MDedge Dermatology

Key clinical point: Despite failing to achieve 20% or higher improvement in American College of Rheumatology (ACR20) criteria at week 104, some patients with psoriatic arthritis (PsA) receiving long-term treatment with apremilast experienced meaningful clinical benefits not completely captured by ACR20 response criteria.

Major finding: At week 104 of apremilast treatment, 58.0%, 41.7%, and 44.3% of patients who failed to achieve ACR20 had a mean improvement in swollen joint count, tender joint count, and Physician’s Global Assessment scores, respectively. Additionally, 33.8% and 68.2% of these patients achieved resolution of enthesitis and dactylitis.

Study details: Findings are pooled analysis of phase 3 studies, PALACE 1, 2, and 3, and included patients randomly assigned to 30 mg apremilast twice daily and classified into those who did not achieve (n = 109) and those who achieved (n = 193) ACR20 response at week 104.

Disclosures: This study was funded by Celgene. All investigators reported ties with various sources including Celgene.

Source: Mease PJ et al. Rheumatol Ther. 2021 Sep 18. doi: 10.1007/s40744-021-00369-x.

Key clinical point: Despite failing to achieve 20% or higher improvement in American College of Rheumatology (ACR20) criteria at week 104, some patients with psoriatic arthritis (PsA) receiving long-term treatment with apremilast experienced meaningful clinical benefits not completely captured by ACR20 response criteria.

Major finding: At week 104 of apremilast treatment, 58.0%, 41.7%, and 44.3% of patients who failed to achieve ACR20 had a mean improvement in swollen joint count, tender joint count, and Physician’s Global Assessment scores, respectively. Additionally, 33.8% and 68.2% of these patients achieved resolution of enthesitis and dactylitis.

Study details: Findings are pooled analysis of phase 3 studies, PALACE 1, 2, and 3, and included patients randomly assigned to 30 mg apremilast twice daily and classified into those who did not achieve (n = 109) and those who achieved (n = 193) ACR20 response at week 104.

Disclosures: This study was funded by Celgene. All investigators reported ties with various sources including Celgene.

Source: Mease PJ et al. Rheumatol Ther. 2021 Sep 18. doi: 10.1007/s40744-021-00369-x.

Key clinical point: Despite failing to achieve 20% or higher improvement in American College of Rheumatology (ACR20) criteria at week 104, some patients with psoriatic arthritis (PsA) receiving long-term treatment with apremilast experienced meaningful clinical benefits not completely captured by ACR20 response criteria.

Major finding: At week 104 of apremilast treatment, 58.0%, 41.7%, and 44.3% of patients who failed to achieve ACR20 had a mean improvement in swollen joint count, tender joint count, and Physician’s Global Assessment scores, respectively. Additionally, 33.8% and 68.2% of these patients achieved resolution of enthesitis and dactylitis.

Study details: Findings are pooled analysis of phase 3 studies, PALACE 1, 2, and 3, and included patients randomly assigned to 30 mg apremilast twice daily and classified into those who did not achieve (n = 109) and those who achieved (n = 193) ACR20 response at week 104.

Disclosures: This study was funded by Celgene. All investigators reported ties with various sources including Celgene.

Source: Mease PJ et al. Rheumatol Ther. 2021 Sep 18. doi: 10.1007/s40744-021-00369-x.

Key clinical point: Patients with psoriasis with the most severe disease were at highest risk of developing psoriatic arthritis (PsA), highlighting the need for regular screening for signs and symptoms of PsA.

Major finding: Overall incidence of PsA in patients with mild, moderate, and severe psoriasis was 2.1 (95% CI 2.1-2.1), 9.9 (95% CI 9.5-10.4), and 17.6 (95% CI 16.9-18.3) events per 100 patient-years, respectively. The 5-year prevalence rate of PsA was highest for patients with severe psoriasis (54.9%) and lowest for those with mild psoriasis (9.9%).

Study details: Findings are from a retrospective analysis of the United States Electronic Health Records database including 114,868 patients with newly diagnosed psoriasis.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ. The investigators reported ties with several sources including Novartis. Some of the investigators declared being current or former employees of Novartis Pharmaceuticals Corporation, Novartis Pharma AG, or KMK Consulting, Inc.

Source: Merola JF et al. J Am Acad Dermatol. 2021 Sep 18. doi: 10.1016/j.jaad.2021.09.019.

Key clinical point: Patients with psoriasis with the most severe disease were at highest risk of developing psoriatic arthritis (PsA), highlighting the need for regular screening for signs and symptoms of PsA.

Major finding: Overall incidence of PsA in patients with mild, moderate, and severe psoriasis was 2.1 (95% CI 2.1-2.1), 9.9 (95% CI 9.5-10.4), and 17.6 (95% CI 16.9-18.3) events per 100 patient-years, respectively. The 5-year prevalence rate of PsA was highest for patients with severe psoriasis (54.9%) and lowest for those with mild psoriasis (9.9%).

Study details: Findings are from a retrospective analysis of the United States Electronic Health Records database including 114,868 patients with newly diagnosed psoriasis.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ. The investigators reported ties with several sources including Novartis. Some of the investigators declared being current or former employees of Novartis Pharmaceuticals Corporation, Novartis Pharma AG, or KMK Consulting, Inc.

