Clinical Edge Journal Scan

Key clinical point: Treatments with galcanezumab and erenumab increase constipation-related gastrointestinal discomfort, while erenumab also worsens stool form and bowel habits in patients with episodic migraine.

Major finding: An increase in the gastrointestinal symptom rating scale-constipation domain score was observed with both galcanezumab (least squares mean change [LSMC] 0.4; P  =  .002) and erenumab (LSMC 0.3; P  =  .016); additionally, erenumab significantly reduced Bristol Stool Form Scale (LSMC −0.5; P  =  .004) and spontaneous bowel movement (LSMC −1.2; P  =  .012) scores. No severe treatment-emergent adverse events were reported.

Study details: This phase 4 clinical trial included 65 patients with episodic migraine with or without aura and without significant gastrointestinal symptoms who were randomized to receive galcanezumab or erenumab.

Disclosures: This study was funded by Eli Lilly and Company. Six authors declared being full-time employees or minor shareholders or statistical contractors at Eli Lilly. Some authors reported receiving grants, contracts, consulting fees, or payment for speaker’s bureaus from various sources, including Eli Lilly.

Source: Kudrow D et al. A phase IV clinical trial of gastrointestinal motility in adult patients with migraine before and after initiation of a calcitonin gene-related peptide ligand (galcanezumab) or receptor (erenumab) antagonist. Headache. 2022 (Sep 16). Doi: 10.1111/head.14390

Key clinical point: Treatments with galcanezumab and erenumab increase constipation-related gastrointestinal discomfort, while erenumab also worsens stool form and bowel habits in patients with episodic migraine.

Major finding: An increase in the gastrointestinal symptom rating scale-constipation domain score was observed with both galcanezumab (least squares mean change [LSMC] 0.4; P  =  .002) and erenumab (LSMC 0.3; P  =  .016); additionally, erenumab significantly reduced Bristol Stool Form Scale (LSMC −0.5; P  =  .004) and spontaneous bowel movement (LSMC −1.2; P  =  .012) scores. No severe treatment-emergent adverse events were reported.

Study details: This phase 4 clinical trial included 65 patients with episodic migraine with or without aura and without significant gastrointestinal symptoms who were randomized to receive galcanezumab or erenumab.

Disclosures: This study was funded by Eli Lilly and Company. Six authors declared being full-time employees or minor shareholders or statistical contractors at Eli Lilly. Some authors reported receiving grants, contracts, consulting fees, or payment for speaker’s bureaus from various sources, including Eli Lilly.

Source: Kudrow D et al. A phase IV clinical trial of gastrointestinal motility in adult patients with migraine before and after initiation of a calcitonin gene-related peptide ligand (galcanezumab) or receptor (erenumab) antagonist. Headache. 2022 (Sep 16). Doi: 10.1111/head.14390

Key clinical point: Treatments with galcanezumab and erenumab increase constipation-related gastrointestinal discomfort, while erenumab also worsens stool form and bowel habits in patients with episodic migraine.

Major finding: An increase in the gastrointestinal symptom rating scale-constipation domain score was observed with both galcanezumab (least squares mean change [LSMC] 0.4; P  =  .002) and erenumab (LSMC 0.3; P  =  .016); additionally, erenumab significantly reduced Bristol Stool Form Scale (LSMC −0.5; P  =  .004) and spontaneous bowel movement (LSMC −1.2; P  =  .012) scores. No severe treatment-emergent adverse events were reported.

Study details: This phase 4 clinical trial included 65 patients with episodic migraine with or without aura and without significant gastrointestinal symptoms who were randomized to receive galcanezumab or erenumab.

Disclosures: This study was funded by Eli Lilly and Company. Six authors declared being full-time employees or minor shareholders or statistical contractors at Eli Lilly. Some authors reported receiving grants, contracts, consulting fees, or payment for speaker’s bureaus from various sources, including Eli Lilly.

