Acneiform rash – dermatological adverse event in the therapy with anti-EGFR monoclonal antibodies

Pharmateca ◽  
2020 ◽  
Vol 8_2020 ◽  
pp. 56-60
Author(s):  
E.A. Shatokhina Shatokhina ◽  
L.S. Kruglova Kruglova ◽  
A.S. Polonckaia Polonckaia ◽  
P.G. Nosikova Nosikova ◽  
◽  
...  
Keyword(s):  
Adverse Event ◽  
Monoclonal Antibodies ◽  
Acneiform Rash

scholarly journals Safety of Combined Treatment With Monoclonal Antibodies and Viscum album L Preparations

2016 ◽  
Vol 17 (1) ◽  
pp. 41-51 ◽  
Author(s):  
Friedemann Schad ◽  
Jan Axtner ◽  
Matthias Kröz ◽  
Harald Matthes ◽  
Megan L. Steele
Keyword(s):  
Monoclonal Antibodies ◽  
Combined Therapy ◽  
Combined Treatment ◽  
Viscum Album ◽  
Combination Strategies ◽  
Acneiform Rash ◽  
Related Quality ◽  
Health Related ◽  
Botanical Drug

Combination strategies involving chemotherapy and monoclonal antibodies (mAb) are commonly used in attempts to produce better clinical outcomes. This practice has led to new and ongoing toxicities that may lead to reductions in dose or noncompliance, limiting the effectiveness of treatment. Viscum album L (VA) preparations are widely used in Europe as additive therapy and have been associated with reduced chemotherapy-related adverse reactions and increased health-related quality of life. Concomitant VA therapy might also reduce toxicity related to mAb. This retrospective study investigated the safety of combined treatment with VA and mAb in cancer patients. A total of 43 patients had combined therapy (474 exposures); 12 had VA without mAb (129 exposures), and 8 had mAb without VA (68 exposures). Most patients (89.3%) received concomitant chemotherapy or supportive therapies. A total of 34 patients (60.7%) experienced 142 adverse events (AEs). Leucopenia (14.1% of all events), acneiform rash (8.5%), and stomatitis (6.3%) occurred most frequently. Longitudinal logistic regression analysis suggested a nearly 5 times higher odds of experiencing an AE following treatment with mAb compared with mAb plus VA (95% CI = 1.53-16.14). Our results, together with theoretical consideration of potential botanical-drug interactions, suggest that combined treatment with VA and mAb is safe.

scholarly journals Monoclonal Antibodies and Progressive Multifocal Leukoencephalopathy

2011 ◽  
Vol 38 (4) ◽  
pp. 565-571 ◽  
Author(s):  
Daniel L. Keene ◽  
Carole Legare ◽  
Elaine Taylor ◽  
Jim Gallivan ◽  
Gloria Mah Cawthorn ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Adverse Event ◽  
Monoclonal Antibodies ◽  
Progressive Multifocal Leukoencephalopathy ◽  
Literature Search ◽  
Drug Product ◽  
Case Reports ◽  
Ibritumomab Tiuxetan ◽  
Potential Association ◽  
Health Canada

Monoclonal antibodies have become an important treatment option for a number of serious conditions. Concerns have arisen about the potential association of these products with progressive multifocal leukoencephalopathy (PML). A list of monoclonal antibodies authorized for sale was derived from the Health Canada Drug Product Database. Case reports of PML after exposure to a monoclonal antibody authorized for use in Canada were retrieved by searching Canada Vigilance and WHO adverse event databases and through a Pub MED/Medline literature search. 182 adverse event case reports were retrieved (adalimumab -1 case, alemtuzumab-14, bevacizumab -3, cetuximab -1, efalizumab - 8, ibritumomab tiuxetan-5, infliximab-4, natalizumab-32, and rituximab-114). The Canadian Product Monographs for natalizumab and ritiximab contain box warnings for PML. A natalizumab registry has been established.

scholarly journals Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation

2020 ◽  
Vol 64 (4) ◽  
Author(s):  
Johan Maertens ◽  
Aaron C. Logan ◽  
Junho Jang ◽  
Gwynn Long ◽  
Jih-Luh Tang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Monoclonal Antibodies ◽  
Cell Transplantation ◽  
Human Cytomegalovirus ◽  
Hematopoietic Cell Transplantation ◽  
Controlled Trial ◽  
Hematopoietic Cell ◽  
Preemptive Therapy ◽  
Phase 2 ◽  
Hematopoietic Stem

