scholarly journals Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: A multi-center retrospective cohort study

Cephalalgia ◽  
2021 ◽  
pp. 033310242110487
Author(s):  
Lucas Hendrik Overeem ◽  
Andreas Peikert ◽  
Maxi Dana Hofacker ◽  
Katharina Kamm ◽  
Ruth Ruscheweyh ◽  
...  
Keyword(s):  
Treatment Option ◽  
Responder Rate ◽  
Cgrp Receptor ◽  
Antibody Treatment ◽  
Acute Medication ◽  
Headache Diary ◽  
Secondary Endpoints ◽  
Daily Headache ◽  
Treatment Switch ◽  
Stratified Analysis

Background Switching between antibody classes might be a treatment option in migraine patients who have not responded to one class of a CGRP-(receptor) monoclonal antibody (mAb), but there are no efficacy data so far. In this real-world analysis, we assessed the treatment response to a CGRP-mAb in patients that have previously failed the CGRP-receptor-mAb erenumab. Methods We analyzed retrospective headache diary data of 78 patients with migraine who switched between CGRP-mAbs classes at four German headache centers either due to lack of efficacy or intolerable side effects. Among these, we identified 25 patients who did not respond to erenumab after three treatment cycles (defined as <30% reduction of monthly headache days) and had complete headache documentation at least one month before and during both treatments. We assessed the ≥30% responder rate at month three after switching from erenumab to a CGRP-mAb (galcanezumab or fremanezumab) (primary endpoint). Secondary endpoints included ≥50% responder rate, monthly headache days, and monthly days with acute medication use. In an exploratory subgroup analysis patients were stratified for daily and non-daily headache. Results The switch from erenumab to a CGRP-mAb led to a ≥30% response in one-third (32%) of the patients after three treatment cycles. A ≥50% response was achieved in 12% of the patients. Monthly headache days were reduced in month three compared to baseline (20.8 ± 7.1 to 17.8 ± 9.1; p = 0.009). Stratified analysis revealed that no patient with daily headache (n = 9) responded to the treatment switch, while a 30% response was achieved by 50% of patients with non-daily headache (n = 16). Conclusion Our findings demonstrate that a relevant proportion of erenumab non-responders might benefit from a treatment switch to a CGRP-mAb. Switching seems to be a promising treatment option especially in migraine patients with non-daily headache.

Daily Headache Diary Improves Diagnosis

2011 ◽  
Vol 39 (11) ◽  
pp. 28-29
Author(s):  
DAMIAN McNAMARA
Keyword(s):  
Headache Diary ◽  
Daily Headache

scholarly journals A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

Cephalalgia ◽  
2018 ◽  
Vol 38 (6) ◽  
pp. 1038-1048 ◽  
Author(s):  
Amaal J Starling ◽  
Stewart J Tepper ◽  
Michael J Marmura ◽  
Ejaz A Shamim ◽  
Matthew S Robbins ◽  
...  
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Primary Endpoint ◽  
Medication Use ◽  
Responder Rate ◽  
Migraine Prevention ◽  
Performance Goal ◽  
Open Label ◽  
Data Set ◽  
Headache Diary

Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) ( p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) ( p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number NCT02357381

Observational, open-label, non-randomized study on the efficacy of onabotulinumtoxinA in the treatment of nummular headache: The pre-numabot study

Cephalalgia ◽  
2019 ◽  
Vol 39 (14) ◽  
pp. 1818-1826 ◽  
Author(s):  
David García-Azorín ◽  
Javier Trigo-López ◽  
Álvaro Sierra ◽  
Laura Blanco-García ◽  
Enrique Martínez-Pías ◽  
...  
Keyword(s):  
Acute Treatment ◽  
Randomized Study ◽  
Primary Headache ◽  
Responder Rate ◽  
Open Label ◽  
Serious Adverse Events ◽  
Sensory Fibre ◽  
Nummular Headache ◽  
Secondary Endpoints ◽  
Headache Patients

