Side Effects of ibrutinib: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Main Research Findings

Ibrutinib is a drug that is effective in treating B-cell malignancies such as chronic lymphocytic leukemia (CLL). However, ibrutinib can cause side effects such as atrial fibrillation, bleeding, and hypertension. 2 , 5

Ibrutinib inhibits the proliferation and survival of B cells by inhibiting the B-cell receptor signaling pathway. 16 Ibrutinib works by inhibiting an enzyme called BTK (Bruton tyrosine kinase). 18

Ibrutinib is a drug that provides a new option for the treatment of CLL, but it is important to understand the risk of side effects. 4

Reasons for Side Effects

Ibrutinib inhibits BTK, which inhibits the proliferation and survival of B cells, but BTK is also expressed in other cells, which can cause side effects. 18

Ibrutinib is a drug that non-covalently inhibits BTK. 10 Non-covalent BTK inhibitors are thought to have less off-target effects and lower risk of side effects than covalent BTK inhibitors. 25

Common Side Effects

Atrial fibrillation

Ibrutinib has been reported to cause atrial fibrillation. 2 , 5

Bleeding

Ibrutinib has been reported to increase the risk of bleeding. 5 , 18

Hypertension

Ibrutinib has been reported to cause hypertension. 4

Eye side effects

Ibrutinib may cause eye side effects such as uveitis. 3

Skin side effects

Ibrutinib may cause skin side effects such as rash and nail abnormalities. 7

Infection

Ibrutinib may increase the risk of infection due to its immunosuppressive effects. 14

Other side effects

Ibrutinib may cause side effects such as diarrhea, fatigue, nausea, joint pain, and fever. 9

Countermeasures for Side Effects

Atrial fibrillation

Atrial fibrillation may occur with ibrutinib administration. 2 , 5

Atrial fibrillation may be improved by stopping ibrutinib administration or by administering antiarrhythmic drugs. 2

Bleeding

Bleeding may occur with ibrutinib administration. 5

Patients at high risk of bleeding may need to stop ibrutinib administration or be given hemostatic drugs. 18

Hypertension

Ibrutinib can cause hypertension. 4

Hypertension can be improved by administering antihypertensive drugs. 4

Comparison of Studies

Commonalities

Many studies have shown that ibrutinib is effective in treating CLL. 26

Many studies have shown that ibrutinib can cause side effects such as atrial fibrillation, bleeding, and hypertension. 2 , 5

Differences

The incidence of ibrutinib side effects varies between studies. 5

The risk of ibrutinib side effects varies depending on factors such as patient age, ibrutinib dose, concomitant medications, and medical history. 5

Points to Note Regarding Application to Daily Life

Ibrutinib is an effective drug for treating CLL, but it has side effects. 4

If you are considering taking ibrutinib, consult your doctor and make sure you understand the risks and benefits of treatment before you start. 15

Limitations of Current Research

The long-term side effects of ibrutinib are not yet fully understood. 2

Future Research Directions

Research is needed to assess the long-term side effects of ibrutinib. 2

New treatments need to be developed to reduce the side effects of ibrutinib. 18

Biomarkers need to be developed to predict the risk of ibrutinib side effects. 5

Conclusion

Ibrutinib is an effective drug for treating CLL, but it can cause side effects such as atrial fibrillation, bleeding, and hypertension. 2 , 5

If you are considering taking ibrutinib, consult your doctor and make sure you understand the risks and benefits of treatment before you start. 15

