Off-label use of rituximab in dermatology: pemphigus treatment

Since its approval in 1997 by the FDA (United States Food and Drug Administration), rituximab has been used for certain B-cell lymphomas and treatment-resistant rheumatoid arthritis. Nevertheless, over the past 14 years, many case reports have demonstrated the efficacy of off-label rituximab in several dermatological inflammatory conditions. This study describes two cases of pemphigus vulgaris and two cases of pemphigus foliaceous that were treated with rituximab at 375 mg/m2 once a week for 4 weeks, and that responded well to treatment.

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Rituximab therapy in pemphigus and other autoantibody-mediated diseases

F1000Research ◽

10.12688/f1000research.9476.1 ◽

2017 ◽

Vol 6 ◽

pp. 83 ◽

Cited By ~ 11

Author(s):

Nina A. Ran ◽

Aimee S. Payne

Keyword(s):

Granulomatosis With Polyangiitis ◽

Microscopic Polyangiitis ◽

The United States ◽

Cell Marker ◽

Off Label Use ◽

Off Label ◽

Non Hodgkin Lymphoma ◽

United States Food ◽

Blistering Disease ◽

States Food

Rituximab, a monoclonal antibody targeting the B cell marker CD20, was initially approved in 1997 by the United States Food and Drug Administration (FDA) for the treatment of non-Hodgkin lymphoma. Since that time, rituximab has been FDA-approved for rheumatoid arthritis and vasculitides such as granulomatosis with polyangiitis and microscopic polyangiitis. Additionally, rituximab has been used off-label in the treatment of numerous other autoimmune diseases, with notable success in pemphigus, an autoantibody-mediated skin blistering disease. The efficacy of rituximab therapy in pemphigus has spurred interest in its potential to treat other autoantibody-mediated diseases. This review summarizes the efficacy of rituximab in pemphigus and examines its off-label use in other select autoantibody-mediated diseases.

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Off-Label Therapeutic Potential of Crisaborole

Journal of Cutaneous Medicine and Surgery ◽

10.1177/1203475420909794 ◽

2020 ◽

Vol 24 (3) ◽

pp. 292-296 ◽

Cited By ~ 1

Author(s):

Caitlyn Makins ◽

Ravina Sanghera ◽

Parbeer S. Grewal

Keyword(s):

Therapeutic Potential ◽

Case Reports ◽

Controlled Trial ◽

Seborrheic Dermatitis ◽

Off Label Use ◽

Off Label ◽

Therapeutic Uses ◽

Adults And Children ◽

Dermatologic Disease ◽

Label Use

Crisaborole, a topical phosphodiesterase-4 inhibitor, was recently approved in 2016 for the treatment of mild to moderate atopic dermatitis in adults and children greater than 2 years of age. Since that time, several case reports and a small randomized controlled trial have been published regarding the off-label use of crisaborole for the treatment of other inflammatory dermatologic disorders. This paper reviews the current, albeit limited, evidence for off-label use of crisaborole for psoriasis, seborrheic dermatitis, vitiligo, and inflammatory linear verrucous epidermal nevus. Additional potential therapeutic uses for crisaborole are also postulated, based on its mechanism of action. Future studies are required to elucidate the full therapeutic potential of crisaborole; however, it is a welcome addition to the current nonsteroid topical treatments for inflammatory dermatologic disease.

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Complications of Polydioxanone Foil Use in Nasal Surgery: A Case Series

Facial Plastic Surgery ◽

10.1055/s-0038-1632399 ◽

2018 ◽

Vol 34 (03) ◽

pp. 312-317 ◽

Cited By ~ 1

Author(s):

Andrew Frankel ◽

Oren Friedman ◽

Leo Wang

Keyword(s):

Case Series ◽

Septal Cartilage ◽

Saddle Nose ◽

Nasal Surgery ◽

The Past ◽

Saddle Nose Deformity ◽

United States Food ◽

States Food ◽

Nose Deformity ◽

Pds Foil

AbstractPolydioxanone (PDS) foil is widely recognized as a septal cartilage replacement during rhinoplasties and is thought to be completely resorbable and biodegradable. Since its United States Food and Drug Administration approval in 2010, PDS foil has drawn significant enthusiasm and many surgeons consider it an ideal implantable biomaterial as reflected in numerous studies highlighting its benefits. However, scant literature exists highlighting relevant complications of PDS plates that may potentially lead to cavalier overuse. This descriptive case series assesses the outcomes of PDS foil usage in three patients seen for septoplasty at two independent institutions over the past 5 years. Our results demonstrate that PDS plate usage can lead to septal cartilage loss and resultant saddle nose deformıty associated with prolonged postoperative edema and inflammation. To our knowledge, this is the largest case series of this reported phenomenon.

