Background
The effectiveness of onabotulinumtoxinA (BTX‐A) has been established in primary trigeminal neuralgia (TN). However, to the best of our knowledge, the efficacy of BTX‐A in secondary TN has ...not yet been studied.
Objective
This study aimed to investigate the efficacy of BTX‐A treatment in patients with multiple sclerosis–related trigeminal neuralgia (TN‐MS) and compare the efficacy of BTX‐A treatment between patients with primary trigeminal neuralgia (TN‐P) and patients with TN‐MS.
Methods
This was a retrospective medical record–review study. Demographic and clinical features and severity and frequency of pain before and 2 weeks after the BTX‐A administration were extracted from the patient files. BTX‐A was injected into the painful area subcutaneously and/or submucosally. BTX‐A injections were performed by the same physician using the same methods. A reduction in severity and/or frequency of pain ≥50% was considered therapeutic efficacy.
Results
Fifty‐three patients were included in this study. We classified 22 (42%) as TN‐P and 31 (58%) as TN‐MS. Treatment with BTX‐A was effective in 16 of 31 (52%) patients with TN‐MS and 10 of 22 (45%) with TN‐P. BTX‐A treatment was less effective in patients with a history of interventional treatments and more effective in patients with concomitant continuous pain (p = 0.007; odds ratio OR: 0.020–0.53 and p = 0.047; OR: 0.046–0.98, respectively).
Conclusion
The BTX‐A treatment was found to be effective in at least half of our cohort with TN‐MS. Concomitant continuous pain and history of interventional treatments to the trigeminal nerve or ganglion might be predictive factors for the efficacy of BTX‐A treatment.
Background and purpose
Using the treatment goal of “no evidence of disease activity” (NEDA) incorporating magnetic resonance imaging (MRI) re‐baselining, we aimed to assess the efficacy of ...ocrelizumab in patients with relapsing‐remitting multiple sclerosis with a prior suboptimal response, defined by MRI or relapse criteria, to one or two disease‐modifying therapies (DMTs).
Methods
CASTING was a prospective, international, multicenter, single‐arm, open‐label phase 3 trial (NCT02861014). Patients (Expanded Disability Status Scale EDSS score ≤ 4.0, with discontinued prior DMT of ≥6 months duration due to suboptimal disease control) received intravenous ocrelizumab 600 mg every 24 weeks for 96 weeks. The primary endpoint was NEDA (defined as absence of relapses, disability progression, and inflammatory MRI measures, with prespecified MRI re‐baselining at Week 8) over 96 weeks.
Results
A total of 680 patients were enrolled, 167 (24.6%) based on MRI activity only. At Week 96, 74.8% (95% confidence interval CI 71.3–78.0, n/N = 492/658) of patients had NEDA. NEDA was highest among patients enrolled due to MRI activity alone (80.6% 95% CI 68.6–89.6, n/N = 50/62) versus those enrolled for relapse (75.1% 95% CI 69.0–80.6, n/N = 172/229) or for relapse with MRI (70.5% 95% CI 60.0–79.0, n/N = 74/105). NEDA across subgroups was highest in patients with a baseline EDSS score <2.5 (77.2% 95% CI 72.8–81.2, n/N = 315/408). NEDA was higher in patients receiving one prior DMT (77.6% 95% CI 73.2–81.6, n/N = 312/402) versus two prior DMTs (70.3% 95% CI 64.3–75.8, n/N = 180/256).
Conclusions
In patients switching therapy due to suboptimal disease control, treatment with ocrelizumab led to an overall high NEDA rate across a wide range of disease‐related and demographic subgroups, regardless of prior treatment background, with no new safety signals detected.
Data from the phase IIIb CASTING trial in patients with relapsing‐remitting multiple sclerosis with a suboptimal response to one or two prior DMTs shows that switching to ocrelizumab led to a high proportion of patients with no evidence of disease activity (NEDA; defined as absence of relapses, disability progression, and inflammatory MRI measures, with prespecified magnetic resonance imaging re‐baselining at Week 8) at the end of the 96‐week treatment period.
isabelle.lawrence@potentieldaction.com (I. Lawrence).
