ABSTRACT
BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. METHODS: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months. RESULTS: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication. CONCLUSIONS: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced. TRIAL REGISTRATION: BASEC ID 2018-02,375 in the Register of All Projects in Switzerland (RAPS).
Subject(s)
Migraine Disorders , Quality of Life , Humans , Adult , Adolescent , Child , Switzerland , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Receptors, Calcitonin Gene-Related Peptide , Headache , Delivery of Health CareABSTRACT
Purpose: Mortality from COVID-19 among kidney transplant recipients (KTR) is unacceptably high, and their response to up to three vaccinations against SARSCoV- 2 is strongly impaired. We provide the first systematic analysis of serological response to up to five repeated vaccinations in nonresponding KTR. Method(s): We retrospectively analyzed serological response to basic immunization, as well as administration of three, four and five doses of SARS-CoV-2 vaccine in KTR from December 27, 2020 until December 31, 2021. In particular, the influence of different dose adjustment regimens for mycophenolic acid (MPA) on serological response to fourth vaccination was analyzed. Result(s): In total, 4.277 vaccinations against SARS-CoV-2 in 1.478 patients were analyzed. Serological response was 19.5% after 1.203 basic immunizations, and increased to 29.4%, 55.6%, and 57.5% after 603 third, 250 fourth and 40 fifth vaccinations, resulting in a cumulative response rate of 88.7% (figure 1A-B). Patients with belatacept immunosuppression show impaired cumulative serological response (4.4%, 12.4%, and 16.4%) in comparison to patients with calcineurin inhibitor (CNI)- based immunosuppression (19.1%, 37.6%, and 70.1%) after basic immunization, three, and four vaccinations (figure 1C-F). In patients with CNI and MPA maintenance immunosuppression, pausing MPA and adding 5 mg prednisolone equivalent before the fourth vaccination increased serological response rate to 75% in comparison to no dose adjustment (52%) or dose reduction (46%) without occurence of rejections (figure 2). Conclusion(s): Repeated SARS-CoV-2 vaccination of up to five times effectively induces serological response in kidney transplant recipients. It can be enhanced by pausing MPA at the time of vaccination. Patients with belatacept immunosuppression are unlikely to achieve sufficient serological response and require different approaches.