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Head to Toe: Recommendations for Physician Head and Shoe Coverings to Limit COVID-19 Transmission
Personal protective equipment (PPE) is an important component in limiting transmission of SARS-CoV-2. The World Health Organization and Centers for Disease Control and Prevention issued guidelines for appropriate PPE use, but recommendations for head and shoe coverings are lacking. In this article, we analyze the literature on pathogen transmission via hair and shoes and make evidence-based recommendations for PPE selection during the COVID-19 pandemic.
Pathogens on Shoes and Hair
Hair and shoes may act as vehicles for pathogen transmission. In a study that simulated contamination of uncovered skin in health care workers after intubating manikins in respiratory distress, 8 (100%) had fluorescent markers on the hair, 6 (75%) on the neck, and 4 (50%) on the shoes.1 In another study of postsurgical operating room (OR) surfaces (517 cultures), uncovered shoe tops and reusable hair coverings had 10-times more bacterial colony–forming units compared to other surfaces. On average, disposable shoe covers/head coverings had less than one-third bacterial colony–forming units compared with uncovered shoes/reusable hair coverings.2
Hair characteristics and coverings may affect pathogen transmission. Exposed hair may collect bacteria, as Staphylococcus aureus and Staphylococcus epidermidis attach to both scalp and facial hair. In one case, β-hemolytic streptococci cultured from the scalp of a perioperative nurse was linked to postsurgical infections in 20 patients.3 Hair coverings include bouffant caps and skullcaps. The bouffant cap is similar to a shower cap; it is relatively loose and secured around the head with elastic. The skullcap, or scrub cap, is tighter but leaves the neck nape and sideburns exposed. In a study comparing disposable bouffant caps, disposable skullcaps, and home-laundered cloth skullcaps worn by 2 teams of 5 surgeons, the disposable bouffant caps had the highest permeability, penetration, and microbial shed of airborne particles.4
Physicians’ shoes may act as fomites for transmission of pathogens to patients. In a study of 41 physicians and nurses in an acute care hospital, shoe soles were positive for at least one pathogen in 12 (29.3%) participants; methicillin-resistant Staphylococcus aureus was most common. Additionally, 98% (49/50) of shoes worn outdoors showed positive bacterial cultures compared to 56% (28/50) of shoes reserved for the OR only.5 In a study examining ventilation effects on airborne pathogens in the OR, 15% of OR airborne bacteria originated from OR floors, and higher bacterial counts correlated with a higher number of steps in the OR.2 In another study designed to evaluate SARS-CoV-2 distribution on hospital floors, 70% (7/10) of quantitative polymerase chain reaction assays performed on floor samples from intensive care units were positive. In addition, 100% (3/3) of swabs taken from hospital pharmacy floors with no COVID-19 patients were positive for SARS-CoV-2, meaning contaminated shoes likely served as vectors.6 Middle East respiratory syndrome, SARS-CoV-2, and influenza viruses may survive on porous and nonporous materials for hours to days.7Enterococcus, Candida, and Aspergillus may survive on textiles for up to 90 days.3
Recommendations for Hair and Shoe Coverings
We recommend that physicians utilize disposable skullcaps to cover the hair and consider a hooded gown or coverall for neck/ear coverage. We also recommend that physicians designate shoes that remain in the workplace and can be easily washed or disinfected at least weekly; physicians may choose to wash or disinfect shoes more often if they frequently are performing procedures that generate aerosols. Additionally, physicians should always wear shoe coverings when caring for patients (Table 1).
Our hair and shoe covering recommendations may serve to protect dermatologists when caring for patients. These protocols may be particularly important for dermatologists performing high-risk procedures, including facial surgery, intraoral/intranasal procedures, and treatment with ablative lasers and facial injectables, especially when the patient is unmasked. These recommendations may limit viral transmission to dermatologists and also protect individuals living in their households. Additional established guidelines by the American Academy of Dermatology, American Society for Dermatologic Surgery, and World Health Organization are listed in Table 2.8-10
Current PPE recommendations that do not include hair and shoe coverings may be inadequate for limiting SARS-CoV-2 exposure between and among physicians and patients. Adherence to head covering and shoe recommendations may aid in reducing unwanted SARS-CoV-2 transmission in the health care setting, even as the pandemic continues.
