Gianna Melillo

 based on real-world data collected from the West German Headache Center at the University Hospital Essen, Germany, concluded erenumab appears to be a promising treatment option for patients with highly therapy-refractory 

 by the FDA in 2018, is a calcitonin gene-related peptide (CGRP) inhibitor administered via self-injection once a month. The treatment works by blocking the CGRP receptor, which is believed to play a crucial role in migraine. Erenumab can be injected as a 70- or 140 mg dose in adults with migraine.

In the past, clinical trials on CGRP inhibitors were only performed in migraineurs who had failed up to 4 prophylactic medications. “Although there are indications of good effectiveness under real-world conditions, data on highly therapy-refractory patients that had failed more than 4 prophylactic treatments are missing, yet,” the authors said.

They analyzed routine clinical data of patients with episodic (EM) and chronic migraine (CM) between November 2018 and December 2019 who received 70 mg of erenumab for 3 months (n = 100). The majority of patients included were female (82%), 26% suffered from EM, and 74% suffered from CM. Forty-nine patients with CM also reported additional medication overuse headache (MOH).

All participants completed a paper-based headache diary, and most patients answered questionnaires regarding different aspects of migraine attacks including intensity, duration, effect of acute therapy, effect on aura, need for rest, dizziness, nausea, phono-and photophobia, and therapy satisfaction.

At the time of the study, “all treated patients had tried at least 5 (when EM) and 6 (when CM) approved prophylactic drugs previously without sufficient treatment effects, had discontinued those due to side effects, or were not eligible for intake due to contraindication,” the researchers said.

Analyses revealed that after 3 months of erenumab therapy:

57.7% (n = 15) of patients with EM and 41.9% (n = 31) with CM had at least a 50% reduction in monthly migraine days (MMD)

53% (n = 39) of patients with CM returned from chronic to episodic course of migraine

46.9% (n = 23) of patients with MOH were no longer suffering from MOH

Subjective improvement of migraine intensity and duration was reported by 70.5% (n = 67) and 58.9% (n = 53) of the patients, respectively

Subjective treatment effects on migraine-associated vegetative symptoms were small while the efficacy of acute medication was largely unchanged with therapy

Self-reported general satisfaction with therapy was high (very satisfactory/satisfactory, 61.3% [n = 57]; moderately satisfactory, 20.4% [n = 19]; unsatisfactory/very unsatisfactory, 18.3% [n = 17])

42% of patients reported adverse effects, mainly digestive problems or constipation (23.8%, n = 10), injection-site skin symptoms or itching (23.8%, n = 10), fatigue or a feeling of exhaustion (16.7%, n = 7), and insomnia (9.5%, n = 4)

“Efficacy of erenumab in highly therapy-refractory patients is comparable to results from clinical trials of patients that had failed fewer prophylactic medications prior treatment,” the authors write. However, further data will show the extent to which the effect remains stable during long-term treatment.

Data included in the study are mainly based on subjective reports from patients, marking a limitation in the study.

Scheffler A, Messel O, Wurthmann S, et al. Erenumab in highly therapy-refractory migraine patients: first German real-world evidence. 

 2020;21(1):84. doi:10.1186/s10194-020-01151-0

Articles

A study based on real-world data collected from the West German Headache Center at the University Hospital Essen, Germany, concluded erenumab appears to be a promising treatment option for patients with highly therapy-refractory migraine. 

Real-Word Evidence Outlines Efficacy of Erenumab for Highly Therapy-Refractory Migraine

Results from a large population-based cohort 

 (RA) had a lower rate of incident type 2 

 (T2D) compared with the general non-RA population and cohorts with hypertension, osteoarthritis (OA), and psoriatic arthritis (PsA).

“Proinflammatory cytokines such as tumor-necrosis factor alpha (TNFα) and interleukin-6 (IL-6) play critical roles in RA pathogenesis and simultaneously interfere with insulin-signaling mechanisms which are associated with insulin resistance and T2D,” authors write. Because of this, the risk of T2D, a traditional cardiovascular disease (CVD) risk factor, “may be increased in RA and could be a target for intervention to reduce CVD related mortality.”