ABSTRACT Human cytomegalovirus (HCMV) can cause significant disease in immunocompromised patients, and treatment options are limited by toxicities. CSJ148 is a combination of two anti-HCMV human monoclonal antibodies (LJP538 and LJP539) that bind to and inhibit the functions of viral HCMV glycoprotein B (gB) and the pentameric complex, consisting of glycoproteins gH, gL, UL128, UL130, and UL131. In this phase 2, randomized, placebo-controlled trial, we evaluated the safety and efficacy of CSJ148 for prophylaxis of HCMV in patients undergoing allogeneic hematopoietic stem cell transplantation. As would be expected in the study population, all the patients (100%) reported at least one treatment-emergent adverse event. There were 22 deaths during this study, and over 80% of the patients receiving placebo or CSJ148 developed at least one adverse event of grade 3 or higher severity. No subject who received antibody developed a hypersensitivity- or infusion-related reaction. CSJ148-treated patients showed trends toward decreased viral load, shorter median duration of preemptive therapy, and fewer courses of preemptive therapy. However, the estimated probability that CSJ148 decreases the need for preemptive therapy compared to placebo was 69%, with a risk ratio of 0.89 and a 90% credible interval of 0.61 to 1.31. The primary efficacy endpoint was therefore not met, indicating that CSJ148 did not prevent clinically significant HCMV reactivation in recipients of allogeneic hematopoietic cell transplants. (This study has been registered at ClinicalTrials.gov under identifier NCT02268526 and at EudraCT under number 2017-002047-15.)

scholarly journals Radioimmunotherapy in Non-Hodgkin’s Lymphoma: Retrospective Adverse Event Profiling of Zevalin and Bexxar

2019 ◽  
Vol 12 (4) ◽  
pp. 141 ◽  
Author(s):  
Sachpekidis ◽  
Jackson ◽  
Soldatos
Keyword(s):  
Adverse Event ◽  
Monoclonal Antibodies ◽  
Hodgkin’S Lymphoma ◽  
Single Agent ◽  
Adverse Event Reporting System ◽  
Hodgkin's Lymphoma ◽  
World Health ◽  
Antibody Treatment ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

The development of monoclonal antibodies has dramatically changed the outcome of patients with non-Hodgkin’s lymphoma (NHL), the most common hematological malignancy. However, despite the satisfying results of monoclonal antibody treatment, only few NHL patients are permanently cured with single-agent therapies. In this context, radioimmunotherapy, the administration of radionuclides conjugated to monoclonal antibodies, is aimed to augment the single-agent efficacy of immunotherapy in order to deliver targeted radiation to tumors, particularly CD20+ B-cell lymphomas. Based on evidence from several trials in NHL, the radiolabeled antibodies 90Y-ibritumomab tiuxetan (Zevalin, Spectrum Pharmaceuticals) and 131I-tositumomab (Bexxar, GlaxoSmithKline) received FDA approval in 2002 and 2003, respectively. However, none of the two radioimmunotherapeutic agents has been broadly applied in clinical practice. The main reason for the under-utilization of radioimmunotherapy includes economic and logistic considerations. However, concerns about potential side effects have also been raised. Driven by these developments, we performed retrospective analysis of adverse events reporting Zevalin or Bexxar, extracted from the FDA’s Adverse Event Reporting System (FAERS) and the World Health Organization’s VigiBase repository. Our results indicate that the two radioimmunotherapeutic agents have both related and distinct side effect profiles and confirm their known toxicological considerations. Our work also suggests that computational analysis of real-world post-marketing data can provide informative clinical insights. While more prospective studies are necessary to fully characterize the efficacy and safety of radioimmunotherapy, we expect that it has not yet reached its full therapeutic potential in modern hematological oncology.

