scholarly journals Mab-Mig: Registry of the Spanish Neurological Society of Erenumab for Migraine Prevention. Three-Months Results

2021 ◽  
Author(s):  
Robert Belvís ◽  
Pablo Irimia ◽  
Patricia Pozo-Rosich ◽  
Carmen González-Oria ◽  
Antonio Cano ◽  
...  
Keyword(s):  
Adverse Event ◽  
Medication Overuse Headache ◽  
Real Life ◽  
Preventive Treatment ◽  
Neurological Society ◽  
Free Access ◽  
Migraine Prevention ◽  
Frequent Adverse Event ◽  
Treatment Medication ◽  
Access Program

Abstract Background Erenumab was approved in Europe for migraine prevention in patients with ≥4 monthly migraine days (MMD). In Spain, Novartis started a personalized managed access program which allowed free access to erenumab before official reimbursement. The Headache Study Group of the Spanish Neurological Society started a registry to monitor real-world safety and efficacy, and all Spanish headache experts were invited to participate. Methods Patients fulfilled ICHD3 criteria for migraine and had ≥ 4MMD. Sociodemographic and clinical data were registered as well as MMD, headache frequency (MHD), prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and PROs: HIT6, MIDAS, and PGIC. A >50% reduction of MMD after 3 months was considered as response. Results We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 hospitals from February 2019 – to – June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Average of prior preventive treatment failure was >7 (BoNT/A had been used by 95.2%). Most patients (67,6%) started with erenumab 70mg. 61% of patients were also taking oral preventive drugs or getting simultaneous BoNT/A (27.6%). Responder rate was 37.1% and the mean reduction of MMD was -6.28 and MHD: -8.6. Regarding PROs: MIDAS: -35 p., HIT6: -11.6 p., PIGC: 4.7 p. Predictors of good response were: HIT6 score ( p =0.01), prior preventive treatment failures ( p =0.026), absence of MOH ( p =0.039), and simultaneous BoNT/A treatment ( p <0.001). 20% had adverse event, but only two of them were severe (0.9%) which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%). Conclusion In real-life, in a personalized managed access program, erenumab shows a good profile of efficacy and an excellent safety in migraine prevention in our cohort of refractory patients.

scholarly journals MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Robert Belvís ◽  
Pablo Irimia ◽  
Patricia Pozo-Rosich ◽  
Carmen González-Oria ◽  
Antonio Cano ◽  
...  
Keyword(s):  
Adverse Event ◽  
Medication Overuse Headache ◽  
Real Life ◽  
Preventive Treatment ◽  
Neurological Society ◽  
Free Access ◽  
Migraine Prevention ◽  
Global Improvement ◽  
Patient Reported ◽  
Access Program

Abstract Background Erenumab was approved in Europe for migraine prevention in patients with ≥ 4 monthly migraine days (MMDs). In Spain, Novartis started a personalized managed access program, which allowed free access to erenumab before official reimbursement. The Spanish Neurological Society started a prospective registry to evaluate real-world effectiveness and tolerability, and all Spanish headache experts were invited to participate. We present their first results. Methods Patients fulfilled the ICHD-3 criteria for migraine and had ≥ 4 MMDs. Sociodemographic and clinical data were registered as well as MMDs, monthly headache days, MHDs, prior and concomitant preventive treatment, medication overuse headache (MOH), migraine evolution, adverse events, and patient-reported outcomes (PROs): headache impact test (HIT-6), migraine disability assessment questionnaire (MIDAS), and patient global improvement change (PGIC). A > 50% reduction of MMDs after 12 weeks was considered as a response. Results We included 210 patients (female 86.7%, mean age 46.4 years old) from 22 Spanish hospitals from February 2019 to June 2020. Most patients (89.5%) suffered from chronic migraine with a mean evolution of 8.6 years. MOH was present in 70% of patients, and 17.1% had migraine with aura. Patients had failed a mean of 7.8 preventive treatments at baseline (botulinum toxin type A—BoNT/A—had been used by 95.2% of patients). Most patients (67.6%) started with erenumab 70 mg. Sixty-one percent of patients were also simultaneously taking oral preventive drugs and 27.6% were getting simultaneous BoNT/A. Responder rate was 37.1% and the mean reduction of MMDs and MHDs was -6.28 and -8.6, respectively. Changes in PROs were: MIDAS: -35 points, HIT-6: -11.6 points, PIGC: 4.7 points. Predictors of good response were prior HIT-6 score < 80 points (p = 0.01), ≤ 5 prior preventive treatment failures (p = 0.026), absence of MOH (p = 0.039), and simultaneous BoNT/A treatment (p < 0.001). Twenty percent of patients had an adverse event, but only two of them were severe (0.9%), which led to treatment discontinuation. Mild constipation was the most frequent adverse event (8.1%). Conclusions In real-life, in a personalized managed access program, erenumab shows a good effectiveness profile and an excellent tolerability in migraine prevention in our cohort of refractory patients.

