The ultimate guide to the anti-CGRP monoclonal antibodies galaxy

Mascarella, Davide; Matteo, Eleonora; Favoni, Valentina; Cevoli, Sabina

doi:10.1007/s10072-022-06199-1

Cited by 7 publications

(8 citation statements)

References 63 publications

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“…A slight pattern of increase in the mean monthly dosage units of triptans dispensed per patient was observed between the 12th and 15th month from therapy initiation, likely due to the mandatory interruption of anti‐CGRP therapy after 12 months of treatment according to national reimbursement criteria. These findings seem to confirm the efficacy of these medications reported from clinical trials and real‐world studies 48 . Concerning evidence from observational studies, Tepper and colleagues 49 reported that the mean number of triptan claims observed 6 months after treatment initiation was halved compared to baseline (i.e., from 2.41 to 0.87 claims per month).…”

Section: Discussionsupporting

confidence: 75%

Patterns of anti‐CGRP mAbs use and variation of triptan consumption following treatment initiation: A descriptive drug utilization study in the Tuscany region, Italy

Hyeraci,

Paoletti,

Iannone

et al. 2023

Headache

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ObjectiveTo describe the pattern of anti‐calcitonin gene–related peptide monoclonal antibodies (anti‐CGRP mAbs) utilization in the Tuscany region, Italy, and the variation of triptan consumption after treatment initiation.BackgroundGiven the recent commercialization of anti‐CGRP mAbs as migraine preventive medications, real‐world evidence on their patterns of utilization and their impact on migraine abortive medication use is still limited.MethodsA retrospective, descriptive, cohort study on the real‐world utilization of anti‐CGRP mAbs was performed using the population‐based regional administrative database of Tuscany. Patients with ≥1 anti‐CGRP mAb dispensing (namely erenumab, galcanezumab, fremanezumab) between April 1, 2019, and September 30, 2021, were identified. The first dispensing was the cohort entry (CE). New users (NUs) were patients with no anti‐CGRP mAb dispensing before CE. Kaplan–Meier (KM) curves were plotted to describe the cumulative probability of remaining with the initial anti‐CGRP mAb during a 15‐month follow‐up period as a measure of treatment persistence. Among NUs with ≥2 triptan dispensings during the 6 months before CE (i.e., baseline), the mean monthly number of triptan dosage units dispensed was measured in five consecutive follow‐up time windows (months 1–3, 4–6, 7–9, 10–12, 13–15) and the difference from the baseline was calculated.ResultsA total of 624 NUs (erenumab = 295, galcanezumab = 223, fremanezumab = 106) were identified, of whom 188 (78%) were women. Mean age was 49.2 years (standard deviation [SD] = 12.6). The survival to discontinuation at 6, 12, and 15 months was about 69%, 48%, and 6%, respectively. The survival to switch was about 6% at 15 months. The observed variation of triptan consumption at 3/6/9/12/15 months and the corresponding SD was −4.4 [8.2]/−5.2 [9.0]/−5.5 [9.2]/−5.4 [9.2]/−4.5 [10.0], respectively.ConclusionPatient demographics reflect the place of these medications in therapy. Overall, findings seem to indicate a favorable tolerability and effectiveness profile. Further studies are warranted to better establish the long‐term comparative effectiveness, safety, and cost effectiveness of anti‐CGRP mAbs compared to other preventive medications.

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Section: Discussionsupporting

confidence: 75%

Patterns of anti‐CGRP mAbs use and variation of triptan consumption following treatment initiation: A descriptive drug utilization study in the Tuscany region, Italy

Hyeraci,

Paoletti,

Iannone

et al. 2023

Headache

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“…Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway are among the most useful therapeutic tools for migraine prevention due to a favorable efficacy/tolerability profile coupled to a considerable speed of action [1]. Prospective, multicenter, real-world evidence (RWE) studies hinted that their effectiveness is higher than efficacy, suggesting that unilateral pain (alone or associated with unilateral cranial autonomic symptoms or allodynia) may represent a positive response predictor [2][3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study

