The potentially fatal parechovirus is now circulating in multiple states, causing fevers, seizures, and sepsis-like symptoms, including confusion and extreme pain, according to the CDC.

Human parechoviruses are common in children and most have been infected before they start kindergarten, the CDC said. Between 6 months and 5 years of age, symptoms include an upper respiratory tract infection, fever, and rash.

But infants younger than 3 months may have more serious, and possibly fatal, infections. They may get “sepsis-like illness, seizures, and meningitis or meningoencephalitis, particularly in infants younger than 1 month,” the CDC said. At least one newborn has reportedly died from the infection.

Parechovirus can spread like other common germs, from feces that are later ingested – likely due to poor handwashing – and through droplets sent airborne by coughing or sneezing. It can be transmitted by people both with and without symptoms of the infection.

The microbe can reproduce for 1-3 weeks in the upper respiratory tract and up to 6 months in the gastrointestinal tract, the CDC said.

Kristina Angel Bryant, MD, a pediatric infectious disease specialist at the University of Louisville Hospital, says parechoviruses often cause rashes on the hands and feet, which some experts refer to as “mittens and booties.”

The CDC is urging doctors to test for parechovirus if they recognize these symptoms in infants if there is no other explanation for what might be distressing them.

There is no specific treatment for parechovirus. And with no standard testing system in place, experts are unsure if the number of parechovirus cases is higher in 2022 than in previous years.

The message for parents, Dr. Bryant says, is: Don’t panic. “This is not a new virus.”

“One of the most common symptoms is fever, and in some kids, that is the only symptom,” she says. “Older infants and toddlers may have only cold symptoms, and some kids have no symptoms at all.”

Parents can take the usual steps to protect their child from the viral illness, including diligent handwashing and having less contact with people who are sick, Dr. Bryant says.

A version of this article first appeared on Medscape.com.

The potentially fatal parechovirus is now circulating in multiple states, causing fevers, seizures, and sepsis-like symptoms, including confusion and extreme pain, according to the CDC.

Human parechoviruses are common in children and most have been infected before they start kindergarten, the CDC said. Between 6 months and 5 years of age, symptoms include an upper respiratory tract infection, fever, and rash.

But infants younger than 3 months may have more serious, and possibly fatal, infections. They may get “sepsis-like illness, seizures, and meningitis or meningoencephalitis, particularly in infants younger than 1 month,” the CDC said. At least one newborn has reportedly died from the infection.

Parechovirus can spread like other common germs, from feces that are later ingested – likely due to poor handwashing – and through droplets sent airborne by coughing or sneezing. It can be transmitted by people both with and without symptoms of the infection.

The microbe can reproduce for 1-3 weeks in the upper respiratory tract and up to 6 months in the gastrointestinal tract, the CDC said.

Kristina Angel Bryant, MD, a pediatric infectious disease specialist at the University of Louisville Hospital, says parechoviruses often cause rashes on the hands and feet, which some experts refer to as “mittens and booties.”

The CDC is urging doctors to test for parechovirus if they recognize these symptoms in infants if there is no other explanation for what might be distressing them.

There is no specific treatment for parechovirus. And with no standard testing system in place, experts are unsure if the number of parechovirus cases is higher in 2022 than in previous years.

The message for parents, Dr. Bryant says, is: Don’t panic. “This is not a new virus.”

“One of the most common symptoms is fever, and in some kids, that is the only symptom,” she says. “Older infants and toddlers may have only cold symptoms, and some kids have no symptoms at all.”

Parents can take the usual steps to protect their child from the viral illness, including diligent handwashing and having less contact with people who are sick, Dr. Bryant says.

A version of this article first appeared on Medscape.com.

The potentially fatal parechovirus is now circulating in multiple states, causing fevers, seizures, and sepsis-like symptoms, including confusion and extreme pain, according to the CDC.

Human parechoviruses are common in children and most have been infected before they start kindergarten, the CDC said. Between 6 months and 5 years of age, symptoms include an upper respiratory tract infection, fever, and rash.

But infants younger than 3 months may have more serious, and possibly fatal, infections. They may get “sepsis-like illness, seizures, and meningitis or meningoencephalitis, particularly in infants younger than 1 month,” the CDC said. At least one newborn has reportedly died from the infection.

Parechovirus can spread like other common germs, from feces that are later ingested – likely due to poor handwashing – and through droplets sent airborne by coughing or sneezing. It can be transmitted by people both with and without symptoms of the infection.

The microbe can reproduce for 1-3 weeks in the upper respiratory tract and up to 6 months in the gastrointestinal tract, the CDC said.

Kristina Angel Bryant, MD, a pediatric infectious disease specialist at the University of Louisville Hospital, says parechoviruses often cause rashes on the hands and feet, which some experts refer to as “mittens and booties.”

The CDC is urging doctors to test for parechovirus if they recognize these symptoms in infants if there is no other explanation for what might be distressing them.

There is no specific treatment for parechovirus. And with no standard testing system in place, experts are unsure if the number of parechovirus cases is higher in 2022 than in previous years.

The message for parents, Dr. Bryant says, is: Don’t panic. “This is not a new virus.”

“One of the most common symptoms is fever, and in some kids, that is the only symptom,” she says. “Older infants and toddlers may have only cold symptoms, and some kids have no symptoms at all.”

Parents can take the usual steps to protect their child from the viral illness, including diligent handwashing and having less contact with people who are sick, Dr. Bryant says.

A version of this article first appeared on Medscape.com.

Key clinical point: Intravenous (IV) ketorolac plus metoclopramide failed to improve pain intensity in children presenting to the emergency department (ED) for the acute treatment of migraine compared with metoclopramide monotherapy.

Major finding: The mean change in pain intensity as assessed by a 100 mm Visual Analog Scale at 120 minutes was −44 mm (95% CI 32-57 mm) in the monotherapy group and −36 mm (95% CI 23-49 mm) in the ketorolac group, corresponding to a mean difference of 8 mm between the groups (P = .355),with no significant between-group difference in headache recurrence and adverse events.

Study details: Findings arefrom a double-blind, randomized placebo-controlled trialincluding 53children aged 6-17 years presenting to the ED for the acute treatment of migraine. They were randomly assigned to receive IV ketorolac plus metoclopramide (n=26) or IV metoclopramide plus placebo (n=27).

Disclosures: This study was funded by the Canadian Institutes of Health Research through a Drug Safety and Effectiveness Network grant. The authors declared no conflicts of interest.

Source: Richer LP et al.A randomized trial of ketorolac and metoclopramide for migraine in the emergency department.Headache. 2022; 62: 681-689(Jun 7). Doi:10.1111/head.14307

Key clinical point: Intravenous (IV) ketorolac plus metoclopramide failed to improve pain intensity in children presenting to the emergency department (ED) for the acute treatment of migraine compared with metoclopramide monotherapy.

Major finding: The mean change in pain intensity as assessed by a 100 mm Visual Analog Scale at 120 minutes was −44 mm (95% CI 32-57 mm) in the monotherapy group and −36 mm (95% CI 23-49 mm) in the ketorolac group, corresponding to a mean difference of 8 mm between the groups (P = .355),with no significant between-group difference in headache recurrence and adverse events.

Study details: Findings arefrom a double-blind, randomized placebo-controlled trialincluding 53children aged 6-17 years presenting to the ED for the acute treatment of migraine. They were randomly assigned to receive IV ketorolac plus metoclopramide (n=26) or IV metoclopramide plus placebo (n=27).

Disclosures: This study was funded by the Canadian Institutes of Health Research through a Drug Safety and Effectiveness Network grant. The authors declared no conflicts of interest.

Source: Richer LP et al.A randomized trial of ketorolac and metoclopramide for migraine in the emergency department.Headache. 2022; 62: 681-689(Jun 7). Doi:10.1111/head.14307

Key clinical point: Intravenous (IV) ketorolac plus metoclopramide failed to improve pain intensity in children presenting to the emergency department (ED) for the acute treatment of migraine compared with metoclopramide monotherapy.

Major finding: The mean change in pain intensity as assessed by a 100 mm Visual Analog Scale at 120 minutes was −44 mm (95% CI 32-57 mm) in the monotherapy group and −36 mm (95% CI 23-49 mm) in the ketorolac group, corresponding to a mean difference of 8 mm between the groups (P = .355),with no significant between-group difference in headache recurrence and adverse events.

Study details: Findings arefrom a double-blind, randomized placebo-controlled trialincluding 53children aged 6-17 years presenting to the ED for the acute treatment of migraine. They were randomly assigned to receive IV ketorolac plus metoclopramide (n=26) or IV metoclopramide plus placebo (n=27).

Disclosures: This study was funded by the Canadian Institutes of Health Research through a Drug Safety and Effectiveness Network grant. The authors declared no conflicts of interest.

Source: Richer LP et al.A randomized trial of ketorolac and metoclopramide for migraine in the emergency department.Headache. 2022; 62: 681-689(Jun 7). Doi:10.1111/head.14307

Key clinical point: Patients hospitalized with refractory chronic migraine treated with continuous multiday lidocaine infusions showed a significant improvement in pain immediately after the infusion, with some patients maintaining this improvement at 1 month.