Keywords
Benefit Keywords
Chronic B-cell malignancy treatment
2
Hematological disorder treatment
3
Improved progression-free survival
4
Cancer treatment
5
CLL and CRC treatment
6
B-cell malignancy treatment
7
B-cell malignancy treatment
8
B-cell malignancy treatment
9
Antitumor potency
BTK inhibition
10
Minimized Side Effects
11
Improved prognosis
Treatment of B-cell malignancies
13
B-cell lymphoma treatment
14
CLL treatment
Reduced side effects
15
Anti-tumor effects
BTKi for CLL
16
Chronic lymphocytic leukemia treatment
17
Antithrombotic potential
Treatment for COVID-19
18
Ibrutinib outcomes
19
Lymphoma cell inhibition
20
CLL treatment
21
B-cell malignancies treatment
22
MCL BTK inhibition
25
CLL treatment
Fixed-duration treatment
MCL treatment
26
BTK inhibitor development
Lymphoma treatment
27
Improved survival
28
Risk Keywords
Disease flare
1
Atrial fibrillation
Bleeding risk
2
Uveitis
3
Atrial fibrillation
Bleeding
Hypertension
4
Atrial fibrillation
Bleeding events
5
Paronychia
Periungual granulation
7
Atrial fibrillation
Bleeding
Hypertension
8
Atrial fibrillation
Cytopenias
Diarrhea
Fatigue
Nausea
Rash
Upper respiratory tract infection
9
Atrial Fibrillation
Cardiac Events
11
Increased thyroid requirements
12
Atrial fibrillation
Cardiovascular events
13
Immunodeficiency
14
Atrial fibrillation
Bleeding
Diarrhea
15
Infection susceptibility
Off-target effects
16
Immune-related effects
17
Bleeding
18
Diffuse edema
Pericardial effusion
Pleural effusion
Serositis
19
Atrial fibrillation
Bleeding
Hypertension
22
Adverse prognosis
No antitumor effect
23
Adverse events
Hospitalization
Increased costs
24
BTK inhibitor side effects
Resistance mutations
25
BTK inhibitor resistance
BTK inhibitor side effects
26
Drug resistance
Off-target effects
27
Cardiovascular toxicity
28
Literature analysis of 28 papers
Positive Content
25
Neutral Content
0
Negative Content
3
Article Type
1
1
1
9
26
1.

Disease Flare During Temporary Interruption of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia.

Author: HampelPaul J, CallTimothy G, RabeKari G, DingWei, MuchtarEli, KenderianSaad S, WangYucai, LeisJose F, WitzigThomas E, KoehlerAmber B, FonderAmie L, SchwagerSusan M, Van DykeDaniel L, BraggioEsteban, SlagerSusan L, KayNeil E, ParikhSameer A

Disease flare

This study examines the frequency and characteristics of disease flares in patients with chronic lymphocytic leukemia (CLL) when ibrutinib is temporarily held. It aims to identify risk factors and assess clinical outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

High incidence of atrial fibrillation in patients treated with ibrutinib.

Author: BaptisteFlorian, CautelaJennifer, AncedyYan, ResseguierNoémie, AurranThérèse, FarnaultLaure, EscudierMarion, AmmarChloé, GaubertMélanie, DolladilleCharles, BarraudJeremie, PeyrolMichael, CohenAriel, PaganelliFranck, AlexandreJoachim, EderhyStephane, ThunyFranck

Chronic B-cell malignancy treatment
Atrial fibrillation
Bleeding risk

This study aimed to determine the incidence and predictors of atrial fibrillation (AF) as a common side effect of ibrutinib, a drug used for treating chronic B-cell malignancies. It also analyzed the management and outcome of ibrutinib-related AF (IRAF).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Ibrutinib-related uveitis: A report of two severe cases.

Author: BohnMarcela, Bravo-LjubeticLuciano, LeeRichard W J, PetrushkinHarry

Hematological disorder treatment
Uveitis

This report presents two cases of severe uveitis associated with ibrutinib, a drug used to treat hematological disorders. Uveitis is not a previously reported side effect of ibrutinib.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

Risk of bleeding complications and atrial fibrillation associated with ibrutinib treatment: A systematic review and meta-analysis.

Author: PellegriniLuca, NovakUrban, AndresMartin, SuterThomas, NaglerMichael

Cancer treatment
Atrial fibrillation
Bleeding events

This systematic review and meta-analysis investigated the risk of bleeding and atrial fibrillation associated with ibrutinib, a drug used to treat certain blood cancers. The results suggest that the risk of these events in clinical practice may be higher than estimated in randomized controlled trials.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

6.

Ibrutinib and panitumumab used in combination safely in a patient with metachronous colorectal cancer and chronic lymphocytic leukemia.

