Abametapir for the Treatment of Head Lice: A Drug Review

Objective This article reviews the pharmacology, safety, efficacy, and clinical importance of abametapir 0.74% (Xeglyze) for the treatment of head lice. Data Sources From 2020 to May 2021, a systematic review of the MEDLINE and EMBASE databases was conducted using the terms abametapir, Xeglyze, Ha44, and head lice. Bibliographies, Food and Drug Administration (FDA) drug package inserts, and ClinicalTrials.gov were searched for further information. Study Selection and Data Extraction All relevant full-text articles in English were considered for inclusion, with a final article date range of 1999 to 2020. Data Synthesis Abametapir chelates heavy metal cations and inhibits metalloproteinases critical to louse ova development, hatching, and adult survival. In phase II, abametapir had direct ovicidal activity inhibiting 100% of treated louse eggs from hatching, compared with 64% in the vehicle-treated group. In two identical phase III clinical trials, subjects treated with a single 10-minute application of abametapir had greater treatment success compared with vehicle-treated subjects, with 81.1% success versus 50.9% in study 1 ( P = 0.001) and 81.8% versus 47.2% in study 2 ( P < 0.001). Abametapir was well tolerated, with only mild adverse effects. Relevance to Patient Care and Clinical Practice Abametapir is a newly FDA-approved, single-application treatment for head lice in patients aged 6 months and older. This review highlights the safety and efficacy of abametapir in the treatment of head lice. Conclusions In the wake of increasing widespread resistance to first-line treatment options, abametapir offers a safe and effective new treatment option for head lice infestations.

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Matter of TIME: the tumor-immune microenvironment of mesothelioma and implications for checkpoint blockade efficacy

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2021-003032 ◽

2021 ◽

Vol 9 (9) ◽

pp. e003032

Author(s):

James Harber ◽

Tamihiro Kamata ◽

Catrin Pritchard ◽

Dean Fennell

Keyword(s):

Treatment Options ◽

Immune Checkpoint Blockade ◽

Checkpoint Blockade ◽

Phase Iii ◽

Immune Microenvironment ◽

Incurable Cancer ◽

Phase Iii Clinical Trials ◽

Dismal Prognosis ◽

Tumor Immune Microenvironment ◽

Cancer Tumor

Malignant pleural mesothelioma (MPM) is an incurable cancer with a dismal prognosis and few effective treatment options. Nonetheless, recent positive phase III trial results for immune checkpoint blockade (ICB) in MPM herald a new dawn in the fight to advance effective treatments for this cancer. Tumor mutation burden (TMB) has been widely reported to predict ICB in other cancers, but MPM is considered a low-TMB tumor. Similarly, tumor programmed death-ligand 1 (PD-L1) expression has not been proven predictive in phase III clinical trials in MPM. Consequently, the precise mechanisms that determine response to immunotherapy in this cancer remain unknown. The present review therefore aimed to synthesize our current understanding of the tumor immune microenvironment in MPM and reflects on how specific cellular features might impact immunotherapy responses or lead to resistance. This approach will inform stratified approaches to therapy and advance immunotherapy combinations in MPM to improve clinical outcomes further.

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Unmet Medical Needs in Metastatic Lung and Digestive Neuroendocrine Neoplasms

Neuroendocrinology ◽

10.1159/000493319 ◽

2018 ◽

Vol 108 (1) ◽

pp. 18-25 ◽

Cited By ~ 2

Author(s):

Jaume Capdevila ◽

Lisa Bodei ◽

Philippa Davies ◽

Vera Gorbounova ◽

Robert T. Jensen ◽

...

Keyword(s):

Treatment Options ◽

Phase Iii ◽

Neuroendocrine Neoplasms ◽

Limited Evidence ◽

Medical Needs ◽

Phase Iii Clinical Trials ◽

Metastatic Setting ◽

Metastatic Lung ◽

Prospective Phase ◽

Unmet Medical Needs

Unmet medical needs are not infrequent in oncology, and these needs are usually of higher magnitude in rare cancers. The field of neuroendocrine neoplasms (NENs) has evolved rapidly during the last decade, and, currently, a new WHO classification is being implemented and several treatment options are available in the metastatic setting after the results of prospective phase III clinical trials. However, several questions are still unanswered, and decisions in our daily clinical practice should be made with limited evidence. In the 2016 meeting of the advisory board of the European Neuroendocrine Tumor Society (ENETS), the main unmet medical needs in the metastatic NENs setting were deeply discussed, and several proposals to try to solve them are presented in this article, including biomarkers, imaging, and therapy.

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PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines

Annals of Pharmacotherapy ◽

10.1177/1060028020943527 ◽

2020 ◽

pp. 106002802094352

Author(s):

Mary B. Gadarowski ◽

Rima I. Ghamrawi ◽

Sarah L. Taylor ◽

Steven R. Feldman

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Data Extraction ◽

Botulinum Toxin Type A ◽

Botulinum Toxin Type ◽

Phase Iii ◽

Phase Iii Clinical Trials ◽

Study Selection ◽

Pubmed Database ◽

Phase Ii And Iii

Objective: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug. Data sources: A systematic literature review was performed using the terms “glabellar lines AND prabotulinumtoxinA” in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies. Study Selection and Data Extraction: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies. Relevance to Patient Care and Clinical Practice: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians. Conclusion: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.