- Feldman O, Meir M, Shavit D, et al. Exposure to a surrogate measure of contamination from simulated patients by emergency department personnel wearing personal protective equipment. JAMA. 2020;323:2091-2093. doi:10.1001/jama.2020.6633
- Alexander JW, Van Sweringen H, Vanoss K, et al. Surveillance of bacterial colonization in operating rooms. Surg Infect (Larchmt). 2013;14:345-351. doi:10.1089/sur.2012.134
- Blanchard J. Clinical issues—August 2010. AORN Journal. 2010;92:228-232. doi:10.1016/j.aorn.2010.06.001
- Markel TA, Gormley T, Greeley D, et al. Hats off: a study of different operating room headgear assessed by environmental quality indicators. J Am Coll Surg. 2017;225:573-581. doi:10.1016/j.jamcollsurg.2017.08.014
- Kanwar A, Thakur M, Wazzan M, et al. Clothing and shoes of personnel as potential vectors for transfer of health care-associated pathogens to the community. Am J Infect Control. 2019;47:577-579. doi:10.1016/j.ajic.2019.01.028
- Guo ZD, Wang ZY, Zhang SF, et al. Aerosol and surface distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards, Wuhan, China, 2020. Emerg Infect Dis. 2020;26:1583-1591. doi:10.3201/eid2607.200885
- Otter JA, Donskey C, Yezli S, et al. Transmission of SARS and MERS coronaviruses and influenza virus in healthcare settings: the possible role of dry surface contamination. J Hosp Infect. 2016;92:235-250. doi:10.1016/j.jhin.2015.08.027
- Centers for Disease Control and Prevention. Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html#ref10
- American Academy of Dermatology. Clinical guidance for COVID-19. Accessed March 15, 2021. https://www.aad.org/member/practice/coronavirus/clinical-guidance
- Narla S, Alam M, Ozog DM, et al. American Society of Dermatologic Surgery Association (ASDSA) and American Society for Laser Medicine & Surgery (ASLMS) guidance for cosmetic dermatology practices during COVID-19. Updated January 11, 2021. Accessed March 15, 2021. https://www.asds.net/Portals/0/PDF/asdsa/asdsa-aslms-cosmetic-reopening-guidance.pdf
- World Health Organization. Country & technical guidance—coronavirus disease (COVID-19). Accessed March 15, 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance-publications
Personal protective equipment (PPE) is an important component in limiting transmission of SARS-CoV-2. The World Health Organization and Centers for Disease Control and Prevention issued guidelines for appropriate PPE use, but recommendations for head and shoe coverings are lacking. In this article, we analyze the literature on pathogen transmission via hair and shoes and make evidence-based recommendations for PPE selection during the COVID-19 pandemic.
Pathogens on Shoes and Hair
Hair and shoes may act as vehicles for pathogen transmission. In a study that simulated contamination of uncovered skin in health care workers after intubating manikins in respiratory distress, 8 (100%) had fluorescent markers on the hair, 6 (75%) on the neck, and 4 (50%) on the shoes.1 In another study of postsurgical operating room (OR) surfaces (517 cultures), uncovered shoe tops and reusable hair coverings had 10-times more bacterial colony–forming units compared to other surfaces. On average, disposable shoe covers/head coverings had less than one-third bacterial colony–forming units compared with uncovered shoes/reusable hair coverings.2
Hair characteristics and coverings may affect pathogen transmission. Exposed hair may collect bacteria, as Staphylococcus aureus and Staphylococcus epidermidis attach to both scalp and facial hair. In one case, β-hemolytic streptococci cultured from the scalp of a perioperative nurse was linked to postsurgical infections in 20 patients.3 Hair coverings include bouffant caps and skullcaps. The bouffant cap is similar to a shower cap; it is relatively loose and secured around the head with elastic. The skullcap, or scrub cap, is tighter but leaves the neck nape and sideburns exposed. In a study comparing disposable bouffant caps, disposable skullcaps, and home-laundered cloth skullcaps worn by 2 teams of 5 surgeons, the disposable bouffant caps had the highest permeability, penetration, and microbial shed of airborne particles.4
Physicians’ shoes may act as fomites for transmission of pathogens to patients. In a study of 41 physicians and nurses in an acute care hospital, shoe soles were positive for at least one pathogen in 12 (29.3%) participants; methicillin-resistant Staphylococcus aureus was most common. Additionally, 98% (49/50) of shoes worn outdoors showed positive bacterial cultures compared to 56% (28/50) of shoes reserved for the OR only.5 In a study examining ventilation effects on airborne pathogens in the OR, 15% of OR airborne bacteria originated from OR floors, and higher bacterial counts correlated with a higher number of steps in the OR.2 In another study designed to evaluate SARS-CoV-2 distribution on hospital floors, 70% (7/10) of quantitative polymerase chain reaction assays performed on floor samples from intensive care units were positive. In addition, 100% (3/3) of swabs taken from hospital pharmacy floors with no COVID-19 patients were positive for SARS-CoV-2, meaning contaminated shoes likely served as vectors.6 Middle East respiratory syndrome, SARS-CoV-2, and influenza viruses may survive on porous and nonporous materials for hours to days.7Enterococcus, Candida, and Aspergillus may survive on textiles for up to 90 days.3
Recommendations for Hair and Shoe Coverings
We recommend that physicians utilize disposable skullcaps to cover the hair and consider a hooded gown or coverall for neck/ear coverage. We also recommend that physicians designate shoes that remain in the workplace and can be easily washed or disinfected at least weekly; physicians may choose to wash or disinfect shoes more often if they frequently are performing procedures that generate aerosols. Additionally, physicians should always wear shoe coverings when caring for patients (Table 1).
