Clinical Edge Journal Scan

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Administration of gonadotropin-releasing hormone analogs (GnRHa) with chemotherapy reduced the risk for premature ovarian insufficiency (POI) in premenopausal women with breast cancer.

Major finding: At 12 months after chemotherapy, POI was reported by 10.3% vs 44.5% of patients in the GnRHa + chemotherapy vs chemotherapy-only group (odds ratio, 0.23; P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 superiority trial including 330 premenopausal women with stages I-III operable breast cancer who were randomly assigned to GnRHa (3.6 mg of goserelin or 3.75 mg of leuprorelin) + chemotherapy or chemotherapy alone.

Disclosures: This study was funded by the Science and Technology Commission, Shanghai, and Zhejiang Medical Association. Dr. Zong reported receiving grants from the Science and Technology Commission of Shanghai Municipality.

Source: Zong X et al. JAMA Oncol. 2021 Dec 30. doi: 10.1001/jamaoncol.2021.6214.

Key clinical point: Administration of gonadotropin-releasing hormone analogs (GnRHa) with chemotherapy reduced the risk for premature ovarian insufficiency (POI) in premenopausal women with breast cancer.

Major finding: At 12 months after chemotherapy, POI was reported by 10.3% vs 44.5% of patients in the GnRHa + chemotherapy vs chemotherapy-only group (odds ratio, 0.23; P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 superiority trial including 330 premenopausal women with stages I-III operable breast cancer who were randomly assigned to GnRHa (3.6 mg of goserelin or 3.75 mg of leuprorelin) + chemotherapy or chemotherapy alone.

Disclosures: This study was funded by the Science and Technology Commission, Shanghai, and Zhejiang Medical Association. Dr. Zong reported receiving grants from the Science and Technology Commission of Shanghai Municipality.

Source: Zong X et al. JAMA Oncol. 2021 Dec 30. doi: 10.1001/jamaoncol.2021.6214.

Key clinical point: Administration of gonadotropin-releasing hormone analogs (GnRHa) with chemotherapy reduced the risk for premature ovarian insufficiency (POI) in premenopausal women with breast cancer.

Major finding: At 12 months after chemotherapy, POI was reported by 10.3% vs 44.5% of patients in the GnRHa + chemotherapy vs chemotherapy-only group (odds ratio, 0.23; P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 superiority trial including 330 premenopausal women with stages I-III operable breast cancer who were randomly assigned to GnRHa (3.6 mg of goserelin or 3.75 mg of leuprorelin) + chemotherapy or chemotherapy alone.

Disclosures: This study was funded by the Science and Technology Commission, Shanghai, and Zhejiang Medical Association. Dr. Zong reported receiving grants from the Science and Technology Commission of Shanghai Municipality.

Source: Zong X et al. JAMA Oncol. 2021 Dec 30. doi: 10.1001/jamaoncol.2021.6214.

Key clinical point: Residual cancer burden (RCB) after neoadjuvant chemotherapy was prognostic for event-free survival (EFS) in each hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) subtype of breast cancer.

Major finding: RCB was prognostic for EFS with the hazard ratio associated with each unit increase in RCB being 1.69 (P < .0001) for the overall population and ranging from 1.52 in HR-positive/HER2-negative group to 2.09 in HR-negative/HER2-positive group (P < .0001 for all subtypes).

Study details: Findings are pooled analysis of 4 trials and 8 clinical cohorts, including 5,161 adult patients with primary stage I-III breast cancer treated with neoadjuvant chemotherapy followed by surgery.

Disclosures: This study was funded by the National Cancer Institute, USA. Some of the authors declared serving as a consultant, data and safety monitoring advisor, and/or receiving grants, funding, personal fees, travel support, and honoraria from several sources.

Source: Yau C et al. Lancet Oncol. 2021 Dec 10. doi: 10.1016/S1470-2045(21)00589-1.

Key clinical point: Residual cancer burden (RCB) after neoadjuvant chemotherapy was prognostic for event-free survival (EFS) in each hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) subtype of breast cancer.

Major finding: RCB was prognostic for EFS with the hazard ratio associated with each unit increase in RCB being 1.69 (P < .0001) for the overall population and ranging from 1.52 in HR-positive/HER2-negative group to 2.09 in HR-negative/HER2-positive group (P < .0001 for all subtypes).

Study details: Findings are pooled analysis of 4 trials and 8 clinical cohorts, including 5,161 adult patients with primary stage I-III breast cancer treated with neoadjuvant chemotherapy followed by surgery.

Disclosures: This study was funded by the National Cancer Institute, USA. Some of the authors declared serving as a consultant, data and safety monitoring advisor, and/or receiving grants, funding, personal fees, travel support, and honoraria from several sources.

Source: Yau C et al. Lancet Oncol. 2021 Dec 10. doi: 10.1016/S1470-2045(21)00589-1.

Key clinical point: Residual cancer burden (RCB) after neoadjuvant chemotherapy was prognostic for event-free survival (EFS) in each hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) subtype of breast cancer.

Major finding: RCB was prognostic for EFS with the hazard ratio associated with each unit increase in RCB being 1.69 (P < .0001) for the overall population and ranging from 1.52 in HR-positive/HER2-negative group to 2.09 in HR-negative/HER2-positive group (P < .0001 for all subtypes).

Study details: Findings are pooled analysis of 4 trials and 8 clinical cohorts, including 5,161 adult patients with primary stage I-III breast cancer treated with neoadjuvant chemotherapy followed by surgery.

Disclosures: This study was funded by the National Cancer Institute, USA. Some of the authors declared serving as a consultant, data and safety monitoring advisor, and/or receiving grants, funding, personal fees, travel support, and honoraria from several sources.

