Biologics in patients with skin diseases

Veilleux, Mylène S.; Shear, Neil H.

doi:10.1016/j.jaci.2017.03.012

Cited by 30 publications

(21 citation statements)

References 73 publications

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“…The use of biologics in dermatology has been the subject of some recent excellent reviews [1][2][3] and highlights the number of cutaneous disorders for which these targeted therapeutics are both indicated for use or being used off-label. As well, of interest to the dermatologist, a significant number of biologics which have been developed for non-dermatological use have been associated with a multitude of cutaneous adverse events.…”

Section: VIImentioning

confidence: 99%

“…The primary endpoint of a 75% improvement in the psoriasis area severity index was achieved in approximately 20% patients, with some noted to have a lasting response of up to 1 year [2] . In 2016, ixekizumab, a humanized IgG4 antibody that neutralizes IL-17A, was approved by the FDA for the treatment of moderate-to-severe psoriasis [1] . Approximately 89% of ixekizumab-treated patients achieve PASI 75 improvement.…”

Section: VIImentioning

confidence: 99%

“…In addition to the approved indication of moderate-to-severe psoriasis, adalimumab is also approved for the treatment of hidradenitis suppurativa (HS). As well, TNF antagonists have been used off-label in the treatment of pyoderma gangrenosum, chronic spontaneous urticaria, urticarial vasculitis, and atopic dermatitis [1] .…”

Section: VIImentioning

confidence: 99%

“…The anti-IL-12/23 molecule ustekinumab is also approved for the treatment of moderate-tosevere chronic plaque psoriasis and has also been used off-label in the treatment of HS [1] .…”

Section: VIImentioning

confidence: 99%

“…bimekizumab) [1] . New targets including IL-23 have been identified and drugs targeting IL-23 including guselkumab (just approved by the FDA), and tildrakizumab and others under development, such as risankizumab and mirikizumab [1] .…”

Section: Introduction -Biologics In Dermatology: Indications and Off-mentioning

confidence: 99%

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Adverse Reactions to Biologics

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Bibliographic Indices. This publication is listed in bibliographic services, including Current Contents ® and Index Medicus.Disclaimer. The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publisher and the editor(s). The appearance of advertisements in the book is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.Drug Dosage. The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any change in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.

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Section: VIImentioning

confidence: 99%

Section: VIImentioning

confidence: 99%

Section: VIImentioning

confidence: 99%

“…The anti-IL-12/23 molecule ustekinumab is also approved for the treatment of moderate-tosevere chronic plaque psoriasis and has also been used off-label in the treatment of HS [1] .…”

Section: VIImentioning

confidence: 99%

Section: Introduction -Biologics In Dermatology: Indications and Off-mentioning

confidence: 99%

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How Similar Is Biosimilar? A Comparison of Infliximab Therapeutics in Regard to Charge Variant Profile and Antigen Binding Affinity

Beyer

Walch

Jungbauer

et al. 2018

Biotechnology Journal

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Biosimilars are increasing in economic importance. Just how similar a biosimilar needs to be to gain market approval is currently still decided on a per case basis. The authors try to shed light on one often cited critical quality attribute of monoclonal antibodies, namely charge heterogeneity. Using high resolution electrophoretic and chromatographic methods, the authors are able to separate and quantify the charge variant content of infliximab originator and three biosimilars. Additionally the authors quantified and compared the antigen binding affinity in an SPR based binding assay and analyzed the glycosylation pattern of all four of these infliximab biosimilar products. Even though the analytical methods did not show full similarity between originator and some biosimilars, all of the biosimilars have gained approval based on their clinical comparability. The authors would therefore argue, that analytical comparison is not always a good predictor for clinical interchangeability. Any future regulatory framework for the approval of biosimilars should reflect that the parameters chosen for analytical comparability have to be chosen carefully.

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Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of JNJ‐61178104, a Novel Tumor Necrosis Factor‐Alpha and Interleukin‐17A Bispecific Antibody, in Healthy Subjects

Akpalu

Frederick

Nnane

et al. 2019

The Journal of Clinical Pharma

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The safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of JNJ-61178104, a novel anti-tumor necrosis factor-alpha (TNFα) and anti-interleukin-17A (IL-17A) bispecific antibody,were investigated in a placebo-controlled,first-in-human study.Healthy subjects (n = 54) received a single dose of JNJ-61178104 by either intravenous infusion (0.1, 0.3, 1, 3, and 10 mg/kg) or subcutaneous injection (1 mg/kg). Blood samples for measurement of serum JNJ-61178104 concentrations, total IL-17A, total TNFα, and detection of antidrug antibodies were collected for up to 16 weeks after dosing and assessed using electrochemiluminescence immunoassays. PK parameters were calculated by noncompartmental analysis and estimated by nonlinear mixed-effects modeling. JNJ-61178104 was generally well tolerated in healthy subjects. For the intravenous cohorts, mean maximum concentration, and area under the concentration-time curve values increased in a dose-proportional manner. Mean clearance ranged from 6.73 to 9.99 mL/day/kg, mean volume of distribution at terminal phase after intravenous administration ranged from 51.0 to 91.9 mL/kg, and mean half-life ranged from 4.3 to 9.7 days following intravenous administration. After a single subcutaneous dose of 1 mg/kg, median time to maximum concentration was 4.0 days, mean bioavailability was 52.0% and mean half-life was 5.3 days. A linear 2-compartment population model with first-order elimination adequately characterized the pharmacokinetics with parameters consistent with noncompartmental analysis estimates. Body weight and antidrug antibodies were significant covariates on JNJ-61178104 clearance. The time to reach mean maximum serum total TNFα and total IL-17A concentrations appeared to be dose dependent across the 0.1 mg/kg to 10 mg/kg IV dose groups. All subjects who received active treatment were antidrug antibody positive after dosing with JNJ-61178104.

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Biologics in patients with skin diseases

Abstract: Biologic agents are important therapeutic options for treating multiple moderate-to-severe cutaneous diseases. Monoclonal antibodies already in use or under investigation are targeted for psoriasis, atopic dermatitis, melanoma, hidradenitis suppurativa, and pemphigus vulgaris.

Cited by 30 publications

References 73 publications

Preliminaries

Preliminaries

How Similar Is Biosimilar? A Comparison of Infliximab Therapeutics in Regard to Charge Variant Profile and Antigen Binding Affinity

Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of JNJ‐61178104, a Novel Tumor Necrosis Factor‐Alpha and Interleukin‐17A Bispecific Antibody, in Healthy Subjects

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