Background Nummular headache is a primary headache characterised by superficial, coin-shaped pain. Superficial sensory fibre dysfunction might be involved in its pathophysiology. Considering the mechanism of action of onabotulinumtoxinA, it could be a reasonable option in treatment of nummular headache. The aim of the study was to evaluate the efficacy and tolerability of onabotulinumtoxinA in a series of nummular headache patients. Patients and methods This was an observational, prospective, non-randomized and open-label study. Nummular headache patients with at least 10 headache days in three preceding months were included. They were administered 25 units of onabotulinumtoxinA. The primary endpoint was the decrease of headache days per month, evaluated between weeks 20 to 24, compared with baseline. The secondary endpoints included reduction of intense headache days and acute treatment days evaluated between weeks 20–24 and weeks 8–12, compared with baseline. The 30%, 50% and 75% responder rates were determined, and tolerability described. Results We included 53 patients, 67.9% females, with a median age of 54 years. Preventive treatment had been used previously in 60.4% of patients. The median diameter of the nummular headache was 5 cm. At baseline, the number of headache days per month was 24.5 (7.3); the number of intense headache days was 12.5 (10.1), and the number of acute treatment days was 12.8 (7.8). After onabotulinumtoxinA, the mean number of headache days per month decreased to 6.9 (9.3) between weeks 20 and 24 ( p < 0.001). Secondary endpoints concerning intense headache days per month and acute treatment days per month were also statistically significant ( p < 0.001). The 50% responder rate, evaluated between weeks 20 and 24, was 77.4% and the 75% responder rate was 52.8%. Concerning tolerability, 26 patients (49.1%) experienced an adverse event (AE), the commonest being injection-site pain in 12 cases (22.6%). There were no moderate or severe AEs. Conclusion It was found that after injecting onabotulinumtoxinA, the number of headache days per month was reduced in nummular headache patients. The number of intense headache days per month and acute treatment days were also lowered. No serious adverse events occurred during treatment.

BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: Results from a phase II study

Cephalalgia ◽  
2010 ◽  
Vol 31 (5) ◽  
pp. 573-584 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Piero Barbanti ◽  
Carl Dahlöf ◽  
Uwe Reuter ◽  
Julia Habeck ◽  
...  
Keyword(s):  
Phase Ii Study ◽  
Dependent Manner ◽  
Acute Migraine ◽  
Study Medication ◽  
Cgrp Receptor ◽  
Group 14 ◽  
Primary Analysis ◽  
Calcitonin Gene ◽  
Secondary Endpoints ◽  
Dose Dependent

Methods: Four hundred and sixty-one adult subjects with migraine were randomised to one of five treatments, the oral antagonist at the calcitonin gene-related peptide (CGRP) receptor BI 44370 TA (50 mg, 200 mg, 400 mg), active comparator eletriptan 40 mg or placebo. The analysis included 341 subjects who took study medication. Results: The primary endpoint, pain-free after two hours, was reached by significantly more subjects in the BI 44370 TA 400 mg (20/73 = 27.4%) and eletriptan 40 mg (24/69 = 34.8%) groups compared to placebo (6/70 = 8.6%, p = .0016), but not by subjects in the BI 44370 TA 200 mg group (14/65 = 21.5%). The effect of 50 mg BI 44370 TA (5/64 = 7.8%) was similar to that of placebo. Analysis of secondary endpoints supported the conclusion from the primary analysis. The frequency of adverse events was low in all groups. Conclusion: Efficacy of BI 44370 TA was shown in a dose-dependent manner in the treatment of acute migraine attacks.

A comparison between prospective Internet-based and paper diary recordings of headache among adolescents in the general population

Cephalalgia ◽  
2015 ◽  
Vol 36 (4) ◽  
pp. 335-345 ◽  
Author(s):  
Anne-Berit Krogh ◽  
Bo Larsson ◽  
Øyvind Salvesen ◽  
Mattias Linde
Keyword(s):  
General Population ◽  
Response Rate ◽  
Cluster Sampling ◽  
Cross Sectional ◽  
School Based ◽  
Paper Diary ◽  
Acute Medication ◽  
Headache Diary ◽  
User Acceptability ◽  
Time Assessment

Aim The aim of this article was to develop and apply an Internet-based headache diary (i-diary) for adolescents and compare it with a paper-diary (p-diary) regarding adherence, user acceptability and recorded headache activity. Methods In a cross-sectional school-based study, a representative sample of 488 adolescents aged 12–18 years were randomly allocated by cluster sampling to record for three weeks in i-diaries or p-diaries their headache intensity, disability, and use of acute medication. Results A significantly ( p = 0.008) higher proportion of adolescents in the i-diary group used the diary at least once during the 21-day period (86% vs 76% for the p-diary). However, the p-diary group completed a significantly ( p < 0.001) higher number of diary days (20.8 vs 15.0 days for the i-diary). The response rate for the i-diary-group was largely evenly distributed over the study period; conversely, approximately two-thirds of the adolescents using the p-diary responded on all 21 days, whereas one-fourth did not respond at all. The two diary types were rated as equal in easiness to remember ( p = 0.25), but the i-diaries were more bothersome to use ( p = 0.029). Conclusion Although p-diary users completed a higher proportion of diary days, i-diaries provided more reliable and credible estimates of headache parameters because of better real-time assessment.

