MDedge Rheumatology

Key clinical point: Peficitinib (ASP015K) showed improvement in clinical outcomes, which was maintained throughout the treatment duration of 32 months along with a generally tolerable safety profile in patients with rheumatoid arthritis (RA).

Major finding: The American College of Rheumatology (ACR)20, ACR50, and ACR70 response rates were maintained throughout from baseline (71.6%, 52.1%, and 34.7%, respectively) to the end of treatment (78.7%, 63.3%, and 44.1%, respectively). Treatment-emergent adverse events, mostly grade 1 or 2 in severity, were experienced by 94.4% of patients, leading to drug discontinuation in 16.6% of patients. 

Study details: Findings are from the final analysis of an open-label long-term extension study involving 843 Asian patients with RA who previously completed phase 2b and phase 3 studies of peficitinib.

Disclosures: This work was funded by the Astellas Pharma, Inc. The authors including the lead author reported receiving grants, speaker’s fees, consultancy fees, personal fees, and/or honoraria from various sources including Astellas Pharma, Inc. Four of the authors reported being employees of Astellas Pharma, Inc.

Source: Takeuchi T et al. Rheumatol Ther. 2021 Mar 3. doi: 10.1007/s40744-021-00280-5.

Key clinical point: Peficitinib (ASP015K) showed improvement in clinical outcomes, which was maintained throughout the treatment duration of 32 months along with a generally tolerable safety profile in patients with rheumatoid arthritis (RA).

Major finding: The American College of Rheumatology (ACR)20, ACR50, and ACR70 response rates were maintained throughout from baseline (71.6%, 52.1%, and 34.7%, respectively) to the end of treatment (78.7%, 63.3%, and 44.1%, respectively). Treatment-emergent adverse events, mostly grade 1 or 2 in severity, were experienced by 94.4% of patients, leading to drug discontinuation in 16.6% of patients. 

Study details: Findings are from the final analysis of an open-label long-term extension study involving 843 Asian patients with RA who previously completed phase 2b and phase 3 studies of peficitinib.

Disclosures: This work was funded by the Astellas Pharma, Inc. The authors including the lead author reported receiving grants, speaker’s fees, consultancy fees, personal fees, and/or honoraria from various sources including Astellas Pharma, Inc. Four of the authors reported being employees of Astellas Pharma, Inc.

Source: Takeuchi T et al. Rheumatol Ther. 2021 Mar 3. doi: 10.1007/s40744-021-00280-5.

Key clinical point: Peficitinib (ASP015K) showed improvement in clinical outcomes, which was maintained throughout the treatment duration of 32 months along with a generally tolerable safety profile in patients with rheumatoid arthritis (RA).

Major finding: The American College of Rheumatology (ACR)20, ACR50, and ACR70 response rates were maintained throughout from baseline (71.6%, 52.1%, and 34.7%, respectively) to the end of treatment (78.7%, 63.3%, and 44.1%, respectively). Treatment-emergent adverse events, mostly grade 1 or 2 in severity, were experienced by 94.4% of patients, leading to drug discontinuation in 16.6% of patients. 

Study details: Findings are from the final analysis of an open-label long-term extension study involving 843 Asian patients with RA who previously completed phase 2b and phase 3 studies of peficitinib.

Disclosures: This work was funded by the Astellas Pharma, Inc. The authors including the lead author reported receiving grants, speaker’s fees, consultancy fees, personal fees, and/or honoraria from various sources including Astellas Pharma, Inc. Four of the authors reported being employees of Astellas Pharma, Inc.

Source: Takeuchi T et al. Rheumatol Ther. 2021 Mar 3. doi: 10.1007/s40744-021-00280-5.

Key clinical point: Patients with early rheumatoid arthritis (RA) who initiated biological vs. triple therapy after inadequate response to methotrexate (MTX) were more likely to achieve sustained remission (SR).

Major finding: Patients initiating biological vs. triple therapy were more likely to achieve short-term and long-term SR at 1 year (adjusted odds ratio [aOR], 1.79; 95% confidence interval [CI], 1.18-2.71 and aOR, 1.86; 95% CI, 1.00-3.48, respectively) and 2 years (aOR, 1.92; 95% CI, 1.21-3.06 and aOR, 1.62; 95% CI, 0.94-2.79, respectively) from treatment initiation.

Study details: Findings are from an analysis of 1,502 patients with relatively early RA who initiated biological (biological disease-modifying antirheumatic drugs+MTX; n=1,155) or triple (MTX+sulfasalazine+hydroxychloroquine/chloroquine; n=347) therapy as the first treatment strategy after inadequate response to MTX monotherapy.

Disclosures: This work funded by the Swedish Rheumatism Association, the Medical Faculty of Lund University, Alfred Österlund ́s Foundation, Greta and Johan Kock ́s foundation, the King Gustaf V Foundation, Lund University Hospital, Professor Nanna Svartz Foundation, and Anna-Greta Crafoord Foundation. The authors declared no conflicts of interest.

Source: Källmark H et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41720.

Key clinical point: Patients with early rheumatoid arthritis (RA) who initiated biological vs. triple therapy after inadequate response to methotrexate (MTX) were more likely to achieve sustained remission (SR).

Major finding: Patients initiating biological vs. triple therapy were more likely to achieve short-term and long-term SR at 1 year (adjusted odds ratio [aOR], 1.79; 95% confidence interval [CI], 1.18-2.71 and aOR, 1.86; 95% CI, 1.00-3.48, respectively) and 2 years (aOR, 1.92; 95% CI, 1.21-3.06 and aOR, 1.62; 95% CI, 0.94-2.79, respectively) from treatment initiation.