Patients with OA also tend to exhibit known risk factors for T2D such advanced age and obesity, while prior studies have found PsA to be associated with increased risk of diabetes compared with the general population. In addition, both hypertension and PsA are associated with metabolic dysregulation and increase the risk of diabetes.

As previous epidemiologic studies have yielded inconsistent relative risk estimates for the relationship between T2D in RA, researchers set out to examine this risk using a large US commercial database, which amassed information from 449,327 patients. The risk of incident T2D in RA patients was compared with 4 different non-RA groups: general non-RA patients, those with hypertension, those with OA, and those with PsA.

The Optum Clinformatics Data Mart (Optum) is a commercial health insurance claims database which includes data from January 2005 through December of 2017. Optum also provides information on demographics, hospital admissions, emergency room visits, outpatient visits and other metrics throughout all 50 US states.

Patients with RA were matched to the general non-RA, hypertension, and OA patients based on age, sex, and index date with a 1:1:1:1 ratio. Because of a substantially smaller PsA cohort, matching was not conducted with this population. Researchers also collected all covariates during the 365-day baseline period prior to and on the index date.

In total, 108,568 matched patients in the RA, general non-RA, hypertension, and OA cohorts were included in the study. Average age among these cohorts was around 56 while the majority (77.3%) were female. In the PsA cohort, patients had an average age of around 47 and 48.3% were female.

During the median of 1.6 (range, 0.6-3.3) years of follow-up, the incidence rate (IR) of T2D was the lowest in the RA cohort (7.0 per 1000 person-years) and highest (12.3 per 1000 person-years) in the hypertension cohort

Crude IRs of T2D per 1000 person-years was 7.4 in the general non-RA cohort, 7.8 in the OA cohort, and 9.9 in the PsA cohort

After adjusting for over 40 baseline covariates, RA was associated with a 24% to 35% lower risk of incident T2D compared with the 4 comparison groups

Prevalence of obesity was the highest in hypertension cohort (14.8%), followed by OA (14.4%), PsA (10.7%), RA (8.9%), and the general non-RA cohorts (7.4%)

Cardiovascular comorbidities were generally more prevalent in the hypertension cohort than other cohorts

A higher risk of hip fracture in the RA cohort was found compared with the general non-RA cohort and the hypertension cohort

“While systemic inflammation in RA increases the risk of CVD, our findings unexpectedly show that having RA itself does not confer an increased risk of T2D compared with 4 different comparator groups,” 

 Seoyoung C. Kim, MD, a lead author of the study.

As the study mainly used diagnosis codes and pharmacy dispensing records in claims data, potential misclassification of cohorts and covariates may exist, marking a limitation to the study. Baseline obesity also tends to be underreported and may not have been accurately captured in claims data, while residual confounding may exist due to unmeasured covariates such as body mass index, diet, and physical activity.

“Since all RA patients included in our study were treated with at least 1 disease-modifying antirheumatic drug, our study is unable to test the association between no treatment or undertreatment for RA and risk of T2D,” Kim said.

Future studies are warranted to determine whether untreated or undertreated RA is associated with a greater risk of developing T2D, authors conclude.

Jin Y, Chen SK, Liu J and Kim SC. Risk of incident type 2 diabetes among patients with rheumatoid arthritis: a population-based cohort study. 

 Published online August 4, 2020. doi:10.1002/acr.24343

Results from a large population-based cohort study, published in Arthritis Care & Research, found individuals with rheumatoid arthritis (RA) had a lower rate of incident type 2 diabetes (T2D) compared with the general non-RA population and cohorts with with hypertension, osteoarthritis (OA), and psoriatic arthritis (PsA). 

Study Finds Rheumatoid Arthritis Associated With Lower T2D Risk

 suggest researchers can leverage big data to triage 

 clinic appointments, balancing the glaucoma progression risk against the morbidity risk from coronavirus disease 2019 (COVID-19) exposure during ophthalmic care.

Due to social distancing measures currently in place across the country, eye care professionals have had to determine whether patients’ appointments can be safely postponed. This process involves weighing the risks of patients’ glaucoma worsening during the interim vs the morbidity risk of acquiring COVID-19 while seeking ophthalmic care. When social distancing restrictions are eased, ophthalmologists will also need to prioritize which patients they see first.