Source: Kudrow D et al. A phase IV clinical trial of gastrointestinal motility in adult patients with migraine before and after initiation of a calcitonin gene-related peptide ligand (galcanezumab) or receptor (erenumab) antagonist. Headache. 2022 (Sep 16). Doi: 10.1111/head.14390

Key clinical point: Patients with migraine and low serum levels of calcitonin gene-related peptide-like immunoreactivity (CGRP-LI) at 2-4 weeks after initiating erenumab experienced a greater reduction in monthly migraine days (MMD) at 3 months after treatment initiation; however, CGRP-LI levels at treatment initiation showed no effect on clinical response.

Major finding: Absolute reduction in MMD after 3 months of initiating erenumab was significantly associated with serum CGRP-LI levels after 2-4 weeks of erenumab treatment (β −2.13; P  =  .003) but not with those before starting erenumab treatment (β −0.80; P  =  .24).

Study details: Findings are from a study including 94 patients with episodic or chronic migraine with/without aura who previously failed ≥4 migraine prophylactics and were treated with erenumab (70 mg) once every 4 weeks.

Disclosures: This study was supported by Vici grant from the Dutch Research Council. Two authors declared receiving consultancy or industry grant support or independent support from various sources, including Dutch Research Council.

Source: de Vries Lentsch S et al. Serum CGRP in migraine patients using erenumab as preventive treatment. J Headache Pain. 2022;23:120 (Sep 12). Doi: 10.1186/s10194-022-01483-z

Key clinical point: Patients with migraine and low serum levels of calcitonin gene-related peptide-like immunoreactivity (CGRP-LI) at 2-4 weeks after initiating erenumab experienced a greater reduction in monthly migraine days (MMD) at 3 months after treatment initiation; however, CGRP-LI levels at treatment initiation showed no effect on clinical response.

Major finding: Absolute reduction in MMD after 3 months of initiating erenumab was significantly associated with serum CGRP-LI levels after 2-4 weeks of erenumab treatment (β −2.13; P  =  .003) but not with those before starting erenumab treatment (β −0.80; P  =  .24).

Study details: Findings are from a study including 94 patients with episodic or chronic migraine with/without aura who previously failed ≥4 migraine prophylactics and were treated with erenumab (70 mg) once every 4 weeks.

Disclosures: This study was supported by Vici grant from the Dutch Research Council. Two authors declared receiving consultancy or industry grant support or independent support from various sources, including Dutch Research Council.

Source: de Vries Lentsch S et al. Serum CGRP in migraine patients using erenumab as preventive treatment. J Headache Pain. 2022;23:120 (Sep 12). Doi: 10.1186/s10194-022-01483-z

Key clinical point: Patients with migraine and low serum levels of calcitonin gene-related peptide-like immunoreactivity (CGRP-LI) at 2-4 weeks after initiating erenumab experienced a greater reduction in monthly migraine days (MMD) at 3 months after treatment initiation; however, CGRP-LI levels at treatment initiation showed no effect on clinical response.

Major finding: Absolute reduction in MMD after 3 months of initiating erenumab was significantly associated with serum CGRP-LI levels after 2-4 weeks of erenumab treatment (β −2.13; P  =  .003) but not with those before starting erenumab treatment (β −0.80; P  =  .24).

Study details: Findings are from a study including 94 patients with episodic or chronic migraine with/without aura who previously failed ≥4 migraine prophylactics and were treated with erenumab (70 mg) once every 4 weeks.

Disclosures: This study was supported by Vici grant from the Dutch Research Council. Two authors declared receiving consultancy or industry grant support or independent support from various sources, including Dutch Research Council.

Source: de Vries Lentsch S et al. Serum CGRP in migraine patients using erenumab as preventive treatment. J Headache Pain. 2022;23:120 (Sep 12). Doi: 10.1186/s10194-022-01483-z

Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] −10.64; 95% CI −12.31 to −8.97), with a ≥50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB −11.70; 95% CI −13.86 to −9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] −10.64; 95% CI −12.31 to −8.97), with a ≥50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB −11.70; 95% CI −13.86 to −9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] −10.64; 95% CI −12.31 to −8.97), with a ≥50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB −11.70; 95% CI −13.86 to −9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

Key clinical point: Patients with migraine treated with anti-calcitonin gene-related peptide (anti-CGRP) receptor monoclonal antibodies (mAb), erenumab and fremanezumab, reported an increase in systolic and diastolic blood pressure, with most having blood pressure within normal limits but some requiring antihypertensive treatment.