Study details: Findings are from an analysis of 1,502 patients with relatively early RA who initiated biological (biological disease-modifying antirheumatic drugs+MTX; n=1,155) or triple (MTX+sulfasalazine+hydroxychloroquine/chloroquine; n=347) therapy as the first treatment strategy after inadequate response to MTX monotherapy.

Disclosures: This work funded by the Swedish Rheumatism Association, the Medical Faculty of Lund University, Alfred Österlund ́s Foundation, Greta and Johan Kock ́s foundation, the King Gustaf V Foundation, Lund University Hospital, Professor Nanna Svartz Foundation, and Anna-Greta Crafoord Foundation. The authors declared no conflicts of interest.

Source: Källmark H et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41720.

Key clinical point: Patients with early rheumatoid arthritis (RA) who initiated biological vs. triple therapy after inadequate response to methotrexate (MTX) were more likely to achieve sustained remission (SR).

Major finding: Patients initiating biological vs. triple therapy were more likely to achieve short-term and long-term SR at 1 year (adjusted odds ratio [aOR], 1.79; 95% confidence interval [CI], 1.18-2.71 and aOR, 1.86; 95% CI, 1.00-3.48, respectively) and 2 years (aOR, 1.92; 95% CI, 1.21-3.06 and aOR, 1.62; 95% CI, 0.94-2.79, respectively) from treatment initiation.

Study details: Findings are from an analysis of 1,502 patients with relatively early RA who initiated biological (biological disease-modifying antirheumatic drugs+MTX; n=1,155) or triple (MTX+sulfasalazine+hydroxychloroquine/chloroquine; n=347) therapy as the first treatment strategy after inadequate response to MTX monotherapy.

Disclosures: This work funded by the Swedish Rheumatism Association, the Medical Faculty of Lund University, Alfred Österlund ́s Foundation, Greta and Johan Kock ́s foundation, the King Gustaf V Foundation, Lund University Hospital, Professor Nanna Svartz Foundation, and Anna-Greta Crafoord Foundation. The authors declared no conflicts of interest.

Source: Källmark H et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41720.

Bimekizumab, an investigational humanized monoclonal antibody that inhibits both interleukin-17A and -17F, proved far more efficacious than adalimumab for treatment of moderate to severe plaque psoriasis in the head-to-head, phase 3 BE SURE trial, Jerry Bagel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.

“Results demonstrated that bimekizumab was superior to adalimumab over 16 weeks of treatment in terms of the speed, depth, and durability of skin clearance,” reported Dr. Bagel, a dermatologist at the Psoriasis Center of Central New Jersey, East Windsor.

The Food and Drug Administration is now reviewing UCB’s application for marketing approval of bimekizumab for treatment of moderate to severe psoriasis in adults.

BE SURE was a 478-patient, double-blind, phase 3 trial in which patients were randomized to one of three regimens: 320 mg of bimekizumab every 4 weeks; the tumor necrosis factor blocker adalimumab (Humira) at 40 mg every 2 weeks for 24 weeks, followed by a switch to bimekizumab at 320 mg every 4 weeks; or 320 mg of bimekizumab every 4 weeks for 16 weeks, then ratcheting back to dosing every 8 weeks. The trial concluded at week 56, Dr. Bagel explained at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.

The two coprimary endpoints were the 16-week rates of a 90% improvement from baseline in Psoriasis Area and Severity Index score, or PASI 90 response, and an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear. Bimekizumab every 4 weeks bested adalimumab on both endpoints, with a PASI 90 rate of 86.2%, compared with 47.2%, and a IGA 0/1 rate of 85.3% versus 57.2%. The 16-week PASI 100 response rate was 60.8% with bimekizumab and 23.9% with adalimumab.

The response to bimekizumab was notably fast: already by week 4, the PASI 75 rate was 76.4%, compared with 31.4% with adalimumab. And once patients switched from adalimumab to bimekizumab at week 24, their response rates shot up rapidly. Bimekizumab was equally effective whether dosed at 320 mg every 4 weeks or at maintenance dosing every 8 weeks, such that at week 56 patients in all three study arms had PASI 90 rates of 82%-84%.

The most frequent treatment-emergent adverse events associated with bimekizumab were oral candidiasis, nasopharyngitis, and upper respiratory tract infection. The oral candidiasis, which occurred in 13.2% of patients on bimekizumab every 4 weeks, was mainly mild to moderate, localized, and in no instance led to discontinuation of therapy, according to Dr. Bagel.

“Very impressive data,” commented session comoderator Linda Stein Gold, MD. “This study shows some data that’s potentially unprecedented. Bimekizumab was superior to one of the drugs that we know, we’ve used, and know is very, very effective.”

“Note the speed of this drug,” added comoderator Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn. “It achieved at week 4 the efficacy that it took adalimumab until week 16 to reach. So it is a very fast drug. Bimekizumab will be the fastest drug you’ve ever, ever worked with.”

“You’ll see in the bimekizumab studies about a fivefold increased frequency of oral candidiasis relative to our more legacy IL-17 inhibitors, such as ixekizumab, secukinumab, and brodalumab. I think that means approximately one in five or one in six patients will have some form of candidiasis when you treat them with bimekizumab,” he said. Therefore, he added, “in some patients you’ll have to manage oral candidiasis. Most affected patients don’t leave the studies, so it’s manageable, but you’ll have to become something of an authority on how to treat with, for example, oral antifungal swish-and-swallow, swish-and-spit, or oral fluconazole. And some of these patients will have recurrent infections.”

It’s a prospect that doesn’t concern Dr. Stein Gold. “This is a side effect that we can treat. We can see it, we’re comfortable with it, and it’s certainly something we can get a handle on,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.

BE SURE was funded by UCB. Dr. Bagel reported serving as a speaker for, consultant to, and paid investigator for AbbVie, Celgene, Eli Lilly, Leo Pharma, Novartis, and Ortho Pharmaceuticals. Dr. Stein Gold and Dr. Strober reported having financial relationships with numerous pharmaceutical companies.

