- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Rapidly Progressive Dementia from treatment with a novel IGF-1R inhibitor (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_2628;
Although CAA was first diagnosed during this work up, the rapid progression of his symptoms, as well as fluctuation and response to immune-modulatory treatments, is not consistent with this as a sole cause of his symptoms. IGF-1 has been shown to play a role in the central nervous system as a promotor of neuronal survival, and has been demonstrated to be beneficial in limiting the extent of damage in animal models of hypoxic-ischemic stroke.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche, Actemra IV (tocilizumab) / Roche, JW Pharma
Journal: Treatment Of Moderate To Severe Orbitopathy: Current Modalities And Perspectives. (Pubmed Central) - Feb 4, 2022
Improved understanding of pathophysiological mechanisms has allowed the use of non specific immunomodulatory agents, currently under evaluation, and which place in the therapeutic strategy remains to be determined. Very recently, new promising therapeutic advances has emerged with the identification of new therapeutic targets such as the TSH receptor and IGF-1 receptor complex.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Clinical, Journal: Teprotumumab and Hearing Loss: Case Series and Proposal for Audiologic Monitoring. (Pubmed Central) - Jan 28, 2022
Due to the novelty of teprotumumab and the lack of a comprehensive understanding of its effect on hearing, the authors endorse prospective investigations of hearing loss in the setting of teprotumumab treatment. Until the results of such studies are available, the authors think it prudent to adopt a surveillance protocol to include an audiogram and tympanometry before, during and after infusion, and when prompted by new symptoms of hearing dysfunction.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: Graves' orbitopathy (Pubmed Central) - Jan 19, 2022
The current concept for Graves' orbitopathy is as follows: first anti-inflammatory therapy then surgical correction of the permanent defects. This might be modified in the future, due to the promising effects of targeted therapies.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: Thyroid Eye Disease, Teprotumumab, and Hearing Loss: An Evolving Role for Otolaryngologists. (Pubmed Central) - Jan 6, 2022
As otolaryngologists who historically play a significant role in the multidisciplinary treatment of thyroid disease and its associated complications, we should be aware of and monitor the otologic side effects of teprotumumab. Clinicians who prescribe teprotumumab should strongly consider monitoring patients' hearing with an audiologist and otolaryngologist.
- |||||||||| Review, Journal: Cytokines as Targets of Novel Therapies for Graves' Ophthalmopathy. (Pubmed Central) - Dec 23, 2021
Drugs that target cytokines (etanercept, tocilizumab, infliximab, adalimumab) have been tested in GO, with encouraging results...A multicenter, randomized, placebo-controlled, double-masked trial has investigated the human monoclonal blocking antibody directed against IGF-1R, teprotumumab, reporting its effectiveness in GO. In conclusion, large, controlled and randomized studies are needed to evaluate new possible targeted therapies for GO.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Review, Journal: Insulin-Like Growth Factor Pathway and the Thyroid. (Pubmed Central) - Dec 23, 2021
Based on those findings, the development of teprotumumab, a β-arrestin biased agonist as a therapeutic has resulted in the first medication approved by the US FDA for the treatment of TAO. Teprotumumab is now in wide clinical use in North America.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: Teprotumumab: The Dawn of Therapies in Moderate-to-Severe Thyroid-Associated Ophthalmopathy. (Pubmed Central) - Dec 16, 2021
Recently two TMB clinical trials had been implemented in TAO patients, indicating dramatic reductions in disease activity and severity, which approved its use for the treatment of TAO in the US. This review summarizes the treatments of TAO, focusing on the pathogenesis of IGF-1R in TAO and its application prospects.