L’étude de phase IIIb CASTING évalue l’efficacité et la tolérance d’OCR dans la SEP récurrente-rémittente (SEP-RR) avec réponse sous-optimale aux ...DMT pris ≥ 6 mois. L’étude d’extension en ouvert LIBERTO inclut les patients des études de phase IIIb/IV dont CASTING.
Évaluer l’efficacité et la tolérance d’OCR sur 4 ans chez les patients SEP-RR avec réponse sous-optimale aux DMT antérieurs dans CASTING-LIBERTO.
Les patients ayant complété les 2 années de traitement dans CASTING pouvaient poursuivre le traitement par OCR (600mg IV toutes les 24 semaines pendant 2 ans) dans LIBERTO. Les critères d’évaluation incluaient l’absence de signe d’activité de la maladie (NEDA) avec IRM de rebaseline à la semaine 8 (absence de poussées, de progression confirmée du handicap CDP à 24 semaines, de lésions T1 rehaussées par le gadolinium T1Gd+ et de lésions T2 nouvelles/élargies T2N/E) et la tolérance.
Au global, 12/17 pays participant à CASTING ont poursuivi avec LIBERTO (439/680 patients de CASTING). Les caractéristiques des patients étaient homogènes (CASTING/LIBERTO : âge 34,2/36,0 ans, 64,1/62,9 % de femmes, EDSS moyen 2,1/2,0). Après 4 ans dans CASTING-LIBERTO, 56,8 % des patients étaient en NEDA, 64,6 % sans activité clinique (84,1 % pas de poussées, 73,9 % pas de CDP) et 87,2 % sans activité à l’IRM (96,8 % pas de T1Gd+, 87,2 % pas de T2N/E).
Sur 71 patients présentant une activité clinique dans CASTING, 45 (63,4 %) étaient en NEDA dans LIBERTO. Sur 246 patients de CASTING-LIBERTO en NEDA dans CASTING, 189 (76,8 %) l’ont maintenu dans LIBERTO. Au total, 92,7 % des patients ont rapporté des événements indésirables (EI), 8,7 % des EI graves. Des infections ont été observées chez 8,7 % des patients. Trois (0,7 %) patients de LIBERTO ont arrêté OCR à cause d’EI. Aucun décès dans LIBERTO.
La majorité des patients SEP-RR avec une réponse sous-optimale aux DMT antérieurs et ayant switché sous OCR étaient en NEDA durant les 4 ans de suivi de CASTING-LIBERTO. Aucun nouveau signal de tolérance n’a été observé.
Headache among children and adolescents is an important health problem. In this school-based epidemiological study conducted in Istanbul, we aimed to reveal the frequency of headaches in this ...population, define the risk factors associated with headaches, and establish the effect of headaches on the quality of life in this population.
The child and adolescent versions of the Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation structured questionnaire were conducted in 30 schools in Istanbul. The diagnosis was made based on the International Classification of Headache Disorders III-(ICHD-3) beta version. Risk factors associated with headaches were analyzed in a binary logistic regression model.
Among the 5944 students (boys = 3011 50.7%, girls 2933 49.3%) who completed the survey and were enrolled in this study, 3354 (56.4%) reported a headache ever. The prevalence of headaches was significantly higher in girls (62.6% vs. 50.4%, P < 0.001). Migraine prevalence was found to be 5.2%, whereas tension-type headache (TTH) prevalence was 26.1%. Being a female, age, living on the European side, and headache history in the family were found to be associated with an increased risk of having a headache. Pupils with headaches reported that they missed an average of 0.5 ± 1.5 school days due to headaches.
TTH was found to be the most common headache syndrome in Istanbul metropolitan area. Considering the effect of headaches on school success and quality of life in childhood, it is clear that the correct diagnosis of headaches and careful handling of risk factors are crucial for this population.