MedscapeLIVE! and this news organization are owned by the same parent company.

[email protected]

Bimekizumab, an investigational humanized monoclonal antibody that inhibits both interleukin-17A and -17F, proved far more efficacious than adalimumab for treatment of moderate to severe plaque psoriasis in the head-to-head, phase 3 BE SURE trial, Jerry Bagel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.

“Results demonstrated that bimekizumab was superior to adalimumab over 16 weeks of treatment in terms of the speed, depth, and durability of skin clearance,” reported Dr. Bagel, a dermatologist at the Psoriasis Center of Central New Jersey, East Windsor.

The Food and Drug Administration is now reviewing UCB’s application for marketing approval of bimekizumab for treatment of moderate to severe psoriasis in adults.

BE SURE was a 478-patient, double-blind, phase 3 trial in which patients were randomized to one of three regimens: 320 mg of bimekizumab every 4 weeks; the tumor necrosis factor blocker adalimumab (Humira) at 40 mg every 2 weeks for 24 weeks, followed by a switch to bimekizumab at 320 mg every 4 weeks; or 320 mg of bimekizumab every 4 weeks for 16 weeks, then ratcheting back to dosing every 8 weeks. The trial concluded at week 56, Dr. Bagel explained at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.

The two coprimary endpoints were the 16-week rates of a 90% improvement from baseline in Psoriasis Area and Severity Index score, or PASI 90 response, and an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear. Bimekizumab every 4 weeks bested adalimumab on both endpoints, with a PASI 90 rate of 86.2%, compared with 47.2%, and a IGA 0/1 rate of 85.3% versus 57.2%. The 16-week PASI 100 response rate was 60.8% with bimekizumab and 23.9% with adalimumab.

The response to bimekizumab was notably fast: already by week 4, the PASI 75 rate was 76.4%, compared with 31.4% with adalimumab. And once patients switched from adalimumab to bimekizumab at week 24, their response rates shot up rapidly. Bimekizumab was equally effective whether dosed at 320 mg every 4 weeks or at maintenance dosing every 8 weeks, such that at week 56 patients in all three study arms had PASI 90 rates of 82%-84%.

The most frequent treatment-emergent adverse events associated with bimekizumab were oral candidiasis, nasopharyngitis, and upper respiratory tract infection. The oral candidiasis, which occurred in 13.2% of patients on bimekizumab every 4 weeks, was mainly mild to moderate, localized, and in no instance led to discontinuation of therapy, according to Dr. Bagel.

“Very impressive data,” commented session comoderator Linda Stein Gold, MD. “This study shows some data that’s potentially unprecedented. Bimekizumab was superior to one of the drugs that we know, we’ve used, and know is very, very effective.”

“Note the speed of this drug,” added comoderator Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn. “It achieved at week 4 the efficacy that it took adalimumab until week 16 to reach. So it is a very fast drug. Bimekizumab will be the fastest drug you’ve ever, ever worked with.”

“You’ll see in the bimekizumab studies about a fivefold increased frequency of oral candidiasis relative to our more legacy IL-17 inhibitors, such as ixekizumab, secukinumab, and brodalumab. I think that means approximately one in five or one in six patients will have some form of candidiasis when you treat them with bimekizumab,” he said. Therefore, he added, “in some patients you’ll have to manage oral candidiasis. Most affected patients don’t leave the studies, so it’s manageable, but you’ll have to become something of an authority on how to treat with, for example, oral antifungal swish-and-swallow, swish-and-spit, or oral fluconazole. And some of these patients will have recurrent infections.”

It’s a prospect that doesn’t concern Dr. Stein Gold. “This is a side effect that we can treat. We can see it, we’re comfortable with it, and it’s certainly something we can get a handle on,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.

BE SURE was funded by UCB. Dr. Bagel reported serving as a speaker for, consultant to, and paid investigator for AbbVie, Celgene, Eli Lilly, Leo Pharma, Novartis, and Ortho Pharmaceuticals. Dr. Stein Gold and Dr. Strober reported having financial relationships with numerous pharmaceutical companies.

MedscapeLIVE! and this news organization are owned by the same parent company.

[email protected]

Bimekizumab, an investigational humanized monoclonal antibody that inhibits both interleukin-17A and -17F, proved far more efficacious than adalimumab for treatment of moderate to severe plaque psoriasis in the head-to-head, phase 3 BE SURE trial, Jerry Bagel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.

“Results demonstrated that bimekizumab was superior to adalimumab over 16 weeks of treatment in terms of the speed, depth, and durability of skin clearance,” reported Dr. Bagel, a dermatologist at the Psoriasis Center of Central New Jersey, East Windsor.

The Food and Drug Administration is now reviewing UCB’s application for marketing approval of bimekizumab for treatment of moderate to severe psoriasis in adults.

BE SURE was a 478-patient, double-blind, phase 3 trial in which patients were randomized to one of three regimens: 320 mg of bimekizumab every 4 weeks; the tumor necrosis factor blocker adalimumab (Humira) at 40 mg every 2 weeks for 24 weeks, followed by a switch to bimekizumab at 320 mg every 4 weeks; or 320 mg of bimekizumab every 4 weeks for 16 weeks, then ratcheting back to dosing every 8 weeks. The trial concluded at week 56, Dr. Bagel explained at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.

The two coprimary endpoints were the 16-week rates of a 90% improvement from baseline in Psoriasis Area and Severity Index score, or PASI 90 response, and an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear. Bimekizumab every 4 weeks bested adalimumab on both endpoints, with a PASI 90 rate of 86.2%, compared with 47.2%, and a IGA 0/1 rate of 85.3% versus 57.2%. The 16-week PASI 100 response rate was 60.8% with bimekizumab and 23.9% with adalimumab.