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FDA Considers Classification of ECT

CNS Spectrums ◽

10.1017/s1092852900023920 ◽

2009 ◽

Vol 14 (12) ◽

pp. 668-670 ◽

Cited By ~ 1

Author(s):

S.H. Lisanby ◽

Stefano Pallanti ◽

Thomas E. Schlaepfer

Keyword(s):

Brain Stimulation ◽

The United States ◽

Treatment Resistant Depression ◽

Treatment Resistant ◽

United States Food ◽

Recent Developments ◽

States Food ◽

Resistant Depression ◽

Deep Brain

With the increasing number of new brain stimulation techniques now available and on the horizon, does electroconvulsive therapy (ECT) still have a role? As clinicians and researchers we say most definitely “yes”. ECT is the most effective and rapidly acting treatment for severe forms of depression and other disorders. Transcranial magnetic stimulation has shown promise but mainly for less severely ill and less treatment resistant patients. Deep brain stimulation (DBS) has shown promise for the more resistant cases but its invasiveness limits its use. Results from only ∼50 patients treated worldwide are available and at present it is not approved by the United States Food and Drug Administration for depression. Vagus nerve stimulation, less invasive than DBS but still a surgical procedure, is presently FDA approved for acute treatment resistant depression but published efficacy rates fall short of those seen with ECT. Therefore, there continues to be an important role for ECT in the treatment of severe psychiatric disorders. But will ECT always be there when our patients need it? Somewhat unexpected recent developments at the FDA may impact the future availability of ECT to severely depressed patients. Here we provide background on the classification of ECT devices, the FDA reclassification process, and the process for providing FDA input in these critical deliberations.

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Immunotherapies in Genitourinary Oncology: Where Are We Now? Where Are We Going?

Cancers ◽

10.3390/cancers13205065 ◽

2021 ◽

Vol 13 (20) ◽

pp. 5065

Author(s):

Albert Jang ◽

David M. Adler ◽

Grant P. Rauterkus ◽

Mehmet A. Bilen ◽

Pedro C. Barata

Keyword(s):

Clinical Trials ◽

Immune Checkpoint ◽

Checkpoint Inhibitors ◽

Treatment Options ◽

The United States ◽

The Past ◽

United States Food ◽

States Food ◽

Genitourinary Cancers ◽

Tumor Types

For decades, limited options existed to treat metastatic genitourinary cancers, including treatment options that could be classified as immunotherapy. Historically, immunotherapy centered on systemic cytokines for the treatment of metastatic kidney cancer, which had several adverse effects, as well as the Bacillus Calmette–Guérin vaccine for non-metastatic bladder cancer. Within the past decade, advances in immunotherapy have led to several approvals from the United States Food and Drug Administration, particularly in the field of immune checkpoint inhibition. Immune checkpoint inhibitors (ICIs) are now being used extensively to treat multiple solid tumors, including kidney and bladder cancers, and they are also being tested in many other cancers. Despite encouraging data from phase 2/3 clinical trials, less is known about biomarkers that may predict better response to ICIs. The effect of ICIs in genitourinary cancers is heterogeneous, with some tumor types having little clinical data available, or ICIs having limited activity in other tumors. In this review, we briefly discuss approved immunotherapy agents prior to the time of ICIs. Then, given the emergence of this class of agents, we summarize the several important ICIs and the clinical trials that led to their approval. Finally, we mention ongoing and future clinical trials.

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Remdesivir (GS-5734) for COVID-19 Treatment: Past and Recent Updates

Coronaviruses ◽

10.2174/2666796701999201216102250 ◽

2020 ◽

Vol 01 ◽

Author(s):

Santhosh Arul ◽

Haripriya Dayalan

Keyword(s):

Rna Synthesis ◽

Ebola Virus ◽

Control Measures ◽

The Novel ◽

Off Label Use ◽

Off Label ◽

The Past ◽

Different Strains ◽

And Control ◽

Viral Outbreak

Background: SARS-CoV-2 is a pandemic now and several preventive and control measures have been taken by several countries to contain and treat the disease. WHO has been working meticulously and have been providing up to date information and statistics on incidences and death. Several broad spectrum anti-viral drugs are available and have been used in the past to fight against the viral outbreak. Recently Remdesivir, an experimental prodrug from Gilead Sciences have been found potential to be used as a therapy to treat the COVID-19. Objective: Here we have reviewed the previous findings that are available in the literature and report several findings that are crucial and provide up to date information. Results : Remdesivir was initially invented for use against Ebola virus treatment and has proved potential against different strains of Ebola, Nipah, and other strains of coronaviruses. Clinical trials with Remdesivir for COVID-19 patients have begun and several off label use of Remdesivir is reported recently. Currently the drug seems to have effect against the SARS-CoV-2 virus with side effects among few patients. The results although are not conclusive are partly promising. This review provides past and recent updates on the use of Remdesivir. Conclusion: From the review we conclude that the drug Remdesivir is known to exhibit its mechanism of action by terminating the RNA synthesis and it is a potential drug against the novel corona virus.