Major finding: Medianpain ratings decreased from 7.0 on admission to 1.0 at discharge (P< .001), with 87.8% of admissions being cases of acute response. Among acute responders with data on average pain, 43.2% demonstrated sustained response at 1 month.

Study details: The data come from a retrospective cohort study of 609 hospital admissions involving 537 patients with refractory chronic migraine who received continuous multiday lidocaine infusions.

Disclosures: This study did not receive any specific funding. SD Silberstein declared serving as a consultant and advisory panel member for and receiving honoraria from various sources.

Source: Schwenk ES et al. Lidocaine infusions for refractory chronic migraine: A retrospective analysis. Reg Anesth Pain Med. 2022;47:408-413(May 23). Doi:10.1136/rapm-2021-103180

Key clinical point: Patients hospitalized with refractory chronic migraine treated with continuous multiday lidocaine infusions showed a significant improvement in pain immediately after the infusion, with some patients maintaining this improvement at 1 month.

Major finding: Medianpain ratings decreased from 7.0 on admission to 1.0 at discharge (P< .001), with 87.8% of admissions being cases of acute response. Among acute responders with data on average pain, 43.2% demonstrated sustained response at 1 month.

Study details: The data come from a retrospective cohort study of 609 hospital admissions involving 537 patients with refractory chronic migraine who received continuous multiday lidocaine infusions.

Disclosures: This study did not receive any specific funding. SD Silberstein declared serving as a consultant and advisory panel member for and receiving honoraria from various sources.

Source: Schwenk ES et al. Lidocaine infusions for refractory chronic migraine: A retrospective analysis. Reg Anesth Pain Med. 2022;47:408-413(May 23). Doi:10.1136/rapm-2021-103180

Key clinical point: Patients hospitalized with refractory chronic migraine treated with continuous multiday lidocaine infusions showed a significant improvement in pain immediately after the infusion, with some patients maintaining this improvement at 1 month.

Major finding: Medianpain ratings decreased from 7.0 on admission to 1.0 at discharge (P< .001), with 87.8% of admissions being cases of acute response. Among acute responders with data on average pain, 43.2% demonstrated sustained response at 1 month.

Study details: The data come from a retrospective cohort study of 609 hospital admissions involving 537 patients with refractory chronic migraine who received continuous multiday lidocaine infusions.

Disclosures: This study did not receive any specific funding. SD Silberstein declared serving as a consultant and advisory panel member for and receiving honoraria from various sources.

Source: Schwenk ES et al. Lidocaine infusions for refractory chronic migraine: A retrospective analysis. Reg Anesth Pain Med. 2022;47:408-413(May 23). Doi:10.1136/rapm-2021-103180

Key clinical point: Cold interventions, includingcold-gel headband, cold-gel cap, and intraoral cooling, provide instant relief from pain in patients with migraine; however, their long-term effects on pain are not significant.

Major finding: The cold intervention group vs. control group led to a significant reduction in pain on a visual analog scale score at 30 minutes (standard mean difference [SMD] −3.21; P = .02) but a nonsignificant reduction in the score at 24 hours (SMD −0.44; P = .07) after the intervention.

Study details: This was a meta-analysis of 6 studies (4 randomized controlled trials and 2 quasi-experimental studies) that included adult patients with migraine who underwent a cold intervention.

Disclosures: The study was partially sponsored by the Ministry of Science and Technology, Israel. The authors declared no conflicts of interest.

Source: Hsu Y-Y et al.Cold intervention for relieving migraine symptoms: A systematic review and meta-analysis. J Clin Nurs. 2022 (May 20). Doi:10.1111/jocn.16368

Key clinical point: Cold interventions, includingcold-gel headband, cold-gel cap, and intraoral cooling, provide instant relief from pain in patients with migraine; however, their long-term effects on pain are not significant.

Major finding: The cold intervention group vs. control group led to a significant reduction in pain on a visual analog scale score at 30 minutes (standard mean difference [SMD] −3.21; P = .02) but a nonsignificant reduction in the score at 24 hours (SMD −0.44; P = .07) after the intervention.

Study details: This was a meta-analysis of 6 studies (4 randomized controlled trials and 2 quasi-experimental studies) that included adult patients with migraine who underwent a cold intervention.

Disclosures: The study was partially sponsored by the Ministry of Science and Technology, Israel. The authors declared no conflicts of interest.

Source: Hsu Y-Y et al.Cold intervention for relieving migraine symptoms: A systematic review and meta-analysis. J Clin Nurs. 2022 (May 20). Doi:10.1111/jocn.16368

Key clinical point: Cold interventions, includingcold-gel headband, cold-gel cap, and intraoral cooling, provide instant relief from pain in patients with migraine; however, their long-term effects on pain are not significant.

Major finding: The cold intervention group vs. control group led to a significant reduction in pain on a visual analog scale score at 30 minutes (standard mean difference [SMD] −3.21; P = .02) but a nonsignificant reduction in the score at 24 hours (SMD −0.44; P = .07) after the intervention.

Study details: This was a meta-analysis of 6 studies (4 randomized controlled trials and 2 quasi-experimental studies) that included adult patients with migraine who underwent a cold intervention.

Disclosures: The study was partially sponsored by the Ministry of Science and Technology, Israel. The authors declared no conflicts of interest.

Source: Hsu Y-Y et al.Cold intervention for relieving migraine symptoms: A systematic review and meta-analysis. J Clin Nurs. 2022 (May 20). Doi:10.1111/jocn.16368

Key clinical point: As a migraine preventive agent, fremanezumab is effective across the full patient spectrum, including those with episodic migraine (EM), chronic migraine (CM), and difficult-to-treat (DTT) migraine (patients with medication overuse [MO], major depressive disorder [MDD], generalized anxiety disorder [GAD], or exposure to a different calcitonin gene-related peptide monoclonal antibody [CGRP mAb]).

Major finding: At month 6,the mean monthly migraine days reduced in patients with EM (−7.7 days), CM (−10.1 days), MO (−10.8 days), MDD (−9.9 days), GAD (−9.5 days), and prior CGRP mAb exposure (−9.0 days).

Study details: Findings are from aretrospective, online chart review study that collected data from 1003 patients with EM/CM aged ≥18 years at fremanezumab initiation, including those with DTT migraine, and 421 clinicians treating patients with EM/CM in a US-based practice.

Disclosures: This study was funded by Teva Pharmaceuticals. All authors declared being current or former employees of Teva Pharmaceuticals or Analysis Group, which performed these analyses funded by Teva.

Source: Driessen MT et al.Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine. J Headache Pain. 2022;23:56(May 16). Doi:10.1186/s10194-022-01415-x

Key clinical point: As a migraine preventive agent, fremanezumab is effective across the full patient spectrum, including those with episodic migraine (EM), chronic migraine (CM), and difficult-to-treat (DTT) migraine (patients with medication overuse [MO], major depressive disorder [MDD], generalized anxiety disorder [GAD], or exposure to a different calcitonin gene-related peptide monoclonal antibody [CGRP mAb]).

Major finding: At month 6,the mean monthly migraine days reduced in patients with EM (−7.7 days), CM (−10.1 days), MO (−10.8 days), MDD (−9.9 days), GAD (−9.5 days), and prior CGRP mAb exposure (−9.0 days).

Study details: Findings are from aretrospective, online chart review study that collected data from 1003 patients with EM/CM aged ≥18 years at fremanezumab initiation, including those with DTT migraine, and 421 clinicians treating patients with EM/CM in a US-based practice.

Disclosures: This study was funded by Teva Pharmaceuticals. All authors declared being current or former employees of Teva Pharmaceuticals or Analysis Group, which performed these analyses funded by Teva.

Source: Driessen MT et al.Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine. J Headache Pain. 2022;23:56(May 16). Doi:10.1186/s10194-022-01415-x

Key clinical point: As a migraine preventive agent, fremanezumab is effective across the full patient spectrum, including those with episodic migraine (EM), chronic migraine (CM), and difficult-to-treat (DTT) migraine (patients with medication overuse [MO], major depressive disorder [MDD], generalized anxiety disorder [GAD], or exposure to a different calcitonin gene-related peptide monoclonal antibody [CGRP mAb]).

Major finding: At month 6,the mean monthly migraine days reduced in patients with EM (−7.7 days), CM (−10.1 days), MO (−10.8 days), MDD (−9.9 days), GAD (−9.5 days), and prior CGRP mAb exposure (−9.0 days).

Study details: Findings are from aretrospective, online chart review study that collected data from 1003 patients with EM/CM aged ≥18 years at fremanezumab initiation, including those with DTT migraine, and 421 clinicians treating patients with EM/CM in a US-based practice.

Disclosures: This study was funded by Teva Pharmaceuticals. All authors declared being current or former employees of Teva Pharmaceuticals or Analysis Group, which performed these analyses funded by Teva.