Source: Yau C et al. Lancet Oncol. 2021 Dec 10. doi: 10.1016/S1470-2045(21)00589-1.

For many years, sorafenib was the only FDA-approved systemic treatment for patients with uHCC. Initial case reports of remarkable responses of tumors to immunotherapy, and results of the Phase I/II CheckMate-040 clinical trial, led to the September 2017 FDA approval of nivolumab for the treatment of patients with uHCC after progression on sorafenib. Thereafter, several randomized clinical trials comparing sorafenib to immunotherapy and immunotherapy combinations were initiated, including the comparison of nivolumab to sorafenib. In June 2019 it was announced that this trial did not reach its prespecified endpoint, and the FDA approval for the uHCC indication was voluntarily withdrawn. In December 2021, Yau et al published the final results of the CheckMate-459 randomized trial that included 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372) in the first line setting.  The primary endpoint was overall survival (OS) assessed in the intention-to-treat population. The median OS was 16.4 months (95% CI 13.9–18.4) with nivolumab and 14.7 months (11.9–17.2) with sorafenib (hazard ratio 0.85 [95% CI 0.72–1.02]; P = 0.075; minimum follow-up 22.8 months). Serious treatment-related adverse events were reported in 43 (12%) patients receiving nivolumab and 39 (11%) patients receiving sorafenib. The authors concluded that though first-line nivolumab treatment did not significantly improve OS compared with sorafenib, single-agent nivolumab might be considered a treatment option for patients in whom tyrosine kinase inhibitors or antiangiogenic drugs are not safe.

Cheng et al reported an update on the outcomes of the IMbrave150 study, 12 months after the primary analysis. This study established atezolizumab and bevacizumab as the current standard of care for the initial systemic treatment of patients with uHCC. The median OS was 19.2 months (95% CI 17.0-23.7) with atezolizumab/bevacizumab and 13.4 months (95% CI 11.4-16.9) with sorafenib (hazard ratio [HR], 0.66; 95% CI 0.52-0.85; descriptive P < 0.001). The overall response rate (ORR) was 30% with atezolizumab/bevacizumab, while treatment-related grade 3/4 adverse events occurred in 143 (43%) of 329 receiving atezolizumab/bevacizumab and 72 (46%) of 156 receiving sorafenib. Treatment-related grade 5 events occurred in 6 (2%) and 1 (<1%) patients. Therefore, atezolizumab/bevacizumab remains the first-line standard of care for patients with uHCC.

Finally, Jácome et al undertook a combined analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), with 1,657 patients with uHCC and who were treated with either immunotherapy (n=985) or sorafenib (in the first-line setting) or placebo (in the sorafenib-refractory setting) (n=672). The conclusion of the meta-analysis was that checkpoint inhibitors were associated with superior OS (HR, 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and ORR (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04) than the comparators, confirming that immunotherapy remains an integral part of the treatment of patients with uHCC.

For many years, sorafenib was the only FDA-approved systemic treatment for patients with uHCC. Initial case reports of remarkable responses of tumors to immunotherapy, and results of the Phase I/II CheckMate-040 clinical trial, led to the September 2017 FDA approval of nivolumab for the treatment of patients with uHCC after progression on sorafenib. Thereafter, several randomized clinical trials comparing sorafenib to immunotherapy and immunotherapy combinations were initiated, including the comparison of nivolumab to sorafenib. In June 2019 it was announced that this trial did not reach its prespecified endpoint, and the FDA approval for the uHCC indication was voluntarily withdrawn. In December 2021, Yau et al published the final results of the CheckMate-459 randomized trial that included 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372) in the first line setting.  The primary endpoint was overall survival (OS) assessed in the intention-to-treat population. The median OS was 16.4 months (95% CI 13.9–18.4) with nivolumab and 14.7 months (11.9–17.2) with sorafenib (hazard ratio 0.85 [95% CI 0.72–1.02]; P = 0.075; minimum follow-up 22.8 months). Serious treatment-related adverse events were reported in 43 (12%) patients receiving nivolumab and 39 (11%) patients receiving sorafenib. The authors concluded that though first-line nivolumab treatment did not significantly improve OS compared with sorafenib, single-agent nivolumab might be considered a treatment option for patients in whom tyrosine kinase inhibitors or antiangiogenic drugs are not safe.

Cheng et al reported an update on the outcomes of the IMbrave150 study, 12 months after the primary analysis. This study established atezolizumab and bevacizumab as the current standard of care for the initial systemic treatment of patients with uHCC. The median OS was 19.2 months (95% CI 17.0-23.7) with atezolizumab/bevacizumab and 13.4 months (95% CI 11.4-16.9) with sorafenib (hazard ratio [HR], 0.66; 95% CI 0.52-0.85; descriptive P < 0.001). The overall response rate (ORR) was 30% with atezolizumab/bevacizumab, while treatment-related grade 3/4 adverse events occurred in 143 (43%) of 329 receiving atezolizumab/bevacizumab and 72 (46%) of 156 receiving sorafenib. Treatment-related grade 5 events occurred in 6 (2%) and 1 (<1%) patients. Therefore, atezolizumab/bevacizumab remains the first-line standard of care for patients with uHCC.

Finally, Jácome et al undertook a combined analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), with 1,657 patients with uHCC and who were treated with either immunotherapy (n=985) or sorafenib (in the first-line setting) or placebo (in the sorafenib-refractory setting) (n=672). The conclusion of the meta-analysis was that checkpoint inhibitors were associated with superior OS (HR, 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and ORR (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04) than the comparators, confirming that immunotherapy remains an integral part of the treatment of patients with uHCC.