Our hair and shoe covering recommendations may serve to protect dermatologists when caring for patients. These protocols may be particularly important for dermatologists performing high-risk procedures, including facial surgery, intraoral/intranasal procedures, and treatment with ablative lasers and facial injectables, especially when the patient is unmasked. These recommendations may limit viral transmission to dermatologists and also protect individuals living in their households. Additional established guidelines by the American Academy of Dermatology, American Society for Dermatologic Surgery, and World Health Organization are listed in Table 2.8-10
Current PPE recommendations that do not include hair and shoe coverings may be inadequate for limiting SARS-CoV-2 exposure between and among physicians and patients. Adherence to head covering and shoe recommendations may aid in reducing unwanted SARS-CoV-2 transmission in the health care setting, even as the pandemic continues.
Personal protective equipment (PPE) is an important component in limiting transmission of SARS-CoV-2. The World Health Organization and Centers for Disease Control and Prevention issued guidelines for appropriate PPE use, but recommendations for head and shoe coverings are lacking. In this article, we analyze the literature on pathogen transmission via hair and shoes and make evidence-based recommendations for PPE selection during the COVID-19 pandemic.
Pathogens on Shoes and Hair
Hair and shoes may act as vehicles for pathogen transmission. In a study that simulated contamination of uncovered skin in health care workers after intubating manikins in respiratory distress, 8 (100%) had fluorescent markers on the hair, 6 (75%) on the neck, and 4 (50%) on the shoes.1 In another study of postsurgical operating room (OR) surfaces (517 cultures), uncovered shoe tops and reusable hair coverings had 10-times more bacterial colony–forming units compared to other surfaces. On average, disposable shoe covers/head coverings had less than one-third bacterial colony–forming units compared with uncovered shoes/reusable hair coverings.2
Hair characteristics and coverings may affect pathogen transmission. Exposed hair may collect bacteria, as Staphylococcus aureus and Staphylococcus epidermidis attach to both scalp and facial hair. In one case, β-hemolytic streptococci cultured from the scalp of a perioperative nurse was linked to postsurgical infections in 20 patients.3 Hair coverings include bouffant caps and skullcaps. The bouffant cap is similar to a shower cap; it is relatively loose and secured around the head with elastic. The skullcap, or scrub cap, is tighter but leaves the neck nape and sideburns exposed. In a study comparing disposable bouffant caps, disposable skullcaps, and home-laundered cloth skullcaps worn by 2 teams of 5 surgeons, the disposable bouffant caps had the highest permeability, penetration, and microbial shed of airborne particles.4
Physicians’ shoes may act as fomites for transmission of pathogens to patients. In a study of 41 physicians and nurses in an acute care hospital, shoe soles were positive for at least one pathogen in 12 (29.3%) participants; methicillin-resistant Staphylococcus aureus was most common. Additionally, 98% (49/50) of shoes worn outdoors showed positive bacterial cultures compared to 56% (28/50) of shoes reserved for the OR only.5 In a study examining ventilation effects on airborne pathogens in the OR, 15% of OR airborne bacteria originated from OR floors, and higher bacterial counts correlated with a higher number of steps in the OR.2 In another study designed to evaluate SARS-CoV-2 distribution on hospital floors, 70% (7/10) of quantitative polymerase chain reaction assays performed on floor samples from intensive care units were positive. In addition, 100% (3/3) of swabs taken from hospital pharmacy floors with no COVID-19 patients were positive for SARS-CoV-2, meaning contaminated shoes likely served as vectors.6 Middle East respiratory syndrome, SARS-CoV-2, and influenza viruses may survive on porous and nonporous materials for hours to days.7Enterococcus, Candida, and Aspergillus may survive on textiles for up to 90 days.3
Recommendations for Hair and Shoe Coverings
We recommend that physicians utilize disposable skullcaps to cover the hair and consider a hooded gown or coverall for neck/ear coverage. We also recommend that physicians designate shoes that remain in the workplace and can be easily washed or disinfected at least weekly; physicians may choose to wash or disinfect shoes more often if they frequently are performing procedures that generate aerosols. Additionally, physicians should always wear shoe coverings when caring for patients (Table 1).