Source: Driessen MT et al.Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine. J Headache Pain. 2022;23:56(May 16). Doi:10.1186/s10194-022-01415-x

Key clinical point: A dose of 120 mg galcanezumab subcutaneously safely and effectively reduces headache frequency, intensity, and duration in patients with episodic and chronic migraine and previous unsuccessful preventive treatments.

Major finding: The 6-month galcanezumab treatment led to a significant decrease in the headache attack frequency (−14.19 headache days/month; P< .001), headache attack pain intensity (numerical rating scale score −2.74; P< .001), and headache attack duration (−6.65 hours; P< .001).

Study details: The data come from an observational, prospective study including 43 patients with episodic high frequency and chronic migraine and unsuccessful treatment with≥3 preventive medication classes who received monthly 120 mg galcanezumab subcutaneously.

Disclosures: This study received no specific funding. Some authors declared receiving speaker honoraria and travel funding from various sources and serving as associate editors of neurology journals such as European Journal of Neurology.

Source: Silvestro M et al. Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: A real-world experience.J Headache Pain. 2022;23:69(Jun 13. Doi: 10.1186/s10194-022-01436-6

Key clinical point: A dose of 120 mg galcanezumab subcutaneously safely and effectively reduces headache frequency, intensity, and duration in patients with episodic and chronic migraine and previous unsuccessful preventive treatments.

Major finding: The 6-month galcanezumab treatment led to a significant decrease in the headache attack frequency (−14.19 headache days/month; P< .001), headache attack pain intensity (numerical rating scale score −2.74; P< .001), and headache attack duration (−6.65 hours; P< .001).

Study details: The data come from an observational, prospective study including 43 patients with episodic high frequency and chronic migraine and unsuccessful treatment with≥3 preventive medication classes who received monthly 120 mg galcanezumab subcutaneously.

Disclosures: This study received no specific funding. Some authors declared receiving speaker honoraria and travel funding from various sources and serving as associate editors of neurology journals such as European Journal of Neurology.

Source: Silvestro M et al. Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: A real-world experience.J Headache Pain. 2022;23:69(Jun 13. Doi: 10.1186/s10194-022-01436-6

Key clinical point: A dose of 120 mg galcanezumab subcutaneously safely and effectively reduces headache frequency, intensity, and duration in patients with episodic and chronic migraine and previous unsuccessful preventive treatments.

Major finding: The 6-month galcanezumab treatment led to a significant decrease in the headache attack frequency (−14.19 headache days/month; P< .001), headache attack pain intensity (numerical rating scale score −2.74; P< .001), and headache attack duration (−6.65 hours; P< .001).

Study details: The data come from an observational, prospective study including 43 patients with episodic high frequency and chronic migraine and unsuccessful treatment with≥3 preventive medication classes who received monthly 120 mg galcanezumab subcutaneously.

Disclosures: This study received no specific funding. Some authors declared receiving speaker honoraria and travel funding from various sources and serving as associate editors of neurology journals such as European Journal of Neurology.

Source: Silvestro M et al. Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: A real-world experience.J Headache Pain. 2022;23:69(Jun 13. Doi: 10.1186/s10194-022-01436-6

Key clinical point: A higher dose of onabotulinumtoxinA (Botox®) may decrease the number of headache and severe headache days in patients with chronic migraine who had an unsatisfactory response to the conventional 150-unit dose.

Major finding: After receiving 3 rounds of 200 units onabotulinumtoxinA, patients had a significant reduction in headache (13.62±10.79 to 11.02±10.61) and severe headache (5.88±6.73 to 4.01±4.89) days (both P< .001).

Study details: This retrospective paired comparison study included 175 patients with chronic migraine who received ≥3 rounds of 150 units onabotulinumtoxinA followed by ≥3 rounds of 200 units onabotulinumtoxinA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Zandieh A, Cutrer FM. OnabotulinumtoxinA in chronic migraine: Is the response dose dependent?BMC Neurol. 2022;22:218(Jun 13). Doi:10.1186/s12883-022-02742-x

Key clinical point: A higher dose of onabotulinumtoxinA (Botox®) may decrease the number of headache and severe headache days in patients with chronic migraine who had an unsatisfactory response to the conventional 150-unit dose.

Major finding: After receiving 3 rounds of 200 units onabotulinumtoxinA, patients had a significant reduction in headache (13.62±10.79 to 11.02±10.61) and severe headache (5.88±6.73 to 4.01±4.89) days (both P< .001).

Study details: This retrospective paired comparison study included 175 patients with chronic migraine who received ≥3 rounds of 150 units onabotulinumtoxinA followed by ≥3 rounds of 200 units onabotulinumtoxinA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Zandieh A, Cutrer FM. OnabotulinumtoxinA in chronic migraine: Is the response dose dependent?BMC Neurol. 2022;22:218(Jun 13). Doi:10.1186/s12883-022-02742-x

Key clinical point: A higher dose of onabotulinumtoxinA (Botox®) may decrease the number of headache and severe headache days in patients with chronic migraine who had an unsatisfactory response to the conventional 150-unit dose.

Major finding: After receiving 3 rounds of 200 units onabotulinumtoxinA, patients had a significant reduction in headache (13.62±10.79 to 11.02±10.61) and severe headache (5.88±6.73 to 4.01±4.89) days (both P< .001).

Study details: This retrospective paired comparison study included 175 patients with chronic migraine who received ≥3 rounds of 150 units onabotulinumtoxinA followed by ≥3 rounds of 200 units onabotulinumtoxinA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Zandieh A, Cutrer FM. OnabotulinumtoxinA in chronic migraine: Is the response dose dependent?BMC Neurol. 2022;22:218(Jun 13). Doi:10.1186/s12883-022-02742-x

The Food and Drug Administration has approved topical ruxolitinib (Opzelura) for the treatment of nonsegmental vitiligo in patients aged 12 years or older, the manufacturer, Incyte, announced on July 18. The treatment, which was approved for treating mild to moderate atopic dermatitis in September 2021, is a cream formulation of ruxolitinib, a Janus kinase 1 (JAK1)/JAK2 inhibitor.

Previously, no treatment was approved to repigment patients with vitiligo, says David Rosmarin, MD, vice chair for research and education in the department of dermatology at Tufts Medical Center, Boston. “It’s important to have options that we can give to patients that are both safe and effective to get them the desired results,” Dr. Rosmarin, the lead investigator of the phase 3 clinical trials of topical ruxolitinib, said in an interview. Vitiligo is “a disease that can really affect quality of life. Some people [with vitiligo] feel as if they’re being stared at or they’re being bullied; they don’t feel confident. It can affect relationships and intimacy.”

Approval was based on the results of two phase 3 trials (TruE-V1 and TruE-V2) in 674 patients with nonsegmental vitiligo aged 12 years or older. At 24 weeks, about 30% of the patients on treatment, applied twice a day, achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 8% and 13% among those in the vehicle groups in the two trials.

At 52 weeks, about 50% of the patients treated with topical ruxolitinib achieved F-VASI75.

Also, using self-reporting as measured by the Vitiligo Noticeability Scale, about 30%-40% of patients described their vitiligo as being “a lot less noticeable” or “no longer noticeable” at week 52. Dr. Rosmarin reported the 52-week results at the 2022 annual meeting of the American Academy of Dermatology.

The trial group used 1.5% ruxolitinib cream twice daily for the full year. The vehicle group began using ruxolitinib halfway through the trial. In this group, 26.8% and 29.6% achieved F-VASI 75 at 52 weeks in the two trials.

For treating vitiligo, patients are advised to apply a thin layer of topical ruxolitinib to affected areas twice a day, “up to 10% body surface area,” according to the prescribing information, which adds: “Satisfactory patient response may require treatment … for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be reevaluated by the health care provider.”

The most common side effects during the vehicle-controlled part of the trials were development of acne and pruritus at the application site, headache, urinary tract infections, erythema at the application site, and pyrexia, according to the company.

The approved label for topical ruxolitinib includes a boxed warning about serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis – which, the warning notes, is based on reports in patients treated with oral JAK inhibitors for inflammatory conditions.

Dr. Rosmarin believes that using this drug with other therapies, like light treatment, might yield even better responses. The available data are in patients treated with ruxolitinib as monotherapy, without complementary therapies.

William Damsky, MD, PhD, professor of dermatology and dermatopathology at Yale University, New Haven, who was not involved in the trials, said what is most exciting about this drug is its novelty. Although some topical steroids are used off-label to treat vitiligo, their efficacy is far from what’s been observed in these trials of topical ruxolitinib, he told this news organization. “It’s huge for a number of reasons. … One very big reason is it just provides some hope” for the many patients with vitiligo who, over the years, have been told “that there’s nothing that could be done for their disease, and this really changes that.”