Source: Merola JF et al. J Am Acad Dermatol. 2021 Sep 18. doi: 10.1016/j.jaad.2021.09.019.

Key clinical point: Patients with psoriasis with the most severe disease were at highest risk of developing psoriatic arthritis (PsA), highlighting the need for regular screening for signs and symptoms of PsA.

Major finding: Overall incidence of PsA in patients with mild, moderate, and severe psoriasis was 2.1 (95% CI 2.1-2.1), 9.9 (95% CI 9.5-10.4), and 17.6 (95% CI 16.9-18.3) events per 100 patient-years, respectively. The 5-year prevalence rate of PsA was highest for patients with severe psoriasis (54.9%) and lowest for those with mild psoriasis (9.9%).

Study details: Findings are from a retrospective analysis of the United States Electronic Health Records database including 114,868 patients with newly diagnosed psoriasis.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ. The investigators reported ties with several sources including Novartis. Some of the investigators declared being current or former employees of Novartis Pharmaceuticals Corporation, Novartis Pharma AG, or KMK Consulting, Inc.

Source: Merola JF et al. J Am Acad Dermatol. 2021 Sep 18. doi: 10.1016/j.jaad.2021.09.019.

Key clinical point: When choosing biologic medicines, patients with psoriatic arthritis (PsA) preferred oral medications and prioritized ability to work/lead a normal life and avoiding serious complications over clinical measures of improvement.

Major finding: Patients preferred oral vs. subcutaneous or intravenous routes (β coefficient 1.00; fixed parameter) and prioritized avoiding severe adverse events (β 0.72, 95% CI 0.50-0.95) and ability to attend normal activities (β 0.66; 95% CI 0.36-0.96) over improvement in enthesitis pain (β 0.28; 95% CI 0.20-0.36), psoriasis (β 0.28; 95% CI 0.20-0.36), and increasing chance of remission (β 0.27; 95% CI 0.19-0.36).

Study details: Findings are from a discrete choice experiment including 150 survey respondents with PsA, of which 75 patients were receiving biologics, 83 had an experience of biologic therapy, and 41 had an experience of 2 or more biologics.

Disclosures: The study had no funding to declare. Dr. Hassett declared receiving speaker fees or advisory board fees from AbbVie and Amgen.

Source: Sumpton D et al. Arthritis Care Res. 2021 Sep 13. doi: 10.1002/acr.24782.

Key clinical point: When choosing biologic medicines, patients with psoriatic arthritis (PsA) preferred oral medications and prioritized ability to work/lead a normal life and avoiding serious complications over clinical measures of improvement.

Major finding: Patients preferred oral vs. subcutaneous or intravenous routes (β coefficient 1.00; fixed parameter) and prioritized avoiding severe adverse events (β 0.72, 95% CI 0.50-0.95) and ability to attend normal activities (β 0.66; 95% CI 0.36-0.96) over improvement in enthesitis pain (β 0.28; 95% CI 0.20-0.36), psoriasis (β 0.28; 95% CI 0.20-0.36), and increasing chance of remission (β 0.27; 95% CI 0.19-0.36).

Study details: Findings are from a discrete choice experiment including 150 survey respondents with PsA, of which 75 patients were receiving biologics, 83 had an experience of biologic therapy, and 41 had an experience of 2 or more biologics.

Disclosures: The study had no funding to declare. Dr. Hassett declared receiving speaker fees or advisory board fees from AbbVie and Amgen.

Source: Sumpton D et al. Arthritis Care Res. 2021 Sep 13. doi: 10.1002/acr.24782.

Key clinical point: When choosing biologic medicines, patients with psoriatic arthritis (PsA) preferred oral medications and prioritized ability to work/lead a normal life and avoiding serious complications over clinical measures of improvement.

Major finding: Patients preferred oral vs. subcutaneous or intravenous routes (β coefficient 1.00; fixed parameter) and prioritized avoiding severe adverse events (β 0.72, 95% CI 0.50-0.95) and ability to attend normal activities (β 0.66; 95% CI 0.36-0.96) over improvement in enthesitis pain (β 0.28; 95% CI 0.20-0.36), psoriasis (β 0.28; 95% CI 0.20-0.36), and increasing chance of remission (β 0.27; 95% CI 0.19-0.36).

Study details: Findings are from a discrete choice experiment including 150 survey respondents with PsA, of which 75 patients were receiving biologics, 83 had an experience of biologic therapy, and 41 had an experience of 2 or more biologics.

Disclosures: The study had no funding to declare. Dr. Hassett declared receiving speaker fees or advisory board fees from AbbVie and Amgen.

Source: Sumpton D et al. Arthritis Care Res. 2021 Sep 13. doi: 10.1002/acr.24782.

Key clinical point: Evaluation with power Doppler ultrasound revealed a rapid and significant reduction of synovitis in patients with psoriatic arthritis (PsA) upon treatment with secukinumab.

Major finding: At week 12, the adjusted mean change in the global European League Against Rheumatism (EULAR) and the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) (EULAR-OMERACT) synovitis score was significantly higher in secukinumab vs. placebo group (−9 vs. −6; difference −3; P = .004), with the effect of secukinumab evident as early as week 1 of treatment initiation. The incidence of treatment-emergent adverse events in secukinumab vs. placebo group was 58% vs. 57%.

