An Immune-Mediated Adverse Event Potentially Related to Rituximab

Immunotherapy with checkpoint inhibitors has transformed the treatment of cancer, but frequently results in immune-mediated adverse events affecting multiple organs, amongst which endocrine adverse events are frequent. The patterns of endocrine adverse events differ between inhibitors of the CTLA-4 and PD-1/PD-L1 pathways, but most frequently involve the thyroid and pituitary with insulin deficient diabetes also emerging as an important adverse event. These frequently result in long-lasting hormone deficiency requiring replacement. This review explores the mechanism of action of checkpoint inhibitors and details the expected endocrine adverse events and typical presentations. The effect of high-dose glucocorticoids therapy to treat nonendocrine adverse events is also discussed.

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Long-term safety and efficacy of daclizumab beta in relapsing–remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study

Journal of Neurology ◽

10.1007/s00415-020-09835-y ◽

2020 ◽

Vol 267 (10) ◽

pp. 2851-2864 ◽

Cited By ~ 2

Author(s):

Ralf Gold ◽

Ernst-Wilhelm Radue ◽

Gavin Giovannoni ◽

Krzysztof Selmaj ◽

Eva Kubala Havrdova ◽

...

Keyword(s):

Multiple Sclerosis ◽

Adverse Event ◽

Extension Study ◽

Open Label ◽

Immune Mediated ◽

Relapsing Remitting ◽

Open Label Extension ◽

Relapsing Remitting Multiple Sclerosis ◽

Beta Dose

Abstract Objective SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED. Methods Eligible participants who completed 1–2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION. Results Ninety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0–24 was 0.21 (0.16–0.29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17.4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time. Conclusions The effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED. Trial registration Clinicaltrials.gov NCT01051349; first registered on January 15, 2010.

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Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database

Journal of Pharmaceutical Health Care and Sciences ◽

10.1186/s40780-019-0149-z ◽

2019 ◽

Vol 5 (1) ◽

Author(s):

Iku Niinomi ◽

Keiko Hosohata ◽

Yasuhiro Mori ◽

Yuki Yamaguchi ◽

Tomohito Wakabayashi ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Spontaneous Reporting ◽

Drug Event ◽

Reporting Odds Ratio ◽

Pharmaceutical Companies ◽

Patent Expiry ◽

Immune Mediated ◽

Life Threatening ◽

Reported Data

Abstract Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown in the real world. The purpose of this study was to clarify the adverse events associated with IFX originator and its biosimilar using the Japanese Adverse Drug Event Report (JADER) database. Methods Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between the third quarter of 2014 and the fourth quarter of 2018. We calculated the reporting odds ratio and 95% confidence interval for each adverse event. Results We obtained 2771 reports of adverse events associated with IFX originator and 402 reports with IFX biosimilar. Signals were detected for pneumonia, interstitial lung disease, tuberculosis, and sepsis with both IFX originator and its biosimilar, whereas there was no signal for infection with the biosimilar. Conclusions The strength of the association between IFX originator and its biosimilar with adverse events is partly different, but reports were quite limited for the biosimilar compared with originator. It is recommended that research be continued in order to accumulate a wide variety of information, and that newly reported data be placed in the multifaceted viewpoints for improvement of care levels.

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Ipilimumab- and Nivolumab-Induced Colitis Causing Severe Hypokalemia and QTc Prolongation

Case Reports in Oncological Medicine ◽

10.1155/2019/7896749 ◽

2019 ◽

Vol 2019 ◽

pp. 1-2 ◽

Cited By ~ 1

Author(s):

David Anson ◽

Joseph Norton ◽

Benjamin Chaucer ◽

Saurabh Bansal

Keyword(s):

Renal Cell Carcinoma ◽

Adverse Event ◽

Cell Carcinoma ◽

Renal Cell ◽

Clear Cell ◽

Qtc Prolongation ◽

Cell Renal Cell Carcinoma ◽

Immune Mediated

Immune-mediated colitis is an uncommon but well-documented adverse event in patients receiving nivolumab or ipilimumab therapy. In this report, we present a 69-year-old man who developed severe hypokalemia and colitis with significant corrected Q-T segment (QTc) prolongation as a result of combination nivolumab-ipilimumab immunotherapy for clear cell renal cell carcinoma.

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Suspected immune mediated response to COVID-19 vaccine: two individual case reports

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20212385 ◽

2021 ◽

Vol 10 (7) ◽

pp. 851

Author(s):

Sagar R. Bhimani ◽

Sapna D. Gupta ◽

Kamlesh P. Patel ◽

Supriya D. Malhotra

Keyword(s):

Adverse Event ◽

Causal Relation ◽

Case Reports ◽

Vaccine Safety ◽

Individual Case ◽

Adverse Event Following Immunization ◽

First Case ◽

Immune Mediated ◽

Potential Risks

SARS-CoV-2, the virus that causes coronavirus disease 19 (COVID-19), has spread rapidly around the world. Researchers have been working round the clock to develop effective vaccines, which people started receiving in December 2020. Therefore, careful follow-up and surveillance studies for continued vaccine safety monitoring will be needed to ascertain the potential risks of such adverse events or disease. Here, we present two individual cases of pancreatitis and typhilitis following COVID 19 vaccination. In the first case of a 38 years old male patient developed pancreatitis after 4 days of COVID 19 vaccination and in second case, of a 60 years old female patient developing typhilitis after just one day after vaccination. All possible causes of this occurrence were ruled out. Two main factors suggest a possible link to the vaccine, the chronology of the events and the incongruent immune response to the vaccine component. It is not possible to establish a direct causal relation between vaccination and adverse event following immunization; however, this report can be used to alert practitioners to this possibility of adverse event following immunization after COVID-19 vaccine.

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Cytarabine syndrome despite corticosteroid premedication in an adult undergoing induction treatment for acute myelogenous leukemia

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155215607090 ◽

2016 ◽

Vol 22 (6) ◽

pp. 795-800 ◽

Cited By ~ 3

Author(s):

Matthew A Jirasek ◽

Jon D Herrington

Keyword(s):

Adverse Event ◽

Proinflammatory Cytokines ◽

Myelogenous Leukemia ◽

Induction Treatment ◽

Proinflammatory Response ◽

Treatment And Prevention ◽

Immune Mediated ◽

Intravenous Morphine ◽

Acute Myelogenous ◽

Induced Apoptosis

Cytarabine syndrome is a rare clinical condition characterized by fever, malaise, myalgia, arthralgia, and/or rash that occurs after receipt of cytarabine. Our patient developed fever, malaise, and diffuse body pain shortly following cytarabine initiation despite receiving prophylactic dexamethasone. The patient’s discomfort was treated with intravenous morphine and her other symptoms were controlled with a higher dose of dexamethasone. Although the exact cause is not fully understood, cytarabine syndrome is hypothesized to be an immune-mediated response following cytarabine-induced apoptosis that results in a rapid increase in proinflammatory cytokines. While there is no standard therapy for cytarabine syndrome, corticosteroids appear to play a role in the treatment and prevention of the condition by suppressing the proinflammatory response. Since our case describes the development of cytarabine syndrome despite dexamethasone, clinicians should monitor for this adverse event if patients begin exhibiting characteristics of this syndrome.

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