Major finding: At 3 months, patients treated with erenumab or fremanezumab reported a significant increase in systolic (change from baseline [Δ] 5.0 mm Hg; P < .001) and diastolic (Δ 3.3 mm Hg; P < .001) blood pressure, with sustained effects over 1 year of follow-up (P < .001). Antihypertensive treatment was required by 3.7% of patients treated with erenumab.

Study details: This prospective follow-up study included 196 patients with migraine who previously failed ≥4 migraine preventive treatments and received erenumab or fremanezumab and 109 patients with migraine who did not use any migraine prophylactic medication.

Disclosures: This study did not receive any targeted funding. AM van den Brink and GM Terwindt reported receiving independent, consultancy, or industry support from various sources.

Source: de Vries Lentsch S et al. Blood pressure in migraine patients treated with monoclonal anti-CGRP (receptor) antibodies: A prospective follow-up study. Neurology. 2022 (Oct 4). Doi: 10.1212/WNL.0000000000201008

Key clinical point: Patients with migraine treated with anti-calcitonin gene-related peptide (anti-CGRP) receptor monoclonal antibodies (mAb), erenumab and fremanezumab, reported an increase in systolic and diastolic blood pressure, with most having blood pressure within normal limits but some requiring antihypertensive treatment.

Major finding: At 3 months, patients treated with erenumab or fremanezumab reported a significant increase in systolic (change from baseline [Δ] 5.0 mm Hg; P < .001) and diastolic (Δ 3.3 mm Hg; P < .001) blood pressure, with sustained effects over 1 year of follow-up (P < .001). Antihypertensive treatment was required by 3.7% of patients treated with erenumab.

Study details: This prospective follow-up study included 196 patients with migraine who previously failed ≥4 migraine preventive treatments and received erenumab or fremanezumab and 109 patients with migraine who did not use any migraine prophylactic medication.

Disclosures: This study did not receive any targeted funding. AM van den Brink and GM Terwindt reported receiving independent, consultancy, or industry support from various sources.

Source: de Vries Lentsch S et al. Blood pressure in migraine patients treated with monoclonal anti-CGRP (receptor) antibodies: A prospective follow-up study. Neurology. 2022 (Oct 4). Doi: 10.1212/WNL.0000000000201008

Key clinical point: Patients with migraine treated with anti-calcitonin gene-related peptide (anti-CGRP) receptor monoclonal antibodies (mAb), erenumab and fremanezumab, reported an increase in systolic and diastolic blood pressure, with most having blood pressure within normal limits but some requiring antihypertensive treatment.

Major finding: At 3 months, patients treated with erenumab or fremanezumab reported a significant increase in systolic (change from baseline [Δ] 5.0 mm Hg; P < .001) and diastolic (Δ 3.3 mm Hg; P < .001) blood pressure, with sustained effects over 1 year of follow-up (P < .001). Antihypertensive treatment was required by 3.7% of patients treated with erenumab.

Study details: This prospective follow-up study included 196 patients with migraine who previously failed ≥4 migraine preventive treatments and received erenumab or fremanezumab and 109 patients with migraine who did not use any migraine prophylactic medication.

Disclosures: This study did not receive any targeted funding. AM van den Brink and GM Terwindt reported receiving independent, consultancy, or industry support from various sources.

Source: de Vries Lentsch S et al. Blood pressure in migraine patients treated with monoclonal anti-CGRP (receptor) antibodies: A prospective follow-up study. Neurology. 2022 (Oct 4). Doi: 10.1212/WNL.0000000000201008

Key clinical point: Emergent vs elective surgery after bevacizumab exposure was associated with a significantly higher mortality in patients with metastatic colorectal cancer (mCRC), with an interval of >4 weeks between the surgery and last bevacizumab infusion being protective against additional mortality risk.