Barbanti

Egeo²,

Aurilia³

et al. 2023

J Headache Pain

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Background To verify the long-term (24-week) efficacy, safety, and tolerability of fremanezumab in real-life patients with high-frequency episodic migraine (HFEM: ≥ 8 days/month) or chronic migraine (CM: ≥ 15 days/month), and multiple preventive treatment failures. Methods This is a prospective, cohort, real-life study at 28 headache centers on consecutive patients affected by HFEM or CM with multiple preventive treatment failures who were prescribed subcutaneous fremanezumab (225 mg monthly/675 mg quarterly) for ≥ 24 weeks. Primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM at weeks 21–24 compared to baseline. Secondary endpoints encompassed changes in monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS, HIT-6 and MIDAS scores at the same time interval. Changes in MMDs/MHDs, monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS and HIT-6 scores at week 4 were also monitored. Results Four hundred ten patients who had received ≥ 1 dose of fremanezumab were considered for safety analysis while 148 patients treated for ≥ 24 weeks were included in the efficacy analysis. At weeks 21–24, fremanezumab significantly (p < 0.001) reduced MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM compared to baseline. The proportions of ≥ 50%, ≥ 75% and 100% responders at weeks 21-24were 75.0%, 30.8%, 9.6% (HFEM), and 72.9, 44.8 and 1% (CM). A significant (p < 0.001) decrease in MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM was already present at week 4. The proportions of ≥ 50%, ≥ 75%, and 100% responders at week 4 were 67.6%, 32.4%, 11.8% (HFEM) and 67.3%, 40%, 1.8% (CM). CM remitted to episodic migraine and medication overuse to no-medication overuse in 83.3 and 75% of patients at week 24, and in 80 and 72.4% at week 4. Adverse events were rare (2.4%), mild and transient. No patient discontinued treatment for any reason. Conclusions Fremanezumab is characterized by an early and sustained efficacy in HFEM and CM patients with multiple preventive treatment failures in real-life, revealing an optimal safety and tolerability profile.

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“…About 30 years ago, increased CGRP levels in blood samples taken from the jugular vein in migraine attacks were reported that supported the presumption that CGRP may have a crucial role in migraine [21]. Therefore, some agents that block CGRP and its receptors that may potentially reduce migraine attacks have been investigated [5][6][7]. Over time, clinical trials have been conducted with various agents, and CGRP blockade in migraine patients has been found to be statistically more beneficial than placebo in phase 3 studies.…”

Section: Discussionmentioning

confidence: 98%

“…Recent studies have indicated that blocking CGRP can be used in migraine treatment [2][3][4]. Phase 3 studies involving migraine patients revealed that CGRP blockade was significantly more beneficial than placebo [5][6][7]. Yet, systematic reviews in the following years have reported that CGRP blockade may not have a more substantial effect than the current prophylactic treatment options in preventing migraine attacks [8,9].…”

Section: Introductionmentioning

confidence: 99%

Calcitonin Gene-Related Peptide and Adrenomedullin Levels During Ictal and Interictal Periods in Patients With Migraine

Neyal¹,

Fırat²,

Çekmen³

et al. 2023

Cureus

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BackgroundPeptides related to calcitonin gene-related peptide (CGRP) have been suggested to have a role in migraine. Adrenomedullin (AM) might be a candidate molecule because it is related to pain pathways in the peripheral and central nervous systems and uses the same receptors as CGRP. MethodologyIn this study, we examined the serum CGRP and AM levels during unprovoked ictal and interictal periods of 30 migraine patients as well as 25 healthy controls. Another focus of this study was on the association of CGRP and AM levels with clinical features. ResultsMean serum AM levels were 15.80 pg/mL (11.91-21.43 pg/mL) in the ictal and 15.85 pg/mL (12.25-19.29 pg/mL) in the interictal periods in the migraine group and 13.36 pg/mL (10.84-17.18 pg/mL) in the control group. Mean serum CGRP levels were 2.93 pg/mL (2.45-3.90 pg/mL) in the ictal and 3.25 pg/mL (2.85-4.67 pg/mL) in the interictal periods in the migraine group and 3.03 pg/mL (2.48-3.80 pg/mL) in the control group. There were no statistical differences between ictal and/or interictal AM and CGRP levels (p = 0.558 and p = 0.054, respectively) which were also comparable with the results of the control group (p = 0.230, p = 0.295, p = 0.987, p = 0.139, respectively). Ictal serum CGRP and/or AM levels did not correlate with any of the reported clinical features. ConclusionsSerum AM and CGRP levels are similar in interictal and unprovoked ictal periods in migraine patients and as well in controls. These results do not indicate that these molecules do not have a role in migraine pathophysiology. Considering the broad mechanisms of action of peptides in the CGRP family, further studies are needed in larger cohorts.

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The ultimate guide to the anti-CGRP monoclonal antibodies galaxy

Cited by 7 publications

References 63 publications

Patterns of anti‐CGRP mAbs use and variation of triptan consumption following treatment initiation: A descriptive drug utilization study in the Tuscany region, Italy

Patterns of anti‐CGRP mAbs use and variation of triptan consumption following treatment initiation: A descriptive drug utilization study in the Tuscany region, Italy

Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study

Calcitonin Gene-Related Peptide and Adrenomedullin Levels During Ictal and Interictal Periods in Patients With Migraine

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