ABSTRACT
Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) have shown promising effectiveness in migraine management compared to other preventative treatment options. Many questions remain regarding switching between antibody classes as a treatment option in patients with migraine headaches. This preliminary retrospective real-world study explored the treatment response of patients who switched between CGRP mAb classes due to lack of efficacy or poor tolerability. A total of 53 patients with migraine headache switched between three of the CGRP mAbs types due to lack of efficacy of the original prescribed CGRP mAbs, specifically eptinezumab, erenumab, and galcanezumab. Fremanezumab was not included due to unavailability in the UAE. Galcanezumab and eptinezumab target the CGRP ligand (CGRP/L), while erenumab targets CGRP receptors (CGRP/R). The analysis of efficacy demonstrated that some improvements were seen in both class switch cohorts (CGRP/R to CGRP/L and CGRP/L to CGRP/R). The safety of switching between CGRP classes was well observed, as any adverse events presented before the class switch did not lead to the discontinuation of treatment following the later switch. The findings of this study suggest that switching between different classes of CGRP mAbs is a potentially safe and clinically viable practice that may have some applications for those experiencing side effects on their current CGRP mAb or those witnessing suboptimal response.
ABSTRACT
INTRODUCTION: The introduction of clacitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) has revolutionized the treatment of migraines. In clinical practice gepants might be considered as a valid option to treat acute attacks in patients with migraine who are treated with mAbs. However, the safety and tolerability of such a combination is not well addressed in the real-world setting. We designed this study to evaluate the safety and tolerability of combining CGRP mAbs with gepants in the management of migraines. METHODS: This was a retrospective, real-world, exploratory study. The participants included within the study were adult (≥ 18 years) patients diagnosed with migraine. Screening for patients who were treated with at least one GCRP mAbs was done. Data was collected from one site, the American Center for Psychiatry and Neurology, Abu Dhabi UAE. A total of 516 patients taking CGRP mAbs were identified. Extracted data from patients' electronic medical records included patient demographics, migraine characteristics, prescribed treatments, and adverse events (AEs). The tolerability and safety of the combination therapy was evaluated on the basis of documented AEs. RESULTS: Among the identified 516 patients, 234 were administered gepants in addition to the CRGP mAb (215, rimegepant; 19, ubrogepant). Eleven of the 234 patients switched from rimegepant to urogepant as a result of lack of efficacy; one patient switched from urogepant to zolmitriptan because of the lack of insurance coverage of the former medication. Among all the patients included in this study, three AEs were documented. These AEs were generally mild and transient and hence did not lead to discontinuation of treatment. Moreover, 42 of the 234 (17.9%) patients were switched from one class of CGRP mAbs to another at least once while continuing treatment with the assigned gepants. CONCLUSION: The findings of this study demonstrate that combining CGRP mAbs with gepants is a safe and well-tolerated treatment approach for migraine. Future studies are warranted to further validate these findings and explore long-term outcomes.
ABSTRACT
INTRODUCTION: Eptinezumab is a humanized IgG1 immunoglobulin monoclonal antibody administered intravenously as a preventative migraine treatment. Previously conducted randomized, double-blind, placebo-controlled trials exhibited significant reductions in monthly migraine frequency among adults experiencing episodic and chronic migraine. The present study seeks to expand upon the current findings and to evaluate eptinezumab's efficacy as a preventative treatment for chronic and episodic migraine patients in the United Arab Emirates. This study is intended to represent the first real-world evidence and will hopefully serve as a valuable complement to the existing literature on the subject. METHODS: This was a retrospective exploratory study. The participants included within the study were adult (≥ 18 years) patients diagnosed with either episodic or chronic migraine. Patients were categorized according to their history of previous preventative treatment failure. For the final assessment of treatment efficacy, we included only patients with a minimum of 6 months of clinical follow-up data. Patients were assessed at baseline for their monthly migraine frequency and assessed again at months 3 and 6. The primary objective was to evaluate the efficacy of eptinezumab in reducing migraine frequency among chronic and episodic migraine patients. RESULTS: A total of 100 participants were identified, of whom 53 completed the study protocol at month 6. Of the total, 40 (75.47%) were female, 46 (86.79%) were Emirati locals, and 16 (30.19%) were pharmaceutically naïve, having never tried any prior preventative therapy. Additionally, 25 (47.17%) patients met the criteria for chronic migraine (CM), whereas the remaining 28 (52.83%) were diagnosed with episodic migraine (EM). The baseline monthly migraine frequency (MMD) was 12.23 (4.97) days across all participants, 15.56 (3.97) for CM patients, and 9.25 (3.76) for EM patients; by month 6, these frequencies reduced to 3.66 (4.21), 4.76 (5.32), and 2.68 (2.61), respectively. Overall, 58.49% of those enrolled experienced > 75% reduction in MMD frequency by month 6. CONCLUSION: Patients enrolled in this trial experienced clinically significant reductions in MMD by month 6. Eptinezumab was well tolerated and with one AE of significance that led to discontinuation from the study.
ABSTRACT
Background: Psychological distress, such as posttraumatic stress disorder (PTSD), is commonly evaluated using subjective questionnaires, a method prone to self-report bias. The study's working hypothesis was that levels of autonomic dysfunction determined by heart rate variability (HRV) measures are associated with the severity of PTSD in women following pregnancy loss. Methods: This was an observational prospective cohort study with 53 patients enrolled. The DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) PTSD scale (PCL-5) was used to assess the severity of PTSD in women after pregnancy loss. The cardiac autonomic function was assessed using HRV measurements during a deep breathing test using an HRV scanner system with wireless ECG enabling real-time data analysis and visualization. HRV measures were: standard deviation (SD) of normal R-R wave intervals [SDNN, ms], square root of the mean of the sum of the squares of differences between adjacent normal R wave intervals [RMSSD, ms], and the number of all R-R intervals in which the change in consecutive normal sinus intervals exceeds 50 milliseconds divided by the total number of R-R intervals measured [pNN50 = (NN50/n-1)*100%] [pNN50%]. Results: The PCL-5 scores had a statistically significant association with HRV indices (SDNN; RMSSD, and pNN50%). Patients with PTSD had similar mean heart rate values as compared to patients without PTSD (PCL-5), but significantly higher SDNN [median[IQR, interquartile range]: 90.1 (69.1-112.1) vs. 52.5 (36.8-65.6)], RMSSD [59.4 (37.5-74.9) vs. 31.9 (19.3 - 44.0)], and PNN50% values [25.7 (16.4-37.7) vs. 10.6 (1.5-21.9)]. The SDNN of the deep breathing test HRV was effective at distinguishing between patients with PTSD and those without, with an AUC = 0.83 +/- 0.06 (95 % CI 0.94, p = 0.0001) of the ROC model. Conclusions: In this study, HRV indices as biomarkers of cardiac dysautonomia were found to be significantly related to the severity of PTSD symptoms in women after pregnancy loss.