Dr. Rosmarin reports financial relationships with over 20 pharmaceutical companies. Dr. Damsky disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved topical ruxolitinib (Opzelura) for the treatment of nonsegmental vitiligo in patients aged 12 years or older, the manufacturer, Incyte, announced on July 18. The treatment, which was approved for treating mild to moderate atopic dermatitis in September 2021, is a cream formulation of ruxolitinib, a Janus kinase 1 (JAK1)/JAK2 inhibitor.

Previously, no treatment was approved to repigment patients with vitiligo, says David Rosmarin, MD, vice chair for research and education in the department of dermatology at Tufts Medical Center, Boston. “It’s important to have options that we can give to patients that are both safe and effective to get them the desired results,” Dr. Rosmarin, the lead investigator of the phase 3 clinical trials of topical ruxolitinib, said in an interview. Vitiligo is “a disease that can really affect quality of life. Some people [with vitiligo] feel as if they’re being stared at or they’re being bullied; they don’t feel confident. It can affect relationships and intimacy.”

Approval was based on the results of two phase 3 trials (TruE-V1 and TruE-V2) in 674 patients with nonsegmental vitiligo aged 12 years or older. At 24 weeks, about 30% of the patients on treatment, applied twice a day, achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 8% and 13% among those in the vehicle groups in the two trials.

At 52 weeks, about 50% of the patients treated with topical ruxolitinib achieved F-VASI75.

Also, using self-reporting as measured by the Vitiligo Noticeability Scale, about 30%-40% of patients described their vitiligo as being “a lot less noticeable” or “no longer noticeable” at week 52. Dr. Rosmarin reported the 52-week results at the 2022 annual meeting of the American Academy of Dermatology.

The trial group used 1.5% ruxolitinib cream twice daily for the full year. The vehicle group began using ruxolitinib halfway through the trial. In this group, 26.8% and 29.6% achieved F-VASI 75 at 52 weeks in the two trials.

For treating vitiligo, patients are advised to apply a thin layer of topical ruxolitinib to affected areas twice a day, “up to 10% body surface area,” according to the prescribing information, which adds: “Satisfactory patient response may require treatment … for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be reevaluated by the health care provider.”

The most common side effects during the vehicle-controlled part of the trials were development of acne and pruritus at the application site, headache, urinary tract infections, erythema at the application site, and pyrexia, according to the company.

The approved label for topical ruxolitinib includes a boxed warning about serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis – which, the warning notes, is based on reports in patients treated with oral JAK inhibitors for inflammatory conditions.

Dr. Rosmarin believes that using this drug with other therapies, like light treatment, might yield even better responses. The available data are in patients treated with ruxolitinib as monotherapy, without complementary therapies.

William Damsky, MD, PhD, professor of dermatology and dermatopathology at Yale University, New Haven, who was not involved in the trials, said what is most exciting about this drug is its novelty. Although some topical steroids are used off-label to treat vitiligo, their efficacy is far from what’s been observed in these trials of topical ruxolitinib, he told this news organization. “It’s huge for a number of reasons. … One very big reason is it just provides some hope” for the many patients with vitiligo who, over the years, have been told “that there’s nothing that could be done for their disease, and this really changes that.”

Dr. Rosmarin reports financial relationships with over 20 pharmaceutical companies. Dr. Damsky disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved topical ruxolitinib (Opzelura) for the treatment of nonsegmental vitiligo in patients aged 12 years or older, the manufacturer, Incyte, announced on July 18. The treatment, which was approved for treating mild to moderate atopic dermatitis in September 2021, is a cream formulation of ruxolitinib, a Janus kinase 1 (JAK1)/JAK2 inhibitor.

Previously, no treatment was approved to repigment patients with vitiligo, says David Rosmarin, MD, vice chair for research and education in the department of dermatology at Tufts Medical Center, Boston. “It’s important to have options that we can give to patients that are both safe and effective to get them the desired results,” Dr. Rosmarin, the lead investigator of the phase 3 clinical trials of topical ruxolitinib, said in an interview. Vitiligo is “a disease that can really affect quality of life. Some people [with vitiligo] feel as if they’re being stared at or they’re being bullied; they don’t feel confident. It can affect relationships and intimacy.”

Approval was based on the results of two phase 3 trials (TruE-V1 and TruE-V2) in 674 patients with nonsegmental vitiligo aged 12 years or older. At 24 weeks, about 30% of the patients on treatment, applied twice a day, achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 8% and 13% among those in the vehicle groups in the two trials.

At 52 weeks, about 50% of the patients treated with topical ruxolitinib achieved F-VASI75.

Also, using self-reporting as measured by the Vitiligo Noticeability Scale, about 30%-40% of patients described their vitiligo as being “a lot less noticeable” or “no longer noticeable” at week 52. Dr. Rosmarin reported the 52-week results at the 2022 annual meeting of the American Academy of Dermatology.

The trial group used 1.5% ruxolitinib cream twice daily for the full year. The vehicle group began using ruxolitinib halfway through the trial. In this group, 26.8% and 29.6% achieved F-VASI 75 at 52 weeks in the two trials.

For treating vitiligo, patients are advised to apply a thin layer of topical ruxolitinib to affected areas twice a day, “up to 10% body surface area,” according to the prescribing information, which adds: “Satisfactory patient response may require treatment … for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be reevaluated by the health care provider.”

The most common side effects during the vehicle-controlled part of the trials were development of acne and pruritus at the application site, headache, urinary tract infections, erythema at the application site, and pyrexia, according to the company.

The approved label for topical ruxolitinib includes a boxed warning about serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis – which, the warning notes, is based on reports in patients treated with oral JAK inhibitors for inflammatory conditions.

Dr. Rosmarin believes that using this drug with other therapies, like light treatment, might yield even better responses. The available data are in patients treated with ruxolitinib as monotherapy, without complementary therapies.

William Damsky, MD, PhD, professor of dermatology and dermatopathology at Yale University, New Haven, who was not involved in the trials, said what is most exciting about this drug is its novelty. Although some topical steroids are used off-label to treat vitiligo, their efficacy is far from what’s been observed in these trials of topical ruxolitinib, he told this news organization. “It’s huge for a number of reasons. … One very big reason is it just provides some hope” for the many patients with vitiligo who, over the years, have been told “that there’s nothing that could be done for their disease, and this really changes that.”

Dr. Rosmarin reports financial relationships with over 20 pharmaceutical companies. Dr. Damsky disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Billionaire entrepreneur Mark Cuban, owner of the NBA’s Dallas Mavericks, has launched a company offering generic medication at prices that are substantially lower than the current market listings, including several drugs used in oncology.

One of the drugs offering the biggest savings is generic imatinib (originator product Gleevec), which is used for chronic myelogenous leukemia (CML), certain acute lymphocytic leukemia (ALL) and certain types of gastrointestinal stromal tumors (GIST).

Imatinib has a list retail price of $2,502.

At the Mark Cuban pharmacy, it is available for $14.40, which offers a saving of $2,488.

The online pharmacy, known as the Mark Cuban Cost Plus Drug Company (MCCPDC), began operating in January. It is selling more than 100 generic prescription drugs at the cost of ingredients and manufacturing plus 15% margin, $3 pharmacy dispensing fee, and $5 shipping fee.

“We will do whatever it takes to get affordable pharmaceuticals to patients,” said Alex Oshmyansky, MD, PhD, founder and CEO of MCCPDC, in a company statement. “The markup on potentially lifesaving drugs that people depend on is a problem that can’t be ignored. It is imperative that we take action and help expand access to these medications for those who need them most.”

The company is a registered pharmaceutical wholesaler, and as such, can “bypass middlemen and outrageous markups,” the company notes in a press release. They have partnered with the digital health care company Truepill, which built and powers the pharmacy’s website.

At its launch, the pharmacy offered 109 generic medications. So far, the generics offered for oncology include generic anastrozole, letrozole, raloxifene, and tamoxifen for use in breast cancer, as well as the chemotherapy methotrexate and generic imatinib, as mentioned above.  All of the drugs sold through the MCCPDC have prices much lower than in the standard marketplace. Becker’s Hospital Review recently published a list of the 50 drugs with the biggest savings at Cuban’s pharmacy.

At the top of the list was albendazole, an anthelmintic that retails for $6,565. In contrast, the MCCPDC price is $453, which translates to a savings of more than $6,000 for a 30-count supply.

The second-largest savings was for imatinib.  

For the other cancer drugs, the savings were less substantial, reflecting their much lower retail price, but savings still ranged between $66 and $200 per product.

Overall, 14 of the top 50 discounted drugs are slated to save consumers more than $500 for a 30-count supply when purchased from MCCPDC.
 

Medicare could save billions

Medicare would save billions if it used this online pharmacy, say researchers from Harvard University, who recently published a study in Annals of Internal Medicine giving some estimates.

The team analyzed 89 generic drugs listed at MCCPDC and found that Medicare Part D could have saved more than $3 billion in 2020 if they had purchased them at these prices. For example, aripiprazole, a commonly used psychiatric medication, was purchased for more than $2 per pill, while the same generic formulation of the drug is sold by Cuban’s company for $0.24 per pill. Overall, just with this one drug, Medicare could have saved $233 million in 2020.