For many years, sorafenib was the only FDA-approved systemic treatment for patients with uHCC. Initial case reports of remarkable responses of tumors to immunotherapy, and results of the Phase I/II CheckMate-040 clinical trial, led to the September 2017 FDA approval of nivolumab for the treatment of patients with uHCC after progression on sorafenib. Thereafter, several randomized clinical trials comparing sorafenib to immunotherapy and immunotherapy combinations were initiated, including the comparison of nivolumab to sorafenib. In June 2019 it was announced that this trial did not reach its prespecified endpoint, and the FDA approval for the uHCC indication was voluntarily withdrawn. In December 2021, Yau et al published the final results of the CheckMate-459 randomized trial that included 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372) in the first line setting.  The primary endpoint was overall survival (OS) assessed in the intention-to-treat population. The median OS was 16.4 months (95% CI 13.9–18.4) with nivolumab and 14.7 months (11.9–17.2) with sorafenib (hazard ratio 0.85 [95% CI 0.72–1.02]; P = 0.075; minimum follow-up 22.8 months). Serious treatment-related adverse events were reported in 43 (12%) patients receiving nivolumab and 39 (11%) patients receiving sorafenib. The authors concluded that though first-line nivolumab treatment did not significantly improve OS compared with sorafenib, single-agent nivolumab might be considered a treatment option for patients in whom tyrosine kinase inhibitors or antiangiogenic drugs are not safe.

Cheng et al reported an update on the outcomes of the IMbrave150 study, 12 months after the primary analysis. This study established atezolizumab and bevacizumab as the current standard of care for the initial systemic treatment of patients with uHCC. The median OS was 19.2 months (95% CI 17.0-23.7) with atezolizumab/bevacizumab and 13.4 months (95% CI 11.4-16.9) with sorafenib (hazard ratio [HR], 0.66; 95% CI 0.52-0.85; descriptive P < 0.001). The overall response rate (ORR) was 30% with atezolizumab/bevacizumab, while treatment-related grade 3/4 adverse events occurred in 143 (43%) of 329 receiving atezolizumab/bevacizumab and 72 (46%) of 156 receiving sorafenib. Treatment-related grade 5 events occurred in 6 (2%) and 1 (<1%) patients. Therefore, atezolizumab/bevacizumab remains the first-line standard of care for patients with uHCC.

Finally, Jácome et al undertook a combined analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), with 1,657 patients with uHCC and who were treated with either immunotherapy (n=985) or sorafenib (in the first-line setting) or placebo (in the sorafenib-refractory setting) (n=672). The conclusion of the meta-analysis was that checkpoint inhibitors were associated with superior OS (HR, 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and ORR (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04) than the comparators, confirming that immunotherapy remains an integral part of the treatment of patients with uHCC.

Ferrari et al¹ provided information on an open label extension to the “LIBERTY” study which investigated the use of erenumab in subjects with episodic migraine that have failed multiple prior preventive medications. The initial Calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) studies excluded more refractory patients.  Most commercial insurances in the United States have a “step” policy that relates to use of these and other newer medications, meaning that the majority of patient in the US who receive these medications have previously tried other preventive medications. This raised the question whether migraine refractoriness is a negative predictive factor for erenumab.

This long-term open label study is more like the real-world use of erenumab, and as such the results are similar to what many practitioners are seeing in their clinical experience. Approximately 25% of subjects discontinued erenumab, mostly due to ineffectiveness. Adverse events were mild, and although erenumab has warnings for constipation and hypertension, this study did not show either as increasing over 2 years. Erenumab appeared to be tolerable over time. There were no newly noted safety signals in this study.

The efficacy of erenumab also appeared to be stable over time, without the development of tolerance to the medication. There is a slight decrease in the 50% responder rate at 2 years when these more refractory patients are compared to those that did not have multiple treatment failures. This study also looked at “functional parameters,” such as Migraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6), both of which were significantly improved over time.

Although there are some significant limitations in this study-primarily the fact that it is open label—this does give a more representative and real-world sample of patients who will be prescribed erenumab in the United States. Most practitioners will be glad to find that the long-term use of erenumab appears safe, and the efficacy remains stable, even in a more difficult-to-treat population.

A randomized controlled international study investigated the preventive use of occipital nerve blocks in migraine without aura.² The majority of the literature for the use of occipital nerve blocks is for acute treatment, and arguably the most significant study prior to this was Friedman et al³ investigating the use of this procedure in the emergency ward. Prior occipital nerve studies have been inconclusive, and although occipital nerve blocks are considered standard of care for specific conditions in most headache centers, reimbursement is usually very limited. Insurance companies have quoted prior preventive occipital nerve studies to justify non-coverage of these procedures, making access to them for many patients very limited.

Occipital nerve blocks are not performed uniformly, both regarding the medications used—some practitioners use no steroids, some use lidocaine and bupivocaine—and regarding the placement of the injections. In this a small cohort study, 55 subjects were divided into four groups for intervention—one of which was a control group of saline—and all were given one 2.5 mL injection at a point in between the occipital protuberance and the mastoid process bilaterally. Due to adverse events (alopecia and cutaneous atrophy) in two of the triamcinolone groups, recruitment was halted for those two groups. Patients were assessed based on headache duration, frequency, and severity over a 4-week course.

Compared to baseline all interventional groups had significantly decreased headache severity, which did return closer to baseline during the final week. Headache duration was decreased in the first 2 weeks post-injection. Headache frequency was seen to return to baseline at week 4, but prior to that the groups injected with lidocaine had a significant decrease in migraine frequency, with an average decrease in headache days.

Occipital nerve blocks are performed frequently for migraine, occipital neuralgia, cervicogenic headache, and many other conditions with noted tenderness over the occiput. As noted above, they are not performed uniformly—sometimes they are given for acute headache pain or status migranosus, and other times they are used in regular intervals for prevention. This data does finally show a preventive benefit with occipital nerve blocks, and this may allow for modifications in how occipital nerve blocks are currently performed. Based on this study, if given preventively, occipital nerve blocks should only contain topical anesthetics, not steroids, and should be performed on an every 2-3 week basis.