Study details: Findings are 12-week results from ULTIMATE, a phase 3 study including 166 biologic-naive patients with concomitant PsA and synovitis who failed conventional synthetic disease-modifying antirheumatic drugs. Patients were randomly assigned to receive subcutaneous secukinumab (300 mg or 150 mg) or placebo weekly until week 4, followed by 4-weekly dosing until week 52.

Disclosures: This study was funded by Novartis. Some of the authors reported ties with various sources including Novartis. A Duggan, P Goyanka, and C Gaillez declared being employees of or owning stock in Novartis.

Source: D'Agostino MA et al. Rheumatology. 2021 Sep 16. doi: 10.1093/rheumatology/keab628.

Key clinical point: Evaluation with power Doppler ultrasound revealed a rapid and significant reduction of synovitis in patients with psoriatic arthritis (PsA) upon treatment with secukinumab.

Major finding: At week 12, the adjusted mean change in the global European League Against Rheumatism (EULAR) and the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) (EULAR-OMERACT) synovitis score was significantly higher in secukinumab vs. placebo group (−9 vs. −6; difference −3; P = .004), with the effect of secukinumab evident as early as week 1 of treatment initiation. The incidence of treatment-emergent adverse events in secukinumab vs. placebo group was 58% vs. 57%.

Study details: Findings are 12-week results from ULTIMATE, a phase 3 study including 166 biologic-naive patients with concomitant PsA and synovitis who failed conventional synthetic disease-modifying antirheumatic drugs. Patients were randomly assigned to receive subcutaneous secukinumab (300 mg or 150 mg) or placebo weekly until week 4, followed by 4-weekly dosing until week 52.

Disclosures: This study was funded by Novartis. Some of the authors reported ties with various sources including Novartis. A Duggan, P Goyanka, and C Gaillez declared being employees of or owning stock in Novartis.

Source: D'Agostino MA et al. Rheumatology. 2021 Sep 16. doi: 10.1093/rheumatology/keab628.

Key clinical point: Evaluation with power Doppler ultrasound revealed a rapid and significant reduction of synovitis in patients with psoriatic arthritis (PsA) upon treatment with secukinumab.

Major finding: At week 12, the adjusted mean change in the global European League Against Rheumatism (EULAR) and the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) (EULAR-OMERACT) synovitis score was significantly higher in secukinumab vs. placebo group (−9 vs. −6; difference −3; P = .004), with the effect of secukinumab evident as early as week 1 of treatment initiation. The incidence of treatment-emergent adverse events in secukinumab vs. placebo group was 58% vs. 57%.

Study details: Findings are 12-week results from ULTIMATE, a phase 3 study including 166 biologic-naive patients with concomitant PsA and synovitis who failed conventional synthetic disease-modifying antirheumatic drugs. Patients were randomly assigned to receive subcutaneous secukinumab (300 mg or 150 mg) or placebo weekly until week 4, followed by 4-weekly dosing until week 52.

Disclosures: This study was funded by Novartis. Some of the authors reported ties with various sources including Novartis. A Duggan, P Goyanka, and C Gaillez declared being employees of or owning stock in Novartis.

Source: D'Agostino MA et al. Rheumatology. 2021 Sep 16. doi: 10.1093/rheumatology/keab628.

Key clinical point: Patients with psoriasis who initiated biologics were more likely to develop psoriatic arthritis (PsA) than those who initiated phototherapy or oral therapy.

Major finding: The incidence rate of PsA regardless of exposure to any treatment was 9.75 per 1000 person-years vs. 77.26, 61.99, and 26.11 per 1000 person-years among initiators of biologics, oral therapy, and phototherapy, respectively. Patients receiving biologics were at a significantly higher risk of developing PsA vs. those receiving either oral or phototherapy (hazard ratio 4.48; 95% CI 4.23-4.75).

Study details: Findings are from a retrospective cohort study including 193,709 patients with psoriasis without PsA, of which 14,569 biologic and 20,321 cumulative oral and phototherapy initiations were identified.

Disclosures: R Fitzsimmons and A Ogdie received funding from National Psoriasis Foundation. Dr. Gelfand, T Love, and A Ogdie reported ties with several sources.

Source: Meer E et al. Ann Rheum Dis. 2021 Oct 6. doi: 10.1136/annrheumdis-2021-220761.

Key clinical point: Patients with psoriasis who initiated biologics were more likely to develop psoriatic arthritis (PsA) than those who initiated phototherapy or oral therapy.

Major finding: The incidence rate of PsA regardless of exposure to any treatment was 9.75 per 1000 person-years vs. 77.26, 61.99, and 26.11 per 1000 person-years among initiators of biologics, oral therapy, and phototherapy, respectively. Patients receiving biologics were at a significantly higher risk of developing PsA vs. those receiving either oral or phototherapy (hazard ratio 4.48; 95% CI 4.23-4.75).

Study details: Findings are from a retrospective cohort study including 193,709 patients with psoriasis without PsA, of which 14,569 biologic and 20,321 cumulative oral and phototherapy initiations were identified.

Disclosures: R Fitzsimmons and A Ogdie received funding from National Psoriasis Foundation. Dr. Gelfand, T Love, and A Ogdie reported ties with several sources.

Source: Meer E et al. Ann Rheum Dis. 2021 Oct 6. doi: 10.1136/annrheumdis-2021-220761.

