Discontinuing Monoclonal Antibodies Targeting CGRP Pathway After One-Year Treatment: An Observational Longitudinal Cohort Study

Abstract Background: The monoclonal antibodies anti-calcitonin gene-related peptide (mAbs anti-CGRP) pathway revolutionized migraine prevention. However, some drug agencies limited the treatment to one year due to their high costs. This study aimed at evaluating the effect of discontinuing mAbs anti-CGRP on monthly migraine days (MMDs) and disability in high-frequency episodic (HFEM) and chronic migraine (CM) patients. Methods: This observational longitudinal cohort study was conducted at 10 Italian headache centres (November 2019-July 2021). Consecutive adult patients followed up for three months (F-UP1-3) after discontinuation of a one-year erenumab/galcanezumab treatment were enrolled. The primary endpoint was the change in F-UP MMDs. Secondary endpoints included variation in pain intensity (Numerical Rating Scale, NRS), monthly painkiller intake (MPI), and HIT-6 scores. We also assessed from F-UP1 to 3 the ≥50% response rates (RR), relapse rate to CM, and recurrence of Medication Overuse (MO).Results: We enrolled 154 patients (72.1% female, 48.2±11.1 years, 107 CM, 47 HFEM); 91 were treated with erenumab, 63 with galcanezumab. From F-UP1 to F-UP3, MMDs, MPI, NRS, and HIT-6 progressively increased but were still lower at F-UP 3 than baseline (Friedman's analysis of rank, p<.001). In the F-UP 1-3 visits, ≥50%RR frequency did not differ significantly between CM and HFEM patients. However, the median reduction in RR at F-UP3 was higher in HFEM (-47.7% [25th, -79.5; 75th ,-17.0]) than in CM patients (-25.5% [25th, -47.1; 75th ,-3.3]; Mann-Whitney U test; p=.032). Of the 84 baseline CM patients who had reverted to EM, 28 (33.3%) relapsed to CM at F-UP1, 35 (41.7)% at F-UP2, 39 (46.4%) at F-UP3. Of the 64 baseline MO patients ceasing MO, 15 (18.3%) relapsed to MO at F-UP1, 26 (31.6%) at F-UP2, and 30 (42.3%, 11 missing data) at F-UP3. Lower MMDs, MPI, NRS, and HIT-6 and higher RR in the last month of therapy characterized patients with 50% RR at F-UP1 and F-UP3 (Mann-Whitney U test; consistently p<.01).Conclusion: Migraine frequency and disability gradually increased after anti-CGRP mAbs interruption. Most patients did not relapse to MO or CM despite the increase in MMDs. Our data suggest to reconsider mAbs anti-CGRP discontinuation.

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Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study

The Journal of Headache and Pain ◽

10.1186/s10194-021-01363-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Fabrizio Vernieri ◽

Nicoletta Brunelli ◽

Roberta Messina ◽

Carmelina Maria Costa ◽

Bruno Colombo ◽

...

Keyword(s):