scholarly journals Mobile Behavioral Therapy for Headache: Pilot Study (Preprint)

2018 ◽  
Author(s):  
Adam Kirell ◽  
Rebecca Shingleton
Keyword(s):  
Mobile Health ◽  
Relaxation Training ◽  
Medical Condition ◽  
Behavioral Therapy ◽  
Mobile App ◽  
Headache Frequency ◽  
Intervention Period ◽  
Headache Diary ◽  
Daily Headache ◽  
Training Exercises

BACKGROUND Frequently recurring tension headaches, migraines, and orofacial pain affect over 2.4 billion people worldwide, representing the second most prevalent medical condition in the world. In-office behavioral therapy (ie, relaxation and mindfulness exercises) has been shown to be one of the most effective treatment options for these patients. However, it has been underutilized due to stigma, cost, and accessibility. Mobile health apps may be one way to provide accessible, lower cost care in a nonstigmatized environment. As a result, apps are becoming an increasingly popular method for delivering behavioral therapy interventions and may provide an effective means to reach this population. OBJECTIVE The aim of this study was to assess the feasibility and acceptability of delivering a clinically validated behavioral therapy for migraine/headaches through a mobile app. METHODS Twenty-one migraine or headache sufferers met the criteria for severe migraine disability determined by the MIDAS test. Participants completed a two-week baseline period in which they kept a daily headache diary through the Halo app. They then began a four-week intervention period. During this period they were instructed to complete ten minutes of relaxation training exercises provided by the app each day, as well as monitor headaches via the daily headache diary. Relaxation training exercises consisted of various breathing techniques, progressive muscle relaxation, and mindfulness. Headache frequency was tracked throughout the intervention period, and further assessments, such as an in-person interview and posttreatment MIDAS test, were completed at the end of the four-week intervention period. RESULTS Analysis of data showed that there were significant differences between baseline scores (Headache Frequency Average=11.47/mo, MIDAS average=25.4) and postintervention follow-up (Headache Frequency Average=6.63/mo, MIDAS average=11.7, Frequency P<.01, MIDAS P<.01). Postintervention interviews revealed that more than 90% of the participants felt that the Halo beta app was easy to use and provided a benefit to the user. More than 85% of participants enjoyed using a daily headache diary and felt it gave them greater insights into their condition. More than 90% of the patients felt that the relaxation training had helped reduce the frequency of their headaches or headache related disability. CONCLUSIONS We found that mindfulness and relaxation-based interventions administered through the Halo beta app was a feasible and acceptable treatment for people suffering from frequently recurring headaches and migraines or disability associated with headaches and migraines. The pilot demonstrated the potential feasibility and usability of a mobile health app in delivering behavioral therapy for headache and migraine as an adjunct or alternative to in-office behavioral therapy for headache and migraine.

scholarly journals NEOADJUVANT WEEKLY NAB-PACLITAXEL PLUS CARBOPLATIN FOLLOWED BY DOXORUBICIN PLUS CYCLOPHOSPHAMIDE WITH BEVACIZUMAB ADDED CONCURRENTLY TO CHEMOTHERAPY FOR OPERABLE TRIPLE-NEGATIVE INVASIVE BREAST CANCER

1969 ◽  
Vol 2 (1) ◽  
Author(s):  
Jasgit C. Sachdev ◽  
Jessica N. Snider ◽  
Jeffrey W. Allen ◽  
Lee S. Schwartzberg ◽  
Robyn R. Young ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative ◽  
Pathologic Complete Response ◽  
Neoadjuvant Treatment ◽  
Area Under The Curve ◽  
Complete Response ◽  
Antibody Treatment ◽  
Common Grade ◽  
Secondary Endpoints ◽  
Grade 3