Key clinical point: Patients with psoriasis who initiated biologics were more likely to develop psoriatic arthritis (PsA) than those who initiated phototherapy or oral therapy.

Major finding: The incidence rate of PsA regardless of exposure to any treatment was 9.75 per 1000 person-years vs. 77.26, 61.99, and 26.11 per 1000 person-years among initiators of biologics, oral therapy, and phototherapy, respectively. Patients receiving biologics were at a significantly higher risk of developing PsA vs. those receiving either oral or phototherapy (hazard ratio 4.48; 95% CI 4.23-4.75).

Study details: Findings are from a retrospective cohort study including 193,709 patients with psoriasis without PsA, of which 14,569 biologic and 20,321 cumulative oral and phototherapy initiations were identified.

Disclosures: R Fitzsimmons and A Ogdie received funding from National Psoriasis Foundation. Dr. Gelfand, T Love, and A Ogdie reported ties with several sources.

Source: Meer E et al. Ann Rheum Dis. 2021 Oct 6. doi: 10.1136/annrheumdis-2021-220761.

Key clinical point: Disease activity-guided dose optimization (DAGDO) of tumor necrosis factor inhibitor (TNFi) showed no negative effect on disease activity in patients with psoriatic arthritis (PsA).

Major finding: Compared with the full-dose continuation period, the mean disease activity score in 28-joint count C-reactive protein was not significantly different for DAGDO (0.06; P = .44) and stable dose after DAGDO (0.03; P = .72) periods. Moreover, the rate ratio of infections was not different in DAGDO (0.76; P = .57) and stable dose after DAGDO (0.77; P = .60) periods compared to the full-dose continuation period.

Study details: Findings are from 2 controlled, parallel, retrospective cohorts including 153 patients with PsA and 171 patients with axial spondyloarthritis who were doing well taking TNFi and were eligible for DAGDO.

Disclosures: This study did not report any source of funding. Dr. den Broeder A declared receiving consultancy, honoraria, congress invitations, and research grants from various sources.

Source: Michielsens CAJ et al. Rheumatology. 2021 Oct 2. doi: 10.1093/rheumatology/keab741.

Key clinical point: Disease activity-guided dose optimization (DAGDO) of tumor necrosis factor inhibitor (TNFi) showed no negative effect on disease activity in patients with psoriatic arthritis (PsA).

Major finding: Compared with the full-dose continuation period, the mean disease activity score in 28-joint count C-reactive protein was not significantly different for DAGDO (0.06; P = .44) and stable dose after DAGDO (0.03; P = .72) periods. Moreover, the rate ratio of infections was not different in DAGDO (0.76; P = .57) and stable dose after DAGDO (0.77; P = .60) periods compared to the full-dose continuation period.

Study details: Findings are from 2 controlled, parallel, retrospective cohorts including 153 patients with PsA and 171 patients with axial spondyloarthritis who were doing well taking TNFi and were eligible for DAGDO.

Disclosures: This study did not report any source of funding. Dr. den Broeder A declared receiving consultancy, honoraria, congress invitations, and research grants from various sources.

Source: Michielsens CAJ et al. Rheumatology. 2021 Oct 2. doi: 10.1093/rheumatology/keab741.

Key clinical point: Disease activity-guided dose optimization (DAGDO) of tumor necrosis factor inhibitor (TNFi) showed no negative effect on disease activity in patients with psoriatic arthritis (PsA).

Major finding: Compared with the full-dose continuation period, the mean disease activity score in 28-joint count C-reactive protein was not significantly different for DAGDO (0.06; P = .44) and stable dose after DAGDO (0.03; P = .72) periods. Moreover, the rate ratio of infections was not different in DAGDO (0.76; P = .57) and stable dose after DAGDO (0.77; P = .60) periods compared to the full-dose continuation period.

Study details: Findings are from 2 controlled, parallel, retrospective cohorts including 153 patients with PsA and 171 patients with axial spondyloarthritis who were doing well taking TNFi and were eligible for DAGDO.

Disclosures: This study did not report any source of funding. Dr. den Broeder A declared receiving consultancy, honoraria, congress invitations, and research grants from various sources.

Source: Michielsens CAJ et al. Rheumatology. 2021 Oct 2. doi: 10.1093/rheumatology/keab741.

When the COVID-19 pandemic temporarily shuttered in-patient visits to a multispecialty practice in the San Francisco Bay Area in March of 2019, Olga Afanasiev, MD, PhD, and her colleagues saw an opportunity to create a new teledermatology workflow.

“Before COVID, we had zero use of teledermatology,” Dr. Afanasiev, a dermatologist at the practice, said during the annual meeting of the Pacific Dermatologic Association. “We didn’t do photography other than the required pre-biopsy photographs, and minimal evaluation of home photos, in response to the patients who say, ‘Wait, doc. Let me pull out my phone and show my photographs.”

During the very first days of the pandemic, in order to accommodate urgent patient requests, she and her colleagues used cloud services for patients to submit photos for concerning skin conditions or lesions, which were then discussed over commonly available video platforms. But they quickly realized that this would not work long-term so within two months, they created an electronic health record–integrated workflow that they are still using, she said.

Here’s how it works. If the patient request is deemed nonacute or does not require a full-body skin exam, the scheduling team offers that patient a store-and-video evaluation (SAVe) or an in-person visit. If a SAVe visit is requested, the patient is required to submit a photograph of his or her condition, then a medical assistant checks for the presence and quality of up to nine patient-submitted photos and contacts the patient if additional photos are required.