Our hair and shoe covering recommendations may serve to protect dermatologists when caring for patients. These protocols may be particularly important for dermatologists performing high-risk procedures, including facial surgery, intraoral/intranasal procedures, and treatment with ablative lasers and facial injectables, especially when the patient is unmasked. These recommendations may limit viral transmission to dermatologists and also protect individuals living in their households. Additional established guidelines by the American Academy of Dermatology, American Society for Dermatologic Surgery, and World Health Organization are listed in Table 2.8-10
Current PPE recommendations that do not include hair and shoe coverings may be inadequate for limiting SARS-CoV-2 exposure between and among physicians and patients. Adherence to head covering and shoe recommendations may aid in reducing unwanted SARS-CoV-2 transmission in the health care setting, even as the pandemic continues.
- Feldman O, Meir M, Shavit D, et al. Exposure to a surrogate measure of contamination from simulated patients by emergency department personnel wearing personal protective equipment. JAMA. 2020;323:2091-2093. doi:10.1001/jama.2020.6633
- Alexander JW, Van Sweringen H, Vanoss K, et al. Surveillance of bacterial colonization in operating rooms. Surg Infect (Larchmt). 2013;14:345-351. doi:10.1089/sur.2012.134
- Blanchard J. Clinical issues—August 2010. AORN Journal. 2010;92:228-232. doi:10.1016/j.aorn.2010.06.001
- Markel TA, Gormley T, Greeley D, et al. Hats off: a study of different operating room headgear assessed by environmental quality indicators. J Am Coll Surg. 2017;225:573-581. doi:10.1016/j.jamcollsurg.2017.08.014
- Kanwar A, Thakur M, Wazzan M, et al. Clothing and shoes of personnel as potential vectors for transfer of health care-associated pathogens to the community. Am J Infect Control. 2019;47:577-579. doi:10.1016/j.ajic.2019.01.028
- Guo ZD, Wang ZY, Zhang SF, et al. Aerosol and surface distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards, Wuhan, China, 2020. Emerg Infect Dis. 2020;26:1583-1591. doi:10.3201/eid2607.200885
- Otter JA, Donskey C, Yezli S, et al. Transmission of SARS and MERS coronaviruses and influenza virus in healthcare settings: the possible role of dry surface contamination. J Hosp Infect. 2016;92:235-250. doi:10.1016/j.jhin.2015.08.027
- Centers for Disease Control and Prevention. Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html#ref10
- American Academy of Dermatology. Clinical guidance for COVID-19. Accessed March 15, 2021. https://www.aad.org/member/practice/coronavirus/clinical-guidance
- Narla S, Alam M, Ozog DM, et al. American Society of Dermatologic Surgery Association (ASDSA) and American Society for Laser Medicine & Surgery (ASLMS) guidance for cosmetic dermatology practices during COVID-19. Updated January 11, 2021. Accessed March 15, 2021. https://www.asds.net/Portals/0/PDF/asdsa/asdsa-aslms-cosmetic-reopening-guidance.pdf
- World Health Organization. Country & technical guidance—coronavirus disease (COVID-19). Accessed March 15, 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance-publications
- Feldman O, Meir M, Shavit D, et al. Exposure to a surrogate measure of contamination from simulated patients by emergency department personnel wearing personal protective equipment. JAMA. 2020;323:2091-2093. doi:10.1001/jama.2020.6633
- Alexander JW, Van Sweringen H, Vanoss K, et al. Surveillance of bacterial colonization in operating rooms. Surg Infect (Larchmt). 2013;14:345-351. doi:10.1089/sur.2012.134
- Blanchard J. Clinical issues—August 2010. AORN Journal. 2010;92:228-232. doi:10.1016/j.aorn.2010.06.001
- Markel TA, Gormley T, Greeley D, et al. Hats off: a study of different operating room headgear assessed by environmental quality indicators. J Am Coll Surg. 2017;225:573-581. doi:10.1016/j.jamcollsurg.2017.08.014
- Kanwar A, Thakur M, Wazzan M, et al. Clothing and shoes of personnel as potential vectors for transfer of health care-associated pathogens to the community. Am J Infect Control. 2019;47:577-579. doi:10.1016/j.ajic.2019.01.028
- Guo ZD, Wang ZY, Zhang SF, et al. Aerosol and surface distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards, Wuhan, China, 2020. Emerg Infect Dis. 2020;26:1583-1591. doi:10.3201/eid2607.200885