The limitations of this study are significant as well. This is a very small cohort, and the injections were performed in only one manner (one bilateral injection), whereas many practitioners will target the greater and lesser branches of the occipital nerve individually.  There were no exclusion criteria for subjects that already had occipital nerve blocks performed—those patients would be unblinded as there is a different sensation when injected with a topical anesthetic versus normal saline (normal saline does not cause burning subcutaneously).

These results should pave the way for further investigations in the use of occipital and other nerve blocks in the prevention of migraine. This should allow better access for our patients and the possibility of performing these procedures more uniformly in the future.

It can be challenging for many practitioners to determine which medication is ideal for individual situations. This is especially true when treating chronic migraine, where many potential complicating factors can influence positive to negative responses to treatment. The investigators here sought to determine which factors may potentially predict a positive response to galcanezumab.⁴

This is an observational study, where 156 subjects with a diagnosis of chronic migraine were enrolled. There was a 1-month run-in period where the following characteristics were collected: monthly headache days, monthly abortive medication intake, clinical features of migraine, and disability scores (MIDAS and HIT-6). These were tracked over a 3-month period after starting glacanezumab.

Approximately 40% of subjects experienced a 50% reduction in headache frequency. The better responders had a lower body mass index, fewer previously failed preventive medications, unilateral headache pain, and previous good response to triptan use. Surprisingly, the presence of medication overuse was associated with persistent improvement at 3 months as well, with over 60% of subjects with medication overuse no longer overusing acute medications at 3 months.  

This study is helpful in identifying specific features that may allow a practitioner to better recommend CGRP mAb medications, such as galcanezumab. Chronic migraine can offer a challenge to even the best trained clinicians. Patients will often have multiple factors that have led to a conversion from episodic to chronic migraine, and a history of medication failures or intolerances. These patients are often referred specifically due to these challenges.

When deciding on a preventive medication for patients with chronic migraine, we often first consider which oral preventive medications may allow us to treat migraine in addition to another underlying issue—such as insomnia, depression, or hypertension. Although the oral class can improve other comorbidities, intolerance is significantly higher for most of these medications as well. The CGRP mAb class is somewhat more ideal for prevention of migraine; the focus when using this class is for migraine prevention alone, and the side effect profile is more tolerable for most patients. That said, if predictive factors were known a more individualized approach to migraine prevention would be possible.

The authors’ recognition of the factors associated with improvement in patients using glacanezumab allows this better individualization. Based on these results, patients with more unilateral pain, lower BMI, and good response to triptans could be recommended glacanuzumab with a great degree of confidence. This should be irrespective of even high frequency use of acute medications, as most of subjects in this study with medication overuse reverted after 3 months.

There is never a single ideal preventive or acute treatment for migraine in any population, however, recognizing factors that allow for an individualized approach improves the quality of life for our patients, and leaves them less disabled by migraine.

References

1. Ferrari MD et al. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2–4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021(Nov 29).
2. Malekian N et al. Preventive effect of greater occipital nerve block on patients with episodic migraine: A randomized double‐blind placebo‐controlled clinical trial. Cephalalgia. 2021(Nov 17).
3. Friedman BW et al. A Randomized, Sham-Controlled Trial of Bilateral Greater Occipital Nerve Blocks With Bupivacaine for Acute Migraine Patients Refractory to Standard Emergency Department Treatment With Metoclopramide. Headache. 2018(Oct);58(9):1427-34. https://doi.org/10.1111/head.13395.
4. Vernieri F et al. Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study. Eur J Neurol. 2021(Nov 26).

Ferrari et al¹ provided information on an open label extension to the “LIBERTY” study which investigated the use of erenumab in subjects with episodic migraine that have failed multiple prior preventive medications. The initial Calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) studies excluded more refractory patients.  Most commercial insurances in the United States have a “step” policy that relates to use of these and other newer medications, meaning that the majority of patient in the US who receive these medications have previously tried other preventive medications. This raised the question whether migraine refractoriness is a negative predictive factor for erenumab.

This long-term open label study is more like the real-world use of erenumab, and as such the results are similar to what many practitioners are seeing in their clinical experience. Approximately 25% of subjects discontinued erenumab, mostly due to ineffectiveness. Adverse events were mild, and although erenumab has warnings for constipation and hypertension, this study did not show either as increasing over 2 years. Erenumab appeared to be tolerable over time. There were no newly noted safety signals in this study.

The efficacy of erenumab also appeared to be stable over time, without the development of tolerance to the medication. There is a slight decrease in the 50% responder rate at 2 years when these more refractory patients are compared to those that did not have multiple treatment failures. This study also looked at “functional parameters,” such as Migraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6), both of which were significantly improved over time.

Although there are some significant limitations in this study-primarily the fact that it is open label—this does give a more representative and real-world sample of patients who will be prescribed erenumab in the United States. Most practitioners will be glad to find that the long-term use of erenumab appears safe, and the efficacy remains stable, even in a more difficult-to-treat population.

A randomized controlled international study investigated the preventive use of occipital nerve blocks in migraine without aura.² The majority of the literature for the use of occipital nerve blocks is for acute treatment, and arguably the most significant study prior to this was Friedman et al³ investigating the use of this procedure in the emergency ward. Prior occipital nerve studies have been inconclusive, and although occipital nerve blocks are considered standard of care for specific conditions in most headache centers, reimbursement is usually very limited. Insurance companies have quoted prior preventive occipital nerve studies to justify non-coverage of these procedures, making access to them for many patients very limited.