scholarly journals Galcanezumab in migraine prevention: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 13 ◽  
pp. 175628642091808 ◽  
Author(s):  
Panagiotis Gklinos ◽  
Dimos D. Mitsikostas
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Phase Iii ◽  
Controlled Trials ◽  
Migraine Prevention ◽  
Randomized Controlled ◽  
The Mean

Background: Galcanezumab, along with three other monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, represents the latest disease-specific and mechanism-based treatment for the prophylaxis of migraine. Galcanezumab shares data also for the prophylaxis of cluster headache. Objective: To provide a pooled safety and efficacy analysis of all phase III randomized controlled trials of galcanezumab in the preventive therapy of migraine. Methods: A computer-based literature search was conducted on MEDLINE and the US National Institutes of Health Clinical Trials Registry for phase III randomized controlled trials of galcanezumab in migraine prevention. The primary outcome was the mean change in monthly migraine days (MMDs). The proportions of patients who reported at least one adverse event (AE), at least one serious adverse event (SAE) or withdrew from the study were used as safety outcomes. Results: Two trials were included in the efficacy meta-analysis and three in the safety meta-analysis. Migraine preventive treatment with subcutaneous galcanezumab, at both 120 mg and 240 mg dosages, was associated with a significantly greater reduction in the mean number of MMDs versus placebo (120 mg, MD = –1.98, 95% CI = –2.33 to –1.63; p < 0.0001) or (240 mg, MD = –1.86, 95% CI = –2.20 to –1.53; p < 0.0001). Galcanezumab was found to be more efficacious in all key secondary outcomes as well. Regarding safety, most of the adverse events were mild to moderate, while drop-out rates and serious adverse events were low. Conclusions: Galcanezumab is an efficacious and well-tolerated preventive treatment for migraine. Larger clinical trials with longer follow-up periods need to be conducted in order to provide more safety data of the above-mentioned drug.

scholarly journals Lorlatinib in pretreated ALK- or ROS1-positive lung cancer and impact of TP53 co-mutations: results from the German early access program

2021 ◽  
Vol 13 ◽  
pp. 175883592098055 ◽  
Author(s):  
Nikolaj Frost ◽  
Petros Christopoulos ◽  
Diego Kauffmann-Guerrero ◽  
Jan Stratmann ◽  
Richard Riedel ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Survival Rates ◽  
Real Life ◽  
Progression Free Survival ◽  
Leptomeningeal Carcinomatosis ◽  
Resistance Mutations ◽  
Duration Of Treatment ◽  
Tp53 Mutations ◽  
Early Access ◽  
Access Program

