Fremanezumab in the prevention of high-frequency episodic and chronic migraine: Friend (fremanezumab in real world study), the first Italian multicenter, prospective real-life study

2021 ◽  
Vol 429 ◽  
pp. 119272
Author(s):  
Luisa Fofi ◽  
Gabriella Egeo ◽  
Cinzia Aurilia ◽  
Carmelina Costa ◽  
Claudia Altamura ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real World ◽  
High Frequency ◽  
Real Life ◽  
Life Study ◽  
Real Life Study

scholarly journals Erenumab Discontinuation Following 12-Month Treatment: A Multicentric Observational Real-Life Study

2021 ◽  
pp. 10.1212/CPJ.0000000000001112
Author(s):  
Francesca Schiano di Cola ◽  
Salvatore Caratozzolo ◽  
Elisabetta Venturelli ◽  
Ubaldo Balducci ◽  
Vincenzo Sidoti ◽  
...  
Keyword(s):  
High Frequency ◽  
Treatment Cycle ◽  
Real Life ◽  
Migraine Prophylaxis ◽  
Treatment Discontinuation ◽  
Pharmacological Intervention ◽  
Class Iii ◽  
Life Study ◽  
Real Life Study

ABSTRACTOBJECTIVE:to assess migraine outcome following twelve months treatment with erenumab and compare patients who underwent three months erenumab discontinuation following the first treatment cycle to those who continued monthly administrations.METHODS:this is a multicentric observational study in migraine patients in treatment with erenumab. Following a full 12 months treatment cycle (T12) patients could either continue or discontinue erenumab for at least three months. Patients who underwent treatment discontinuation were assessed following three months (T15) to decide whether to start re-treatment. Patients were then assessed following at T16 and T18.RESULTS:Thirty consecutive patients were enrolled. Nineteen patients underwent treatment suspension at T12 up to T15, whereas 11 continued phrophylaxis. At T15, patients who discontinued treatment documented significantly more migraine days (17.06±6.5 vs 4.8±2.5; p < 0.0001) and analgesics consumption (14.8±9.2 vs 4.6±2.5; p = 0.002), compared to those who continued treatment. Following re-treatment, at T16, patients who had previously undergone discontinuation documented a significant improvement in terms of migraine days (9.01±4.4 vs 17.06±6.5; p < 0.0001) and analgesics consumption (9.6±7.3 vs 14.8±9.2; p = 0.004). Such improvement was even greater at T18, comparable to T12.CONCLUSIONS:Following treatment discontinuation, a rapid migraine worsening was found, despite the high clinical response during treatment and at re-treatment, which might be secondary to an untimely interruption of a potentially disease modifying pharmacological intervention. Although clinical improvement was documented following retreatment, given the high frequency and degree of worsening during discontinuation, it seems plausible – even ethical – to re-evaluate current timing of discontinuation.CLASSIFICATION OF EVIDENCE:This study provides class III evidence that people with migraine discontinuing erenumab migraine prophylaxis after 12 months were more likely to have an increase in non-responder status and migraine days than those who continued treatment.

scholarly journals Fremanezumab in the Prevention of High-Frequency Episodic and Chronic Migraine: A 12-Week, Multicenter, Real-Life, Cohort Study (The FRIEND Study).

2021 ◽  
Author(s):  
Piero Barbanti ◽  
Gabriella Egeo ◽  
Cinzia Aurilia ◽  
Florindo d'Onofrio ◽  
Maria Albanese ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
High Frequency ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Drug Effects ◽  
Episodic Migraine ◽  
Primary Study ◽  
Life Study ◽  
Younger Age

Abstract Background Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores the effectiveness, safety, and tolerability of fremanezumab in a real-life population of individuals affected by high-frequency episodic (HFEM: 8-14 days/month) or CM. Methods This is a 12-week multicenter, prospective, cohort, real-life study. We considered all consecutive patients affected by HFEM or CM visited at 9 Italian headache centers from 28/07/2020 to 11/11/2020. Eligible patients were given subcutaneous fremanezumab at the doses of 225 mg monthly or 675 mg quarterly, according to their preference. Primary study endpoints were the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients at weeks 9-12 compared to baseline. Secondary endpoints encompassed variation in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), HIT-6 and MIDAS scores, and ≥50%, ≥75% and 100% responder rates at the same time intervals. Results 67 migraine patients had received ≥1 subcutaneous fremanezumab dose and were considered for safety analysis, while 53 patients completed 12 weeks of treatment and were included also in the effectiveness analysis. Fremanezumab was effective in both HFEM and CM, inducing at week 12 a significant reduction in MMDs (-4.6, p<0.05), MHDs (-9.4, p<0.001), MAI (-5.7, p<0.05; -11.1, p<0.001), NRS (-3.1, p<0.001; -2.5, p<0.001), and MIDAS scores (-58.3, p<0.05; -43.7; p<0.001). HIT-6 was significantly reduced only in HFEM patients (-18.1, p<0.001). Remission from CM to episodic migraine and from MO to no-MO occurred in 75% and 67.7% of the patients. The ≥50%, ≥75% and 100% responder rates at week 12 were 76.5%, 29.4% and 9.9% in HFEM and 58.3%, 25% and 0% in CM. Younger age emerged as a positive response predictor (OR=0.91; 95% CI 0.85-0.98, p=0.013). Treatment-emergent adverse events were uncommon (5.7%) and mild. No patient discontinued fremanezumab for any reason. Conclusions Fremanezumab seems more effective in real-life than in RCTs. Younger age emerges as a potential response predictor.

Erenumab efficacy in highly resistant chronic migraine: a real-life study

2020 ◽  
Vol 41 (S2) ◽  
pp. 457-459
Author(s):  
Umberto Pensato ◽  
Valentina Favoni ◽  
Alessia Pascazio ◽  
Matteo Benini ◽  
Gian Maria Asioli ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real Life ◽  
Life Study ◽  
Real Life Study

Baseline data of the DEVIDE-study: DEnosumab vs Intravenous Ibandronate: a 2-year retrospective head to head real life study

2014 ◽  
Author(s):  
Karin Amrein ◽  
Christian Muschitz ◽  
Doris Wagner ◽  
Thomas R Pieber ◽  
Heinrich Resch ◽  
...  
Keyword(s):  
Real Life ◽  
Baseline Data ◽  
Life Study ◽  
Real Life Study

Pegvisomant: daily versus non daily administration a single centre real life study

2019 ◽  
Author(s):  
Francesca Dassie ◽  
Marco Rosson ◽  
Matteo Parolin ◽  
Lucia Russo ◽  
Sara Mazzocut ◽  
...  
Keyword(s):  
Real Life ◽  
Daily Administration ◽  
Single Centre ◽  
Life Study ◽  
Real Life Study
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