Occipital nerve blocks are not performed uniformly, both regarding the medications used—some practitioners use no steroids, some use lidocaine and bupivocaine—and regarding the placement of the injections. In this a small cohort study, 55 subjects were divided into four groups for intervention—one of which was a control group of saline—and all were given one 2.5 mL injection at a point in between the occipital protuberance and the mastoid process bilaterally. Due to adverse events (alopecia and cutaneous atrophy) in two of the triamcinolone groups, recruitment was halted for those two groups. Patients were assessed based on headache duration, frequency, and severity over a 4-week course.

Compared to baseline all interventional groups had significantly decreased headache severity, which did return closer to baseline during the final week. Headache duration was decreased in the first 2 weeks post-injection. Headache frequency was seen to return to baseline at week 4, but prior to that the groups injected with lidocaine had a significant decrease in migraine frequency, with an average decrease in headache days.

Occipital nerve blocks are performed frequently for migraine, occipital neuralgia, cervicogenic headache, and many other conditions with noted tenderness over the occiput. As noted above, they are not performed uniformly—sometimes they are given for acute headache pain or status migranosus, and other times they are used in regular intervals for prevention. This data does finally show a preventive benefit with occipital nerve blocks, and this may allow for modifications in how occipital nerve blocks are currently performed. Based on this study, if given preventively, occipital nerve blocks should only contain topical anesthetics, not steroids, and should be performed on an every 2-3 week basis.

The limitations of this study are significant as well. This is a very small cohort, and the injections were performed in only one manner (one bilateral injection), whereas many practitioners will target the greater and lesser branches of the occipital nerve individually.  There were no exclusion criteria for subjects that already had occipital nerve blocks performed—those patients would be unblinded as there is a different sensation when injected with a topical anesthetic versus normal saline (normal saline does not cause burning subcutaneously).

These results should pave the way for further investigations in the use of occipital and other nerve blocks in the prevention of migraine. This should allow better access for our patients and the possibility of performing these procedures more uniformly in the future.

It can be challenging for many practitioners to determine which medication is ideal for individual situations. This is especially true when treating chronic migraine, where many potential complicating factors can influence positive to negative responses to treatment. The investigators here sought to determine which factors may potentially predict a positive response to galcanezumab.⁴

This is an observational study, where 156 subjects with a diagnosis of chronic migraine were enrolled. There was a 1-month run-in period where the following characteristics were collected: monthly headache days, monthly abortive medication intake, clinical features of migraine, and disability scores (MIDAS and HIT-6). These were tracked over a 3-month period after starting glacanezumab.

Approximately 40% of subjects experienced a 50% reduction in headache frequency. The better responders had a lower body mass index, fewer previously failed preventive medications, unilateral headache pain, and previous good response to triptan use. Surprisingly, the presence of medication overuse was associated with persistent improvement at 3 months as well, with over 60% of subjects with medication overuse no longer overusing acute medications at 3 months.  

This study is helpful in identifying specific features that may allow a practitioner to better recommend CGRP mAb medications, such as galcanezumab. Chronic migraine can offer a challenge to even the best trained clinicians. Patients will often have multiple factors that have led to a conversion from episodic to chronic migraine, and a history of medication failures or intolerances. These patients are often referred specifically due to these challenges.

When deciding on a preventive medication for patients with chronic migraine, we often first consider which oral preventive medications may allow us to treat migraine in addition to another underlying issue—such as insomnia, depression, or hypertension. Although the oral class can improve other comorbidities, intolerance is significantly higher for most of these medications as well. The CGRP mAb class is somewhat more ideal for prevention of migraine; the focus when using this class is for migraine prevention alone, and the side effect profile is more tolerable for most patients. That said, if predictive factors were known a more individualized approach to migraine prevention would be possible.

The authors’ recognition of the factors associated with improvement in patients using glacanezumab allows this better individualization. Based on these results, patients with more unilateral pain, lower BMI, and good response to triptans could be recommended glacanuzumab with a great degree of confidence. This should be irrespective of even high frequency use of acute medications, as most of subjects in this study with medication overuse reverted after 3 months.

There is never a single ideal preventive or acute treatment for migraine in any population, however, recognizing factors that allow for an individualized approach improves the quality of life for our patients, and leaves them less disabled by migraine.

References

1. Ferrari MD et al. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2–4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021(Nov 29).
2. Malekian N et al. Preventive effect of greater occipital nerve block on patients with episodic migraine: A randomized double‐blind placebo‐controlled clinical trial. Cephalalgia. 2021(Nov 17).
3. Friedman BW et al. A Randomized, Sham-Controlled Trial of Bilateral Greater Occipital Nerve Blocks With Bupivacaine for Acute Migraine Patients Refractory to Standard Emergency Department Treatment With Metoclopramide. Headache. 2018(Oct);58(9):1427-34. https://doi.org/10.1111/head.13395.
4. Vernieri F et al. Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study. Eur J Neurol. 2021(Nov 26).

Ferrari et al¹ provided information on an open label extension to the “LIBERTY” study which investigated the use of erenumab in subjects with episodic migraine that have failed multiple prior preventive medications. The initial Calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) studies excluded more refractory patients.  Most commercial insurances in the United States have a “step” policy that relates to use of these and other newer medications, meaning that the majority of patient in the US who receive these medications have previously tried other preventive medications. This raised the question whether migraine refractoriness is a negative predictive factor for erenumab.

This long-term open label study is more like the real-world use of erenumab, and as such the results are similar to what many practitioners are seeing in their clinical experience. Approximately 25% of subjects discontinued erenumab, mostly due to ineffectiveness. Adverse events were mild, and although erenumab has warnings for constipation and hypertension, this study did not show either as increasing over 2 years. Erenumab appeared to be tolerable over time. There were no newly noted safety signals in this study.