Introduction: We report on the results of the German early access program (EAP) with the third-generation ALK- and ROS1-inhibitor lorlatinib. Patients and Methods: Patients with documented treatment failure of all approved ALK/ROS1-specific therapies or with resistance mutations not covered by approved inhibitors or leptomeningeal carcinomatosis were enrolled and analyzed. Results: In total, 52 patients were included [median age 57 years (range 32–81), 54% female, 62% never smokers, 98% adenocarcinoma]; 71% and 29% were ALK- and ROS1-positive, respectively. G1202R and G2032R resistance mutations prior to treatment with lorlatinib were observed in 10 of 26 evaluable patients (39%), 11 of 39 patients showed TP53 mutations (28%). Thirty-six patients (69%) had active brain metastases (BM) and nine (17%) leptomeningeal carcinomatosis when entering the EAP. Median number of prior specific TKIs was 3 (range 1–4). Median duration of treatment, progression-free survival (PFS), response rate and time to treatment failure were 10.4 months, 8.0 months, 54% and 13.0 months. Calculated 12-, 18- and 24-months survival rates were 65, 54 and 47%, overall survival since primary diagnosis (OS2) reached 79.6 months. TP53 mutations were associated with a substantially reduced PFS (3.7 versus 10.8 month, HR 3.3, p = 0.003) and were also identified as a strong prognostic biomarker (HR for OS2 3.0 p = 0.02). Neither prior treatments with second-generation TKIs nor BM had a significant influence on PFS and OS. Conclusions: Our data from real-life practice demonstrate the efficacy of lorlatinib in mostly heavily pretreated patients, providing a clinically meaningful option for patients with resistance mutations not covered by other targeted therapies and those with BM or leptomeningeal carcinomatosis.

Treatment of medication-overuse headache: A systematic review

Cephalalgia ◽  
2015 ◽  
Vol 36 (4) ◽  
pp. 371-386 ◽  
Author(s):  
Chia-Chun Chiang ◽  
Todd J Schwedt ◽  
Shuu-Jiun Wang ◽  
David W Dodick
Keyword(s):  
Medication Overuse ◽  
Medication Overuse Headache ◽  
Treatment Strategies ◽  
Preventive Treatment ◽  
Early Discontinuation ◽  
Level Of Evidence ◽  
Preventive Medication ◽  
Long Term Prognosis ◽  
Acute Headache

Introduction The objective of this review is to provide an evidence-based discussion of different treatment strategies for medication-overuse headache (MOH). Method We searched PubMed for articles discussing the treatment and prognosis of MOH published between 2004 and August 2014. Titles, abstract and articles were reviewed systematically. The level of evidence provided by each study of the included articles was determined according to the American Academy of Neurology Clinical practice guideline manual. We discuss the level of evidence to support the early discontinuation/withdrawal of overused medications, the level of evidence to support the use of preventive treatment, the short- and long-term prognosis, and the outcome according to the class of drug overused in patients diagnosed with MOH. Results The initial search resulted in 1313 articles; 68 articles met our inclusion criteria and were discussed. The level of evidence to support early discontinuation of overused medications alone is low due to the absence of controlled studies. Adding preventive medication to early discontinuation led to a better outcome than early discontinuation alone. For patients with chronic migraine (CM) and medication overuse (MO), there are large randomized control trials supporting the use of onabotulinumtoxinA and topiramate without early discontinuation of overuse; however, the evidence is limited since data were obtained from post hoc analysis. Conclusion Considering current available evidence and the systemic toxicity of overusing acute headache medication, we suggest discontinuation of the overused medication with the addition of preventive medication. Appropriately sized, randomized controlled trials evaluating the safety and long-term efficacy of preventive medication plus early discontinuation of overuse vs preventive medication alone vs early discontinuation of overuse alone are needed.

Real-life experience with mepolizumab in the French early access program for severe eosinophilic asthma

2019 ◽  
Author(s):  
Alina Gruber ◽  
Camille Taillé ◽  
Pascal Chanez ◽  
Gilles Devouassoux ◽  
Alain Didier ◽  
...  
Keyword(s):  
Life Experience ◽  
Real Life ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Early Access ◽  
Access Program

Osteonecrosis of the jaw (ONJ) in cancer patients (pts) treated with bisphosphonates (B): Results of a monoinstitutional monitoring program

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19601-19601
Author(s):  
N. La Verde ◽  
K. Borgonovo ◽  
M. C. Garassino ◽  
P. Sburlati ◽  
D. Pedretti ◽  
...  
Keyword(s):  
Adverse Event ◽  
Monitoring Program ◽  
Good Control ◽  
Osteonecrosis Of The Jaw ◽  
Primary Tumors ◽  
Lower Lip ◽  
Serious Adverse Event ◽  
Frequent Adverse Event ◽  
Dental Procedures ◽  
Head Neck