Major finding: Emergent vs elective surgery was an independent risk factor for 60-day mortality (adjusted odds ratio [aOR] 1.912; 95% CI 1.220-2.996), with elective surgery within 29-56 days (aOR 0.522; 95% CI 0.310-0.877) and >57 days (aOR 0.540; 95% CI 0.333-0.873) vs within 28 days of last bevacizumab infusion being associated with a significantly lower 60-day mortality.

Study details: The data come from a retrospective study including 2047 patients with mCRC who underwent surgery (emergent 13.78%; elective 86.22%) within 1 year of receiving bevacizumab.

Disclosures: This study was funded by Kaohsiung Veterans General Hospital, Taiwan. No conflicts of interest were declared.

Source: Chen YH et al. Mortality of patients with metastatic colorectal cancer who received elective or emergent operation after exposure to bevacizumab: A nationwide database study. Eur J Surg Oncol. 2022 (Oct 1). Doi: 10.1016/j.ejso.2022.09.018

Key clinical point: Emergent vs elective surgery after bevacizumab exposure was associated with a significantly higher mortality in patients with metastatic colorectal cancer (mCRC), with an interval of >4 weeks between the surgery and last bevacizumab infusion being protective against additional mortality risk.

Major finding: Emergent vs elective surgery was an independent risk factor for 60-day mortality (adjusted odds ratio [aOR] 1.912; 95% CI 1.220-2.996), with elective surgery within 29-56 days (aOR 0.522; 95% CI 0.310-0.877) and >57 days (aOR 0.540; 95% CI 0.333-0.873) vs within 28 days of last bevacizumab infusion being associated with a significantly lower 60-day mortality.

Study details: The data come from a retrospective study including 2047 patients with mCRC who underwent surgery (emergent 13.78%; elective 86.22%) within 1 year of receiving bevacizumab.

Disclosures: This study was funded by Kaohsiung Veterans General Hospital, Taiwan. No conflicts of interest were declared.

Source: Chen YH et al. Mortality of patients with metastatic colorectal cancer who received elective or emergent operation after exposure to bevacizumab: A nationwide database study. Eur J Surg Oncol. 2022 (Oct 1). Doi: 10.1016/j.ejso.2022.09.018

Key clinical point: Emergent vs elective surgery after bevacizumab exposure was associated with a significantly higher mortality in patients with metastatic colorectal cancer (mCRC), with an interval of >4 weeks between the surgery and last bevacizumab infusion being protective against additional mortality risk.

Major finding: Emergent vs elective surgery was an independent risk factor for 60-day mortality (adjusted odds ratio [aOR] 1.912; 95% CI 1.220-2.996), with elective surgery within 29-56 days (aOR 0.522; 95% CI 0.310-0.877) and >57 days (aOR 0.540; 95% CI 0.333-0.873) vs within 28 days of last bevacizumab infusion being associated with a significantly lower 60-day mortality.

Study details: The data come from a retrospective study including 2047 patients with mCRC who underwent surgery (emergent 13.78%; elective 86.22%) within 1 year of receiving bevacizumab.

Disclosures: This study was funded by Kaohsiung Veterans General Hospital, Taiwan. No conflicts of interest were declared.

Source: Chen YH et al. Mortality of patients with metastatic colorectal cancer who received elective or emergent operation after exposure to bevacizumab: A nationwide database study. Eur J Surg Oncol. 2022 (Oct 1). Doi: 10.1016/j.ejso.2022.09.018

Key clinical point: Every 1 in 5 patients who underwent colorectal cancer (CRC) surgery with curative intent required emergency 30-day readmission, with some requiring extended readmission and surgical re-intervention, highlighting the benefits of additional post-discharge follow-ups in patients at a high risk for preventable readmissions.