- Otter JA, Donskey C, Yezli S, et al. Transmission of SARS and MERS coronaviruses and influenza virus in healthcare settings: the possible role of dry surface contamination. J Hosp Infect. 2016;92:235-250. doi:10.1016/j.jhin.2015.08.027
- Centers for Disease Control and Prevention. Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html#ref10
- American Academy of Dermatology. Clinical guidance for COVID-19. Accessed March 15, 2021. https://www.aad.org/member/practice/coronavirus/clinical-guidance
- Narla S, Alam M, Ozog DM, et al. American Society of Dermatologic Surgery Association (ASDSA) and American Society for Laser Medicine & Surgery (ASLMS) guidance for cosmetic dermatology practices during COVID-19. Updated January 11, 2021. Accessed March 15, 2021. https://www.asds.net/Portals/0/PDF/asdsa/asdsa-aslms-cosmetic-reopening-guidance.pdf
- World Health Organization. Country & technical guidance—coronavirus disease (COVID-19). Accessed March 15, 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance-publications
Practice Points
- Consistent use of personal protective equipment, including masks, face shields, goggles, and gloves, may limit transmission of SARS-CoV-2.
- Hair and shoes also may transmit SARS-CoV-2, but recommendations for hair and shoe coverings to prevent SARS-CoV-2 are lacking.
Long-Distance Dermatology: Lessons From an Interview on Remote Practice During a Pandemic and Beyond
For the US health care system, the year 2020 was one of great change as well as extreme pain and hardship: some physical, but much emotional and financial. Dermatologists nationwide have not been sheltered from the winds of change. Yet as with most great challenges, one also can discern great change for the better if you look for it. One area of major growth in the wake of the COVID-19 pandemic is the expansion of telehealth, specifically teledermatology.
Prior to the pandemic, teledermatology was in a phase of modest expansion.1 Since the start of the pandemic, however, the adoption of telemedicine services in the United States has been beyond exponential. Before the pandemic, an estimated 15,000 Medicare recipients received telehealth services on a weekly basis. Yet by the end of April 2020, only 3 months after the first reported case of COVID-19 in the United States, nearly 1.3 million Medicare beneficiaries were utilizing telehealth services on a weekly basis.2 The Centers for Medicare & Medicaid Services has recognized the vast increase in need and responded with the addition of 144 new telehealth services covered by Medicare in the last year. In December 2020, the Centers for Medicare & Medicaid Services moved to make many of the previously provisional policies permanent, expanding long-term coverage for telehealth services,2 and use of teledermatology has expanded in parallel. Although the impetus for this change was simple necessity, the benefits of expanded teledermatology are likely to drive its continued incorporation into our daily practices.
Kevin Wright, MD, is a staff dermatologist at the Naval Medical Center San Diego (San Diego, California) and an Associate Professor of Dermatology at the Uniformed Services University of the Health Sciences (Bethesda, Maryland). In this interview, we discussed his experience incorporating a teledermatology component into his postresidency practice, the pros and cons of teledermatology practice, and ways that residents can prepare for a future in teledermatology.
Would you start by briefly describing your work model now?
My primary job is a Monday-through-Friday classic dermatology clinic job. On the weekends or days off, I see asynchronous and synchronous teledermatology through a specialized platform. On weekends, I tend to see anywhere between 20 and 40 patients in about a 6-hour period with breaks in between.
What does a typical “weekend” day of work look like?
In general, I’ll wake up early before my family and spend maybe an hour working. Oftentimes, that will be in my truck parked down by the beach, where I will go for a run or surf before logging on. If I have 40 visits scheduled that day, I can spend a few hours, message most of them, clarify some aspects of the visit, then go and have breakfast with my family before logging back on and completing the encounters.
Is most of your interaction with patients asynchronous, messaging back and forth to take history?