19601 Background: B reduce bone metastases complications. ONJ is a serious adverse event during B treatment. Therefore, it's necessary to identify some procedures to reduce ONJ injures in a monitoring program. Patients and Methods: We retrospectively reviewed how an active program of prevention based on clinical oral cavity examination, dentists and pts education might improve ONJ outcome in pts receiving pamidronate (P) 90 mg monthly or zoledronate (Z) 4 mg monthly. Results: from October 2003 to October 2006, 154 consecutive pts were treated; 95 females, 59 males; primary tumors: 66 breast, 28 prostate, 26 lung, 9 myeloma, 4 NHL, 21 other. In June 2005 the monitoring program started on all our pts. ONJ was diagnosed in 15/154 (9.7%) pts, 8 before and 7 after June 2005; all pts were treated with Z (total 2,987 courses, range 8–43; median courses/pt 19.4) and 4 pts pretreated also with P (total 124 courses, range 12–43, median courses/pt 31. Tumors: 7 breast, 1 kidney, 2 lung, 1 head-neck, 1 thyroid, 1 NHL, 1 prostate, 1 sarcoma. Concomitant therapies: 14 pts chemotherapy; 7 hormonotherapy; 2 head-neck radiotherapy; 5 steroids. Significant anamnesis: 9 recent dentoalveolar procedures, 4 diabetes. First symptoms: multiple recurrent alveolar abscesses 9, pain 3, dental mobility 1, paresthesia of the lower lip 1, exposed bone 1. Main treatments were: antibiotics and antifungals 11, curettages 3, surgical resections 4 (1 partial maxillectomy, complicated by septic shock and oronasal communication, 2 partial mandibulectomies, 1 segmental mandibular resection). These last 4 pts, that had the worst prognosis, were diagnosed before starting the monitoring program, and they had been treated with aggressive dental procedures at the exordium. 7 new ONJ cases, diagnosed after June 2005 were successfully treated without aggressive dentist interventions, achieving a good control. Conclusions: We remark that ONJ B related is a frequent adverse event (9.7%), especially with Z. A monitoring program based on non- surgical treatment and patients and physicians education may improve its management. No significant financial relationships to disclose.

Real-world data of cabozantinib in patients with VEGF-refractory metastatic renal cell carcinoma (mRCC): Results from the French Early Access Program (CABOREAL).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 683-683
Author(s):  
Marine Gross-Goupil ◽  
Aude Flechon ◽  
Christine Chevreau ◽  
Delphine Topart ◽  
Gwenaelle Gravis ◽  
...  
Keyword(s):  
Real World ◽  
Kinase Inhibitors ◽  
Day Treatment ◽  
Real Life ◽  
Treatment Interruption ◽  
Clinical Decision ◽  
Real World Data ◽  
Dose Modification ◽  
Early Access ◽  
Access Program

683 Background: Cabozantinib (Cabo) is approved in Europe for the treatment of mRCC in first line and after failure of tyrosine kinase inhibitors (TKI). We report the results from real-world use of Cabo in the French Early Access Program (EAP) (CABOREAL [NCT03744585]). Methods: Data were retrospectively collected from 26 centers. Patients (pts) were treated with Cabo during the Temporary Authorization for Use (ATU) period from Sep 12, 2016 to licensing in Feb 19, 2018. Pts were eligible after 2 prior VEGFR TKI unless clinical decision for 2nd line (L). The aim was to evaluate the use and activity of Cabo in real-life conditions. Overall survival (OS) was calculated from initiation of Cabo. Results: Overall, 410 pts were included. Median age was 63 years, 85% had clear-cell histology, 41% and 32% were intermediate/poor IMDC risk, respectively. Pts were mostly ECOG 1 (42%) or 2 (30%); 229 (56%) pts had bone metastasis (mets). Median follow-up was 14.4 months (m). Cabo was used as 2L, 3L and 4L or beyond for 101 (25%), 137 (33%) and 172 (41%) pts respectively; 204 pts (50%) were pretreated with nivolumab (Nivo). Activity results and dose reduction are summarized in the table. Starting dose was 60 mg (290 pts, 71%), 40 mg (109 pts, 27%) and 20 mg (8 pts, 2%). Treatment interruption occurred for 267 pts (65%), dose modification for 240 pts (59%) and schedule change for 64 pts (16%). Median daily dose was 40 mg/day. Treatment discontinuation occurred for 348 (85%) pts, with 86 (25%) due to adverse events. Notably, 184 (54%) pts received a subsequent systemic therapy. Conclusions: We report the largest real-world study of Cabo in mRCC to date. CABOREAL demonstrates that using dose modification, median Cabo duration was 7.6 m in a heavily pretreated population, with the longest treatment duration in patients with prior Nivo exposure. Clinical trial information: NCT03744585. [Table: see text]