Patients with chronic ocular diseases, such as glaucoma, risk experiencing irreversible visual acuity or visual field loss from disease progression if they are unable to receive timely medical care, the researchers explain. “Yet a disproportionately large number of patients with glaucoma are also of older age and have medical comorbidities that predispose them to morbidity and mortality from COVID-19.”

In a cross-sectional study, the researchers used information from a large data repository to develop a flexible and scalable scoring algorithm for patients with glaucoma to aid in triaging those seeking ophthalmologic care.

A total of 1034 patients enrolled in the Sight Outcomes Research Collaborative (SOURCE) Ophthalmology Electronic Health Record Data Repository were included in the study. Specifically, all patients over the age of 18 receiving care at the University of Michigan Kellogg Eye Center, Ann Arbor, between March 16, 2020, and April 16, 2020, were identified.

The researchers classified old age (over 65 years), pregnant or breastfeeding women, and those with chronic morbidities as high-risk populations for COVID-19. Greater statistical weight was also given to those over the age of 80 compared with those aged 65 to 79 years.

Glaucoma severity was characterized based on incisional intraocular surgery in the past 3 months, records of high (≥30 mm Hg) or low (<6 mm Hg) intraocular pressure in the past year, considerable visual field loss in 1 or both eyes, and monocularity.

“For each patient, a COVID-19 morbidity risk score (CS) and glaucoma severity and progression risk score (GS) were determined by assigning point values to the noted characteristics and calculating the sum,” the authors write.

Of those included in the study, the majority were women (56.5%), and the average age was around 67.

Average (SD) glaucoma severity and progression risk score was 4.0 (14.4) points, average COVID-19 morbidity risk score was 27.2 (16.1) points, and average total score (TS) was 31.2 (21.4) points

During pandemic-associated reductions in services, using total score thresholds of 0, 25, and 50 points, 970 appointments (93.8%), 668 appointments (64.6%), and 275 appointments (26.6%), respectively, were identified for postponement and rescheduling

The researchers also demonstrated how the algorithm could be used for specific cases, applying the scoring system to 3 patients.

The scoring algorithm was then validated against glaucoma specialists’ review of patients’ electronic health records to assign them a tier for follow-up care. The findings of the validation exercise “demonstrate that the TSs from our algorithm aligned with glaucoma specialists’ preferences for appointment triaging for most patients,” the authors write.

However, short-term complications and long-term sequelae from COVID-19 were not included in the analysis, marking a limitation to the study. Additional research is also needed to confirm whether the researchers’ prioritization of clinic appointments, based in part on the scoring algorithm, resulted in improved outcomes.

“While our approach is tailored to patients with glaucoma, we believe similar methods may be developed to help offer guidance for appointment rescheduling for other ophthalmic and nonophthalmic conditions during this pandemic and similar situations in the future,” the authors conclude.

Bommakanti NK, Zhou Y, Ehrlich JR, et al. Application of the sigh outcomes research collaborative ophthalmology data repository for triaging patients with glaucoma and clinic appointments during pandemics such as COIVD-19. 

 Published online July 17, 2020. doi:10.1001/jamaophthalmol.2020.2974

New study results published in JAMA Ophthalmology suggest researchers can leverage big data to triage ophthalmic clinic appointments, balancing the glaucoma progression risk against the morbidity risk from coronavirus disease 2019 (COVID-19) exposure during ophthalmic care. 

How Can Big Data Help to Triage Ophthalmology Patients?

Since 1970, changes in US state policies have played an important role in the stagnation and recent decline in life expectancy, while some policies appear to be key levers for improving life expectancy, a new study published in 

“In 2016, life expectancy of American women was 3 years below the female average of high-income countries and 5.8 years below the leader,” authors wrote. In males, life expectancy was 3.4 years below the average and 5.2 years below the leading country for life expectancy. “Given that life expectancy captures overall social, economic, physical and mental well-being, such trends paint a troubling portrait of life and death in the United States.”