Monoclonal Antibodies ◽

Cohort Study ◽

Rating Scale ◽

Response Rate ◽

Medication Overuse ◽

Numerical Rating Scale ◽

Medication Overuse Headache ◽

Longitudinal Cohort Study ◽

Longitudinal Cohort ◽

One Year

Abstract Background Monoclonal antibodies anti-calcitonin gene-related peptide (mAbs anti-CGRP) pathway are effective and safe on migraine prevention. However, some drug agencies limited these treatments to one year due to their high costs. This study aimed at evaluating the effect of discontinuing mAbs anti-CGRP on monthly migraine days (MMDs) and disability in high-frequency episodic (HFEM) and chronic migraine (CM) patients. Methods This observational longitudinal cohort study was conducted at 10 Italian headache centres. Consecutive adult patients were followed-up for three months (F-UP1–3) after discontinuation of a one-year erenumab/galcanezumab treatment. The primary endpoint was the change in F-UP MMDs. Secondary endpoints included variation in pain intensity (Numerical Rating Scale, NRS), monthly acute medication intake (MAMI), and HIT-6 scores. We also assessed from F-UP1 to 3 the ≥50% response rate, relapse rate to CM, and recurrence of Medication Overuse (MO). Results We enrolled 154 patients (72.1% female, 48.2 ± 11.1 years, 107 CM, 47 HFEM); 91 were treated with erenumab, 63 with galcanezumab. From F-UP1 to F-UP3, MMDs, MAMI, NRS, and HIT-6 progressively increased but were still lower at F-UP3 than baseline (Friedman’s analysis of rank, p < .001). In the F-UP1–3 visits, ≥50% response rate frequency did not differ significantly between CM and HFEM patients. However, the median reduction in response rate at F-UP3 was higher in HFEM (− 47.7% [25th, − 79.5; 75th,-17.0]) than in CM patients (− 25.5% [25th, − 47.1; 75th, − 3.3]; Mann-Whitney U test; p = .032). Of the 84 baseline CM patients who had reverted to episodic migraine, 28 (33.3%) relapsed to CM at F-UP1, 35 (41.7%) at F-UP2, 39 (46.4%) at F-UP3. Of the 64 baseline patients suffering of medication overuse headache ceasing MO, 15 (18.3%) relapsed to MO at F-UP1, 26 (31.6%) at F-UP2, and 30 (42.3%, 11 missing data) at F-UP3. Lower MMDs, MAMI, NRS, and HIT-6 and higher response rate in the last month of therapy characterized patients with ≥50% response rate at F-UP1 and F-UP3 (Mann-Whitney U test; consistently p < .01). Conclusion Migraine frequency and disability gradually increased after mAbs anti-CGRP interruption. Most patients did not relapse to MO or CM despite the increase in MMDs. Our data suggest to reconsider mAbs anti-CGRP discontinuation.

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Are asymptomatic ultrasound abnormalities in the achilles tendon of elite soccer players risk factors for symptoms one year later? a longitudinal cohort study

British Journal of Sports Medicine ◽

10.1136/bjsm.2010.081554.21 ◽

2011 ◽

Vol 45 (2) ◽

pp. e1-e1

Author(s):

S. Jhingan ◽

M. Perry ◽

G. O'Driscoll ◽

M. Ahmad ◽

N. Maffulli ◽

...

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Achilles Tendon ◽

Soccer Players ◽

Longitudinal Cohort Study ◽

Longitudinal Cohort ◽

One Year

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The association of pain and stiffness with fatigue in incident polymyalgia rheumatica: baseline results from the polymyalgia rheumatica cohort study

Primary Health Care Research & Development ◽

10.1017/s1463423619000082 ◽

2019 ◽

Vol 20 ◽

Author(s):

J.A. Prior ◽

S. Muller ◽

T. Helliwell ◽

S.L. Hider ◽

K. Barraclough ◽

...

Keyword(s):

General Practice ◽

Cohort Study ◽

Polymyalgia Rheumatica ◽

Symptom Severity ◽

Rating Scale ◽

Numerical Rating Scale ◽

Newly Diagnosed ◽

Fatigue Score ◽

Numerical Rating ◽

The Mean

AbstractWe aimed to examine the association between pain, stiffness and fatigue in newly diagnosed polymyalgia rheumatica (PMR) patients using baseline data from a prospective cohort study. Fatigue is a known, but often ignored symptom of PMR. Newly diagnosed PMR patients were recruited from general practice and mailed a baseline questionnaire. This included a numerical rating scale for pain and stiffness severity, manikins identifying locations of pain and stiffness and the FACIT-Fatigue questionnaire. A total of 652 PMR patients responded (88.5%). The mean age of responders was 72.6 years (SD 9.0) and the majority were female (62.0%). Manikin data demonstrated that bilateral shoulder and hip pain and stiffness were common. The mean fatigue score (FACIT) was 33.9 (SD 12.4). Adjusted regression analysis demonstrated that a higher number of pain sites (23–44 sites) and higher pain and stiffness severity were associated with greater levels of fatigue. In newly diagnosed PMR patients, fatigue was associated with PMR symptom severity.

