[Over one year of B­cell targeted therapy with Ofatumumab s.c.: first results of a prospective, patient-centered real-world observational study]. / Über ein Jahr B-Zell-gerichtete Therapie mit Ofatumumab s.c.: erste Ergebnisse einer prospektiven, patientenzentrierten Real-world-Beobachtungsstudie.

INTRODUCTION: Ofatumumab (Kesimpta™) is a s.c. applicable anti-CD20 antibody, which has been used in Germany since 2021 for the treatment of relapsing multiple sclerosis (RMS). The self-application offers a high degree of independence from intravenous forms of application with highly effective immunotherapy. In this study we recorded the patient-centered experience in 99 out of 127 patients who were adjusted to the drug by us. The aim was to investigate the tolerability and acceptance from the patient's perspective. METHODS: Data collection was carried out using doctor documentation, questionnaires and telephone interviews. RESULTS: The cohort consists of 127 patients. The patients received 2.8 (± SD 1.7) pre-therapies. The mean duration of therapy with Ofatumumab was 9.8 months (± SD 3.5). Structured data were collected from 99 patients. 23% of patients had no side effects during initial application. 19% rated the side effects as "very mild" and 18% as "mild". In addition to chills/fever (48%), headache (46%), limb pain (45%) and "other symptoms" (19%) also occurred. For subsequent injections, 72% of patients reported no side effects. 87% of patients found handling the medication "very easy". There was one relapse event during therapy. CONCLUSION: Our study shows that Ofatumumab is well accepted and tolerated by patients. There was one relapse event during the observation period. The side effects are mild and occur during initial application. No increased tendency to infection could be observed. The data suggest that Ofatumumab is also an effective and safe treatment option for patients with relapsing remitting multiple sclerosis in real-world use.

Peginterferon beta-1a was associated with high adherence and satisfaction in patients with multiple sclerosis in a German real-world study.

BACKGROUND: Peginterferon beta-1a was developed for treatment of relapsing-remitting multiple sclerosis (RRMS) to provide an interferon with increased exposure to facilitate adherence by reducing frequency of application. This non-interventional observational study investigated the adherence to peginterferon beta-1a in real-world clinical practice settings. METHODS: This prospective study was conducted from 1/2015 to 1/2018 at 77 German MS sites. Adult patients with RRMS (previously treated or treatment-naïve) receiving peginterferon beta-1a (125 µg SC every 2 weeks) were eligible for participation. Data were documented every 3 months over 2 years (nine visits). The primary endpoint was the percentage of patients with overall adherence defined as ⩽10% of injections not administered throughout the 24-month observation period. Secondary endpoints included persistence, patient satisfaction, efficacy (relapse activity, disability progression), and tolerability. Patients were invited to participate in an individualised patient support programme. RESULTS: Out of 250 enrolled patients, 190 (aged 18-74 years, 75.3% female) were included in the efficacy analysis. Of those, 74 patients completed the study; 33.2% were treatment-naïve. The proportion of patients with an overall adherence of >90% was 75.7% (95% CI 67.9-81.6). The annualised relapse rate was 0.17. Compared with previous therapies, the scores for treatment satisfaction and convenience were markedly higher with peginterferon beta-1a. Overall, 87.4% participated in the patient support programme, and 47.8% of patients reported adverse events. CONCLUSIONS: Adherence to the bi-weekly treatment with peginterferon beta-1a was very high. Although adherence could have been positively influenced by the well-accepted patient support programme, the extent could not be unequivocally evaluated. Clinical disease activity remained low. Peginterferon beta-1a was well tolerated, and there were no new relevant safety findings.

Hypoechogenicity of brainstem raphe nuclei is associated with increased attack frequency in episodic migraine.

INTRODUCTION: Reduced echogenicity of the brainstem raphe nuclei (BRN) was demonstrated in major depression, possibly indicating serotonergic dysfunction. Postulating that migraine may constitute a "chronic low serotonin syndrome," we aimed to evaluate the echogenicity of midbrain structures, including serotonergic BRN in episodic migraine. METHODS: Transcranial sonography was performed in 39 patients with episodic migraine (median age 35, interquartile range (IQR): 27-47 years; 27 women) and 35 controls (median age 31, IQR: 29-47 years; 19 women). Individuals with concomitant depression were excluded. Echogenicity of BRN, substantia nigra (SN) and third ventricle width was evaluated according to an internationally established examination protocol. RESULTS: Hypoechogenicity of BRN was depicted in 23.1% of migraine patients and 20% of controls, showing no significant difference. Migraine patients with hypoechogenic BRN had significantly higher attack frequency (median 3, IQR 2-5 vs. 1.5, IQR 1-2 days/month; p = 0.029) and a trend toward earlier disease manifestation. The rate of hyperechogenic SN and width of the third ventricle were similar between both groups. We did not observe any differences between migraine patients with and without aura. CONCLUSION: Sonographic findings did not differ between migraine patients and controls. Hypoechogenic BRN correlated to a higher migraine attack frequency, probably indicating more severe disease activity.