The response to bimekizumab was notably fast: already by week 4, the PASI 75 rate was 76.4%, compared with 31.4% with adalimumab. And once patients switched from adalimumab to bimekizumab at week 24, their response rates shot up rapidly. Bimekizumab was equally effective whether dosed at 320 mg every 4 weeks or at maintenance dosing every 8 weeks, such that at week 56 patients in all three study arms had PASI 90 rates of 82%-84%.

The most frequent treatment-emergent adverse events associated with bimekizumab were oral candidiasis, nasopharyngitis, and upper respiratory tract infection. The oral candidiasis, which occurred in 13.2% of patients on bimekizumab every 4 weeks, was mainly mild to moderate, localized, and in no instance led to discontinuation of therapy, according to Dr. Bagel.

“Very impressive data,” commented session comoderator Linda Stein Gold, MD. “This study shows some data that’s potentially unprecedented. Bimekizumab was superior to one of the drugs that we know, we’ve used, and know is very, very effective.”

“Note the speed of this drug,” added comoderator Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn. “It achieved at week 4 the efficacy that it took adalimumab until week 16 to reach. So it is a very fast drug. Bimekizumab will be the fastest drug you’ve ever, ever worked with.”

“You’ll see in the bimekizumab studies about a fivefold increased frequency of oral candidiasis relative to our more legacy IL-17 inhibitors, such as ixekizumab, secukinumab, and brodalumab. I think that means approximately one in five or one in six patients will have some form of candidiasis when you treat them with bimekizumab,” he said. Therefore, he added, “in some patients you’ll have to manage oral candidiasis. Most affected patients don’t leave the studies, so it’s manageable, but you’ll have to become something of an authority on how to treat with, for example, oral antifungal swish-and-swallow, swish-and-spit, or oral fluconazole. And some of these patients will have recurrent infections.”

It’s a prospect that doesn’t concern Dr. Stein Gold. “This is a side effect that we can treat. We can see it, we’re comfortable with it, and it’s certainly something we can get a handle on,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.

BE SURE was funded by UCB. Dr. Bagel reported serving as a speaker for, consultant to, and paid investigator for AbbVie, Celgene, Eli Lilly, Leo Pharma, Novartis, and Ortho Pharmaceuticals. Dr. Stein Gold and Dr. Strober reported having financial relationships with numerous pharmaceutical companies.

MedscapeLIVE! and this news organization are owned by the same parent company.

[email protected]

The United States saw nearly 23% more deaths than expected during the first 9 months of the pandemic, and almost three-quarters of those deaths involved COVID-19.

For comparison, the death rate increased by 2.5% or less annually in recent years.

At the same time, rates of deaths from heart disease, Alzheimer’s disease or dementia, and diabetes also increased from March 1, 2020, to Jan. 2, 2021, especially during COVID-19 surges.

“Excess deaths surged in the east in April, followed by extended summer and early winter surges concentrated in Southern and Western states, respectively. Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states,” lead author Steven H. Woolf, MD, MPH, from the Virginia Commonwealth University, Richmond, and colleagues wrote in a research letter published online April 2, 2021, in JAMA.

COVID-19 mortality included all deaths for which it was cited as an underlying or contributing cause in records from the District of Columbia and 49 states. North Carolina was excluded for insufficient data.
 

More than half a million excess deaths

Between March 1, 2020, and Jan. 2, 2021, the United States experienced 2,801,439 deaths, or 522,368 excess deaths. A total 72.4% of these events were attributed to COVID-19.

Not all racial and ethnic groups were equally represented. For example, the rate of excess deaths was higher among non-Hispanic Black populations, at 208.4 deaths per 100,000. Non-Hispanic White populations experienced 157 deaths per 100,000, and Hispanic populations experienced 139.8 deaths per 100,000.

Further, non-Hispanic Black individuals accounted for 16.9% of the excess deaths but only 12.5% of the U.S. population, which reflects “racial disparities in COVID-19 mortality,” the authors noted.

Not adjusting for population aging is a potential limitation, as was reliance on provisional data and the likelihood that some death certificates were inaccurate.

In February, Anthony S. Fauci, MD, chief medical adviser to President Joe Biden, stated that political divisions likely played a role in the 500,000-plus COVID-19–related deaths in the United States. 

Then a report came out on March 26 indicating that a different U.S. response to the pandemic could have avoided almost 400,000 COVID-19 deaths. In addition, an April 1 study in the CDC’s Morbidity and Mortality Weekly Report revealed that COVID-19 is now the third leading cause of death in the United States, after heart disease and cancer.
 

‘Massive’ excessive mortality

“There is no more visible or alarming manifestation of the toll of the COVID-19 pandemic than the deaths it has caused. In this issue of JAMA, Dr. Woolf and colleagues provide updated analyses that demonstrate that the excess mortality in the U.S. between March 1, 2020, and Jan. 2, 2021, has been massive,” Alan Garber, MD, PhD, wrote in an accompanying editorial.

“It seems likely that COVID-19 will have contributed to nearly as many deaths in the U.S. as the great influenza pandemic of 1918, and more than in any influenza outbreak in the U.S. since then,” added Dr. Garber, provost of Harvard University in Cambridge, Mass.

This study of excess mortality illustrates what is at stake, he added. “Despite the scientific, medical and public health progress of recent decades, the loss of life attributable to the COVID-19 pandemic exceeds the mortality of major wars. No nation should squander this opportunity to do what it takes to prepare for the next one.”

Dr. Woolf and Dr. Garber disclosed no relevant financial relationships. The National Institutes of Health supported the research through its National Center for Advancing Translational Sciences and the National Institute on Aging.