Major finding: Overall, 20.5% (95% CI 20.1%-20.9%) of patients were readmitted within 30 days of discharge after CRC surgery with curative intent, with 12.2% (95% CI 11.9%-12.5%) and 1.9% (95% CI 1.8-2.1%) requiring post-discharge extended re-admission and surgical readmission, respectively. A very shortlength of stay (odds ratio [OR] 2.36; 95% CI 1.95-2.87) and an American Society of Anesthesiology score ≥IV (OR 2.21; 95% CI, 1.56-3.13) were the strongest predictors of emergency 30-day readmission.

Study details: The findings are from a retrospective study including 40,782 patients who had undergone colorectal tumor resection with curative intent.

Disclosures: This study was financially supported by local institutional sources. The authors declared no conflicts of interest.

Source: Clausen J et al. Incidence and clinical predictors of 30-day emergency readmission after colorectal cancer surgery - A nationwide cohort study. Colorectal Dis. 2022 (Oct 5). Doi: 10.1111/codi.16349

Key clinical point: Every 1 in 5 patients who underwent colorectal cancer (CRC) surgery with curative intent required emergency 30-day readmission, with some requiring extended readmission and surgical re-intervention, highlighting the benefits of additional post-discharge follow-ups in patients at a high risk for preventable readmissions.

Major finding: Overall, 20.5% (95% CI 20.1%-20.9%) of patients were readmitted within 30 days of discharge after CRC surgery with curative intent, with 12.2% (95% CI 11.9%-12.5%) and 1.9% (95% CI 1.8-2.1%) requiring post-discharge extended re-admission and surgical readmission, respectively. A very shortlength of stay (odds ratio [OR] 2.36; 95% CI 1.95-2.87) and an American Society of Anesthesiology score ≥IV (OR 2.21; 95% CI, 1.56-3.13) were the strongest predictors of emergency 30-day readmission.

Study details: The findings are from a retrospective study including 40,782 patients who had undergone colorectal tumor resection with curative intent.

Disclosures: This study was financially supported by local institutional sources. The authors declared no conflicts of interest.

Source: Clausen J et al. Incidence and clinical predictors of 30-day emergency readmission after colorectal cancer surgery - A nationwide cohort study. Colorectal Dis. 2022 (Oct 5). Doi: 10.1111/codi.16349

Key clinical point: Every 1 in 5 patients who underwent colorectal cancer (CRC) surgery with curative intent required emergency 30-day readmission, with some requiring extended readmission and surgical re-intervention, highlighting the benefits of additional post-discharge follow-ups in patients at a high risk for preventable readmissions.

Major finding: Overall, 20.5% (95% CI 20.1%-20.9%) of patients were readmitted within 30 days of discharge after CRC surgery with curative intent, with 12.2% (95% CI 11.9%-12.5%) and 1.9% (95% CI 1.8-2.1%) requiring post-discharge extended re-admission and surgical readmission, respectively. A very shortlength of stay (odds ratio [OR] 2.36; 95% CI 1.95-2.87) and an American Society of Anesthesiology score ≥IV (OR 2.21; 95% CI, 1.56-3.13) were the strongest predictors of emergency 30-day readmission.

Study details: The findings are from a retrospective study including 40,782 patients who had undergone colorectal tumor resection with curative intent.

Disclosures: This study was financially supported by local institutional sources. The authors declared no conflicts of interest.

Source: Clausen J et al. Incidence and clinical predictors of 30-day emergency readmission after colorectal cancer surgery - A nationwide cohort study. Colorectal Dis. 2022 (Oct 5). Doi: 10.1111/codi.16349

Key clinical point: Aspartate transaminase to platelet ratio index (APRI), international normalized ratio (INR), and albumin-bilirubin (ALBI) grade can help identify patients with liver-dominant metastatic colorectal cancer (mCRC) who may benefit from transarterial radioembolization (TARE) with ⁹⁰Y resin microspheres.

Major finding: APRI >0.40 independently predicted worse overall survival (OS; hazard ratio [HR] 2.25; P < .0001), progression-free survival (PFS; HR 1.42; P = .0416), and hepatic PFS (HR 1.50; P = .0207). The other independent predictors for worse OS and hepatic PFS were an INR <1 (HR 1.66; P = .0091) and ALBI grade 3 (HR 5.29; P = .0075), respectively.