“We found that Medicare spent $9.6 billion on 89 generic drugs in 2020,” commented lead author Hussain S. Lalani, MD, MPH in a tweet. “It could have saved up to $3.6 billion on 77 of the 89 drugs if it purchased them at the largest quantity sold by Mark Cuban’s Cost Plus Drug Company. The other 12 drugs ($1.5B) did not offer savings.”

Dr. Lalani pointed out that the price transparency provided by MCCPDC is “helping us to understand the cost of many generic drugs and highlights inefficiencies in the supply chain for generic drugs.”

In standard practice, there are “multiple actors” involved in distributing the drug from the pharmaceutical manufacturer to the patient, he explained. “Mark Cuban’s company does not accept health insurance, buys from the manufacturer, and sells it directly to consumers online!”

He added that innovation and policy reform are needed. “We know that many drug prices are outrageous, and the supply chain is also expensive & NOT working right,” he tweeted. “We need a system that delivers innovative, affordable, and accessible medicines for all Americans.”

Commenting on Dr. Lalani’s Twitter thread, Eric Topol, MD, Medscape’s editor-in-chief, said that “the many billions the U.S. could save each year by MCCPDC is remarkable.”

Dr. Topol also noted that the savings estimated in the Annals of Internal Medicine paper were based on fewer than 100 generic drugs that are currently available, but he said that “there will be >1,000 more offered in the next year.”
 

No insurance, no PBMs

Prior to launching the online pharmacy, Mr. Cuban established a pharmacy benefit manager (PBM) operation to serve companies providing prescription coverage in their employee benefit plans. According to a press release, MCCPDC has pledged to be “radically transparent” in its own negotiations as a PBM, revealing the true costs it pays for drugs and eliminating spread pricing and misaligned rebate incentives. MCCPDC anticipates that its PBM could save companies millions of dollars with no changes to its benefits, as it will eliminate the traditional PBM model.

However, the online pharmacy is a cash-only venture, because MCCPDC refuses to pay third-party PBMs in order to be allowed to process insurance claims. But the model allows patients to immediately purchase medications at a cost that is often less than what they might pay when having to deal with deductible and copay requirements.

In the future, MCCPDC plans to start manufacturing medications. The company is currently building a state-of-the-art pharmaceutical facility in Dallas, at which it plans to produce its own high-quality medicines at the lowest possible prices.

A version of this article first appeared on Medscape.com.

Billionaire entrepreneur Mark Cuban, owner of the NBA’s Dallas Mavericks, has launched a company offering generic medication at prices that are substantially lower than the current market listings, including several drugs used in oncology.

One of the drugs offering the biggest savings is generic imatinib (originator product Gleevec), which is used for chronic myelogenous leukemia (CML), certain acute lymphocytic leukemia (ALL) and certain types of gastrointestinal stromal tumors (GIST).

Imatinib has a list retail price of $2,502.

At the Mark Cuban pharmacy, it is available for $14.40, which offers a saving of $2,488.

The online pharmacy, known as the Mark Cuban Cost Plus Drug Company (MCCPDC), began operating in January. It is selling more than 100 generic prescription drugs at the cost of ingredients and manufacturing plus 15% margin, $3 pharmacy dispensing fee, and $5 shipping fee.

“We will do whatever it takes to get affordable pharmaceuticals to patients,” said Alex Oshmyansky, MD, PhD, founder and CEO of MCCPDC, in a company statement. “The markup on potentially lifesaving drugs that people depend on is a problem that can’t be ignored. It is imperative that we take action and help expand access to these medications for those who need them most.”

The company is a registered pharmaceutical wholesaler, and as such, can “bypass middlemen and outrageous markups,” the company notes in a press release. They have partnered with the digital health care company Truepill, which built and powers the pharmacy’s website.

At its launch, the pharmacy offered 109 generic medications. So far, the generics offered for oncology include generic anastrozole, letrozole, raloxifene, and tamoxifen for use in breast cancer, as well as the chemotherapy methotrexate and generic imatinib, as mentioned above.  All of the drugs sold through the MCCPDC have prices much lower than in the standard marketplace. Becker’s Hospital Review recently published a list of the 50 drugs with the biggest savings at Cuban’s pharmacy.

At the top of the list was albendazole, an anthelmintic that retails for $6,565. In contrast, the MCCPDC price is $453, which translates to a savings of more than $6,000 for a 30-count supply.

The second-largest savings was for imatinib.  

For the other cancer drugs, the savings were less substantial, reflecting their much lower retail price, but savings still ranged between $66 and $200 per product.

Overall, 14 of the top 50 discounted drugs are slated to save consumers more than $500 for a 30-count supply when purchased from MCCPDC.
 

Medicare could save billions

Medicare would save billions if it used this online pharmacy, say researchers from Harvard University, who recently published a study in Annals of Internal Medicine giving some estimates.

The team analyzed 89 generic drugs listed at MCCPDC and found that Medicare Part D could have saved more than $3 billion in 2020 if they had purchased them at these prices. For example, aripiprazole, a commonly used psychiatric medication, was purchased for more than $2 per pill, while the same generic formulation of the drug is sold by Cuban’s company for $0.24 per pill. Overall, just with this one drug, Medicare could have saved $233 million in 2020.

“We found that Medicare spent $9.6 billion on 89 generic drugs in 2020,” commented lead author Hussain S. Lalani, MD, MPH in a tweet. “It could have saved up to $3.6 billion on 77 of the 89 drugs if it purchased them at the largest quantity sold by Mark Cuban’s Cost Plus Drug Company. The other 12 drugs ($1.5B) did not offer savings.”

Dr. Lalani pointed out that the price transparency provided by MCCPDC is “helping us to understand the cost of many generic drugs and highlights inefficiencies in the supply chain for generic drugs.”

In standard practice, there are “multiple actors” involved in distributing the drug from the pharmaceutical manufacturer to the patient, he explained. “Mark Cuban’s company does not accept health insurance, buys from the manufacturer, and sells it directly to consumers online!”

He added that innovation and policy reform are needed. “We know that many drug prices are outrageous, and the supply chain is also expensive & NOT working right,” he tweeted. “We need a system that delivers innovative, affordable, and accessible medicines for all Americans.”

Commenting on Dr. Lalani’s Twitter thread, Eric Topol, MD, Medscape’s editor-in-chief, said that “the many billions the U.S. could save each year by MCCPDC is remarkable.”

Dr. Topol also noted that the savings estimated in the Annals of Internal Medicine paper were based on fewer than 100 generic drugs that are currently available, but he said that “there will be >1,000 more offered in the next year.”
 

No insurance, no PBMs

Prior to launching the online pharmacy, Mr. Cuban established a pharmacy benefit manager (PBM) operation to serve companies providing prescription coverage in their employee benefit plans. According to a press release, MCCPDC has pledged to be “radically transparent” in its own negotiations as a PBM, revealing the true costs it pays for drugs and eliminating spread pricing and misaligned rebate incentives. MCCPDC anticipates that its PBM could save companies millions of dollars with no changes to its benefits, as it will eliminate the traditional PBM model.

However, the online pharmacy is a cash-only venture, because MCCPDC refuses to pay third-party PBMs in order to be allowed to process insurance claims. But the model allows patients to immediately purchase medications at a cost that is often less than what they might pay when having to deal with deductible and copay requirements.

In the future, MCCPDC plans to start manufacturing medications. The company is currently building a state-of-the-art pharmaceutical facility in Dallas, at which it plans to produce its own high-quality medicines at the lowest possible prices.

A version of this article first appeared on Medscape.com.

Billionaire entrepreneur Mark Cuban, owner of the NBA’s Dallas Mavericks, has launched a company offering generic medication at prices that are substantially lower than the current market listings, including several drugs used in oncology.

One of the drugs offering the biggest savings is generic imatinib (originator product Gleevec), which is used for chronic myelogenous leukemia (CML), certain acute lymphocytic leukemia (ALL) and certain types of gastrointestinal stromal tumors (GIST).

Imatinib has a list retail price of $2,502.

At the Mark Cuban pharmacy, it is available for $14.40, which offers a saving of $2,488.

The online pharmacy, known as the Mark Cuban Cost Plus Drug Company (MCCPDC), began operating in January. It is selling more than 100 generic prescription drugs at the cost of ingredients and manufacturing plus 15% margin, $3 pharmacy dispensing fee, and $5 shipping fee.

“We will do whatever it takes to get affordable pharmaceuticals to patients,” said Alex Oshmyansky, MD, PhD, founder and CEO of MCCPDC, in a company statement. “The markup on potentially lifesaving drugs that people depend on is a problem that can’t be ignored. It is imperative that we take action and help expand access to these medications for those who need them most.”

The company is a registered pharmaceutical wholesaler, and as such, can “bypass middlemen and outrageous markups,” the company notes in a press release. They have partnered with the digital health care company Truepill, which built and powers the pharmacy’s website.