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

The United States saw nearly 23% more deaths than expected during the first 9 months of the pandemic, and almost three-quarters of those deaths involved COVID-19.

For comparison, the death rate increased by 2.5% or less annually in recent years.

At the same time, rates of deaths from heart disease, Alzheimer’s disease or dementia, and diabetes also increased from March 1, 2020, to Jan. 2, 2021, especially during COVID-19 surges.

“Excess deaths surged in the east in April, followed by extended summer and early winter surges concentrated in Southern and Western states, respectively. Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states,” lead author Steven H. Woolf, MD, MPH, from the Virginia Commonwealth University, Richmond, and colleagues wrote in a research letter published online April 2, 2021, in JAMA.

COVID-19 mortality included all deaths for which it was cited as an underlying or contributing cause in records from the District of Columbia and 49 states. North Carolina was excluded for insufficient data.
 

More than half a million excess deaths

Between March 1, 2020, and Jan. 2, 2021, the United States experienced 2,801,439 deaths, or 522,368 excess deaths. A total 72.4% of these events were attributed to COVID-19.

Not all racial and ethnic groups were equally represented. For example, the rate of excess deaths was higher among non-Hispanic Black populations, at 208.4 deaths per 100,000. Non-Hispanic White populations experienced 157 deaths per 100,000, and Hispanic populations experienced 139.8 deaths per 100,000.

Further, non-Hispanic Black individuals accounted for 16.9% of the excess deaths but only 12.5% of the U.S. population, which reflects “racial disparities in COVID-19 mortality,” the authors noted.

Not adjusting for population aging is a potential limitation, as was reliance on provisional data and the likelihood that some death certificates were inaccurate.

In February, Anthony S. Fauci, MD, chief medical adviser to President Joe Biden, stated that political divisions likely played a role in the 500,000-plus COVID-19–related deaths in the United States. 

Then a report came out on March 26 indicating that a different U.S. response to the pandemic could have avoided almost 400,000 COVID-19 deaths. In addition, an April 1 study in the CDC’s Morbidity and Mortality Weekly Report revealed that COVID-19 is now the third leading cause of death in the United States, after heart disease and cancer.
 

‘Massive’ excessive mortality

“There is no more visible or alarming manifestation of the toll of the COVID-19 pandemic than the deaths it has caused. In this issue of JAMA, Dr. Woolf and colleagues provide updated analyses that demonstrate that the excess mortality in the U.S. between March 1, 2020, and Jan. 2, 2021, has been massive,” Alan Garber, MD, PhD, wrote in an accompanying editorial.

“It seems likely that COVID-19 will have contributed to nearly as many deaths in the U.S. as the great influenza pandemic of 1918, and more than in any influenza outbreak in the U.S. since then,” added Dr. Garber, provost of Harvard University in Cambridge, Mass.

This study of excess mortality illustrates what is at stake, he added. “Despite the scientific, medical and public health progress of recent decades, the loss of life attributable to the COVID-19 pandemic exceeds the mortality of major wars. No nation should squander this opportunity to do what it takes to prepare for the next one.”

Dr. Woolf and Dr. Garber disclosed no relevant financial relationships. The National Institutes of Health supported the research through its National Center for Advancing Translational Sciences and the National Institute on Aging.

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

The United States saw nearly 23% more deaths than expected during the first 9 months of the pandemic, and almost three-quarters of those deaths involved COVID-19.

For comparison, the death rate increased by 2.5% or less annually in recent years.

At the same time, rates of deaths from heart disease, Alzheimer’s disease or dementia, and diabetes also increased from March 1, 2020, to Jan. 2, 2021, especially during COVID-19 surges.

“Excess deaths surged in the east in April, followed by extended summer and early winter surges concentrated in Southern and Western states, respectively. Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states,” lead author Steven H. Woolf, MD, MPH, from the Virginia Commonwealth University, Richmond, and colleagues wrote in a research letter published online April 2, 2021, in JAMA.

COVID-19 mortality included all deaths for which it was cited as an underlying or contributing cause in records from the District of Columbia and 49 states. North Carolina was excluded for insufficient data.
 

More than half a million excess deaths

Between March 1, 2020, and Jan. 2, 2021, the United States experienced 2,801,439 deaths, or 522,368 excess deaths. A total 72.4% of these events were attributed to COVID-19.

Not all racial and ethnic groups were equally represented. For example, the rate of excess deaths was higher among non-Hispanic Black populations, at 208.4 deaths per 100,000. Non-Hispanic White populations experienced 157 deaths per 100,000, and Hispanic populations experienced 139.8 deaths per 100,000.

Further, non-Hispanic Black individuals accounted for 16.9% of the excess deaths but only 12.5% of the U.S. population, which reflects “racial disparities in COVID-19 mortality,” the authors noted.

Not adjusting for population aging is a potential limitation, as was reliance on provisional data and the likelihood that some death certificates were inaccurate.

In February, Anthony S. Fauci, MD, chief medical adviser to President Joe Biden, stated that political divisions likely played a role in the 500,000-plus COVID-19–related deaths in the United States. 

Then a report came out on March 26 indicating that a different U.S. response to the pandemic could have avoided almost 400,000 COVID-19 deaths. In addition, an April 1 study in the CDC’s Morbidity and Mortality Weekly Report revealed that COVID-19 is now the third leading cause of death in the United States, after heart disease and cancer.
 

‘Massive’ excessive mortality

“There is no more visible or alarming manifestation of the toll of the COVID-19 pandemic than the deaths it has caused. In this issue of JAMA, Dr. Woolf and colleagues provide updated analyses that demonstrate that the excess mortality in the U.S. between March 1, 2020, and Jan. 2, 2021, has been massive,” Alan Garber, MD, PhD, wrote in an accompanying editorial.

