Safety profile of SARS-CoV-2 vaccination in patients with antibody-mediated CNS disorders.

OBJECTIVES: In this retrospective multicenter study, we evaluated the safety of SARS-CoV-2 vaccination in patients harboring autoantibodies targeting neuronal surface and/or synaptic antigens. METHODS: From eight Italian Neurology Units, we included patients with: a) serum and/or CSF positivity for specific neuronal autoantibodies; b) a compatible neurological syndrome; and c) available follow-up ≥6 weeks after vaccination with any of the approved SARS-CoV-2 vaccines. Demographics, clinical data, and information regarding previous SARS-CoV-2 infection and vaccination were collected. Disease relapses were considered "post-infectious" or "post-vaccination" when occurring within 6 weeks from infection/vaccination. RESULTS: We included 66 patients; 7/66 (11%) had a previous history of SARS-CoV-2 infection and 1/7 (14%) had post-infection relapses. BNT162b2-Pfizer-BioNTec was administered in 55 cases (83.3%) and mRNA-1273-Moderna in 11 (16.7%). The median number of doses administered per patient was 2 (1-3) and >50% of patients did not experience side effects. Five patients (8%) had post-vaccination relapses (seizure 3/5); 4/5 improved after immunotherapy, while one did not receive immunotherapy and worsened. Patients with post-vaccination relapses had higher disability scores at vaccination (p = 0.025), a trend favoring Leucine-rich glioma-inactivated protein 1 LGI1 glutamic acid decarboxylase 65 (GAD65) antibodies (p =  0.054) and shorter time from last relapse (p = 0.057). DISCUSSION: Our data support the safety of SARS-CoV-2 vaccines in patients with neurological disorders associated with antibodies to neuronal and synaptic antigens.

BEEP-Bodily and Emotional Perception of Pain. A Questionnaire to Measure Reaction to Pain in Chronic Pain Disorders.

Background: The assessment of pain and its impact on quality of life is central to the evaluation of chronic pain syndromes. However, most available tools focus on the nociceptive experience of pain, and at best only consider the occurrence of anxious, depressive, or cognitive problems. Here is a new questionnaire aimed at measuring the multifaceted impact of pain in chronic pain syndromes, the Bodily and Emotional pErception of Pain (BEEP). Methods: All consecutive patients who accessed a center for the treatment of pain were invited to take part in the study. The sample included 222 participants (51 with fibromyalgia, 84 with low back pain; 87 with other chronic pain syndromes). Women were 77% of the sample, the mean age was 61 ± 15. Participants completed the BEEP, the Patient Health Questionnaire-9 (PHQ-9), and the Mood Disorder Questionnaire (MDQ). Results: Reliability was good for all questionnaires. The expected three dimensions of the BEEP were confirmed by confirmatory factor analysis, and a bifactor model with three orthogonal factors showed a good fit as well. Participants diagnosed with fibromyalgia showed higher scores on the BEEP than the participants who had been diagnosed with low back pain or other chronic pain syndromes. The prevalence of probable cases of major depression and bipolar disorder in the sample was higher than expected for non-clinical samples. Levels of depression, as measured by the PHQ-9, were associated with the three dimensions of the BEEP and with the intensity of pain. Conclusions: The BEEP is a promising measure of the impact of pain in daily life and differentiates fibromyalgia from other chronic pain syndromes. The BEEP may be helpful to evaluate the patient's response to the treatment over time and may favor the identification of unmet needs in patients' personal, social, and daily functioning.

The impact of fibromyalgia syndrome and the role of comorbidity with mood and post-traumatic stress disorder in worsening the quality of life.

BACKGROUND:: The aim is to measure the association between fibromyalgia syndrome (FMS) and post-traumatic stress disorder (PTSD), mood and anxiety disorders using reliable psychiatric diagnoses according to Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and with a case-control design. METHODS:: Case-control study with cases (71 consecutive female patients with FMS) and controls (284 subjects without FMS), randomly drawn after a gender- and age-matching technique from the database of an epidemiological survey. Psychiatric diagnoses were conducted according to DSM-IV and carried out by clinical staff using a structured interview (Advanced Neuropsychiatric Tools and Assessment Schedule). QoL was measured by Short Form Health Survey (SF-12). RESULTS:: The lifetime prevalence of major depressive disorder (MDD; 43.7% vs 8.1%, p < .0001), bipolar disorder (BD; 21.1% vs 0.7%, p < .0001), PTSD (8.4% vs 1.4%, p < .0001) and panic disorder (28.2% vs 5.6%, p < .001) was higher in people with FMS than in controls. People with FMS showed a poorer QoL than controls on the SF-12 (26.43 ± 6.04 vs 37.45 ± 5.80, p < .0001). Those with comorbidity with MDD and BD showed a mean SF-12 score of 24.75 ± 6.31 versus 29.52 ± 4.84 ( N = 25) of people with FMS without any mood disorder ( p = .002). The attributable burden of FMS in worsening QoL was found comparable to that of serious chronic diseases such as multiple sclerosis. CONCLUSION:: FMS is a disorder that 'in itself' can have a devastating impact on an individual's life. The frequency of the association with major depressive and bipolar disorders increases the impact on the QoL of people with FMS. One of the causes of this association appears to be the extreme vulnerability to chronic stress that this disorder involves. The findings have important clinical significance: the physician must interpret in the right dimension and with dignity the suffering of the people with FMS.