At its launch, the pharmacy offered 109 generic medications. So far, the generics offered for oncology include generic anastrozole, letrozole, raloxifene, and tamoxifen for use in breast cancer, as well as the chemotherapy methotrexate and generic imatinib, as mentioned above.  All of the drugs sold through the MCCPDC have prices much lower than in the standard marketplace. Becker’s Hospital Review recently published a list of the 50 drugs with the biggest savings at Cuban’s pharmacy.

At the top of the list was albendazole, an anthelmintic that retails for $6,565. In contrast, the MCCPDC price is $453, which translates to a savings of more than $6,000 for a 30-count supply.

The second-largest savings was for imatinib.  

For the other cancer drugs, the savings were less substantial, reflecting their much lower retail price, but savings still ranged between $66 and $200 per product.

Overall, 14 of the top 50 discounted drugs are slated to save consumers more than $500 for a 30-count supply when purchased from MCCPDC.
 

Medicare could save billions

Medicare would save billions if it used this online pharmacy, say researchers from Harvard University, who recently published a study in Annals of Internal Medicine giving some estimates.

The team analyzed 89 generic drugs listed at MCCPDC and found that Medicare Part D could have saved more than $3 billion in 2020 if they had purchased them at these prices. For example, aripiprazole, a commonly used psychiatric medication, was purchased for more than $2 per pill, while the same generic formulation of the drug is sold by Cuban’s company for $0.24 per pill. Overall, just with this one drug, Medicare could have saved $233 million in 2020.

“We found that Medicare spent $9.6 billion on 89 generic drugs in 2020,” commented lead author Hussain S. Lalani, MD, MPH in a tweet. “It could have saved up to $3.6 billion on 77 of the 89 drugs if it purchased them at the largest quantity sold by Mark Cuban’s Cost Plus Drug Company. The other 12 drugs ($1.5B) did not offer savings.”

Dr. Lalani pointed out that the price transparency provided by MCCPDC is “helping us to understand the cost of many generic drugs and highlights inefficiencies in the supply chain for generic drugs.”

In standard practice, there are “multiple actors” involved in distributing the drug from the pharmaceutical manufacturer to the patient, he explained. “Mark Cuban’s company does not accept health insurance, buys from the manufacturer, and sells it directly to consumers online!”

He added that innovation and policy reform are needed. “We know that many drug prices are outrageous, and the supply chain is also expensive & NOT working right,” he tweeted. “We need a system that delivers innovative, affordable, and accessible medicines for all Americans.”

Commenting on Dr. Lalani’s Twitter thread, Eric Topol, MD, Medscape’s editor-in-chief, said that “the many billions the U.S. could save each year by MCCPDC is remarkable.”

Dr. Topol also noted that the savings estimated in the Annals of Internal Medicine paper were based on fewer than 100 generic drugs that are currently available, but he said that “there will be >1,000 more offered in the next year.”
 

No insurance, no PBMs

Prior to launching the online pharmacy, Mr. Cuban established a pharmacy benefit manager (PBM) operation to serve companies providing prescription coverage in their employee benefit plans. According to a press release, MCCPDC has pledged to be “radically transparent” in its own negotiations as a PBM, revealing the true costs it pays for drugs and eliminating spread pricing and misaligned rebate incentives. MCCPDC anticipates that its PBM could save companies millions of dollars with no changes to its benefits, as it will eliminate the traditional PBM model.

However, the online pharmacy is a cash-only venture, because MCCPDC refuses to pay third-party PBMs in order to be allowed to process insurance claims. But the model allows patients to immediately purchase medications at a cost that is often less than what they might pay when having to deal with deductible and copay requirements.

In the future, MCCPDC plans to start manufacturing medications. The company is currently building a state-of-the-art pharmaceutical facility in Dallas, at which it plans to produce its own high-quality medicines at the lowest possible prices.

A version of this article first appeared on Medscape.com.

Patients who take methotrexate for a variety of immune-mediated inflammatory diseases and pause taking the drug following receipt of a COVID-19 vaccine dose did not have a higher risk of disease flare and had higher antireceptor binding domain (anti-RBD) antibody titers and increased immunogenicity when compared with continuing the drug, three recent studies suggest.

In one study, British researchers examined the effects of a 2-week break in methotrexate therapy on anti-RBD titers following receipt of a third COVID-19 vaccine dose. In their paper published in The Lancet: Respiratory Medicine, they reported results from a randomized, open-label, superiority trial that suggested pausing the drug improved immunogenicity, compared with no break.

In two trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2022 Congress, a team from India set out to determine whether holding methotrexate after receiving both doses of a COVID-19 vaccine, or holding it only after the second dose, was safe and effective. They found that pausing methotrexate only following the second dose contributed to a lower flare risk, and that patients had higher anti-RBD titers when holding methotrexate for 2 weeks following each dose.
 

Pausing methotrexate after booster

The 2-week methotrexate break and booster vaccine dose data in the Vaccine Response On Off Methotrexate (VROOM) trial showed that after a month, the geometric mean antispike 1 (S1)-RBD antibody titer was 10,798 U/mL (95% confidence interval [CI], 8,970-12,997) in the group that continued methotrexate and 22,750 U/mL (95% CI, 19,314-26,796) in the group that suspended methotrexate; the geometric mean ratio was 2.19 (P < .0001; mixed-effects model), reported Abhishek Abhishek, MD, PhD, professor of rheumatology at the University of Nottingham in Nottingham, England, and colleagues.

Prior research showed that stopping methotrexate therapy for 2 weeks following the seasonal influenza vaccine contributed to better vaccine immunity among patients with rheumatoid arthritis, but there was no impact of stopping the drug for up to 4 weeks before vaccination on vaccine-related immunity, the researchers noted.

It is crucial in maximizing long-lasting vaccine protection in people who are possibly susceptible through immune suppression at this point in the COVID-19 vaccination regimen, the study team noted.

“Evidence from this study will be useful for policymakers, national immunization advisory committees, and specialist societies formulating recommendations on the use of methotrexate around the time of COVID-19 vaccination. This evidence will help patients and clinicians make informed choices about the risks and benefits of interrupting methotrexate treatment around the time of COVID-19 vaccination, with implications for the potential to extend such approaches to other therapeutics,” they wrote.

In American College of Rheumatology (ACR) guidance for COVID-19 vaccination, the organization advised against using standard synthetic disease-modifying antirheumatic medicines such as methotrexate “for 1-2 weeks (as disease activity allows) after each COVID-19 vaccine dose,” given the at-risk population and public health concerns, Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine and associate physician at Brigham and Women’s Hospital and Harvard Medical School, Boston, and Sara K. Tedeschi, MD, MPH, assistant professor of medicine at Harvard Medical School, noted in an accompanying editorial in The Lancet: Respiratory Medicine.

However, when the ACR developed this statement, there was only one trial involving patients with rheumatoid arthritis who paused methotrexate following seasonal influenza vaccination, the editorialists said.

Expert commentary

This current study is consistent with other studies over the last several months showing that methotrexate harms both humoral and cell-mediated COVID-19 responses, noted Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study. “And so now the new wave of studies are like this one, where they are holding methotrexate experimentally and seeing if it makes a difference,” he said.

“The one shortcoming of this study – and so far, the studies to date – is that no one has looked at whether the experimental hold has resulted in a change in T-cell responses, which ... we are [now] recognizing [the importance of] more and more in long-term protection, particularly in severe disease. Theoretically, holding [methotrexate] might help enhance T-cell responses, but that hasn’t been shown experimentally.”

Dr. Winthrop pointed out that one might get the same benefit from holding methotrexate for 1 week instead of 2 and that there likely is a reduced risk of flare-up from underlying autoimmune disease.

It is still not certain that this benefit extends to other vaccines, Dr. Winthrop noted. “It is probably true for most vaccines that if you hold methotrexate for 1 or 2 weeks, you might see some short-term benefit in responsiveness, but you don’t know that there is any clinical meaningfulness of this. That’s going to take other long-term studies. You don’t know how long this benefit lasts.”
 

Pausing methotrexate during initial COVID vaccine doses

Patients with either rheumatoid arthritis or psoriatic arthritis had higher anti-RBD antibody titers when methotrexate was stopped after both doses of the AstraZeneca vaccine, or simply after the second dose, than when methotrexate was continued, according to results from two single-center, randomized controlled trials called MIVAC I and II, Anu Sreekanth, MD, of Sree Sudheendra Medical Mission in Kochi, Kerala, India, and colleagues reported at EULAR 2022.

Results from MIVAC I indicated that there was a higher flare rate when methotrexate was stopped after both vaccine doses, but there was no difference in flare rate in MIVAC II when methotrexate was stopped only after the second dose as opposed to stopping it after both doses.

In the MIVAC I trial, 158 unvaccinated patients were randomized 1:1 to a cohort in which methotrexate was held for 2 weeks after both doses and a cohort in which methotrexate was continued despite the vaccine. In MIVAC II, 157 patients continued methotrexate while receiving the first vaccine dose. These patients were subsequently randomized either to continue or to stop methotrexate for 2 weeks following the second dose.