“It seems likely that COVID-19 will have contributed to nearly as many deaths in the U.S. as the great influenza pandemic of 1918, and more than in any influenza outbreak in the U.S. since then,” added Dr. Garber, provost of Harvard University in Cambridge, Mass.

This study of excess mortality illustrates what is at stake, he added. “Despite the scientific, medical and public health progress of recent decades, the loss of life attributable to the COVID-19 pandemic exceeds the mortality of major wars. No nation should squander this opportunity to do what it takes to prepare for the next one.”

Dr. Woolf and Dr. Garber disclosed no relevant financial relationships. The National Institutes of Health supported the research through its National Center for Advancing Translational Sciences and the National Institute on Aging.

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

Psoriatic arthritis may be associated with excess mortality risk but the current evidence to support excess mortality in psoriatic arthritis is inconclusive. Nevertheless, identifying risk factors for mortality in patients with psoriatic arthritis is important so that modifiable factors could be addressed. Vela et al investigated whether the cumulative pain experienced by psoriatic arthritis patients was associated with increased mortality. Using data from the Danish nationwide registry of biological therapies (DANBIO), the authors showed that although there was a significant association between pain intensity and mortality (odds ratio 1.06 (95%CI 1.02 to 1.10) per 5 VAS unit increase), no association was found when the analyses was adjusted for confounders including age, CRP, joint counts, HAQ score, treatment, and comorbidities. As expected, recent glucocorticoid use, chronic obstructive pulmonary disease, diabetes mellitus, cancer and cardiovascular disease were associated with excess mortality. The results indicate that mortality in psoriatic arthritis is primarily driven by associated comorbidities; holistic management of psoriatic disease should include management of associated comorbidities.

Comorbidities have a major impact on patients with psoriatic arthritis and influence a patient’s quality of life and function as well as treatment response. Neuropsychiatric comorbidities have been less studied in psoriatic arthritis. An intriguing study by Garcia et al indicate that cognitive impairment may be associated with psoriatic arthritis. In a small cross-sectional study, they demonstrated that patients with psoriatic arthritis score worse on the Montreal Cognitive Assessment (MoCA) tool compared to controls, with executive skills, naming, language, and abstraction being most affected. Further research is required to explore whether other comorbidities such as cerebrovascular disease, depression or sleep disturbances explain the cognitive impairment. Depression and anxiety are also associated with reduced likelihood of achieving remission or low disease activity state in psoriatic arthritis. In a study of 743 patients, Wong et al demonstrated that patients with depression or anxiety are less likely to achieve a state of sustained minimal disease activity. These studies once again highlight the management of comorbidities to achieve improved outcomes in patients with psoriatic arthritis.

New data also indicate efficacy of targeted therapy in psoriatic arthritis. In two phase 3 trials funded by LEO pharma, Mease et al report that brodalumab, an interleukin 17 receptor inhibitor that is already available for the treatment for psoriasis, is efficacious in the treatment of psoriatic arthritis. Although the trial was terminated early, pooled data from the two trials showed that higher proportions of patients on 140 mg and 210 mg of brodalumab achieved American College of Rheumatology (ACR)20 response at week 16 compared to placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001).

There are limited data on treatment withdrawal in patients with psoriatic arthritis. Coates et al investigated whether continued treatment with ixekizumab, an interleukin 17A inhibitor was superior to withdrawing ixekizumab in maintaining minimal disease activity state in patents with psoriatic arthritis. They showed that more patients relapsed rapidly after ixekizumab was withdrawn compared to those continuing ixekizumab treatment. Importantly, >95% of patients who relapsed with treatment withdrawal re-achieved MDA on retreatment with ixekizumab within a median duration of 4.1 weeks. Thus, ixekizumab treatment is best maintained after a patient achieves a state of minimal disease activity. If the treatment needs to be interrupted (e.g., infection, surgery), most patients will re-achieve the state of minimal disease activity on retreatment.

Finally, research continues to demonstrate delayed diagnosis of psoriatic arthritis. Karmacharya et al showed that only 45% of patients receive a diagnosis of psoriatic arthritis by 2 years after symptom onset. This study from the population-based Rochester Epidemiology Project indicates that earlier age of onset of symptoms, the presence of higher body mass index and enthesitis are associated with diagnostic delay. Further education of health care providers and patients with psoriasis about psoriatic arthritis may help reduce diagnostic delay; delayed diagnosis leads to poorer long-term outcomes.

Psoriatic arthritis may be associated with excess mortality risk but the current evidence to support excess mortality in psoriatic arthritis is inconclusive. Nevertheless, identifying risk factors for mortality in patients with psoriatic arthritis is important so that modifiable factors could be addressed. Vela et al investigated whether the cumulative pain experienced by psoriatic arthritis patients was associated with increased mortality. Using data from the Danish nationwide registry of biological therapies (DANBIO), the authors showed that although there was a significant association between pain intensity and mortality (odds ratio 1.06 (95%CI 1.02 to 1.10) per 5 VAS unit increase), no association was found when the analyses was adjusted for confounders including age, CRP, joint counts, HAQ score, treatment, and comorbidities. As expected, recent glucocorticoid use, chronic obstructive pulmonary disease, diabetes mellitus, cancer and cardiovascular disease were associated with excess mortality. The results indicate that mortality in psoriatic arthritis is primarily driven by associated comorbidities; holistic management of psoriatic disease should include management of associated comorbidities.

