According to a panel of experts, teprotumumab can not only be used as a first-line treatment for thyroid eye diseases, but is also suitable for a wider range of patients than were included in the two clinical studies, such as: B. Patients with longer disease duration and more broadly defined activity and severity. The group of clinical researchers published their recommendations for best practices in the Journal of Neuro-Ophthalmology.
Patients with thyroid eye disease (TED) experience dry, red eyes, photophobia, diplopia, and pain with eye movements. TED occurs at rates of 16 and 2.9 per 100,000 in women and men, respectively.
Historically, clinicians have treated TED with nonspecific immunosuppression via corticosteroids and surgical procedures. However, both options come with risks. Teprotumumab, an anti-insulin-like growth factor I receptor (IGF-IR) inhibitor antibody, directly targets proptosis and strabismus.
Continue reading
In clinical trials, patients receiving TED showed greater reductions in proptosis and clinical activity scores compared to placebo. In addition, teprotumumab has been linked to an increased quality of life. The most common side effects were muscle cramps, nausea, and alopecia.
In January 2020, teprotumumab was approved by the US Food and Drug Administration (FDA) for the treatment of TED.
A panel of experts met from October to November 2019 to review the current evidence supporting the use of teprotumumab in TED and to formulate best practice recommendations.
Teprotumumab should be considered first-line therapy for significant TED, as recommended by the panel. In the clinical trial, the treatment was both more effective and safer than the other options, such as corticosteroids.
Teprotumumab can be given to patients on TED at the same time as thyrostatic drugs. The panel said there was no need to wait for the patient to reach a euthyroid state as there was no evidence that thyroid status would affect efficacy or safety.
Although only patients aged 18 to 80 years of age were enrolled in Phase 2 and 3 clinical trials, the Panel noted that teprotumumab may be considered in adolescents and the elderly. In adolescents, doctors should wait for linear growth to stop and consult a pediatric endocrinologist.
Teprotumumab can be prescribed to patients with diabetes, but these patients should be monitored for changes in glycemic control as the IGF-IR pathway helps regulate glucose homeostasis. Teprotumumab should be avoided in women who are pregnant or who may become pregnant. In inflammatory bowel disease (IBD) patients, it remains unclear what results will occur in these patients as they have been excluded from clinical trials.
In general, the panel advises doctors to use the dosage tested in clinical studies. The established dosing protocol consisted of 8 infusions over 6 months. Infusion 1 was dosed at 10 mg / kg by intravenous infusions over 90 minutes. The remaining doses were increased to 20 mg / kg for 60 minutes as there were no side effects of dose 1.
Concomitant use of teprotumumab with biologics is strongly discouraged, but the Panel believes that concomitant use with corticosteroids is acceptable in some cases.
The report concludes that teprotumumab can be used safely and effectively to treat patients with TED, but the panel noted that teprotumumab is still more expensive than treatment alternatives. Clinicians and their patients should weigh the benefits against the costs of treatment.
Disclosure: Several authors stated links with biotech, pharmaceutical, and / or device manufacturers. For a full list of author disclosures, see the original reference.
relation
Douglas RS, Wang Y, Dailey RA, et al. Teprotumumab in Clinical Practice: Recommendations and Considerations from Investigators in the OPTIC Study. J Neuroophthalmol. 2021; 41 (4): 461-468. doi: 10.1097 / WNO.0000000000001134
This article originally appeared on Ophthalmology Advisor