- |||||||||| Tepezza (teprotumumab-trbw) / Roche, Amgen
Enrollment open: TEPEZZA (clinicaltrials.gov) - Dec 7, 2021
P3b/4, N=300, Recruiting,
This review summarizes the treatments of TAO, focusing on the pathogenesis of IGF-1R in TAO and its application prospects. Not yet recruiting --> Recruiting
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Clinical, Review, Journal: Efficacy and Safety of Teprotumumab in Thyroid Eye Disease. (Pubmed Central) - Dec 6, 2021
Evidence also suggests that teprotumumab may exacerbate pre-existing inflammatory bowel disease, worsen hyperglycemia, and be associated with hearing impairment. Patients at risk for these adverse events need to be closely monitored with baseline and periodic assessments.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: Teprotumumab and hearing loss: hear the warnings. (Pubmed Central) - Nov 29, 2021
Patients at risk for these adverse events need to be closely monitored with baseline and periodic assessments. No abstract available
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche, Actemra IV (tocilizumab) / Roche, JW Pharma, Enbrel (etanercept) / Pfizer, Amgen
Review, Journal: Precision Medicine in Graves' Disease and Ophthalmopathy. (Pubmed Central) - Nov 17, 2021
Molecules able to act as antagonists of CXCR3, or to block CXCL10, are also under study. More extensive researches are needed to deepen out these drugs as well as to identify new targeted and effective therapies, that will permit a more precise identification of GD, or GO, patients able to respond to specific targeted therapies.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Clinical, Journal: Early Experience With the Clinical Use of Teprotumumab in a Heterogenous Thyroid Eye Disease Population. (Pubmed Central) - Nov 17, 2021
Patients beyond those defined in the clinical trials, including those affected by stable stage, milder grade, and vision-threatening TED may benefit from this therapy. There are, however, limits on the overall efficacy of this medication in the management of certain physical characteristics in TED including eyelid position and strabismus.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Clinical, Journal, Adverse events: Infusion Center Guidelines for Teprotumumab Infusions: Informed Consent, Safety, and Management of Side Effects. (Pubmed Central) - Nov 17, 2021
Although biologic therapies are a preferred treatment option for many complex immunologic and oncologic conditions, their use in ophthalmology and endocrinology may be more novel. The goals of this article are to introduce this new therapeutic option; discuss its mechanism of action, indications for use, administration protocol, infusion precautions, and informed consent; and review common side effects and management.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Teprotumumab Efficacy in TED Patients With Low Inflammation as Measured by Clinical Activity Score (Morial Convention Center; 255-257) - Oct 20, 2021 - Abstract #AAO2021AAO_1428;
Furthermore, in patients with CAS <3, 10 of 12 (83.3%) were responders, with mean proptosis reduction of 2.6 ± 1.4 mm. Conclusion The results suggest comparable teprotumumab proptosis efficacy in TED patients with low-level inflammation as measured by CAS as previously demonstrated in those with high inflammatory activity.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Teprotumumab-Related Adverse Events in TED (Morial Convention Center; 255-257) - Oct 20, 2021 - Abstract #AAO2021AAO_1427;
However, a small percentage required interruption or cessation of therapy. Protocols for screening, prevention and management of AEs are therefore advised.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Teprotumumab for the Treatment of Recalcitrant TED (Morial Convention Center; HALL C) - Oct 20, 2021 - Abstract #AAO2021AAO_990;
However, a small percentage required interruption or cessation of therapy. Protocols for screening, prevention and management of AEs are therefore advised.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Real-World Adherence With Teprotumumab in TED (Morial Convention Center; HALL C) - Oct 20, 2021 - Abstract #AAO2021AAO_989;
Patients discontinued their prescribed regimen for the following reasons: 84 (8%), adverse event; 15 (1%), noncompliance; five (<1%), site-of-care challenges or payer restrictions; and six (<1%), patient or physician concern. Conclusion Results suggest that adherence to teprotumumab treatment is high in clinical practice, consistent with the controlled trial findings.