Vascular involvement is an important cause of morbidity and mortality in patients with Behçet's syndrome (BS). We aimed to survey the efficacy and safety of infliximab (IFX) in BS patients with ...vascular involvement followed in a dedicated tertiary center.
Charts of all BS patients who used IFX for vascular involvement between 2004 and 2022 were reviewed. Primary endpoint was remission at Month 6, defined as lack of new clinical symptoms and findings associated with vascular lesion, lack of worsening of the primary vascular lesion and a new vascular lesion on imaging, and CRP < 10 mg/L. Relapse was defined as development of a new vascular lesion or recurrence of the preexisting vascular lesion.
Among the 127 patients (102 men, mean age at IFX initiation: 35.8 ± 9.0 years) treated with IFX, 110 (87%) had received IFX for remission induction and 87 of these (79%) were already on immunosuppressives when the vascular lesion requiring IFX developed. The remission rate was 73% (93/127) at Month 6 and 63% (80/127) at Month 12. Seventeen patients experienced relapses. Remission rates were better among patients with pulmonary artery involvement and venous thrombosis compared to patients with non-pulmonary artery involvement and venous ulcers. Fourteen patients had adverse events leading to IFX discontinuation and 4 had died due to lung adenocarcinoma, sepsis, and pulmonary hypertension-related right heart failure due to pulmonary artery thrombosis (n = 2).
Infliximab seems to be effective in majority of BS patients with vascular involvement, even in those who are refractory to immunosuppressives and glucocorticoids.
•Infliximab provided high remission and low relapse rates in vascular Behçet syndrome.•Infliximab is a favorable option for both remission induction and maintenance.•Pulmonary artery and venous involvement responded better than non-pulmonary arteries.
Neurofilament light chain (NfL) represents a promising biomarker for axonal injury. We present the first exploratory study on serum NfL in patients with a clinically isolated syndrome (CIS) and ...healthy controls.
We investigated serum NfL levels in 100 patients with CIS with a short conversion interval to clinically definite multiple sclerosis (MS) (fast converters (FC), median (IQR) conversion time: 110 days (79-139)); 98 patients with non-converting CIS (non-converters (NC), follow-up: 6.5 years (5.3-7.9)); and 92 healthy controls.
NfL levels were higher in FC (24.1 pg/mL (13.5-51.8)) and NC (19.3 pg/mL (13.6-35.2)) than in healthy controls (7.9 pg/mL (5.6-17.2)) (OR=5.85; 95% CI 2.63 to 13.02; p = 1.5 × 10(-5) and OR = 7.03; 95% CI 2.85 to 17.34; p = 2.3 × 10(-5), respectively). When grouping FC and NC, increased serum NfL concentration was also associated with increasing numbers of T2 hyperintense MRI lesions (OR = 2.36; 95% CI 1.21 to 4.59; p = 0.011), gadolinium-enhancing lesions (OR = 2.69; 95% CI 1.13 to 6.41; p=0.026) and higher disability scores (OR = 2.54; 95% CI 1.21 to 5.31; p = 0.013) at CIS diagnosis.
If replicated in future studies, serum NfL may represent a reliable and easily accessible biomarker of early axonal damage in CIS and MS.
Allodynia reflects the clinical correlate of central sensitization, but it is usually neglected in clinical headache management. We aimed to report the prevalence and previously unnoticed ...associations of allodynia in migraineurs by a nationwide face-to-face questionnaire-based study by physicians.
A total of 5323 households were examined for headache according to the diagnostic criteria of International Classification of Headache Disorders-II. Detailed headache features, premonitory signs, demographics, socio-economic status, and hormonal status of female individuals were analyzed with regard to the presence of allodynia in patients with definite migraine.
Allodynia was present in 61.1% of migraineurs in the general population of Turkey. The duration and severity of attacks (P<0.0001), photophobia (P=0.001), phonophobia, and also osmophobia (P<0.0001), as well as premonitory signs (P=0.018), showed significant associations with allodynia. Migraineurs with aura or family history of migraine more often reported allodynia in comparison with those without (P=0.001 and 0.028, respectively). Allodynic migraineurs had a higher rate of physician consults and high levels on the Migraine Disability Assessment questionnaire, reflecting increased burden of headache. Furthermore, migraineurs with allodynia had high probability of attacks close to menses. Migraine improved during pregnancy, but it worsened after menopause or during oral contraceptive use in individuals experiencing allodynia when compared with those without allodynia.