Immediately before the encounter, a medical assistant calls the patient to ensure video connectivity and performs a brief intake history. The patient and physician then connect via a video-capable platform – most commonly Vidyo, which is integrated with EPIC. After the visit, the provider notifies the scheduling team if any additional in-person or virtual follow up is required.

In a half day of practice, Dr. Afanasiev sees about 20 patients via video visits scheduled every 15 minutes. On a recent day, 55% of visits were related to acne and 10% were related to a mole check, which usually resulted in recommendation for biopsy. Most (70%) were existing patients, while 30% were new.

“There is no store-and-forward option at this time, meaning that patients can’t just submit a photo without a visit,” she said. “In addition, part of our consent is, if you don’t show up to your scheduled video visit, your photos will not be reviewed. The photos are linked to the video visit and uploaded to the patient’s chart. The rooming workflow is very similar to in clinic, except you’re at home and the medical assistant is remote.”

In an article recently published in the Journal of the American Academy of Dermatology, Dr. Afanasiev and her colleagues described their experience with this photo plus video teledermatology – SAVe – workflow between March 16, 2020, and Aug. 31, 2020. The researchers analyzed 74,411 dermatology cases encountered by 89 providers who cared for 46,024 patients during that time frame. Most of the encounters (79%) were in-person, while the remaining 21% were digital in nature – SAVe in 89% of cases, followed by telephone/message encounters.

At the initial peak of the COVID-19 pandemic in April 2020, SAVe encounters increased to 72% of all encounters from 0% prior to March 16, 2020, and were sustained at 12% when the clinic reopened in the summer of 2020. Over the study period, the clinic’s incorporation of SAVe increased care access to patients located in 731 unique ZIP codes in and near California. “We also have been able to retain many patients within our system,” Dr. Afanasiev said. “We have a large proportion of patients that require 2-3 hours of travel time to get to our clinic, so virtual visits allowed for increased rural access. It also allowed for flexibility for patients and providers.”

The new workflow also led to faster access to care. The time from referral to an in-person evaluation fell from an average of 56 days in 2019 to average of 27 days in 2020, while the wait time for a virtual visit was just 14 days in 2020. “We were able to see a diverse number of diagnostic categories with both in-person and virtual care, most commonly rashes, acne, dermal growths, and pigmentary disorders,” she said.

For clinicians interested in incorporating a SAVe-like system into their workflow, Dr. Afanasiev advises them to think seriously about consent. “You want to make sure patients understand what they’re getting themselves into,” she said. “You want to make sure they know that some diagnoses cannot be adequately addressed by teledermatology.” Photo quality is also important, she said. “Video quality is not good enough for most of our diagnoses, so photos are an important part of this evaluation. In this day and age, patients are actually pretty good photographers most of the time.”

SDI Productions/E+

She urges practices to carefully think about how they allow patients to submit photos, especially if photographs are not attached to a billable visit.

In her opinion, a good teledermatology platform should have trained support staff with the ability for patients to send photos prior to their visit, and should be safe, secure, and HIPAA compliant. It should also be app and browser compatible and have high resolution and low downtime.

“Into the future, I think it’s important to maintain teledermatology within our clinical practice, especially for remote monitoring of chronic skin diseases,” Dr. Afanasiev said. “Oftentimes we schedule 3- or 6-month follow-ups but often those do not correspond to the patients’ disease flare. They may have had an eczema or psoriatic flare 3 weeks prior, but we see them in clinic with clear skin, which makes it hard to judge how to tailor our treatment. It will also be important for us to understand the safety and security and legal implications of these new practice styles.”

She also referred to technological advances, which she said “will dovetail well with teledermatology, including robust at-home and commercial 3D virtual capture technology, machine learning algorithms for improved photos, and virtual biopsy technology.”

Dr. Afanasiev is a member of the American Academy of Dermatology Teledermatology Task Force. She had no relevant disclosures.
 

[email protected]

When the COVID-19 pandemic temporarily shuttered in-patient visits to a multispecialty practice in the San Francisco Bay Area in March of 2019, Olga Afanasiev, MD, PhD, and her colleagues saw an opportunity to create a new teledermatology workflow.

“Before COVID, we had zero use of teledermatology,” Dr. Afanasiev, a dermatologist at the practice, said during the annual meeting of the Pacific Dermatologic Association. “We didn’t do photography other than the required pre-biopsy photographs, and minimal evaluation of home photos, in response to the patients who say, ‘Wait, doc. Let me pull out my phone and show my photographs.”

During the very first days of the pandemic, in order to accommodate urgent patient requests, she and her colleagues used cloud services for patients to submit photos for concerning skin conditions or lesions, which were then discussed over commonly available video platforms. But they quickly realized that this would not work long-term so within two months, they created an electronic health record–integrated workflow that they are still using, she said.

Here’s how it works. If the patient request is deemed nonacute or does not require a full-body skin exam, the scheduling team offers that patient a store-and-video evaluation (SAVe) or an in-person visit. If a SAVe visit is requested, the patient is required to submit a photograph of his or her condition, then a medical assistant checks for the presence and quality of up to nine patient-submitted photos and contacts the patient if additional photos are required.