When it comes to root causes of these disparities, one major contributor is a rise in so-called “

deaths due to suicide or drug and alcohol abuse

. Different regional policies on firearm use and availability of substance abuse rehabilitation programs can alter expectancy gains or declines across state lines.

“In 2017, life expectancy ranged from 74.6 years in West Virginia to 81.6 years in Hawaii,” authors write. If the 2 states were separate nations, West Virginia would rank 93rd in the world for life expectancy while Hawaii would rank 23rd.

Local policies also affect nearly every aspect of an individual’s life including economic well-being, social relationships, education, housing, lifestyles, and access to medical care, authors point out.

To better understand how shifts in state policy contexts predict life expectancy and how US longevity may change if all states enacted liberal or conservative policies, researchers merged annual data on life expectancy from states between 1970 to 2014 with annual data on 18 state-level policy domains. Previous research has shown state policy contexts began to hyperpolarize after 1970.

The 45 years’ worth of data, collected from the United States Mortality Database, was controlled for differences in state characteristics and populations. Each policy was scored on a 0 to 1 scale to represent the actual range of the policies during the 1970-2014 period on a conservative-to-liberal continuum.

Liberal policies were defined as “expanding state power for economic regulation and redistribution, or for protecting marginalized groups, or restricting state power for punishing deviant social behavior.” Conservative policies were classified as the opposite.

Researchers then calculated a state’s annual score for each policy domain as the sum of liberal policy scores minus the sum of conservative policy scores. Regression models of life expectancy were estimated as a function of time, the 18 policy domain measures, and state-level fixed effects.

Altering all of the state policies to attain maximum liberalism scores predicted the US longevity would be 2.8 years longer among women and 2.1 years longer among men

Altering all policies to have the minimum liberalism score predicted a 2-year reduction in life expectancy among women and a 1.9 year reduction among men

Among the 10 policy domains with a statistically significant association with life expectancy, a more liberal version of 8 domains was associated with longer lives (tobacco, immigration, civil rights, private labor, environment, gun control, LGBT, and abortion, with exceptions of marijuana and voting)

Female life expectancy would be 2.5 years higher within a state if it had the most liberal policies on the environment (environment policy score = 1) than if it had the most conservative

If all states’ policies were identical to Connecticut’s in 2014, (Connecticut made the largest shift toward liberal policies from 1970 to 2014), US life expectancy would be 2 and 1.3 years longer among women and men, respectively

If all states’ policies were identical to Oklahoma in 2014 (it saw the greatest shift toward conservative policies) US life expectancy would be an estimated 1 and 0.5 years shorter among women and men, respectively

From 2010-2014, the shallow upward trend in US life expectancy would have been 25% steeper for women and 13% steeper for men had state policies not changed as they did

If the status quo is maintained, thereby allowing the current policy direction of states to continue, researchers found the results would yield minimal improvements in longevity (0.4 and 0.3 years higher among women and men, respectively).

The inclusion of states’ annual unemployment rates in supplementary analyses yielded the same results, likely reflecting the large amount of information included in the models.

However, authors caution the analyses do not prove state policies have a causal effect on life expectancies.

“Taking these findings together, the slow gains in US longevity may partly reflect the national shift toward some conservative policies that are negatively associated with longevity (eg abortion restrictions, reductions in gun control),” researchers conclude, while this trend offset the national shift toward some liberal policies that are positively associated with longevity (eg environment and civil rights protections).

Montez JK, Beckfield J, Cooney JK, et al. US state policies, politics, and life expectancy. 

. Published online August 4, 2020. doi:10.1111/1468-0009.12469

Life expectancy trends in the United States "paint a troubling portrait of life and death," according to a new study published in The Milibank Quarterly. State policies have played an important role in the stagnation and recent decline in life expectancy.

Author | Gianna Melillo

Articles

Real-Word Evidence Outlines Efficacy of Erenumab for Highly Therapy-Refractory Migraine

Study Finds Rheumatoid Arthritis Associated With Lower T2D Risk

How Can Big Data Help to Triage Ophthalmology Patients?

How Do State Policies Impact Life Expectancy?