Author: KorkmazMustafa, Karakurt EryilmazMelek, KaraağaçMustafa, ArazMurat, ÇeneliÖzcan, ArtaçMehmet

CLL and CRC treatment

Ibrutinib, a Bruton tyrosine kinase inhibitor, and panitumumab, an epidermal growth factor receptor antibody, were used in combination in a patient with metachronous chronic lymphocytic leukemia (CLL) and metastatic colorectal cancer (CRC) without encountering any cumulative or unexpected side effects.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Paronychia and Periungual Granulation as a Novel Side Effect of Ibrutinib: A Case Report.

Author: YorulmazAhu, YalcinBasak

B-cell malignancy treatment
Paronychia
Periungual granulation

Ibrutinib, a Bruton's tyrosine kinase inhibitor, has been associated with paronychia and periungual granulation in addition to its known side effects, suggesting a potential dermatological complication.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

9.

Ibrutinib-induced polyneuropathy: A case report.

Author: CömertPınar, AlbayrakMurat, YıldızAbdulkerim, ŞahinOsman, ÖztürkHacer Berna, Reis ArasMerih

B-cell malignancy treatment
Atrial fibrillation
Cytopenias
Diarrhea
Fatigue
Nausea
Rash
Upper respiratory tract infection

Ibrutinib, a Bruton's tyrosine kinase inhibitor, is well-tolerated for treating B-cell malignancies but can cause side effects like atrial fibrillation, diarrhea, and cytopenias, some of which can be severe.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

10.

Discovery of pyrido[3,4-b]indol-1-one derivatives as novel non-covalent Bruton's tyrosine kinase (BTK) inhibitors.

Author: DouDou, ShaWenjie, DiaoYanyan, SuRongrong, QiaoYunjin, YuZhixiao, ZhaoZhenjiang, LiHonglin, ChenZhuo, XuYufang

Antitumor potency
BTK inhibition

A novel series of pyrido[3,4-b]indol-1-one derivatives exhibit potent inhibitory activity against Bruton's tyrosine kinase (BTK) and show promising antitumor effects in lymphoma cell lines and a xenograft mouse model. These non-covalent BTK inhibitors hold potential for safer and more effective treatment of malignancy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Acalabrutinib-Related Cardiac Toxicities in Patients with Chronic Lymphocytic Leukemia: A Meta-Analysis of Randomized Controlled Trials.

Author: HtutThura Win, HanMyat Min, TheinKyaw Zin

Minimized Side Effects
Atrial Fibrillation
Cardiac Events

Acalabrutinib, a new Bruton's tyrosine kinase inhibitor, has been shown to be effective in treating chronic lymphocytic leukemia. This meta-analysis found that acalabrutinib is associated with an increased risk of cardiac events compared to ibrutinib.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

Increased Thyroid-Hormone Requirements Consistent With Type 3 Deiodinase Induction Related to Ibrutinib in a Thyroidectomized Woman.

Author: MazoriAlon Yehuda, SkamagasMaria

Increased thyroid requirements

This case report links the tyrosine kinase inhibitor (TKI) ibrutinib to increased thyroid hormone requirements in a thyroidectomized woman. The patient's decreased T3:T4, T3:rT3, and T4:rT3 ratios suggested type 3 deiodinase induction and type 2 deiodinase inhibition.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

13.

Diagnosis and Management of Cardiovascular Effects of Bruton's Tyrosine Kinase Inhibitors.

Author: AghelNazanin, Baro VilaRocio C, LuiMichelle, HillisChristopher, LeongDarryl P

Improved prognosis
Treatment of B-cell malignancies
Atrial fibrillation
Cardiovascular events

This review discusses the cardiovascular side effects of Bruton's tyrosine kinase inhibitors (BTKis), specifically atrial fibrillation, and provides guidance on their management in clinical practice.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Life-threatening disseminated enterovirus infection during combined rituximab and ibrutinib maintenance treatment for mantle cell lymphoma: a case report.

Author: HigerMaximilian, CanaDenis, PodlechJuergen, Schadmand-FischerSimin, SchwartingAndreas, TeschnerDaniel, TheobaldMatthias, WölfelThomas, HessGeorg

B-cell lymphoma treatment
Immunodeficiency

Rituximab and ibrutinib are both medications used to treat B-cell non-Hodgkin lymphoma. This review discusses the individual mechanisms of action and potential benefits of combining the two drugs in various clinical scenarios.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

16.