A few states require a phone call, so those are synchronous, and every Medicaid patient requires a video call. I do synchronous visits with all of my isotretinoin patients at first. It’s a mixed bag, but a lot of my visits are done entirely asynchronously.
What attracted you to this model?
During residency, I always felt that many of the ways we saw patients seemed extraordinarily inefficient. My best example of this is isotretinoin follow-ups. Before this year, most of my colleagues were uncomfortable with virtual isotretinoin follow-ups or thought it was a ridiculous idea. Frankly, I never shared this sentiment. Once I had my own board certification, I knew I was going to pursue teledermatology, because seeing kids take a half day off of school to come in for a 10-minute isotretinoin appointment (that’s mainly just a conversation about sports) just didn’t make sense to me. So I knew I wanted to pursue this idea, I just didn’t know exactly how. One day I was approached by a close friend and mentor of mine who had just purchased a teledermatology platform. She asked me if I would like to moonlight once I graduated and I jumped at the opportunity.
What steps did you take prior to graduating to help prepare you to practice teledermatology?
The most important thing I did—and the most important thing I think for third-year residents to do—is to set myself up for success by starting the US Drug Enforcement Administration (DEA) licensure and certification process. Once you have a DEA number, you can apply for Medicare and Medicaid. The nice thing about Medicare is you can start billing immediately after you apply, which is important. The reimbursement isn’t as high, but they pay faster, which allows you to start seeing patients through teledermatology right away. In a pinch, you could see all Medicare patients and make a living until you’ve completed the rest of the process. Once you have a Medicare and Medicaid number, you can apply for credentialing through private payers. However, the Medicare process takes 3 months, and private-payers credentialing takes about 90 days as well. That’s a lot of time! Before finishing residency, I recommend you make sure you have an unrestricted DEA license and you apply for Medicare/Medicaid credentials. Then, when you’re looking at future employment, you can start getting state licenses almost immediately in whatever states you anticipate needing them.
What are the top 3 benefits of incorporating teledermatology into your practice?
Accessibility is one huge benefit. If you’re practicing in a rural area, you’re basically giving [patients] back their time. Teledermatology takes patients much less time, and they get the same level of care. That’s a big selling point. Your patients will be very happy and loyal because of that.
The other thing I never would have foreseen before starting teledermatology is the amazing follow-up you can get. I think many dermatology residents will agree that there are those patients where you think, “Wow, I wish I could see them back. I wonder how they did,” but you never see them again. That’s not the case with teledermatology. I have a running list of all my interesting cases, and I’ll just shoot them a message 2 or 4 weeks later and at their convenience, they can submit a quick photo. I get that excellent feedback, and that’s huge to me for my own personal education and growth.
The third would be experience. I have 24 state medical licenses, and I see patients of all varieties: all socioeconomic backgrounds and skin types and many with severe skin conditions never managed before by a specialist. That, frankly, has increased my comfort level for seeing patients of all types. It forces me to expand my utilization of certain therapies because some people can’t afford 95% of medications we prescribe commonly. I find that challenge very rewarding. It’s something I’m not sure you can achieve by just practicing within your bubble. Inevitably you are going to see a certain type of patient that your hospital or practice attracts by merit of its geography or catchment area. Teledermatology allows you to see the full spectrum of dermatology.
What are the biggest cons to incorporating teledermatology into your practice?
To start off, some patients have boundary issues. Every 200 patients or so, I’ll have someone who submits a visit at 11:30
The second is reimbursement. In other practice models I can bill more in half the time by seeing a patient in person, doing a skin screening and a few biopsies. I believe there’s always a role for teledermatology in any practice, but ultimately dermatologists are pragmatic people who need to be smart about time management. At some point, it becomes difficult to pay the bills if reimbursement is lacking. That’s one of the bigger downsides to teledermatology. We still need to figure out how to reimburse to incentivize what’s best for the patient.
Could you talk more about the effect on work-life balance?
I think the things that make teledermatology appealing are the same things that could end up disrupting your work-life balance. On the positive side, you can vacation in Hawaii, work for 2 hours each morning, and pay for the whole thing. That’s very appealing to me! The downside is that there are always patients in the queue. In some sense, your waiting room is always half-full, 24/7. Mentally, you have to become comfortable with that, and you have to develop boundaries. I have very specific times I do teledermatology and then I log off. This helps me establish boundaries and creates balance.
You touched on it earlier regarding isotretinoin visits, but what other facets of practice do you think are particularly well-suited to teledermatology?