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Development and validation of the fracture risk scale home care (FRS-HC) that predicts one-year incident fracture: an electronic record-linked longitudinal cohort study

BMC Musculoskeletal Disorders ◽

10.1186/s12891-020-03529-2 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Caitlin McArthur ◽

George Ioannidis ◽

Micaela Jantzi ◽

Jonathon D. Adachi ◽

Lora Giangregorio ◽

...

Keyword(s):

Cohort Study ◽

Home Care ◽

Fracture Risk ◽

Electronic Record ◽

Longitudinal Cohort Study ◽

Longitudinal Cohort ◽

Incident Fracture ◽

One Year ◽

Development And Validation ◽

Risk Scale

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One-Year Evolution of Sleep Quality in Older Users of Benzodiazepines: A Longitudinal Cohort Study in Belgian Nursing Home Residents

Drugs & Aging ◽

10.1007/s40266-014-0203-3 ◽

2014 ◽

Vol 31 (9) ◽

pp. 677-682 ◽

Cited By ~ 14

Author(s):

Jolyce Bourgeois ◽

Monique M. Elseviers ◽

Luc Van Bortel ◽

Mirko Petrovic ◽

Robert H. Vander Stichele

Keyword(s):

Cohort Study ◽

Nursing Home ◽

Sleep Quality ◽

Nursing Home Residents ◽

Longitudinal Cohort Study ◽

Longitudinal Cohort ◽

Older Users ◽

One Year

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Treatment of Neuropathic Pain with 5% Lidocaine-Medicated Plaster: Five Years of Clinical Experience

Pain Research and Management ◽

10.1155/2011/359591 ◽

2011 ◽

Vol 16 (4) ◽

pp. 259-263 ◽

Cited By ~ 15

Author(s):

Claire Delorme ◽

Marie L Navez ◽

Valérie Legout ◽

Rodrigue Deleens ◽

Dominique Moyse

Keyword(s):

Neuropathic Pain ◽

General Population ◽

Rating Scale ◽

Numerical Rating Scale ◽

Initial Assessment ◽

Experienced Pain ◽

Numerical Rating ◽

Numerical Rating Scale Score ◽

Excellent Safety Profile ◽

One Year

BACKGROUND: Neuropathic pain is often severe and adversely affects patients’ quality of life.OBJECTIVE: To perform a retrospective, observational study investigating the efficacy and safety of treating refractory chronic neuropathic pain with 5% lidocaine-medicated plaster, in patients attending pain centres.METHODS: Medical records from 467 patients treated with 5% lidocaine-medicated plaster were evaluated for efficacy (maximum and minimum pain intensities and coanalgesic consumption) and adverse events. Data from an initial assessment and at least one follow-up visit had to be available, and separate analyses were conducted for the general population and the subpopulation older than 70 years of age.RESULTS: Of the patients enrolled, 25.0% were older than 70 years of age. While 20.6% had postherpetic neuralgia, 76.3% had other types of peripheral pain. Approximately 78.1% of cases of peripheral neuropathic pain followed surgery, and 23% were post-traumatic pain. The time from onset to referral was more than one year in two-thirds of cases. All patients experienced pain of at least moderate severity (mean [± SD] 11-point numerical rating scale score 5.2±2.4 to 8.2±1.6). Treatment with 5% lidocaine-medicated plaster reduced pain intensity by more than 50% in 45.5% of patients, and by at least 30% in 82.2%. Of note, the consumption of analgesics and coanalgesics was significantly reduced. Results were similar in both the general population and the subpopulation older than 70 years of age, at high risk and often receiving multiple medications.CONCLUSIONS: Treatment of refractory neuropathic pain with 5% lidocaine-medicated plaster clearly demonstrated efficacy and an excellent safety profile in patients with refractory neuropathic pain.

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