BTK Inhibitors in Chronic Lymphocytic Leukemia: Biological Activity and Immune Effects.

Author: PalmaMarzia, MulderTom A, ÖsterborgAnders

Anti-tumor effects
BTKi for CLL
Infection susceptibility
Off-target effects

This review discusses the impact of Bruton's tyrosine kinase inhibitors (BTKIs) on the immune system in patients with chronic lymphocytic leukemia (CLL). BTKIs are effective in treating CLL by blocking B-cell receptor signaling, but their impact on both innate and adaptive immunity needs further investigation. Understanding this impact is crucial for managing infections and ensuring optimal treatment outcomes in CLL patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Duvelisib: a new phosphoinositide-3-kinase inhibitor in chronic lymphocytic leukemia.

Author: FrustaciAnna M, TedeschiAlessandra, DeodatoMarina, ZamprognaGiulia, CairoliRoberto, MontilloMarco

Chronic lymphocytic leukemia treatment
Immune-related effects

Duvelisib is a dual phosphoinositide-3-kinase inhibitor targeting p110-δ/γ that has been approved for relapsed/refractory chronic lymphocytic leukemia. While effective, immune-related effects often lead to treatment suspension.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

21.

Advancements in the Treatment of CLL: The Rise of Zanubrutinib as a Preferred Therapeutic Option.

Author: MolicaStefano, TamConstantine, AllsupDavid, PolliackAaron

CLL treatment

Zanubrutinib (zanu), a second-generation Bruton's tyrosine kinase inhibitor (BTKi), is a promising treatment option for patients with chronic lymphocytic leukemia (CLL). Zanu has demonstrated superior clinical efficacy and a better safety profile compared to ibrutinib, a first-generation BTKi.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

Managing Ibrutinib-Intolerant Patients With B-Cell Malignancies.

Author: MuñozJavier, SarosiekShayna, CastilloJorge J

B-cell malignancies treatment
Atrial fibrillation
Bleeding
Hypertension

This review provides guidance on treating ibrutinib-intolerant patients with B-cell malignancies. Ibrutinib, a Bruton tyrosine kinase (BTK) inhibitor, is approved for treating B-cell malignancies, but off-target adverse effects can limit treatment tolerance. Approaches to address intolerance include managing side effects with supportive care or dose reductions, switching to alternative BTK inhibitors, or abandoning BTK inhibitors for alternative treatments.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

Targeting the IL-2 inducible kinase in melanoma; a phase 2 study of ibrutinib in systemic treatment-refractory distant metastatic cutaneous melanoma: preclinical rationale, biology, and clinical activity (NCI9922).

Author: MoschosStergios J, ErogluZeynep, KhushalaniNikhil I, KendraKari L, AnsstasGeorge, InGino K, WangPeng, LiuGlenn, CollichioFrances A, GoogePaul B, CarsonCraig C, McKinnonKaren, WangHsing-Hui, Nikolaishvilli-FeinbergNana, IvanovaAnastasia, ArrowoodChristy C, Garrett-MeadNancy, ConwayKathleen C, EdmistonSharon N, OllilaDavid W, SerodyJonathan S, ThomasNancy E, IvyS Percy, AgrawalLokesh, DeesElizabeth C, AbbruzzeseJames L

Adverse prognosis
No antitumor effect

Ibrutinib, a Bruton's tyrosine kinase inhibitor, did not show clinical benefit in patients with metastatic melanoma refractory to PD-1 and MAPK inhibitors. Despite inhibiting melanoma cell proliferation and motility in vitro, ibrutinib did not induce antitumor responses in patients.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Treatment patterns, adverse events, healthcare resource use and costs among commercially insured patients with mantle cell lymphoma in the United States.

Author: KabadiShaum M, NearAimee, WadaKeiko, BurudpakdeeChakkarin

Adverse events
Hospitalization
Increased costs

Treatment patterns, adverse events (AEs), and economic burden were examined in commercially insured patients with mantle cell lymphoma (MCL). The most common regimens were R-CHOP, rituximab monotherapy, B-R, and ibrutinib. A majority of patients experienced at least one AE, with increasing AEs linked to higher hospitalization risk and all-cause costs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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