Comorbidities have a major impact on patients with psoriatic arthritis and influence a patient’s quality of life and function as well as treatment response. Neuropsychiatric comorbidities have been less studied in psoriatic arthritis. An intriguing study by Garcia et al indicate that cognitive impairment may be associated with psoriatic arthritis. In a small cross-sectional study, they demonstrated that patients with psoriatic arthritis score worse on the Montreal Cognitive Assessment (MoCA) tool compared to controls, with executive skills, naming, language, and abstraction being most affected. Further research is required to explore whether other comorbidities such as cerebrovascular disease, depression or sleep disturbances explain the cognitive impairment. Depression and anxiety are also associated with reduced likelihood of achieving remission or low disease activity state in psoriatic arthritis. In a study of 743 patients, Wong et al demonstrated that patients with depression or anxiety are less likely to achieve a state of sustained minimal disease activity. These studies once again highlight the management of comorbidities to achieve improved outcomes in patients with psoriatic arthritis.

New data also indicate efficacy of targeted therapy in psoriatic arthritis. In two phase 3 trials funded by LEO pharma, Mease et al report that brodalumab, an interleukin 17 receptor inhibitor that is already available for the treatment for psoriasis, is efficacious in the treatment of psoriatic arthritis. Although the trial was terminated early, pooled data from the two trials showed that higher proportions of patients on 140 mg and 210 mg of brodalumab achieved American College of Rheumatology (ACR)20 response at week 16 compared to placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001).

There are limited data on treatment withdrawal in patients with psoriatic arthritis. Coates et al investigated whether continued treatment with ixekizumab, an interleukin 17A inhibitor was superior to withdrawing ixekizumab in maintaining minimal disease activity state in patents with psoriatic arthritis. They showed that more patients relapsed rapidly after ixekizumab was withdrawn compared to those continuing ixekizumab treatment. Importantly, >95% of patients who relapsed with treatment withdrawal re-achieved MDA on retreatment with ixekizumab within a median duration of 4.1 weeks. Thus, ixekizumab treatment is best maintained after a patient achieves a state of minimal disease activity. If the treatment needs to be interrupted (e.g., infection, surgery), most patients will re-achieve the state of minimal disease activity on retreatment.

Finally, research continues to demonstrate delayed diagnosis of psoriatic arthritis. Karmacharya et al showed that only 45% of patients receive a diagnosis of psoriatic arthritis by 2 years after symptom onset. This study from the population-based Rochester Epidemiology Project indicates that earlier age of onset of symptoms, the presence of higher body mass index and enthesitis are associated with diagnostic delay. Further education of health care providers and patients with psoriasis about psoriatic arthritis may help reduce diagnostic delay; delayed diagnosis leads to poorer long-term outcomes.

Psoriatic arthritis may be associated with excess mortality risk but the current evidence to support excess mortality in psoriatic arthritis is inconclusive. Nevertheless, identifying risk factors for mortality in patients with psoriatic arthritis is important so that modifiable factors could be addressed. Vela et al investigated whether the cumulative pain experienced by psoriatic arthritis patients was associated with increased mortality. Using data from the Danish nationwide registry of biological therapies (DANBIO), the authors showed that although there was a significant association between pain intensity and mortality (odds ratio 1.06 (95%CI 1.02 to 1.10) per 5 VAS unit increase), no association was found when the analyses was adjusted for confounders including age, CRP, joint counts, HAQ score, treatment, and comorbidities. As expected, recent glucocorticoid use, chronic obstructive pulmonary disease, diabetes mellitus, cancer and cardiovascular disease were associated with excess mortality. The results indicate that mortality in psoriatic arthritis is primarily driven by associated comorbidities; holistic management of psoriatic disease should include management of associated comorbidities.

Comorbidities have a major impact on patients with psoriatic arthritis and influence a patient’s quality of life and function as well as treatment response. Neuropsychiatric comorbidities have been less studied in psoriatic arthritis. An intriguing study by Garcia et al indicate that cognitive impairment may be associated with psoriatic arthritis. In a small cross-sectional study, they demonstrated that patients with psoriatic arthritis score worse on the Montreal Cognitive Assessment (MoCA) tool compared to controls, with executive skills, naming, language, and abstraction being most affected. Further research is required to explore whether other comorbidities such as cerebrovascular disease, depression or sleep disturbances explain the cognitive impairment. Depression and anxiety are also associated with reduced likelihood of achieving remission or low disease activity state in psoriatic arthritis. In a study of 743 patients, Wong et al demonstrated that patients with depression or anxiety are less likely to achieve a state of sustained minimal disease activity. These studies once again highlight the management of comorbidities to achieve improved outcomes in patients with psoriatic arthritis.

New data also indicate efficacy of targeted therapy in psoriatic arthritis. In two phase 3 trials funded by LEO pharma, Mease et al report that brodalumab, an interleukin 17 receptor inhibitor that is already available for the treatment for psoriasis, is efficacious in the treatment of psoriatic arthritis. Although the trial was terminated early, pooled data from the two trials showed that higher proportions of patients on 140 mg and 210 mg of brodalumab achieved American College of Rheumatology (ACR)20 response at week 16 compared to placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001).

There are limited data on treatment withdrawal in patients with psoriatic arthritis. Coates et al investigated whether continued treatment with ixekizumab, an interleukin 17A inhibitor was superior to withdrawing ixekizumab in maintaining minimal disease activity state in patents with psoriatic arthritis. They showed that more patients relapsed rapidly after ixekizumab was withdrawn compared to those continuing ixekizumab treatment. Importantly, >95% of patients who relapsed with treatment withdrawal re-achieved MDA on retreatment with ixekizumab within a median duration of 4.1 weeks. Thus, ixekizumab treatment is best maintained after a patient achieves a state of minimal disease activity. If the treatment needs to be interrupted (e.g., infection, surgery), most patients will re-achieve the state of minimal disease activity on retreatment.