Purpose: This phase II neoadjuvant study investigated whether nab paclitaxel, carboplatin and bevacizumab given before neoadjuvant doxorubicin/cyclophosphamide (AC) produced higher pathologic complete response (pCR) rates in triple- negative breast cancer (TNBC) compared with historical results achieved with standard anthracycline/taxane regimens. Patients and Methods: Eligible patients with operable TNBC ≥2 cm received four cycles of carboplatin (area under the curve 6, day 1) plus nab-paclitaxel (100 mg/m2, days 1, 8 and 15) every 28 days, followed by four 14-day cycles of AC neoadjuvantly, with bevacizumab 10 mg/kg every 14 days for the rst 6 cycles of neoadjuvant chemotherapy, resuming postoperatively to complete 1 year of antibody treatment. In breast pCR and pCR (breast + nodes) were primary and secondary endpoints, respectively. Results: Due to slow accrual, the study was closed after enrollment of 42 of 60 planned patients. Of the 38 patients who underwent surgery (ef cacy population), 22 (58%) achieved an in-breast pCR and 19 (50%) achieved a pCR (breast + nodes). Neutropenia was the most common Grade 3/4 adverse event (57% Grade 3 and 31% Grade 4), but only 1 patient required hospitalisation and IV antibiotics for neutropenic fever. Other Grade 3/4 events included anaemia (24%), thrombocytopenia (29%) and peripheral neuropathy (Grade 3, 5%). Conclusion: Our results demonstrate a substantially higher pCR rate, both in-breast and breast + nodes, with the combination of nab paclitaxel plus carboplatin followed by AC, with concurrent bevacizumab, versus historic pCR rates with anthracycline-taxane regimens alone, supporting further investigation of this regimen, preferably in molecularly driven subsets, for the neoadjuvant treatment of patients with TNBC. Key words: Bevacizumab, breast cancer, carboplatin, nab-paclitaxel, neoadjuvant, triple-negative 

Frequent headaches with and without acute medication overuse

2020 ◽  
pp. 284-297
Author(s):  
Christina Sun-Edelstein ◽  
Alan M. Rapoport
Keyword(s):  
Medication Overuse ◽  
Medication Overuse Headache ◽  
Chronic Cluster Headache ◽  
Further Education ◽  
Headache Disorders ◽  
Acute Medication ◽  
Related Quality ◽  
Health Related ◽  
Daily Headache ◽  
Lower Health

The term ‘chronic daily headache’ (CDH) encompasses those headache disorders in which headaches are present on at least 15 days per month. CDH is a significant problem worldwide. Compared to episodic headache disorders, it is associated with more disability, lower health-related quality of life and greater health care resource utilization. However, it remains under-recognized and undertreated. This chapter provides a summary of the management of several CDH subtypes, including chronic migraine, medication overuse headache and chronic cluster headache. International differences in CDH management, as documented in the medical literature and through comments from headache specialists around the world, are also discussed. In order to increase the awareness and treatment of CDH and reduce the associated societal and economic costs, further education, research and public health policies are needed.

scholarly journals Devising and validating a headache diary in a series of patients with chronic daily headache from Colombia

2012 ◽  
Vol 70 (1) ◽  
pp. 40-44 ◽  
Author(s):  
Gabriel F Torres ◽  
Martha I. Otálvaro ◽  
Juan C. Vargas ◽  
Yulexi Castellanos ◽  
Jeimy Xiomara García ◽  
...  
Keyword(s):  
Chronic Daily Headache ◽  
Group Identification ◽  
Reliability And Validity ◽  
Medical Interview ◽  
Writing Group ◽  
Headache Diary ◽  
Valid Instrument ◽  
Daily Headache ◽  
Pain Analgesics ◽  
Selection Of

OBJECTIVE: To devise and test the reliability and validity of a brief headache diary in a series of Colombian patients with chronic daily headache. METHODS: The study was designed in five stages: selection of domains (group of patients and experts); initial devising of the items (writing group); identification of non-understandable items (n=20); assessment of internal consistency (n=100); assessment of validity and assessment of sensitivity to change during seven consecutive days (n=25, 175 observations). RESULTS: Five domains were selected: headache presence, severity and length of pain, analgesics intake, and missing workdays. The headache diary is internally consistent (≈75% of rotated variance), correlates with the medical interview (Spearman's rho and Kendall's tau over 0.8 for each domain) and it has an adequate and stable sensitivity and specificity (82 to 96%). CONCLUSIONS: This headache diary is a reliable and valid instrument and represents the most important features affecting Colombian patients with chronic daily headache.

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