The efficacy of erenumab also appeared to be stable over time, without the development of tolerance to the medication. There is a slight decrease in the 50% responder rate at 2 years when these more refractory patients are compared to those that did not have multiple treatment failures. This study also looked at “functional parameters,” such as Migraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6), both of which were significantly improved over time.

Although there are some significant limitations in this study-primarily the fact that it is open label—this does give a more representative and real-world sample of patients who will be prescribed erenumab in the United States. Most practitioners will be glad to find that the long-term use of erenumab appears safe, and the efficacy remains stable, even in a more difficult-to-treat population.

A randomized controlled international study investigated the preventive use of occipital nerve blocks in migraine without aura.² The majority of the literature for the use of occipital nerve blocks is for acute treatment, and arguably the most significant study prior to this was Friedman et al³ investigating the use of this procedure in the emergency ward. Prior occipital nerve studies have been inconclusive, and although occipital nerve blocks are considered standard of care for specific conditions in most headache centers, reimbursement is usually very limited. Insurance companies have quoted prior preventive occipital nerve studies to justify non-coverage of these procedures, making access to them for many patients very limited.

Occipital nerve blocks are not performed uniformly, both regarding the medications used—some practitioners use no steroids, some use lidocaine and bupivocaine—and regarding the placement of the injections. In this a small cohort study, 55 subjects were divided into four groups for intervention—one of which was a control group of saline—and all were given one 2.5 mL injection at a point in between the occipital protuberance and the mastoid process bilaterally. Due to adverse events (alopecia and cutaneous atrophy) in two of the triamcinolone groups, recruitment was halted for those two groups. Patients were assessed based on headache duration, frequency, and severity over a 4-week course.

Compared to baseline all interventional groups had significantly decreased headache severity, which did return closer to baseline during the final week. Headache duration was decreased in the first 2 weeks post-injection. Headache frequency was seen to return to baseline at week 4, but prior to that the groups injected with lidocaine had a significant decrease in migraine frequency, with an average decrease in headache days.

Occipital nerve blocks are performed frequently for migraine, occipital neuralgia, cervicogenic headache, and many other conditions with noted tenderness over the occiput. As noted above, they are not performed uniformly—sometimes they are given for acute headache pain or status migranosus, and other times they are used in regular intervals for prevention. This data does finally show a preventive benefit with occipital nerve blocks, and this may allow for modifications in how occipital nerve blocks are currently performed. Based on this study, if given preventively, occipital nerve blocks should only contain topical anesthetics, not steroids, and should be performed on an every 2-3 week basis.

The limitations of this study are significant as well. This is a very small cohort, and the injections were performed in only one manner (one bilateral injection), whereas many practitioners will target the greater and lesser branches of the occipital nerve individually.  There were no exclusion criteria for subjects that already had occipital nerve blocks performed—those patients would be unblinded as there is a different sensation when injected with a topical anesthetic versus normal saline (normal saline does not cause burning subcutaneously).

These results should pave the way for further investigations in the use of occipital and other nerve blocks in the prevention of migraine. This should allow better access for our patients and the possibility of performing these procedures more uniformly in the future.

It can be challenging for many practitioners to determine which medication is ideal for individual situations. This is especially true when treating chronic migraine, where many potential complicating factors can influence positive to negative responses to treatment. The investigators here sought to determine which factors may potentially predict a positive response to galcanezumab.⁴

This is an observational study, where 156 subjects with a diagnosis of chronic migraine were enrolled. There was a 1-month run-in period where the following characteristics were collected: monthly headache days, monthly abortive medication intake, clinical features of migraine, and disability scores (MIDAS and HIT-6). These were tracked over a 3-month period after starting glacanezumab.

Approximately 40% of subjects experienced a 50% reduction in headache frequency. The better responders had a lower body mass index, fewer previously failed preventive medications, unilateral headache pain, and previous good response to triptan use. Surprisingly, the presence of medication overuse was associated with persistent improvement at 3 months as well, with over 60% of subjects with medication overuse no longer overusing acute medications at 3 months.  

This study is helpful in identifying specific features that may allow a practitioner to better recommend CGRP mAb medications, such as galcanezumab. Chronic migraine can offer a challenge to even the best trained clinicians. Patients will often have multiple factors that have led to a conversion from episodic to chronic migraine, and a history of medication failures or intolerances. These patients are often referred specifically due to these challenges.

When deciding on a preventive medication for patients with chronic migraine, we often first consider which oral preventive medications may allow us to treat migraine in addition to another underlying issue—such as insomnia, depression, or hypertension. Although the oral class can improve other comorbidities, intolerance is significantly higher for most of these medications as well. The CGRP mAb class is somewhat more ideal for prevention of migraine; the focus when using this class is for migraine prevention alone, and the side effect profile is more tolerable for most patients. That said, if predictive factors were known a more individualized approach to migraine prevention would be possible.

The authors’ recognition of the factors associated with improvement in patients using glacanezumab allows this better individualization. Based on these results, patients with more unilateral pain, lower BMI, and good response to triptans could be recommended glacanuzumab with a great degree of confidence. This should be irrespective of even high frequency use of acute medications, as most of subjects in this study with medication overuse reverted after 3 months.

There is never a single ideal preventive or acute treatment for migraine in any population, however, recognizing factors that allow for an individualized approach improves the quality of life for our patients, and leaves them less disabled by migraine.

References

1. Ferrari MD et al. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2–4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021(Nov 29).
2. Malekian N et al. Preventive effect of greater occipital nerve block on patients with episodic migraine: A randomized double‐blind placebo‐controlled clinical trial. Cephalalgia. 2021(Nov 17).
3. Friedman BW et al. A Randomized, Sham-Controlled Trial of Bilateral Greater Occipital Nerve Blocks With Bupivacaine for Acute Migraine Patients Refractory to Standard Emergency Department Treatment With Metoclopramide. Headache. 2018(Oct);58(9):1427-34. https://doi.org/10.1111/head.13395.
4. Vernieri F et al. Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study. Eur J Neurol. 2021(Nov 26).