Finally, research continues to demonstrate delayed diagnosis of psoriatic arthritis. Karmacharya et al showed that only 45% of patients receive a diagnosis of psoriatic arthritis by 2 years after symptom onset. This study from the population-based Rochester Epidemiology Project indicates that earlier age of onset of symptoms, the presence of higher body mass index and enthesitis are associated with diagnostic delay. Further education of health care providers and patients with psoriasis about psoriatic arthritis may help reduce diagnostic delay; delayed diagnosis leads to poorer long-term outcomes.

Key clinical point: More than half of patients with PsA had a diagnostic delay of >2 years.

Major finding: The percentage of patients receiving a diagnosis of PsA by 2 years after symptom onset was 45%. Factors associated with a diagnostic delay of >2 years included earlier age at onset of symptoms, higher body mass index, and enthesitis.

Study details: The data come from a retrospective, population-based cohort of 164 incident adult PsA patients.

Disclosures: The study used resources of the Rochester Epidemiology Project, which is supported by various National Institutes of Health grants. P Karmacharya and A Duarte-García reported receiving individual research grants. A Ogdie and JM Davis reported ties with various pharmaceutical companies. The remaining authors declared no conflicts of interest.

Source: Karmacharya P et al. J Rheumatol. 2021 Feb 15. doi: 10.3899/jrheum.201199.

Key clinical point: More than half of patients with PsA had a diagnostic delay of >2 years.

Major finding: The percentage of patients receiving a diagnosis of PsA by 2 years after symptom onset was 45%. Factors associated with a diagnostic delay of >2 years included earlier age at onset of symptoms, higher body mass index, and enthesitis.

Study details: The data come from a retrospective, population-based cohort of 164 incident adult PsA patients.

Disclosures: The study used resources of the Rochester Epidemiology Project, which is supported by various National Institutes of Health grants. P Karmacharya and A Duarte-García reported receiving individual research grants. A Ogdie and JM Davis reported ties with various pharmaceutical companies. The remaining authors declared no conflicts of interest.

Source: Karmacharya P et al. J Rheumatol. 2021 Feb 15. doi: 10.3899/jrheum.201199.

Key clinical point: More than half of patients with PsA had a diagnostic delay of >2 years.

Major finding: The percentage of patients receiving a diagnosis of PsA by 2 years after symptom onset was 45%. Factors associated with a diagnostic delay of >2 years included earlier age at onset of symptoms, higher body mass index, and enthesitis.

Study details: The data come from a retrospective, population-based cohort of 164 incident adult PsA patients.

Disclosures: The study used resources of the Rochester Epidemiology Project, which is supported by various National Institutes of Health grants. P Karmacharya and A Duarte-García reported receiving individual research grants. A Ogdie and JM Davis reported ties with various pharmaceutical companies. The remaining authors declared no conflicts of interest.

Source: Karmacharya P et al. J Rheumatol. 2021 Feb 15. doi: 10.3899/jrheum.201199.

Key clinical point: There is favorable agreement between ultrasound (US) and magnetic resonance imaging (MRI) for detecting inflammatory changes in finger joints of patients with psoriatic arthritis (PsA). Additionally, there is a favorable agreement between US, radiography and MRI for detecting destructive changes.

Major finding: The absolute agreement between US and MRI was in the range of good-to-very good for detecting synovitis (85%-96%), flexor tenosynovitis (93%-98%), and extensor paratenonitis (95%-98%). Agreement between US, MRI and radiography was also good-to-very good for detecting erosions (96%-98%) and bone proliferations (71%-93%).

Study details: The data come from a study of 100 consecutive PsA patients who underwent clinical assessment and concomitant radiographic, US and MRI evaluations of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints of one hand.

Disclosures: The study was supported by an investigator-initiated research grant sponsored by Johnson and Johnson. The authors declared no conflicts of interest.

Source: Polachek A et al. Rheumatology (Oxford). 2021 Mar 17. doi: 10.1093/rheumatology/keab272.

Key clinical point: There is favorable agreement between ultrasound (US) and magnetic resonance imaging (MRI) for detecting inflammatory changes in finger joints of patients with psoriatic arthritis (PsA). Additionally, there is a favorable agreement between US, radiography and MRI for detecting destructive changes.

Major finding: The absolute agreement between US and MRI was in the range of good-to-very good for detecting synovitis (85%-96%), flexor tenosynovitis (93%-98%), and extensor paratenonitis (95%-98%). Agreement between US, MRI and radiography was also good-to-very good for detecting erosions (96%-98%) and bone proliferations (71%-93%).

Study details: The data come from a study of 100 consecutive PsA patients who underwent clinical assessment and concomitant radiographic, US and MRI evaluations of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints of one hand.

Disclosures: The study was supported by an investigator-initiated research grant sponsored by Johnson and Johnson. The authors declared no conflicts of interest.

Source: Polachek A et al. Rheumatology (Oxford). 2021 Mar 17. doi: 10.1093/rheumatology/keab272.

Key clinical point: There is favorable agreement between ultrasound (US) and magnetic resonance imaging (MRI) for detecting inflammatory changes in finger joints of patients with psoriatic arthritis (PsA). Additionally, there is a favorable agreement between US, radiography and MRI for detecting destructive changes.

Major finding: The absolute agreement between US and MRI was in the range of good-to-very good for detecting synovitis (85%-96%), flexor tenosynovitis (93%-98%), and extensor paratenonitis (95%-98%). Agreement between US, MRI and radiography was also good-to-very good for detecting erosions (96%-98%) and bone proliferations (71%-93%).

Study details: The data come from a study of 100 consecutive PsA patients who underwent clinical assessment and concomitant radiographic, US and MRI evaluations of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints of one hand.

Disclosures: The study was supported by an investigator-initiated research grant sponsored by Johnson and Johnson. The authors declared no conflicts of interest.

Source: Polachek A et al. Rheumatology (Oxford). 2021 Mar 17. doi: 10.1093/rheumatology/keab272.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

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

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

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

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

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

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.