Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register

The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48–0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76–1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13311-020-01001-6.Key Words: Multiple sclerosis, injectable DMTs, oral DMTs, real-world setting, EDSS score     

Cognitive assessment in multiple sclerosis—an Italian consensus

The aim of this consensus paper was to define the state of the art on cognitive assessment of persons with multiple sclerosis (PwMS), with the purpose of providing recommendations for the Italian centers involved in MS management. While there are no formal guidelines published regarding the assessment of cognitive function in MS, on the basis of an expert opinion meeting, held in Milan (Italy) on July 4, 2016, we report the recommendations of a panel of Italian experts including MS neurologists and neuropsychologists for the assessment and follow-up of cognitive function in adult MS subjects.     

Thyroid autoimmunity and recurrent miscarriage

Citation Ticconi C, Giuliani E, Veglia M, Pietropolli A, Piccione E, Di Simone N. Thyroid autoimmunity and recurrent miscarriage. Am J Reprod Immunol 2011; 66: 452–459 Problem To investigate the role of antithyroid autoantibodies (ATA) in recurrent miscarriage (RM). Methods In this case‐control study, a total of 160 women with RM and 100 healthy women were investigated for the presence of serum ATA directed against thyreoglobulin (TG‐Ab), thyroid peroxidase (TPO‐Ab) and TSH receptor (TSHr‐Ab), which were determined by either chemiluminescence or radioimmunoassay. Results Antithyroid autoantibodies were detected in 46 (28.75%) women with RM and in 13 (13%) women of the control group (P < 0.05). The frequencies for TG‐Ab and TPO‐Ab were higher in RM than in control women. Among the women of RM group, 91.3% of ATA+ women were positive also for other autoantibodies. The majority of study women were euthyroid. Conclusions Antithyroid autoantibodies, particularly TG‐Ab, are associated with RM and could be an expression of a more general maternal immune system abnormality leading to RM. ATA could have a role in RM irrespective of thyroid hormone status.     

Anxiety in terminally ill cancer patients

Context

Anxiety in terminal cancer is linked to diminished quality of life, yet overall it is poorly understood with regard to prevalence and relationship to other aspects of psychological distress.

Objectives

This study examines anxiety in terminally ill cancer patients, including the prevalence of anxiety symptoms, the relationship between anxiety and depression, differences in anxiety between participants receiving inpatient palliative care and those receiving outpatient care, and characteristics that distinguish highly anxious from less anxious patients.

Methods

Participants were 194 patients with terminal cancer. Approximately half (n = 103) were receiving inpatient care in a palliative care facility and half (n = 91) were receiving outpatient care in a tertiary care cancer center. The Hospital Anxiety and Depression Scale was used to assess anxiety and depression, and was administered along with measures of hopelessness, desire for hastened death, and social support.

Results

Moderately elevated anxiety symptoms were found in 18.6% of participants (n = 36) and 12.4% (n = 24) had clinically significant anxiety symptoms. Level of anxiety did not differ between the two treatment settings. However, participants receiving palliative care reported significantly higher levels of depression and desire for hastened death. A multivariate prediction model indicated that belief in an afterlife, social support, and anxiolytic and antidepressant use were unique, significant predictors of anxiety.

Conclusion

Severity of anxiety symptoms did not differ between the study sites, suggesting that anxiety may differ from depression and desire for hastened death in the course that it takes over the duration of terminal cancer.     

A novel nasal endoscopic approach for removing displaced dental implants from the maxillary sinus

Introduction

Over the last 30 years, dental implants have become widespread all over the world. Though the implantation procedure is standardized and safe, the displacement of implants into the maxillary sinus can occur. The aim of the study has been to describe a novel combined nasal endoscopic approach through the middle and lower meatus for managing dental implants displaced into the maxillary sinus.

A prospective investigation of predictive parameters for post-surgical recurrences in sinonasal polyposis

Even after appropriate surgical therapy, a significant number of patients with chronic rhinosinusitis with nasal polyps (CRSwNP) experience recurrences. The end-point of this prospective study was to apply univariate and multivariate statistical models to identify clinical, pathological, and laboratory variables that could predict CRSwNP recurrence after endoscopic sinus surgery. The study enrolled 143 patients between 2010 and 2013, who were all treated by the same surgeon for CRSwNP. Twenty-one patients developed recurrent polyposis. The recurrence rate was significantly higher for the eosinophilic than for the non-eosinophilic type (p = 0.020). Among the patients who developed a recurrence, the disease-free interval was significantly shorter for those with eosinophilic-type polyposis (p = 0.003). Univariate statistical analysis disclosed significant associations between CRSwNP recurrence and age (p = 0.035), allergy (p = 0.014), and eosinophilic granulomatosis with polyangiitis (p = 0.01). The multivariate model showed that only histological evidence of the eosinophilic type of CRSwNP retained an independent prognostic significance in relation to recurrent polyposis (p = 0.033). Judging from our results, it is reasonable to consider both stricter follow-up protocols and postoperative adjuvant medical treatments for patients with a histological diagnosis of eosinophilic-type CRSwNP.     

Evolution of transmitted HIV-1 drug resistance in HIV-1-infected patients in Italy from 2000 to 2010

Prevalence and predictors of transmitted drug resistance (TDR), defined as the presence of at least one WHO surveillance drug resistance mutation (SDRM), were investigated in antiretroviral-na?ve HIV-1-infected patients, with a genotypic resistance test (GRT) performed ≤6 months before starting cART between 2000 and 2010. 3163 HIV-1 sequences were selected (69% subtype B). Overall, the prevalence of TDR was 12% (13.2% subtype B, 9% non-B). TDR significantly declined overall and for the single drug classes. Older age independently predicted increased odds of TDR, whereas a more recent GRT, a higher HIV-RNA and C vs. B subtype predicted lower odds of TDR.