- |||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Clinical, Journal: New-Onset of Inflammatory Bowel Disease in a Patient Treated With Teprotumumab for Thyroid Associated Ophthalmopathy. (Pubmed Central) - Oct 6, 2021
Despite treatment with budesonide and mesalamine, the patient continued to be symptomatic one and a half months after cessation of teprotumumab and required infliximab to achieve good control of her inflammatory bowel disease. This case represents the first report of new-onset inflammatory bowel disease arising during treatment with teprotumumab.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: Facial and Eyelid Changes in Thyroid Eye Disease Are Reversed by Teprotumumab. (Pubmed Central) - Sep 23, 2021
There was no relationship between previous steroid use and total body weight reduction and changes in facial volume. TED may cause significant tissue expansion across the entire face and this may be reduced following teprotumumab therapy.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: Teprotumumab for non-inflammatory thyroid eye disease (TED): evidence for increased IGF-1R expression. (Pubmed Central) - Sep 22, 2021
Our findings demonstrate for the first time, that teprotumumab, a blocking antibody to the IGF-1R reduces proptosis in a series of patients with non-inflammatory TED. Overexpression of the IGF-1R in orbital tissue from patients with non-inflammatory disease compared to controls may be an important consideration for effect.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche, Actemra IV (tocilizumab) / Roche, JW Pharma
Clinical, Clinical guideline, Review, Journal: THE 2021 EUROPEAN GROUP ON GRAVES' ORBITOPATHY (EUGOGO) CLINICAL PRACTICE GUIDELINES FOR THE MEDICAL MANAGEMENT OF GRAVES' ORBITOPATHY. (Pubmed Central) - Sep 10, 2021
Sight threatening GO is treated with several high single doses of iv methylprednisolone per week and, if unresponsive, with urgent orbital decompression. Rehabilitative surgery (orbital decompression, squint and eyelid surgery) is indicated for inactive residual GO manifestations.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: JNO Literature Commentary. (Pubmed Central) - Sep 5, 2021
Bilateral dysthyroid compressive optic neuropathy responsive to teprotumumab...doi: 10.1001/jamaophthalmol.2020.5329. PMID: 33270081; PMCID: PMC7716256.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Review, Journal: Thyroid eye disease: Redefining its management-A review. (Pubmed Central) - Sep 2, 2021
Until recently, the management of TED is a long arduous course with supportive therapy, followed by an extensive surgical treatment plan to reverse the disease endpoints. Teprotumumab offers an early, safe therapeutic intervention to help reverse disease end points such as diplopia and proptosis and improve quality of life.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Roche
Journal: Teprotumumab for the treatment of thyroid eye disease. (Pubmed Central) - Aug 26, 2021
Clinical trials indicated that proptosis response of teprotumumab was 83%, and clinical activity score, diplopia, and quality of life were also better than placebo. Teprotumumab was well tolerated, common adverse reactions included muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, and dry skin.
- |||||||||| Tepezza (teprotumumab-trbw) / Roche, Amgen
Trial completion date, Trial primary completion date: A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) (clinicaltrials.gov) - Aug 25, 2021
P1, N=25, Recruiting,
Teprotumumab was well tolerated, common adverse reactions included muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, and dry skin. Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Apr 2022 --> Apr 2023
- |||||||||| Tepezza (teprotumumab-trbw) / Roche, Amgen
Enrollment open, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: A Study Evaluating TEPEZZA (clinicaltrials.gov) - Aug 6, 2021
P4, N=57, Recruiting,
Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Apr 2022 --> Apr 2023 Not yet recruiting --> Recruiting | N=39 --> 57 | Trial completion date: Apr 2022 --> Apr 2023 | Initiation date: Oct 2020 --> Aug 2021 | Trial primary completion date: Sep 2021 --> Sep 2022
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Genmab
Review, Journal: Updates on the understanding and management of thyroid eye disease. (Pubmed Central) - Jul 16, 2021
Teprotumumab is an antibody targeted against IGF-1R...Advances in our understanding of the pathophysiology of TED, therefore, are leading to more targeted therapeutic options, and we are entering an exciting new phase in the management of TED. This review will cover recent insights into the understanding of TED pathophysiology and novel treatment options as well as ongoing studies of new potential treatment options for TED.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Genmab
Preclinical, Journal: Inhibition of Fibrotic Contraction by Sirolimus (Rapamycin) in an Ex Vivo Model of Thyroid Eye Disease. (Pubmed Central) - Jul 14, 2021
Clinical case reports, now supplemented by this in vitro evidence, support the initiation of a clinical trial to treat the fibrotic sequelae of TED with this already-approved agent. Such an "off-the-shelf" therapy is a welcome prospect for TED treatment, particularly one available at a low price.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Genmab
Journal: Advances in steroid sparing medical management of active thyroid eye disease. (Pubmed Central) - Jul 3, 2021
Due to the common and predictable side effects of long-term and high-dose steroid use, there has been a continuous effort to find alternative steroid-sparing medical management options for TED. This review highlights the various research studies that support the use of these medications.
- |||||||||| Tepezza (teprotumumab) / Horizon Therapeutics, Genmab
Clinical, Journal: Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomised, double-masked, placebo-controlled, multicentre trials. (Pubmed Central) - Jun 26, 2021
Teprotumumab markedly improved the clinical course of thyroid eye disease in all patient subgroups examined from the two trials, with most patients maintaining responses in the long-term. Analyses of the effect of teprotumumab retreatment on non-responders and those who flare after response, as well as further studies in a broader population of thyroid eye disease are ongoing.
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