Cemiplimab- and nivolumab-induced myasthenia gravis: two clinical cases

2021 ◽  
pp. 030089162110405
Author(s):  
Fabio Canino ◽  
Giuseppe Pugliese ◽  
Cinzia Baldessari ◽  
Stefano Greco ◽  
Roberta Depenni ◽  
...  
Keyword(s):  
Adverse Event ◽  
Monoclonal Antibodies ◽  
Elderly Patients ◽  
Myasthenia Gravis ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitor ◽  
De Novo ◽  
Checkpoint Inhibitor ◽  
Cancer Center ◽  
Inhibitor Treatment

Immune-related myasthenia gravis is a rare, disabling, and potentially fatal adverse event of immune checkpoint inhibitor treatment. It is important to identify and manage it promptly. We present two cases of immune-related de novo myasthenia gravis observed at the Modena Cancer Center in two elderly patients treated with two anti-PD-1 monoclonal antibodies: cemiplimab and nivolumab.

Clinical Experience with Calcitonin Gene-Related Peptide (CGRP) in Patients with Post-Concussion Headaches

Neurology ◽  
2020 ◽  
Vol 95 (20 Supplement 1) ◽  
pp. S8.1-S8
Author(s):  
Matthew Kluko ◽  
Warren D. Spinner ◽  
Shakira S. Shanker
Keyword(s):  
Adverse Event ◽  
Monoclonal Antibodies ◽  
Clinical Experience ◽  
Retrospective Review ◽  
Fixed Dose ◽  
Calcitonin Gene ◽  
Discontinuation Of Treatment ◽  
Patient Reported ◽  
Dependent Mechanism

ObjectiveTo evaluate the role of CGRP Antagonists in the management of Post-Concussion Headaches.BackgroundHeadaches are one of the most common, debilitating symptoms experienced in post-concussion patients. Previous studies show these symptoms are mediated through a CGRP dependent mechanism. Injectable monoclonal antibodies directed against CGRP have seen widespread use for the management of migraines since their approval in 2018, however there has been minimal evaluation of their effectiveness in managing post-concussion headaches.Design/MethodsA retrospective review of post-concussion patients who were administered intramuscular CGRP Antagonists once monthly in a fixed dose. This study examined reported severity of headaches evaluated at the initial clinical examinations compared to subsequent examinations post-administration of medication.ResultsOf 3 subjects evaluated and receiving erenumab (n = 2) or fremanezumab (n = 1), all showed some form of improvement in their symptoms. Mean (SD) age was 51.7 (6.23). Of these subjects, one patient reported = 1 adverse event (AE). No subjects had serious AE that required discontinuation of treatment.ConclusionsCGRP Antagonists show potential to be a useful approach for the management of post-concussion headaches.

Restless legs-like syndrome as an emergent adverse event of CGRP monoclonal antibodies: A report of two cases

Cephalalgia ◽  
2021 ◽  
pp. 033310242110178
Author(s):  
Vicente González-Quintanilla ◽  
Sara Pérez-Pereda ◽  
Andrea González-Suárez ◽  
Jorge Madera ◽  
María Toriello ◽  
...  
Keyword(s):  
Adverse Event ◽  
Monoclonal Antibodies ◽  
Iron Deficiency ◽  
Adverse Events ◽  
Restless Legs Syndrome ◽  
Postmarketing Surveillance ◽  
Restless Legs ◽  
Plastic Changes ◽  
Refractory Migraine ◽  
Sensory Fibers

Background One of the advantages of CGRP monoclonal antibodies is their excellent safety and tolerability. However, postmarketing surveillance, is essential to detect potential rare emergent adverse events. Objectives To report two patients who developed restless legs syndrome symptoms after treatment with CGRP antibodies. Methods and results Two women with chronic refractory migraine, with no significant medical antecedents, developed typical restless legs syndrome symptoms 1.5 and 4 months after starting erenumab 140 mg, respectively. In case 1 symptoms resolved when erenumab was stopped for two months but reappeared on galcanezumab. In both patients migraine attacks had dramatically decreased and no iron deficiency was found. Conclusions Even though caution is needed before establishing a causal relationship, these cases suggest that restless legs-like symptoms might be an emergent adverse event of CGRP antibodies, regardless of the mechanism of action. We propose that plastic changes in CGRP sensory fibers, which are very abundant in legs, induced by CGRP monoclonal antibodies could be the reason for restless legs syndrome development.

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