfa-2a(Rhein-Minapharm)

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100 Patents (Medical) associated with Peginterferon alfa-2a(Rhein-Minapharm)

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404

Literatures (Medical) associated with Peginterferon alfa-2a(Rhein-Minapharm)

27 May 2024·Ocular Immunology and Inflammation

Effectiveness of Pegylated Interferon Alpha-2a in Post-Uveitic Macular Edema Previously Responding to Non-Pegylated Interferon

Article

Author: Gozzi, F. ; Adani, C. ; Aldigeri, R. ; De Simone, L. ; Cimino, L. ; Bolletta, E. ; Mastrofilippo, V. ; Salvarani, C. ; Gentile, P.

PURPOSETo evaluate the efficacy of pegylated interferon (PEG-IFN) alpha-2a to treat post-uveitic relapsing macular edema (ME) after withdrawal of non-PEG IFN alpha-2a or 2b to maintain treatment efficacy.METHODSThis retrospective study investigated subjects with post-uveitic ME who received weekly subcutaneous PEG-IFN alpha-2a injections. Comparisons between baseline central macular thickness (CMT) and best-corrected visual acuity (BCVA) and those at all follow-up visits were made.RESULTSSix patients (nine eyes) were treated and followed up for six months. CMT (mean [standard deviation]) decreased from 375[117] to 283[39] μm after one month (p < 0.001), remaining significantly lower up to the final follow-up visit at six months (275[38] μm, p = 0.008), and BCVA (0.21[0.16] logMAR at baseline) showed an improvement of 0.12[0.11] logMAR (p = 0.026) at six months. Neither recurrences nor any serious adverse events were recorded.CONCLUSIONSPost-uveitic ME patients were effectively and safely treated with PEG-IFN alpha-2a.

19 Jul 2023·Contrast Media & Molecular Imaging

Retracted: Efficacy and Safety of Peginterferon α-2a and Entecavir Tenofovir in the Treatment of Chronic Hepatitis B Genotype C

Author: Yu, Jiao ; Xu, Dong

[This retracts the article DOI: 10.1155/2022/7623832.].

01 Apr 2023·Drug Safety

Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System

Article

Author: Franzè, Silvia ; Crisafulli, Salvatore ; Moretti, Ugo ; Minghetti, Paola ; Cutroneo, Paola Maria ; Sottosanti, Laura ; Zanoni, Giovanna ; Trifirò, Gianluca ; Marchione, Pasquale ; Ferrajolo, Carmen ; Fontana, Andrea ; Luxi, Nicoletta

BACKGROUND AND OBJECTIVEEvidence highlights the allergenic potential of PEGylated drugs because of the production of anti-polyethylene glycol immunoglobulins. We investigated the risk of hypersensitivity reactions of PEGylated drugs using the Italian spontaneous adverse drug reaction reporting system database.METHODSWe selected adverse drug reaction reports attributed to medicinal products containing PEGylated active substances and/or PEGylated liposomes from the Italian Spontaneous Reporting System in the period between its inception and March 2021. As comparators, we extracted adverse drug reaction reports of medicinal products containing the same non-PEGylated active substances and/or non-PEGylated liposomes (or compounds belonging to the same mechanistic class). A descriptive analysis of reports of hypersensitivity reactions was performed. Reporting rates and time to onset of hypersensitivity reactions were also calculated in the period between January 2009 and March 2021. As a measure of disproportionality, we calculated the reporting odds ratio.RESULTSOverall, 3865 adverse drug reaction reports were related to PEGylated medicinal products and 11,961 to their non-PEGylated comparators. Around two-thirds of patients were female and reports mostly concerned patients aged between 46 and 64 years. The frequency of hypersensitivity reactions reporting was higher among PEGylated versus non-PEGylated medicinal products (11.7% vs 9.4%, p < 0.0001). The hypersensitivity reaction reporting rates were higher for PEGylated medicinal products versus non-PEGylated medicinal products, with reporting rate ratios that ranged from 1.4 (95% confidence interval 0.8-2.5) for pegfilgrastim versus filgrastim to 20.0 (95% confidence interval 2.8-143.5) for peginterferon alpha-2a versus interferon alpha-2a. The median time to onset of hypersensitivity reactions was 10 days (interquartile range: 0-61) for PEGylated medicinal products, and 36 days (interquartile range: 3-216) for non-PEGylated comparators. Statistically significant reporting odds ratios were observed when comparing the reporting of hypersensitivity reactions for PEGylated versus non-PEGylated medicinal products (reporting odds ratio: 1.3; 95% confidence interval 1.1-1.4). However, when using all other drugs as comparators, the disproportionality analysis showed no association with hypersensitivity reactions for PEGylated nor non-PEGylated medicinal products, thus suggesting that many other triggers of drug-induced hypersensitivity reactions play a major role.CONCLUSIONSThe findings of this analysis of the Italian spontaneous adverse drug reaction database suggest a potential involvement for PEGylation in triggering drug-related hypersensitivity reactions, especially clinically relevant reactions. However, when comparing both PEGylated and non-PEGylated drugs under study to all other drugs no disproportionate reporting of hypersensitivity reactions was observed, probably due to a masking effect owing to the presence in the same database of other medicinal products increasing the threshold required to highlight a safety signal when the entire database is used as a reference.

100 Deals associated with Peginterferon alfa-2a(Rhein-Minapharm)

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External Link

KEGG	Wiki	ATC	Drug Bank
D02747	-	L03AB11	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C	Egypt	Rhein-Minapharm	01 Jan 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCD2023	Not Applicable	Cutaneous T-Cell Lymphoma	105	PEG IFN a-2a	(cobpjlbwkk) = fyhfrxahah xtadzcroxl (ijviozxtpb ) View more	-	08 Jul 2023
IAS2015	Not Applicable	HIV Infections \| Hepatitis C	-	pegIFN-a 2a 180 mg/week	lvdidkjwhn(nowaqxukqi) = zaadaykzih hclmndggrl (wpwokzuton ) View more	-	01 Jan 2015
				pegIFN-a 2a 360 mg/week	lvdidkjwhn(nowaqxukqi) = rnnhwbivba hclmndggrl (wpwokzuton ) View more
ASN2010	Not Applicable	Hepatitis C, Chronic	28	PEGIFN-alpha-2a + Ribavirin	efmegphsgc(ietmwgvtpt) = Dose reductions of PEGIFN and ribavirin were required for hematological side effects iqhsuxevim (fkmxlrtkrc ) View more	Negative	16 Nov 2010
IAS2010	Not Applicable	HIV Infections \| Hepatitis C, Chronic	-	peginterferon alpha-2a (CASE group)	aiqjektgkr(tzgwbzhuja) = 17(46%) patients in CASE group and 15(45%) in CONTROL group experienced adverse events (AEs) (p=0.99) ufadnemmtm (astlxaqtom ) View more	-	01 Jan 2010
				peginterferon alpha-2a (CONTROL group)
IAS2008	Not Applicable	Coinfection	105	PEG-INF alpha-2a	skqqopyygo(aghjhetkel) = viuzwsjequ tfnpqpvswj (fmpddjkkfq )	-	01 Jan 2008
				PEG-INF alpha-2b	skqqopyygo(aghjhetkel) = eqroexsfrx tfnpqpvswj (fmpddjkkfq )

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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