There are a few that I’ve incorporated into my practice quite aggressively. Almost all acne is going to go to a teledermatology visit. That’s in large part due to payer parity. For the most part, you make the same doing an acne visit online as you will doing it in person. Your patients will be getting the same level of care, better follow-up, and you’ll make the same amount of money. Another thing I do as a patient courtesy is wound checks postsurgery or post-Mohs [micrographic surgery]. There is a huge benefit there to seeing your patients because you can identify infections early, answer simple questions, and reduce in-person clinic visits. That’s a win.
What are visit types you feel are not well-suited to teledermatology or that you approach with more caution?
This will be different for everyone to some degree. I think practitioners need to be alert and use their best judgement when approaching any new patient or new concern. Pigmented lesions certainly give me pause. Although the technology is getting better every day, I believe there is still a gap between seeing a photo of a lesion and seeing a pigmented lesion in person, being able to get up close and examine it dermoscopically. Teledermoscopy, however, is an emerging business model as well, and it will be interesting to see what role this can play as it gets incorporated.
You mentioned having medical licenses in several states. Can you describe the process you went through to obtain these licenses?
It’s a painful process. I started realizing this was something I wanted to incorporate after residency, so I started looking into applying for medical licenses early. Teledermatology companies often will reimburse you and help you to get licenses. I was lucky enough to get assistance, which was essential because it is an onerous process. If you can work that into your contract during negotiations that would be ideal. Not everyone will be as lucky as I was, though. If that doesn’t pertain to you, pick a few states that have larger populations around you, where you know that they have a lot of need and start applying there. Be aware that medical licensure takes about 6 months. Having this started around mid–third year is important.
Employers want someone they can use right away, so I found it very beneficial to approach an employer and be able to explain to them tangibly where you are in the process. For example, “I’ve got my DEA license, Medicare, Medicaid number, and I have licensure in your state and all the surrounding states.” You then have a leg to stand on with your negotiating. If you do the legwork and can then negotiate a higher percentage, you’ll make up the licensure fees in a half day of work. It’s an investment toward your professional career.
Any final thoughts?
I think that insurers are very interested in teledermatology because there’s a potential for huge cost savings. As the dust settles with COVID-19 and we see how telemedicine has changed medicine in general, I really think that payers are going to be more aggressive about requiring teledermatology from their dermatologists. I think residents need to anticipate that teledermatology will be some part of their practice in the future and should start planning now to be prepared for this brave new world going forward.
- Yim KM, Florek AG, Oh DH, et al. Teledermatology in the United States: an update in a dynamic era. Telemed J E Health. 2018;24:691-697.
- Shatzkes MM, Borha EL. Permanent expansion of Medicare telehealth services. The National Law Review website. Published December 7, 2020. Accessed April 13, 2021. https://www.natlawreview.com/article/permanent-expansion-medicare-telehealth-services
For the US health care system, the year 2020 was one of great change as well as extreme pain and hardship: some physical, but much emotional and financial. Dermatologists nationwide have not been sheltered from the winds of change. Yet as with most great challenges, one also can discern great change for the better if you look for it. One area of major growth in the wake of the COVID-19 pandemic is the expansion of telehealth, specifically teledermatology.
Prior to the pandemic, teledermatology was in a phase of modest expansion.1 Since the start of the pandemic, however, the adoption of telemedicine services in the United States has been beyond exponential. Before the pandemic, an estimated 15,000 Medicare recipients received telehealth services on a weekly basis. Yet by the end of April 2020, only 3 months after the first reported case of COVID-19 in the United States, nearly 1.3 million Medicare beneficiaries were utilizing telehealth services on a weekly basis.2 The Centers for Medicare & Medicaid Services has recognized the vast increase in need and responded with the addition of 144 new telehealth services covered by Medicare in the last year. In December 2020, the Centers for Medicare & Medicaid Services moved to make many of the previously provisional policies permanent, expanding long-term coverage for telehealth services,2 and use of teledermatology has expanded in parallel. Although the impetus for this change was simple necessity, the benefits of expanded teledermatology are likely to drive its continued incorporation into our daily practices.
Kevin Wright, MD, is a staff dermatologist at the Naval Medical Center San Diego (San Diego, California) and an Associate Professor of Dermatology at the Uniformed Services University of the Health Sciences (Bethesda, Maryland). In this interview, we discussed his experience incorporating a teledermatology component into his postresidency practice, the pros and cons of teledermatology practice, and ways that residents can prepare for a future in teledermatology.
Would you start by briefly describing your work model now?