The findings from MIVAC I demonstrated the flare rate was lower in the methotrexate-continue group than in the methotrexate-pause group (8% vs. 25%; P = .005) and that the median anti-RBD titer was significantly higher for the methotrexate-pause group than the methotrexate-continue group (2,484 vs. 1,147; P = .001).

The results from MIVAC II trial indicated that there was no difference in flare rates between the two study groups (7.9% vs. 11.8%; P = .15). Yet, the median anti-RBD titer was significantly higher in the methotrexate-pause cohort than in the methotrexate-continue cohort (2,553 vs. 990; P = .001).

The report suggests there is a flare risk when methotrexate is stopped, Dr. Sreekanth noted. “It appears more logical to hold only after the second dose, as comparable anti-RBD titers are generated” with either approach, Dr. Sreekanth said.

Expert commentary: MIVAC I and II

Inés Colmegna, MD, associate professor at McGill University in Montreal, noted that it was intriguing that the risk of flares in MIVAC II is half of that reported after each of the doses of MIVAC I. “It is also worth emphasizing that despite the reported frequency of flares, the actual disease activity [as measured by the Disease Activity Score in 28 joints] in patients who did or did not withhold methotrexate was similar.

“MIVAC I and II have practical implications as they help to adequately inform patients about the risk and benefit trade of withholding methotrexate post–COVID-19 vaccination,” Dr. Colmegna told this news organization.

“Additional information would help to [further] interpret the findings of these studies, including whether any of the participants were taking any other DMARDs; data on the severity of the flares and functional impact; analysis of factors that predict the risk of flares, such as higher doses of methotrexate; [and change in] disease activity scores pre- and postvaccination,” Dr. Colmegna concluded.

Dr. Abhishek disclosed relationships with Springer, UpTodate, Oxford, Immunotec, AstraZeneca, Inflazome, NGM Biopharmaceuticals, Menarini Pharmaceuticals, and Cadila Pharmaceuticals. Dr. Abhishek is cochair of the ACR/EULAR CPPD Classification Criteria Working Group and the OMERACT CPPD Working Group. Dr. Sparks disclosed relationships with Gilead, Boehringer Ingelheim, Amgen, Bristol-Myers Squibb, and AbbVie, unrelated to this study. Dr. Tedeschi disclosed relationships with ModernaTx and NGM Biopharmaceuticals. Dr. Winthrop disclosed a research grant and serving as a scientific consultant for Pfizer. Dr. Sreekanth  and Dr. Colmegna have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who take methotrexate for a variety of immune-mediated inflammatory diseases and pause taking the drug following receipt of a COVID-19 vaccine dose did not have a higher risk of disease flare and had higher antireceptor binding domain (anti-RBD) antibody titers and increased immunogenicity when compared with continuing the drug, three recent studies suggest.

In one study, British researchers examined the effects of a 2-week break in methotrexate therapy on anti-RBD titers following receipt of a third COVID-19 vaccine dose. In their paper published in The Lancet: Respiratory Medicine, they reported results from a randomized, open-label, superiority trial that suggested pausing the drug improved immunogenicity, compared with no break.

In two trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2022 Congress, a team from India set out to determine whether holding methotrexate after receiving both doses of a COVID-19 vaccine, or holding it only after the second dose, was safe and effective. They found that pausing methotrexate only following the second dose contributed to a lower flare risk, and that patients had higher anti-RBD titers when holding methotrexate for 2 weeks following each dose.
 

Pausing methotrexate after booster

The 2-week methotrexate break and booster vaccine dose data in the Vaccine Response On Off Methotrexate (VROOM) trial showed that after a month, the geometric mean antispike 1 (S1)-RBD antibody titer was 10,798 U/mL (95% confidence interval [CI], 8,970-12,997) in the group that continued methotrexate and 22,750 U/mL (95% CI, 19,314-26,796) in the group that suspended methotrexate; the geometric mean ratio was 2.19 (P < .0001; mixed-effects model), reported Abhishek Abhishek, MD, PhD, professor of rheumatology at the University of Nottingham in Nottingham, England, and colleagues.

Prior research showed that stopping methotrexate therapy for 2 weeks following the seasonal influenza vaccine contributed to better vaccine immunity among patients with rheumatoid arthritis, but there was no impact of stopping the drug for up to 4 weeks before vaccination on vaccine-related immunity, the researchers noted.

It is crucial in maximizing long-lasting vaccine protection in people who are possibly susceptible through immune suppression at this point in the COVID-19 vaccination regimen, the study team noted.

“Evidence from this study will be useful for policymakers, national immunization advisory committees, and specialist societies formulating recommendations on the use of methotrexate around the time of COVID-19 vaccination. This evidence will help patients and clinicians make informed choices about the risks and benefits of interrupting methotrexate treatment around the time of COVID-19 vaccination, with implications for the potential to extend such approaches to other therapeutics,” they wrote.

In American College of Rheumatology (ACR) guidance for COVID-19 vaccination, the organization advised against using standard synthetic disease-modifying antirheumatic medicines such as methotrexate “for 1-2 weeks (as disease activity allows) after each COVID-19 vaccine dose,” given the at-risk population and public health concerns, Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine and associate physician at Brigham and Women’s Hospital and Harvard Medical School, Boston, and Sara K. Tedeschi, MD, MPH, assistant professor of medicine at Harvard Medical School, noted in an accompanying editorial in The Lancet: Respiratory Medicine.

However, when the ACR developed this statement, there was only one trial involving patients with rheumatoid arthritis who paused methotrexate following seasonal influenza vaccination, the editorialists said.

Expert commentary

This current study is consistent with other studies over the last several months showing that methotrexate harms both humoral and cell-mediated COVID-19 responses, noted Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study. “And so now the new wave of studies are like this one, where they are holding methotrexate experimentally and seeing if it makes a difference,” he said.

“The one shortcoming of this study – and so far, the studies to date – is that no one has looked at whether the experimental hold has resulted in a change in T-cell responses, which ... we are [now] recognizing [the importance of] more and more in long-term protection, particularly in severe disease. Theoretically, holding [methotrexate] might help enhance T-cell responses, but that hasn’t been shown experimentally.”

Dr. Winthrop pointed out that one might get the same benefit from holding methotrexate for 1 week instead of 2 and that there likely is a reduced risk of flare-up from underlying autoimmune disease.

It is still not certain that this benefit extends to other vaccines, Dr. Winthrop noted. “It is probably true for most vaccines that if you hold methotrexate for 1 or 2 weeks, you might see some short-term benefit in responsiveness, but you don’t know that there is any clinical meaningfulness of this. That’s going to take other long-term studies. You don’t know how long this benefit lasts.”
 

Pausing methotrexate during initial COVID vaccine doses

Patients with either rheumatoid arthritis or psoriatic arthritis had higher anti-RBD antibody titers when methotrexate was stopped after both doses of the AstraZeneca vaccine, or simply after the second dose, than when methotrexate was continued, according to results from two single-center, randomized controlled trials called MIVAC I and II, Anu Sreekanth, MD, of Sree Sudheendra Medical Mission in Kochi, Kerala, India, and colleagues reported at EULAR 2022.

Results from MIVAC I indicated that there was a higher flare rate when methotrexate was stopped after both vaccine doses, but there was no difference in flare rate in MIVAC II when methotrexate was stopped only after the second dose as opposed to stopping it after both doses.

In the MIVAC I trial, 158 unvaccinated patients were randomized 1:1 to a cohort in which methotrexate was held for 2 weeks after both doses and a cohort in which methotrexate was continued despite the vaccine. In MIVAC II, 157 patients continued methotrexate while receiving the first vaccine dose. These patients were subsequently randomized either to continue or to stop methotrexate for 2 weeks following the second dose.

The findings from MIVAC I demonstrated the flare rate was lower in the methotrexate-continue group than in the methotrexate-pause group (8% vs. 25%; P = .005) and that the median anti-RBD titer was significantly higher for the methotrexate-pause group than the methotrexate-continue group (2,484 vs. 1,147; P = .001).

The results from MIVAC II trial indicated that there was no difference in flare rates between the two study groups (7.9% vs. 11.8%; P = .15). Yet, the median anti-RBD titer was significantly higher in the methotrexate-pause cohort than in the methotrexate-continue cohort (2,553 vs. 990; P = .001).

The report suggests there is a flare risk when methotrexate is stopped, Dr. Sreekanth noted. “It appears more logical to hold only after the second dose, as comparable anti-RBD titers are generated” with either approach, Dr. Sreekanth said.

Expert commentary: MIVAC I and II

Inés Colmegna, MD, associate professor at McGill University in Montreal, noted that it was intriguing that the risk of flares in MIVAC II is half of that reported after each of the doses of MIVAC I. “It is also worth emphasizing that despite the reported frequency of flares, the actual disease activity [as measured by the Disease Activity Score in 28 joints] in patients who did or did not withhold methotrexate was similar.