Immediately before the encounter, a medical assistant calls the patient to ensure video connectivity and performs a brief intake history. The patient and physician then connect via a video-capable platform – most commonly Vidyo, which is integrated with EPIC. After the visit, the provider notifies the scheduling team if any additional in-person or virtual follow up is required.

In a half day of practice, Dr. Afanasiev sees about 20 patients via video visits scheduled every 15 minutes. On a recent day, 55% of visits were related to acne and 10% were related to a mole check, which usually resulted in recommendation for biopsy. Most (70%) were existing patients, while 30% were new.

“There is no store-and-forward option at this time, meaning that patients can’t just submit a photo without a visit,” she said. “In addition, part of our consent is, if you don’t show up to your scheduled video visit, your photos will not be reviewed. The photos are linked to the video visit and uploaded to the patient’s chart. The rooming workflow is very similar to in clinic, except you’re at home and the medical assistant is remote.”

In an article recently published in the Journal of the American Academy of Dermatology, Dr. Afanasiev and her colleagues described their experience with this photo plus video teledermatology – SAVe – workflow between March 16, 2020, and Aug. 31, 2020. The researchers analyzed 74,411 dermatology cases encountered by 89 providers who cared for 46,024 patients during that time frame. Most of the encounters (79%) were in-person, while the remaining 21% were digital in nature – SAVe in 89% of cases, followed by telephone/message encounters.

At the initial peak of the COVID-19 pandemic in April 2020, SAVe encounters increased to 72% of all encounters from 0% prior to March 16, 2020, and were sustained at 12% when the clinic reopened in the summer of 2020. Over the study period, the clinic’s incorporation of SAVe increased care access to patients located in 731 unique ZIP codes in and near California. “We also have been able to retain many patients within our system,” Dr. Afanasiev said. “We have a large proportion of patients that require 2-3 hours of travel time to get to our clinic, so virtual visits allowed for increased rural access. It also allowed for flexibility for patients and providers.”

The new workflow also led to faster access to care. The time from referral to an in-person evaluation fell from an average of 56 days in 2019 to average of 27 days in 2020, while the wait time for a virtual visit was just 14 days in 2020. “We were able to see a diverse number of diagnostic categories with both in-person and virtual care, most commonly rashes, acne, dermal growths, and pigmentary disorders,” she said.

For clinicians interested in incorporating a SAVe-like system into their workflow, Dr. Afanasiev advises them to think seriously about consent. “You want to make sure patients understand what they’re getting themselves into,” she said. “You want to make sure they know that some diagnoses cannot be adequately addressed by teledermatology.” Photo quality is also important, she said. “Video quality is not good enough for most of our diagnoses, so photos are an important part of this evaluation. In this day and age, patients are actually pretty good photographers most of the time.”

SDI Productions/E+

She urges practices to carefully think about how they allow patients to submit photos, especially if photographs are not attached to a billable visit.

In her opinion, a good teledermatology platform should have trained support staff with the ability for patients to send photos prior to their visit, and should be safe, secure, and HIPAA compliant. It should also be app and browser compatible and have high resolution and low downtime.

“Into the future, I think it’s important to maintain teledermatology within our clinical practice, especially for remote monitoring of chronic skin diseases,” Dr. Afanasiev said. “Oftentimes we schedule 3- or 6-month follow-ups but often those do not correspond to the patients’ disease flare. They may have had an eczema or psoriatic flare 3 weeks prior, but we see them in clinic with clear skin, which makes it hard to judge how to tailor our treatment. It will also be important for us to understand the safety and security and legal implications of these new practice styles.”

She also referred to technological advances, which she said “will dovetail well with teledermatology, including robust at-home and commercial 3D virtual capture technology, machine learning algorithms for improved photos, and virtual biopsy technology.”

Dr. Afanasiev is a member of the American Academy of Dermatology Teledermatology Task Force. She had no relevant disclosures.
 

[email protected]

When the COVID-19 pandemic temporarily shuttered in-patient visits to a multispecialty practice in the San Francisco Bay Area in March of 2019, Olga Afanasiev, MD, PhD, and her colleagues saw an opportunity to create a new teledermatology workflow.

“Before COVID, we had zero use of teledermatology,” Dr. Afanasiev, a dermatologist at the practice, said during the annual meeting of the Pacific Dermatologic Association. “We didn’t do photography other than the required pre-biopsy photographs, and minimal evaluation of home photos, in response to the patients who say, ‘Wait, doc. Let me pull out my phone and show my photographs.”

During the very first days of the pandemic, in order to accommodate urgent patient requests, she and her colleagues used cloud services for patients to submit photos for concerning skin conditions or lesions, which were then discussed over commonly available video platforms. But they quickly realized that this would not work long-term so within two months, they created an electronic health record–integrated workflow that they are still using, she said.

Here’s how it works. If the patient request is deemed nonacute or does not require a full-body skin exam, the scheduling team offers that patient a store-and-video evaluation (SAVe) or an in-person visit. If a SAVe visit is requested, the patient is required to submit a photograph of his or her condition, then a medical assistant checks for the presence and quality of up to nine patient-submitted photos and contacts the patient if additional photos are required.

Immediately before the encounter, a medical assistant calls the patient to ensure video connectivity and performs a brief intake history. The patient and physician then connect via a video-capable platform – most commonly Vidyo, which is integrated with EPIC. After the visit, the provider notifies the scheduling team if any additional in-person or virtual follow up is required.