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Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis

Annals of Pharmacotherapy ◽

10.1177/1060028019885836 ◽

2019 ◽

Vol 54 (4) ◽

pp. 380-387 ◽

Cited By ~ 3

Author(s):

Wendy Li ◽

Rima Ghamrawi ◽

Wasim Haidari ◽

Steven R. Feldman

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Plaque Psoriasis ◽

Data Extraction ◽

Severity Index ◽

Phase Iii ◽

Cochrane Library ◽

Severe Plaque Psoriasis ◽

Phase Iii Clinical Trials ◽

Interleukin 23

Objective: Risankizumab (Skyrizi), an interleukin-23 (IL-23) antagonist, was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in April 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this drug. Data Sources: A systematic literature review was performed using the terms “psoriasis AND risankizumab” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles written in English between January 2000 and October 2019 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary end point at week 16 in phase III trials, more patients achieved Psoriasis Area and Severity Index 90 receiving 150 mg risankizumab (72%-75%) compared with placebo (2.0%-4.9%, P < 0.001), 45 or 90 mg ustekinumab (42.0%-48%, P < 0.0001), and 40 mg adalimumab (47%, P < 0.0001). More patients achieved a static Physician’s Global Assessment score of 0 or 1 receiving 150 mg risankizumab (84%-88%) compared with placebo (5.1%-7.8%, P < 0.001), 45 or 90 mg ustekinumab (62%-63%, P < 0.0001), and 40 mg adalimumab (60%, P < 0.0001). Risankizumab was well tolerated across all studies. Conclusion: Risankizumab is a newly FDA-approved IL-23 inhibitor that shows particular promise in the treatment of plaque psoriasis. Based on this review, it is an effective and safe addition to the armamentarium of biologics that are currently available.

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Immunotherapy of multiple sclerosis

Acta Neuropsychiatrica ◽

10.1017/s092427080003266x ◽

2009 ◽

Vol 21 (S2) ◽

pp. 27-34 ◽

Cited By ~ 2

Author(s):

Sven G. Meuth ◽

Stefan Bittner ◽

Heinz Wiendl

Keyword(s):

Multiple Sclerosis ◽

Clinical Evidence ◽

Treatment Options ◽

Phase Iii ◽

The Past ◽

Phase Iii Clinical Trials ◽

New Treatment ◽

System Disorder ◽

Immunomodulatory Therapies ◽

Ms Therapy

Abstract:Multiple sclerosis (MS) is regarded as a prototypic inflammatory autoimmune central nervous system disorder causing neurological disability in young adults. Recommended basic immunomodulatory therapies of MS are currently interferon beta and glatiramer acetate. Both have proven to be clinically and paraclinically effective and clinical evidence suggests that treatment should be initiated as early as possible.However, despite the fact that therapeutic options for MS have significantly been widened over the past decade there is still tremendous activity in the search for new treatment options for MS.One important development in the field is reflected by the substantial number of promising results for oral therapies. Various phase III clinical trials are currently being initiated or are already underway evaluating the efficacy of a variety of orally administered agents, including cladribine, teriflunomide, laquinimod, fingolimod and fumaric acid. It is hoped that these oral therapies for MS further broaden our armament for MS therapy.

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Perihilar Cholangiocarcinoma

10.2310/cgso.16063 ◽

2019 ◽

Author(s):

Michele M. Gage ◽

Matthew J. Weiss

Keyword(s):

Adjuvant Therapy ◽

Hilar Cholangiocarcinoma ◽

Treatment Options ◽

Treatment Success ◽

Survival Rates ◽

Perihilar Cholangiocarcinoma ◽

Phase Iii ◽

Major Surgery ◽

R0 Resection ◽

Klatskin Tumor

Hilar cholangiocarcinomas (HCs) are a diverse group of aggressive tumors often diagnosed late in disease due to their typically longitudinal spread along the biliary system. Only approximately one-third of HCs are the candidates for resection, which offers the only chance for cure. However, even following resection, recurrence is common, and 5-year survival rates after surgery remain dismal at 20 to 42%. A thorough preoperative work-up and risk stratification for major surgery are critical to treatment success and maximizing the likelihood of an R0 resection. Due to the relatively few large phase III randomized controlled trials for HC, data are lacking on the optimal adjuvant treatment. Recent results of the BILCAP trial are promising for improved survival after surgery with adjuvant therapy, particularly capecitabine. When resection is not an option, prognosis is poor with median survival of less than 12 months. However, there are multiple chemotherapy-based treatment options that have demonstrated prolonging survival, with combined gemcitabine and cisplatin as first-line therapy. Liver transplantation should be considered on protocol for unresectable HC in the absence of metastatic disease. Palliative options, such as photodynamic therapy or radiation, may also be considered in advanced disease. This review contains 2 figures, 5 tables, and 41 references. Key Words: adjuvant therapy in cholangiocarcinoma, hilar cholangiocarcinoma, Klatskin tumor, metastatic cholangiocarcinoma, perihilar cholangiocarcinoma, portal dissection, surgery for hilar cholangiocarcinoma, outcomes in hilar cholangiocarcinoma