“MIVAC I and II have practical implications as they help to adequately inform patients about the risk and benefit trade of withholding methotrexate post–COVID-19 vaccination,” Dr. Colmegna told this news organization.

“Additional information would help to [further] interpret the findings of these studies, including whether any of the participants were taking any other DMARDs; data on the severity of the flares and functional impact; analysis of factors that predict the risk of flares, such as higher doses of methotrexate; [and change in] disease activity scores pre- and postvaccination,” Dr. Colmegna concluded.

Dr. Abhishek disclosed relationships with Springer, UpTodate, Oxford, Immunotec, AstraZeneca, Inflazome, NGM Biopharmaceuticals, Menarini Pharmaceuticals, and Cadila Pharmaceuticals. Dr. Abhishek is cochair of the ACR/EULAR CPPD Classification Criteria Working Group and the OMERACT CPPD Working Group. Dr. Sparks disclosed relationships with Gilead, Boehringer Ingelheim, Amgen, Bristol-Myers Squibb, and AbbVie, unrelated to this study. Dr. Tedeschi disclosed relationships with ModernaTx and NGM Biopharmaceuticals. Dr. Winthrop disclosed a research grant and serving as a scientific consultant for Pfizer. Dr. Sreekanth  and Dr. Colmegna have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who take methotrexate for a variety of immune-mediated inflammatory diseases and pause taking the drug following receipt of a COVID-19 vaccine dose did not have a higher risk of disease flare and had higher antireceptor binding domain (anti-RBD) antibody titers and increased immunogenicity when compared with continuing the drug, three recent studies suggest.

In one study, British researchers examined the effects of a 2-week break in methotrexate therapy on anti-RBD titers following receipt of a third COVID-19 vaccine dose. In their paper published in The Lancet: Respiratory Medicine, they reported results from a randomized, open-label, superiority trial that suggested pausing the drug improved immunogenicity, compared with no break.

In two trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2022 Congress, a team from India set out to determine whether holding methotrexate after receiving both doses of a COVID-19 vaccine, or holding it only after the second dose, was safe and effective. They found that pausing methotrexate only following the second dose contributed to a lower flare risk, and that patients had higher anti-RBD titers when holding methotrexate for 2 weeks following each dose.
 

Pausing methotrexate after booster

The 2-week methotrexate break and booster vaccine dose data in the Vaccine Response On Off Methotrexate (VROOM) trial showed that after a month, the geometric mean antispike 1 (S1)-RBD antibody titer was 10,798 U/mL (95% confidence interval [CI], 8,970-12,997) in the group that continued methotrexate and 22,750 U/mL (95% CI, 19,314-26,796) in the group that suspended methotrexate; the geometric mean ratio was 2.19 (P < .0001; mixed-effects model), reported Abhishek Abhishek, MD, PhD, professor of rheumatology at the University of Nottingham in Nottingham, England, and colleagues.

Prior research showed that stopping methotrexate therapy for 2 weeks following the seasonal influenza vaccine contributed to better vaccine immunity among patients with rheumatoid arthritis, but there was no impact of stopping the drug for up to 4 weeks before vaccination on vaccine-related immunity, the researchers noted.

It is crucial in maximizing long-lasting vaccine protection in people who are possibly susceptible through immune suppression at this point in the COVID-19 vaccination regimen, the study team noted.

“Evidence from this study will be useful for policymakers, national immunization advisory committees, and specialist societies formulating recommendations on the use of methotrexate around the time of COVID-19 vaccination. This evidence will help patients and clinicians make informed choices about the risks and benefits of interrupting methotrexate treatment around the time of COVID-19 vaccination, with implications for the potential to extend such approaches to other therapeutics,” they wrote.

In American College of Rheumatology (ACR) guidance for COVID-19 vaccination, the organization advised against using standard synthetic disease-modifying antirheumatic medicines such as methotrexate “for 1-2 weeks (as disease activity allows) after each COVID-19 vaccine dose,” given the at-risk population and public health concerns, Jeffrey A. Sparks, MD, MMSc, assistant professor of medicine and associate physician at Brigham and Women’s Hospital and Harvard Medical School, Boston, and Sara K. Tedeschi, MD, MPH, assistant professor of medicine at Harvard Medical School, noted in an accompanying editorial in The Lancet: Respiratory Medicine.

However, when the ACR developed this statement, there was only one trial involving patients with rheumatoid arthritis who paused methotrexate following seasonal influenza vaccination, the editorialists said.

Expert commentary

This current study is consistent with other studies over the last several months showing that methotrexate harms both humoral and cell-mediated COVID-19 responses, noted Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study. “And so now the new wave of studies are like this one, where they are holding methotrexate experimentally and seeing if it makes a difference,” he said.

“The one shortcoming of this study – and so far, the studies to date – is that no one has looked at whether the experimental hold has resulted in a change in T-cell responses, which ... we are [now] recognizing [the importance of] more and more in long-term protection, particularly in severe disease. Theoretically, holding [methotrexate] might help enhance T-cell responses, but that hasn’t been shown experimentally.”

Dr. Winthrop pointed out that one might get the same benefit from holding methotrexate for 1 week instead of 2 and that there likely is a reduced risk of flare-up from underlying autoimmune disease.

It is still not certain that this benefit extends to other vaccines, Dr. Winthrop noted. “It is probably true for most vaccines that if you hold methotrexate for 1 or 2 weeks, you might see some short-term benefit in responsiveness, but you don’t know that there is any clinical meaningfulness of this. That’s going to take other long-term studies. You don’t know how long this benefit lasts.”
 

Pausing methotrexate during initial COVID vaccine doses

Patients with either rheumatoid arthritis or psoriatic arthritis had higher anti-RBD antibody titers when methotrexate was stopped after both doses of the AstraZeneca vaccine, or simply after the second dose, than when methotrexate was continued, according to results from two single-center, randomized controlled trials called MIVAC I and II, Anu Sreekanth, MD, of Sree Sudheendra Medical Mission in Kochi, Kerala, India, and colleagues reported at EULAR 2022.

Results from MIVAC I indicated that there was a higher flare rate when methotrexate was stopped after both vaccine doses, but there was no difference in flare rate in MIVAC II when methotrexate was stopped only after the second dose as opposed to stopping it after both doses.

In the MIVAC I trial, 158 unvaccinated patients were randomized 1:1 to a cohort in which methotrexate was held for 2 weeks after both doses and a cohort in which methotrexate was continued despite the vaccine. In MIVAC II, 157 patients continued methotrexate while receiving the first vaccine dose. These patients were subsequently randomized either to continue or to stop methotrexate for 2 weeks following the second dose.

The findings from MIVAC I demonstrated the flare rate was lower in the methotrexate-continue group than in the methotrexate-pause group (8% vs. 25%; P = .005) and that the median anti-RBD titer was significantly higher for the methotrexate-pause group than the methotrexate-continue group (2,484 vs. 1,147; P = .001).

The results from MIVAC II trial indicated that there was no difference in flare rates between the two study groups (7.9% vs. 11.8%; P = .15). Yet, the median anti-RBD titer was significantly higher in the methotrexate-pause cohort than in the methotrexate-continue cohort (2,553 vs. 990; P = .001).

The report suggests there is a flare risk when methotrexate is stopped, Dr. Sreekanth noted. “It appears more logical to hold only after the second dose, as comparable anti-RBD titers are generated” with either approach, Dr. Sreekanth said.

Expert commentary: MIVAC I and II

Inés Colmegna, MD, associate professor at McGill University in Montreal, noted that it was intriguing that the risk of flares in MIVAC II is half of that reported after each of the doses of MIVAC I. “It is also worth emphasizing that despite the reported frequency of flares, the actual disease activity [as measured by the Disease Activity Score in 28 joints] in patients who did or did not withhold methotrexate was similar.

“MIVAC I and II have practical implications as they help to adequately inform patients about the risk and benefit trade of withholding methotrexate post–COVID-19 vaccination,” Dr. Colmegna told this news organization.

“Additional information would help to [further] interpret the findings of these studies, including whether any of the participants were taking any other DMARDs; data on the severity of the flares and functional impact; analysis of factors that predict the risk of flares, such as higher doses of methotrexate; [and change in] disease activity scores pre- and postvaccination,” Dr. Colmegna concluded.

Dr. Abhishek disclosed relationships with Springer, UpTodate, Oxford, Immunotec, AstraZeneca, Inflazome, NGM Biopharmaceuticals, Menarini Pharmaceuticals, and Cadila Pharmaceuticals. Dr. Abhishek is cochair of the ACR/EULAR CPPD Classification Criteria Working Group and the OMERACT CPPD Working Group. Dr. Sparks disclosed relationships with Gilead, Boehringer Ingelheim, Amgen, Bristol-Myers Squibb, and AbbVie, unrelated to this study. Dr. Tedeschi disclosed relationships with ModernaTx and NGM Biopharmaceuticals. Dr. Winthrop disclosed a research grant and serving as a scientific consultant for Pfizer. Dr. Sreekanth  and Dr. Colmegna have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.