scholarly journals ASSESSING THE DISABILITY INCLUSIVENESS OF UNIVERSITY BUILDINGS IN HONG KONG

2016 ◽  
Vol 20 (2) ◽  
pp. 184-197 ◽  
Author(s):  
Wai Kin LAU ◽  
Daniel Chi Wing HO ◽  
Yung YAU
Keyword(s):  
Hong Kong ◽  
Indoor Air ◽  
Physical Disability ◽  
Real Life ◽  
Assessment Tools ◽  
Free Access ◽  
Building Performance ◽  
Environmental Friendliness ◽  
Persons With Disabilities ◽  
University Buildings

Tended to view disability inclusion as merely another mandate, building and construction practitioners have yet to recognize its value in social sustainability. In academia, similarly, it has received less attention than other building performance attributes such as environmental friendliness and indoor air quality. With rights to access now acknowledged as basic human rights, there is demand for a tool to assess building disability inclusiveness, indicating the extent to which building considerations include persons with disabilities (PWDs). This paper proposes a Building Inclusiveness Assessment Score (BIAS) to fill the existing gap. The BIAS framework comprises two hierarchies of inclusion attributes identified from literature, guides, and standards of barrier-free access and universal design. The final product consists of two building disability inclusiveness assessment tools: the Physical Disability Inclusion Sub-score (PDIS) and the Visual Impairment Inclusion Sub-score (VIIS). These are simple, quantitative, objective tools for assessing buildings. We performed a Monte Carlo simulation to validate the assessment protocols. Following the validation, we assessed 48 university buildings at four universities in Hong Kong to illustrate the real-life application of the tools.

Cost-Effectiveness of Migraine Prevention: The Case of Topiramate in the UK

Cephalalgia ◽  
2006 ◽  
Vol 26 (12) ◽  
pp. 1473-1482 ◽  
Author(s):  
JS Brown ◽  
G Papadopoulos ◽  
PJ Neumann ◽  
M Price ◽  
M Friedman ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Preventive Treatment ◽  
Cost Effective ◽  
Health Utility ◽  
Quality Adjusted Life Year ◽  
Migraine Prevention ◽  
Migraine Frequency ◽  
Cost Effective Treatment ◽  
The Uk ◽  
The Cost

The aim of this study was to assess the cost-effectiveness of topiramate vs. no preventive treatment in the UK. Model inputs included baseline migraine frequency, treatment discontinuation and response, preventive and acute medical cost per attack [2005 GBP (£)] and gain in health utility. Outcomes included monthly migraines averted, acute and preventive treatment costs and cost per quality-adjusted life year (QALY). Topiramate was associated with 1.8 fewer monthly migraines and a QALY gain of 0.0384. The incremental cost of topiramate vs. no preventive treatment was about £10 per migraine averted and £5700 per QALY. Results are sensitive to baseline monthly migraine frequency, triptan use rate and the gain in utility. Incorporating savings from reduced work loss (about £36 per month) suggests that topiramate would be cost saving compared with no preventive treatment. This analysis suggests that topiramate is a cost-effective treatment for migraine prevention compared with no preventive treatment.

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