Key clinical point: Ubrogepant was effective and safe in patients with migraine, regardless of prior or concomitant preventive medication use.

Major finding: Ubrogepant vs. placebo was associated with significantly higher responder rates for pain freedom (P £ .005), absence of most bothersome symptom (50 mg ubrogepant vs. placebo; P £ .001), and pain relief (P £ .011) at 2 hours, with the responder rates not being significantly different among patients with vs. without preventive medication use (all P > .05). No serious or treatment-related adverse events were reported.

Study details: Findings are from a pooled analysis of ACHIEVE I and ACHIEVE II phase 3 trials (n = 2,247) and the long-term safety extension trial (n = 813) including patients with migraine with or without a history of preventive medication use.

Disclosures: This study was funded by Allergan (before its acquisition by AbbVie). Some investigators, including the lead author, reported advising or consulting for; being a speaker, on the board of directors, or a contributing author for; receiving grants, research support, and honoraria from; holding stocks or patents with; or employment with various sources including Allergan and AbbVie.

Source: Blumenfeld AM et al. Add Ther. 2021 (Dec 7). Doi: 10.1007/s12325-021-01923-3.

Key clinical point: Ubrogepant was effective and safe in patients with migraine, regardless of prior or concomitant preventive medication use.

Major finding: Ubrogepant vs. placebo was associated with significantly higher responder rates for pain freedom (P £ .005), absence of most bothersome symptom (50 mg ubrogepant vs. placebo; P £ .001), and pain relief (P £ .011) at 2 hours, with the responder rates not being significantly different among patients with vs. without preventive medication use (all P > .05). No serious or treatment-related adverse events were reported.

Study details: Findings are from a pooled analysis of ACHIEVE I and ACHIEVE II phase 3 trials (n = 2,247) and the long-term safety extension trial (n = 813) including patients with migraine with or without a history of preventive medication use.

Disclosures: This study was funded by Allergan (before its acquisition by AbbVie). Some investigators, including the lead author, reported advising or consulting for; being a speaker, on the board of directors, or a contributing author for; receiving grants, research support, and honoraria from; holding stocks or patents with; or employment with various sources including Allergan and AbbVie.

Source: Blumenfeld AM et al. Add Ther. 2021 (Dec 7). Doi: 10.1007/s12325-021-01923-3.

Key clinical point: Ubrogepant was effective and safe in patients with migraine, regardless of prior or concomitant preventive medication use.

Major finding: Ubrogepant vs. placebo was associated with significantly higher responder rates for pain freedom (P £ .005), absence of most bothersome symptom (50 mg ubrogepant vs. placebo; P £ .001), and pain relief (P £ .011) at 2 hours, with the responder rates not being significantly different among patients with vs. without preventive medication use (all P > .05). No serious or treatment-related adverse events were reported.

Study details: Findings are from a pooled analysis of ACHIEVE I and ACHIEVE II phase 3 trials (n = 2,247) and the long-term safety extension trial (n = 813) including patients with migraine with or without a history of preventive medication use.

Disclosures: This study was funded by Allergan (before its acquisition by AbbVie). Some investigators, including the lead author, reported advising or consulting for; being a speaker, on the board of directors, or a contributing author for; receiving grants, research support, and honoraria from; holding stocks or patents with; or employment with various sources including Allergan and AbbVie.

Source: Blumenfeld AM et al. Add Ther. 2021 (Dec 7). Doi: 10.1007/s12325-021-01923-3.

Key clinical point: Fremanezumab was effective and well tolerated over 12 weeks in older patients with chronic or episodic migraine.

Major finding: Quarterly and monthly fremanezumab vs. placebo showed greater reduction in monthly average migraine days (least-squares mean change from baseline [D] −4.3 and −4.6 vs. −2.3), headache days of at least moderate severity (D −3.9 and −4.2 vs. −2.1), and acute medication use (D −3.7 and −4.0 vs. −1.3) over 12 weeks (all P < .05). Adverse events were similar across groups.

Study details: Findings are pooled subgroup analysis of 3 phase 3 studies (HALO CM, HALO EM, and FOCUS) including 246 participants aged ≥60 years with chronic or episodic migraine with an inadequate response to 2-4 prior migraine preventives. They were randomly assigned to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo.

Disclosures: This study was funded by Teva Pharmaceuticals Ltd. Some investigators, including the lead author, reported participating in clinical trials and receiving honoraria, research support, and legal or personal fees from and being former or current employees of various sources, including Teva Pharmaceuticals.

Source: Nahas SJ et al. J Headache Pain. 2021;22:141 (Nov 24). Doi: 10.1186/s10194-021-01351-2.

Key clinical point: Fremanezumab was effective and well tolerated over 12 weeks in older patients with chronic or episodic migraine.

Major finding: Quarterly and monthly fremanezumab vs. placebo showed greater reduction in monthly average migraine days (least-squares mean change from baseline [D] −4.3 and −4.6 vs. −2.3), headache days of at least moderate severity (D −3.9 and −4.2 vs. −2.1), and acute medication use (D −3.7 and −4.0 vs. −1.3) over 12 weeks (all P < .05). Adverse events were similar across groups.

Study details: Findings are pooled subgroup analysis of 3 phase 3 studies (HALO CM, HALO EM, and FOCUS) including 246 participants aged ≥60 years with chronic or episodic migraine with an inadequate response to 2-4 prior migraine preventives. They were randomly assigned to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo.