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Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective

The British Journal of Psychiatry ◽

10.1192/bjp.2019.102 ◽

2019 ◽

Vol 215 (2) ◽

pp. 447-448 ◽

Cited By ~ 2

Author(s):

Álvaro López-Díaz ◽

Manuel Murillo-Izquierdo ◽

Elisa Moreno-Mellado

Keyword(s):

Clinical Practice ◽

Public Healthcare ◽

Evidence Based ◽

European Perspective ◽

Treatment Resistant Depression ◽

Off Label Use ◽

Treatment Resistant ◽

Off Label ◽

Resistant Depression ◽

Label Use

SummaryKetamine therapy for treatment-resistant depression in European national health systems may only be considered after attempting all evidence-based antidepressant strategies outlined in clinical guidelines. This paper seeks to explain the ethical, regulatory and procedural framework for the off-label use of ketamine for treatment-resistant depression within a public healthcare system.Declaration of interestNone.

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Progress in Anti-Mammarenavirus Drug Development

Viruses ◽

10.3390/v13071187 ◽

2021 ◽

Vol 13 (7) ◽

pp. 1187

Author(s):

Yu-Jin Kim ◽

Victor Venturini ◽

Juan C. de la Torre

Keyword(s):

Drug Development ◽

Current Knowledge ◽

Antiviral Drug ◽

High Morbidity ◽

Off Label Use ◽

Vaccine Candidates ◽

Off Label ◽

The Past ◽

Human Infections ◽

Significant Mortality

Mammarenaviruses are prevalent pathogens distributed worldwide, and several strains cause severe cases of human infections with high morbidity and significant mortality. Currently, there is no FDA-approved antiviral drugs and vaccines against mammarenavirus and the potential treatment option is limited to an off-label use of ribavirin that shows only partial protective effect and associates with side effects. For the past few decades, extensive research has reported potential anti-mammarenaviral drugs and their mechanisms of action in host as well as vaccine candidates. This review describes current knowledge about mammarenavirus virology, progress of antiviral drug development, and technical strategies of drug screening.

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Quantifying the increasing use of anti-vascular endothelial growth factor therapy in ophthalmology

McGill Journal of Medicine ◽

10.26443/mjm.v13i1.247 ◽

2020 ◽

Vol 13 (1) ◽

Author(s):

Jonathan Micieli ◽

Andrew Micieli

Keyword(s):

Clinical Trials ◽

Growth Factor ◽

Case Reports ◽

Retinal Pigment ◽

Phase Iii ◽

Off Label Use ◽

Off Label ◽

Phase Iii Clinical Trials ◽

Age Related ◽

Label Use

Introduction: Bevacizumab (Avastin; genetech Inc., South San fran- cisco, CA) and ranibizumab (Lucentis, genetech Inc.) are two anti-Vascular Endo- thelial growth factor (VEgf) agents used in increasing amounts off-label to treat ocular conditions. To date, no study has quantifed how far reaching these therapies have been in treating eye disease and compared their off-label use to the number of clinical trials performed. Method: A systematic search of Ovid MEdLINE using the keywords bevacizumab and ranibizumab limited to “Case Reports” was used as an index of the number of diseases treated. Each keyword was also limited to “Clinical Trials, All” and “Phase III Clinical Trials” to discern the quality of evidence for these uses.Results: Bevacizumab has been utilized for the treatment of 58 different ocular conditions, but only 14 conditions were studied in a trial, and none were part of a phase III clinical trial. Ranibizumab has been used for 17 different eye conditions, with only 6 studied in a trial and only 1 disease, “wet” age-related macular degenera- tion reported in 4 phase III trials. In the case reports, there were 21 different adverse events ascribed to bevacizumab and 2 to ranibizumab with retinal pigment epithelial tears being the most common. Conclusion: Bevacizumab is one of the most far reaching drugs in ophthalmology and even medicine, but it is not yet supported by high quality evidence. The much higher cost of ranibizumab may be responsible for bevacizumab’s popularity among eye specialists. Patients should be fully informed about the off-label use of bevacizumab and the associated risks with its use.

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