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Perihilar Cholangiocarcinoma

10.2310/7800.16063 ◽

2019 ◽

Author(s):

Michele M. Gage ◽

Matthew J. Weiss

Keyword(s):

Adjuvant Therapy ◽

Hilar Cholangiocarcinoma ◽

Treatment Options ◽

Treatment Success ◽

Survival Rates ◽

Perihilar Cholangiocarcinoma ◽

Phase Iii ◽

Major Surgery ◽

R0 Resection ◽

Klatskin Tumor

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Updates in the Systemic Treatment of Hepatocellular Carcinoma

Oncology & Hematology Review (US) ◽

10.17925/ohr.2018.14.2.76 ◽

2018 ◽

Vol 14 (2) ◽

pp. 76

Author(s):

Emerson Y Chen ◽

Charles D Lopez ◽

Gina M Vaccaro ◽

◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Drug Targets ◽

Systemic Treatment ◽

Treatment Options ◽

Phase Iii ◽

Phase Iii Clinical Trials ◽

Recent Phase ◽

Novel Drug ◽

Near Future ◽

Novel Drug Targets

Oncology drug development has recently introduced new systemic treatment options for hepatocellular carcinoma (HCC). Here we consider the general approaches to diagnostic workup, staging, and overall management of HCC with emphasis on systemic treatment options based on recent phase III clinical trials. Novel drug targets involving immunotherapy may change how we treat HCC in the near future.

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Hydrogen Peroxide 40% for the Treatment of Seborrheic Keratoses

Annals of Pharmacotherapy ◽

10.1177/1060028020941793 ◽

2020 ◽

Vol 55 (2) ◽

pp. 216-221

Author(s):

Colton H. Funkhouser ◽

Kathleen M. Coerdt ◽

Wasim Haidari ◽

Michael A. Cardis

Keyword(s):

Hydrogen Peroxide ◽

Clinical Trials ◽

Phase Ii ◽

Treatment Options ◽

Phase Iii ◽

Treatment Modalities ◽

Cochrane Library ◽

Seborrheic Keratosis ◽

Safe Alternative ◽

Phase Iii Clinical Trials

Objective: Hydrogen peroxide 40% (HP40) was approved by the US Food and Drug Administration for topical treatment of seborrheic keratosis (SK) in December 2017. This article will review phase II and III clinical trials to assess the drug’s efficacy, safety, and clinical application. Data Sources: A systematic literature review was performed using the terms “Eskata AND seborrheic keratosis,” and “hydrogen peroxide AND seborrheic keratosis” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Abstraction: Articles written in English between January 2000 and mid-June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: In 2 phase III clinical trials, 4% and 8% of patients treated with HP40 had a Physician Lesion Assessment score of zero for all 4 SKs, respectively, compared with 0% in both vehicle groups at the primary end point of day 106 ( P < 0.01; P < 0.0001). Relevance to Patient Care and Clinical Practice: HP40, although less effective, has a better safety profile than other treatment options. It should be especially considered for treatment of facial SKs, where it is most efficacious and where other treatment modalities, such as cryotherapy, are more challenging. Conclusions: HP40 is a new, safe alternative treatment for SKs, although it is expensive and only modestly effective, both of which somewhat limit its overall utility. HP40 is a promising topical alternative, particularly for cosmetically sensitive locations, such as the face.

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Overcoming Ibrutinib Resistance in Chronic Lymphocytic Leukemia

Cancers ◽

10.3390/cancers11121834 ◽

2019 ◽

Vol 11 (12) ◽

pp. 1834 ◽

Cited By ~ 6

Author(s):

Bartosz Puła ◽

Aleksandra Gołos ◽

Patryk Górniak ◽

Krzysztof Jamroziak

Keyword(s):

Chronic Lymphocytic Leukemia ◽

Treatment Options ◽

Clinical Problem ◽

Lymphocytic Leukemia ◽

Phase Iii ◽

Clinical Activity ◽

Primary Resistance ◽

Phase Iii Clinical Trials ◽

Treatment Naïve ◽

Ibrutinib Resistance

Ibrutinib is the first Bruton’s tyrosine kinase (BTK) inhibitor, which showed significant clinical activity in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients regardless of cytogenetic risk factors. Recent results of phase III clinical trials in treatment-naïve CLL patients shift the importance of the agent to frontline therapy. Nevertheless, beside its clinical efficacy, ibrutinib possesses some off-target activity resulting in ibrutinib-characteristic adverse events including bleeding diathesis and arrhythmias. Furthermore, acquired and primary resistance to the drug have been described. As the use of ibrutinib in clinical practice increases, the problem of resistance is becoming apparent, and new methods of overcoming this clinical problem arise. In this review, we summarize the mechanisms of BTK inhibitors’ resistance and discuss the post-ibrutinib treatment options.

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