In a half day of practice, Dr. Afanasiev sees about 20 patients via video visits scheduled every 15 minutes. On a recent day, 55% of visits were related to acne and 10% were related to a mole check, which usually resulted in recommendation for biopsy. Most (70%) were existing patients, while 30% were new.

“There is no store-and-forward option at this time, meaning that patients can’t just submit a photo without a visit,” she said. “In addition, part of our consent is, if you don’t show up to your scheduled video visit, your photos will not be reviewed. The photos are linked to the video visit and uploaded to the patient’s chart. The rooming workflow is very similar to in clinic, except you’re at home and the medical assistant is remote.”

In an article recently published in the Journal of the American Academy of Dermatology, Dr. Afanasiev and her colleagues described their experience with this photo plus video teledermatology – SAVe – workflow between March 16, 2020, and Aug. 31, 2020. The researchers analyzed 74,411 dermatology cases encountered by 89 providers who cared for 46,024 patients during that time frame. Most of the encounters (79%) were in-person, while the remaining 21% were digital in nature – SAVe in 89% of cases, followed by telephone/message encounters.

At the initial peak of the COVID-19 pandemic in April 2020, SAVe encounters increased to 72% of all encounters from 0% prior to March 16, 2020, and were sustained at 12% when the clinic reopened in the summer of 2020. Over the study period, the clinic’s incorporation of SAVe increased care access to patients located in 731 unique ZIP codes in and near California. “We also have been able to retain many patients within our system,” Dr. Afanasiev said. “We have a large proportion of patients that require 2-3 hours of travel time to get to our clinic, so virtual visits allowed for increased rural access. It also allowed for flexibility for patients and providers.”

The new workflow also led to faster access to care. The time from referral to an in-person evaluation fell from an average of 56 days in 2019 to average of 27 days in 2020, while the wait time for a virtual visit was just 14 days in 2020. “We were able to see a diverse number of diagnostic categories with both in-person and virtual care, most commonly rashes, acne, dermal growths, and pigmentary disorders,” she said.

For clinicians interested in incorporating a SAVe-like system into their workflow, Dr. Afanasiev advises them to think seriously about consent. “You want to make sure patients understand what they’re getting themselves into,” she said. “You want to make sure they know that some diagnoses cannot be adequately addressed by teledermatology.” Photo quality is also important, she said. “Video quality is not good enough for most of our diagnoses, so photos are an important part of this evaluation. In this day and age, patients are actually pretty good photographers most of the time.”

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She urges practices to carefully think about how they allow patients to submit photos, especially if photographs are not attached to a billable visit.

In her opinion, a good teledermatology platform should have trained support staff with the ability for patients to send photos prior to their visit, and should be safe, secure, and HIPAA compliant. It should also be app and browser compatible and have high resolution and low downtime.

“Into the future, I think it’s important to maintain teledermatology within our clinical practice, especially for remote monitoring of chronic skin diseases,” Dr. Afanasiev said. “Oftentimes we schedule 3- or 6-month follow-ups but often those do not correspond to the patients’ disease flare. They may have had an eczema or psoriatic flare 3 weeks prior, but we see them in clinic with clear skin, which makes it hard to judge how to tailor our treatment. It will also be important for us to understand the safety and security and legal implications of these new practice styles.”

She also referred to technological advances, which she said “will dovetail well with teledermatology, including robust at-home and commercial 3D virtual capture technology, machine learning algorithms for improved photos, and virtual biopsy technology.”

Dr. Afanasiev is a member of the American Academy of Dermatology Teledermatology Task Force. She had no relevant disclosures.
 

[email protected]

Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.

All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.

All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

Among patients with immune-mediated inflammatory diseases (IMIDs) who get COVID-19, the risk for hospitalization and death is lower if they are receiving tumor necrosis factor (TNF) inhibitor monotherapy, compared with receiving most other common drugs for these conditions, with or without TNF inhibitors, according to a study published in JAMA Network Open The only combination not associated with an increased risk for hospitalization or death was TNF inhibitor therapy with methotrexate.

“These findings support the continued use of TNF inhibitor monotherapy during the pandemic and warrant further research investigating the association of other biologic therapies with COVID-19 outcomes,” write Zara Izadi, MPharm, of the University of California, San Francisco, and her colleagues. “Treatment with TNF inhibitor combination therapy was associated with a more favorable safety profile when methotrexate rather than azathioprine/6-mercaptopurine was used, suggesting that clinicians would benefit from weighing the risks versus benefits of deescalating treatment or changing medications when a patient is receiving concomitant TNF inhibitors and azathioprine/6-mercaptopurine,” they write.
 

Findings mirror those seen in other settings

These findings are in line with what has been found in other settings, according to Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center, vice chair of clinical research, and medical director of the dermatology clinical studies unit at the University of Pennsylvania, Philadelphia.

“In the beginning of the pandemic, there was concern about use of immune-modulating treatments, and many patients self-discontinued treatments like TNF inhibitors,” Dr. Gelfand, who was not involved in the study, told this news organization. “This has ultimately proved unnecessary and unfortunately resulted in harm to many patients due to flaring of their underlying disease.”

Dr. Gelfand emphasized the importance of vaccinating patients against COVID-19 as soon as possible and of getting a third dose for those who are already fully vaccinated with the Pfizer or Moderna shots, as recommended by the Centers for Disease Control and Prevention.