Study details: This study evaluated 237 patients with liver-dominant mCRC from the prospective observational CIRSE Registry for SIR-Spheres Therapy (CIRT) study scheduled to receive TARE with ⁹⁰Y resin microspheres.

Disclosures: The CIRT study was funded by SIRTEX Medical Europe GmbH (Bonn, Germany). Some authors declared receiving grants, consulting fees, honoraria, or lecture and travel support from or serving on data safety monitoring or advisory boards for various sources, including SIRTEX.

Source: Schaefer N et al, on behalf of the CIRT Principal Investigators. Prognostic factors for effectiveness outcomes after transarterial radioembolization in metastatic colorectal cancer: Results from the multicentre observational study CIRT. Clin Colorectal Cancer. 2022 (Sep 19). Doi: 10.1016/j.clcc.2022.09.002

Key clinical point: Aspartate transaminase to platelet ratio index (APRI), international normalized ratio (INR), and albumin-bilirubin (ALBI) grade can help identify patients with liver-dominant metastatic colorectal cancer (mCRC) who may benefit from transarterial radioembolization (TARE) with ⁹⁰Y resin microspheres.

Major finding: APRI >0.40 independently predicted worse overall survival (OS; hazard ratio [HR] 2.25; P < .0001), progression-free survival (PFS; HR 1.42; P = .0416), and hepatic PFS (HR 1.50; P = .0207). The other independent predictors for worse OS and hepatic PFS were an INR <1 (HR 1.66; P = .0091) and ALBI grade 3 (HR 5.29; P = .0075), respectively.

Study details: This study evaluated 237 patients with liver-dominant mCRC from the prospective observational CIRSE Registry for SIR-Spheres Therapy (CIRT) study scheduled to receive TARE with ⁹⁰Y resin microspheres.

Disclosures: The CIRT study was funded by SIRTEX Medical Europe GmbH (Bonn, Germany). Some authors declared receiving grants, consulting fees, honoraria, or lecture and travel support from or serving on data safety monitoring or advisory boards for various sources, including SIRTEX.

Source: Schaefer N et al, on behalf of the CIRT Principal Investigators. Prognostic factors for effectiveness outcomes after transarterial radioembolization in metastatic colorectal cancer: Results from the multicentre observational study CIRT. Clin Colorectal Cancer. 2022 (Sep 19). Doi: 10.1016/j.clcc.2022.09.002

Key clinical point: Aspartate transaminase to platelet ratio index (APRI), international normalized ratio (INR), and albumin-bilirubin (ALBI) grade can help identify patients with liver-dominant metastatic colorectal cancer (mCRC) who may benefit from transarterial radioembolization (TARE) with ⁹⁰Y resin microspheres.

Major finding: APRI >0.40 independently predicted worse overall survival (OS; hazard ratio [HR] 2.25; P < .0001), progression-free survival (PFS; HR 1.42; P = .0416), and hepatic PFS (HR 1.50; P = .0207). The other independent predictors for worse OS and hepatic PFS were an INR <1 (HR 1.66; P = .0091) and ALBI grade 3 (HR 5.29; P = .0075), respectively.

Study details: This study evaluated 237 patients with liver-dominant mCRC from the prospective observational CIRSE Registry for SIR-Spheres Therapy (CIRT) study scheduled to receive TARE with ⁹⁰Y resin microspheres.

Disclosures: The CIRT study was funded by SIRTEX Medical Europe GmbH (Bonn, Germany). Some authors declared receiving grants, consulting fees, honoraria, or lecture and travel support from or serving on data safety monitoring or advisory boards for various sources, including SIRTEX.

Source: Schaefer N et al, on behalf of the CIRT Principal Investigators. Prognostic factors for effectiveness outcomes after transarterial radioembolization in metastatic colorectal cancer: Results from the multicentre observational study CIRT. Clin Colorectal Cancer. 2022 (Sep 19). Doi: 10.1016/j.clcc.2022.09.002