The duration, severity, and disability of migraine attacks, photophobia, phonophobia, and osmophobia, as well as premonitory signs, showed significant associations with allodynia in the general population. Moreover, migraineurs with aura or family history of migraine more often reported allodynia, and allodynic migraneurs were more sensitive to hormonal changes. Allodynia, which seems to indicate higher tendency to central sensitization, should be implemented in daily headache practice to predict the prognosis and high levels of migraineous involvement.
Objective
The aim of this population-based validated study was to determine the course of tension-type headache and migraine and to evaluate the predictors of persistence.
Methods
We evaluated the ...course of headache in a large population from the first assessment in 2008 through a second assessment in 2013. Then we examined the factors associated with persistent migraine and persistent tension-type headache.
Results
Our study in 2013 revealed that only 42.9% of definite migraineurs in 2008 received the same diagnosis again, and of the remaining migraineurs 23.3% were newly diagnosed as definite tension-type headache; 11.6% evolved into probable tension-type headache, 6.4% changed to probable migraine, and 15.8% were headache free. The 17.7% of patients with definite tension-type headache in 2008 were newly diagnosed as having probable tension-type headache, 14.7% as having definite migraine, 6.4% as having probable migraine, and 28.9% as headache free in 2013, and only 32.3% received the definite tension-type headache diagnosis again. Binary logistic regression analysis showed nausea, throbbing and severe headache were the significant parameters for persistent migraine. A multiple regression analysis model with stepwise variable selection revealed that nausea, throbbing and severe headache and osmophobia remained in the final model as predictors of migraine persistence. We found no predictive factor for persistent tension-type headache.
Conclusion
Migraine and tension-type headache did not seem to show a simple bidirectional linear worsening from headache-free state to definite migraine or vice versa, hence the transitions between them are more chaotic, reflecting that there are still unknown modifiers and modulators. Certain headache characteristics of migraine might predict persistent migraine.
Background:
It is unclear if all patients with relapsing–remitting multiple sclerosis (RRMS) ultimately develop progressive MS. Onset of progressive disease course seems to be age- rather than ...disease duration-dependent. Some forms of progressive MS (e.g. primary progressive MS (PPMS)) are uncommon in population-based studies. Ascertainment of patients with PPMS from clinic-based populations can facilitate a powerful comparison of age at progression onset between secondary progressive MS (SPMS) and PPMS but may introduce unclear biases.
Objective:
Our aim is to confirm that onset of progressive disease course is more relevant to the patient’s age than the presence or duration of a pre-progression relapsing disease course in MS.
Methods:
We studied a population-based MS cohort (n=210, RRMS n=109, progressive MS n=101) and a clinic-based progressive MS cohort (n=754). Progressive course was classified as primary (PPMS; n=322), single attack (SAPMS; n=112) and secondary progressive (SPMS; n=421). We studied demographics (chi2 or t-test), age-of-progression-onset (t-test) and time to Expanded Disability Status Scale of 6 (EDSS6) (Kaplan–Meier analyses).
Results:
Sex ratio (p=0.58), age at progression onset (p=0.37) and time to EDSS6 (p=0.16) did not differ between the cohorts. Progression had developed before age 75 in 99% of patients with known progressive disease course; 38% with RRMS did not develop progression by age 75. Age at progression onset did not differ between SPMS (44.9±9.6), SAPMS (45.5±9.6) and PPMS (45.7±10.8). In either cohort, only 2% of patients had reached EDSS6 before onset of progression.
Conclusions:
Patients with RRMS do not inevitably develop a progressive disease course. Onset of progression is more dependent on age than the presence or duration of a pre-progression symptomatic disease course. Moderate disability is sustained predominantly after the onset of a progressive disease course in MS.
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