Disclosures: This study was funded by Teva Pharmaceuticals Ltd. Some investigators, including the lead author, reported participating in clinical trials and receiving honoraria, research support, and legal or personal fees from and being former or current employees of various sources, including Teva Pharmaceuticals.

Source: Nahas SJ et al. J Headache Pain. 2021;22:141 (Nov 24). Doi: 10.1186/s10194-021-01351-2.

Key clinical point: Fremanezumab was effective and well tolerated over 12 weeks in older patients with chronic or episodic migraine.

Major finding: Quarterly and monthly fremanezumab vs. placebo showed greater reduction in monthly average migraine days (least-squares mean change from baseline [D] −4.3 and −4.6 vs. −2.3), headache days of at least moderate severity (D −3.9 and −4.2 vs. −2.1), and acute medication use (D −3.7 and −4.0 vs. −1.3) over 12 weeks (all P < .05). Adverse events were similar across groups.

Study details: Findings are pooled subgroup analysis of 3 phase 3 studies (HALO CM, HALO EM, and FOCUS) including 246 participants aged ≥60 years with chronic or episodic migraine with an inadequate response to 2-4 prior migraine preventives. They were randomly assigned to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo.

Disclosures: This study was funded by Teva Pharmaceuticals Ltd. Some investigators, including the lead author, reported participating in clinical trials and receiving honoraria, research support, and legal or personal fees from and being former or current employees of various sources, including Teva Pharmaceuticals.

Source: Nahas SJ et al. J Headache Pain. 2021;22:141 (Nov 24). Doi: 10.1186/s10194-021-01351-2.

Key clinical point: Patients with migraine are more likely to suffer from dry eye than patients without migraine.

Major finding: The prevalence of dry eye was significantly higher in patients with vs. without migraine (odds ratio, 1.55; P < .001).

Study details: Findings are from a meta-analysis of 7 case-control or cross-sectional studies including a total population of 1,033,288 individuals with or without migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China and Fundamental Research Funds of the State Key Laboratory of Ophthalmology. The authors declared no conflict of interests.

Source: Chen H et al. Cornea. 2021 (Nov 6). Doi: 10.1097/ICO.0000000000002851.

Key clinical point: Patients with migraine are more likely to suffer from dry eye than patients without migraine.

Major finding: The prevalence of dry eye was significantly higher in patients with vs. without migraine (odds ratio, 1.55; P < .001).

Study details: Findings are from a meta-analysis of 7 case-control or cross-sectional studies including a total population of 1,033,288 individuals with or without migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China and Fundamental Research Funds of the State Key Laboratory of Ophthalmology. The authors declared no conflict of interests.

Source: Chen H et al. Cornea. 2021 (Nov 6). Doi: 10.1097/ICO.0000000000002851.

Key clinical point: Patients with migraine are more likely to suffer from dry eye than patients without migraine.

Major finding: The prevalence of dry eye was significantly higher in patients with vs. without migraine (odds ratio, 1.55; P < .001).

Study details: Findings are from a meta-analysis of 7 case-control or cross-sectional studies including a total population of 1,033,288 individuals with or without migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China and Fundamental Research Funds of the State Key Laboratory of Ophthalmology. The authors declared no conflict of interests.

Source: Chen H et al. Cornea. 2021 (Nov 6). Doi: 10.1097/ICO.0000000000002851.

Key clinical point: Prevalence of migraine was higher in patients with celiac disease (CD) vs. healthy controls, with patients with CD and migraine showing worse gastrointestinal symptoms compared with those without migraine.

Major finding: The prevalence of migraine was higher in patients with vs. without CD (20.7% vs. 11.9%; P < .001). Patients with CD with vs. without migraine headache had a higher prevalence of abdominal pain (80.1% vs. 71.8%; P = .025), constipation (47.8% vs. 35.5%; P = .011), and diarrhea (60.8% vs. 45.9%; P = .002).

Study details: This case-control cross-sectional study included 1,000 adult patients with CD and 1,000 healthy controls.

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

Source: Fanaeian MM et al. PLoS One. 2021;16(11):e0259502 (Nov 17). Doi:  10.1371/journal.pone.0259502.

Key clinical point: Prevalence of migraine was higher in patients with celiac disease (CD) vs. healthy controls, with patients with CD and migraine showing worse gastrointestinal symptoms compared with those without migraine.

Major finding: The prevalence of migraine was higher in patients with vs. without CD (20.7% vs. 11.9%; P < .001). Patients with CD with vs. without migraine headache had a higher prevalence of abdominal pain (80.1% vs. 71.8%; P = .025), constipation (47.8% vs. 35.5%; P = .011), and diarrhea (60.8% vs. 45.9%; P = .002).

Study details: This case-control cross-sectional study included 1,000 adult patients with CD and 1,000 healthy controls.

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

Source: Fanaeian MM et al. PLoS One. 2021;16(11):e0259502 (Nov 17). Doi:  10.1371/journal.pone.0259502.

Key clinical point: Prevalence of migraine was higher in patients with celiac disease (CD) vs. healthy controls, with patients with CD and migraine showing worse gastrointestinal symptoms compared with those without migraine.

Major finding: The prevalence of migraine was higher in patients with vs. without CD (20.7% vs. 11.9%; P < .001). Patients with CD with vs. without migraine headache had a higher prevalence of abdominal pain (80.1% vs. 71.8%; P = .025), constipation (47.8% vs. 35.5%; P = .011), and diarrhea (60.8% vs. 45.9%; P = .002).

Study details: This case-control cross-sectional study included 1,000 adult patients with CD and 1,000 healthy controls.

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

Source: Fanaeian MM et al. PLoS One. 2021;16(11):e0259502 (Nov 17). Doi:  10.1371/journal.pone.0259502.