“I typically recommend this third dose be taken 6 months after the second dose,” Dr. Gelfand said. “The good news is that TNF inhibitors do not seem to meaningfully impact response to mRNA vaccines.”
 

Study details

The researchers analyzed data from three international registries of adults with rheumatic diseases, inflammatory bowel disease, and psoriasis who had COVID-19 between March 12, 2020, and Feb. 1, 2021. The registries included the Secure Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) registry, the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), and the physician-reported registry from the Global Rheumatology Alliance (GRA).

The population included 6,077 patients from 74 countries. About half of the cohort (52.9%) were from Europe; more than half were women (58.6%). The average age was 48 years. A little over one-third of the patients (35.3%) had rheumatoid arthritis, 25.3% had Crohn’s disease, 12.5% had ulcerative colitis, 10.3% had spondyloarthritis, and 9.3% had psoriatic arthritis. Smaller percentages had psoriasis (4.9%), another type of arthritis or multiple types (1.7%), or another inflammatory bowel disease (0.6%).

One in five patients (21.3%) were hospitalized, and 3.1% died. The researchers compared outcomes for those who were receiving TNF inhibitor therapy alone to outcomes for those who were taking azathioprine/6-mercaptopurine therapy (alone or with a TNF inhibitor), methotrexate (alone or with a TNF inhibitor), and Janus kinase (JAK) inhibitors. They adjusted their analysis to account for active disease and common comorbidities, as well as geography and the period during the pandemic in which the person was admitted, because treatment regimens and hospitalization indications have varied over time.

All of the therapies except the combination of TNF inhibitors and methotrexate were associated with higher odds of hospitalization and death than TNF inhibitor monotherapy.

The researchers explored several possible explanations for the findings, including the possibility that high serum TNF concentrations may have been associated with more organ damage at the time of COVID-19 admission, owing to interaction with SARS-CoV-2–associated hyperinflammation.

“Therefore, blocking TNF could inhibit this detrimental immune response,” the authors write. “Multiple case series reporting favorable outcomes among patients receiving TNF inhibitor therapy support this assertion.”

Another possibility relates to the effects of taking non–TNF inhibitor medications for immunosuppression. The authors note that thiopurine medications are linked to a greater risk for opportunistic viral infections and that JAK inhibitors may reduce the body’s ability to clear the virus because of its suppression of innate immune response.

The authors also postulate that methotrexate may lower the likelihood of cytokine storm linked to COVID-19, even though methotrexate monotherapy was associated with poorer outcomes. “This association could mean that TNF inhibitor therapy is exerting a protective benefit or that methotrexate therapy is exerting a harmful consequence,” the authors write.

 

Caution needed in interpreting uncontrolled, registry-based data

The findings were not surprising to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, who was not involved in the research.

Northwestern University

“We’ve been monitoring IBD [inflammatory bowel disease] patients through the Secure registry similar to the rheumatologic and dermatologic societies and have not identified a signal of harm from any international groups,” Dr. Hanauer told this news organization. He noted that these registries also have not shown an increased risk for COVID-19 complications among patients receiving TNF inhibitors, antiadhesion therapies, or anti–IL12/23 inhibitors, compared with the general population not taking these therapies.

The study’s size and the diversity of patients strengthen its findings. However, the registries’ use of convenience sampling increases the potential for reporting bias, although the results remained similar after a sensitivity analysis. The study also lacked a control group, and the registries did not collect data uniformly.

“These are databases that rely on reporting from investigators and are not comprehensive prospective studies,” Dr. Hanauer noted as another study limitation.

Dr. Gelfand similarly advised caution in interpreting these findings, inasmuch as the study is a “collection of spontaneous reports” that should be viewed as hypothesis-generating rather than testing.

“Fortunately, more rigorous studies have been conducted, typically in large medical record systems, and have confirmed the hypothesis that TNF inhibitors are associated with a lower risk of poor COVID-19 outcomes, compared to other treatments,” Dr. Gelfand said.

Previous smaller studies similarly found better outcomes among patients taking TNF inhibitors, compared with other therapies, but their participants were predominantly from North America and Europe, noted Licio A. Velloso, MD, PhD, of the University of Campinas, in São Paulo, in an accompanying commentary.

On the basis of the findings of this study, “which included a much larger sample comprising distinct diseases and patients with a multitude of genetic backgrounds, the evidence in favor of the continued use of TNF inhibitor monotherapy for patients with IMIDs during the COVID-19 pandemic has become more substantial,” Dr. Velloso writes. “The finding that maintenance of TNF inhibitor monotherapy is associated with reductions in the risk of severe COVID-19 among patients with IMIDs offers new perspective that may guide health care professionals in the difficult decisions regarding therapeutic approaches among this specific group of patients.”

The research was funded by the American College of Rheumatology, the European Alliance of Associations for Rheumatology, the United Kingdom’s National Institute for Health Research Biomedical Research Center, and the Psoriasis Association. Many authors reported receiving grants and/or personal fees from a variety of pharmaceutical companies. Dr. Velloso has disclosed no relevant financial relationships. Dr. Hanauer has served as a consultant to companies that market TNF inhibitors. Dr. Gelfand has consulted for and received research grants from companies that market TNF inhibitors.

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

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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