My primary job is a Monday-through-Friday classic dermatology clinic job. On the weekends or days off, I see asynchronous and synchronous teledermatology through a specialized platform. On weekends, I tend to see anywhere between 20 and 40 patients in about a 6-hour period with breaks in between.
What does a typical “weekend” day of work look like?
In general, I’ll wake up early before my family and spend maybe an hour working. Oftentimes, that will be in my truck parked down by the beach, where I will go for a run or surf before logging on. If I have 40 visits scheduled that day, I can spend a few hours, message most of them, clarify some aspects of the visit, then go and have breakfast with my family before logging back on and completing the encounters.
Is most of your interaction with patients asynchronous, messaging back and forth to take history?
A few states require a phone call, so those are synchronous, and every Medicaid patient requires a video call. I do synchronous visits with all of my isotretinoin patients at first. It’s a mixed bag, but a lot of my visits are done entirely asynchronously.
What attracted you to this model?
During residency, I always felt that many of the ways we saw patients seemed extraordinarily inefficient. My best example of this is isotretinoin follow-ups. Before this year, most of my colleagues were uncomfortable with virtual isotretinoin follow-ups or thought it was a ridiculous idea. Frankly, I never shared this sentiment. Once I had my own board certification, I knew I was going to pursue teledermatology, because seeing kids take a half day off of school to come in for a 10-minute isotretinoin appointment (that’s mainly just a conversation about sports) just didn’t make sense to me. So I knew I wanted to pursue this idea, I just didn’t know exactly how. One day I was approached by a close friend and mentor of mine who had just purchased a teledermatology platform. She asked me if I would like to moonlight once I graduated and I jumped at the opportunity.
What steps did you take prior to graduating to help prepare you to practice teledermatology?
The most important thing I did—and the most important thing I think for third-year residents to do—is to set myself up for success by starting the US Drug Enforcement Administration (DEA) licensure and certification process. Once you have a DEA number, you can apply for Medicare and Medicaid. The nice thing about Medicare is you can start billing immediately after you apply, which is important. The reimbursement isn’t as high, but they pay faster, which allows you to start seeing patients through teledermatology right away. In a pinch, you could see all Medicare patients and make a living until you’ve completed the rest of the process. Once you have a Medicare and Medicaid number, you can apply for credentialing through private payers. However, the Medicare process takes 3 months, and private-payers credentialing takes about 90 days as well. That’s a lot of time! Before finishing residency, I recommend you make sure you have an unrestricted DEA license and you apply for Medicare/Medicaid credentials. Then, when you’re looking at future employment, you can start getting state licenses almost immediately in whatever states you anticipate needing them.
What are the top 3 benefits of incorporating teledermatology into your practice?
Accessibility is one huge benefit. If you’re practicing in a rural area, you’re basically giving [patients] back their time. Teledermatology takes patients much less time, and they get the same level of care. That’s a big selling point. Your patients will be very happy and loyal because of that.
The other thing I never would have foreseen before starting teledermatology is the amazing follow-up you can get. I think many dermatology residents will agree that there are those patients where you think, “Wow, I wish I could see them back. I wonder how they did,” but you never see them again. That’s not the case with teledermatology. I have a running list of all my interesting cases, and I’ll just shoot them a message 2 or 4 weeks later and at their convenience, they can submit a quick photo. I get that excellent feedback, and that’s huge to me for my own personal education and growth.
The third would be experience. I have 24 state medical licenses, and I see patients of all varieties: all socioeconomic backgrounds and skin types and many with severe skin conditions never managed before by a specialist. That, frankly, has increased my comfort level for seeing patients of all types. It forces me to expand my utilization of certain therapies because some people can’t afford 95% of medications we prescribe commonly. I find that challenge very rewarding. It’s something I’m not sure you can achieve by just practicing within your bubble. Inevitably you are going to see a certain type of patient that your hospital or practice attracts by merit of its geography or catchment area. Teledermatology allows you to see the full spectrum of dermatology.
What are the biggest cons to incorporating teledermatology into your practice?
To start off, some patients have boundary issues. Every 200 patients or so, I’ll have someone who submits a visit at 11:30
The second is reimbursement. In other practice models I can bill more in half the time by seeing a patient in person, doing a skin screening and a few biopsies. I believe there’s always a role for teledermatology in any practice, but ultimately dermatologists are pragmatic people who need to be smart about time management. At some point, it becomes difficult to pay the bills if reimbursement is lacking. That’s one of the bigger downsides to teledermatology. We still need to figure out how to reimburse to incentivize what’s best for the patient.
Could you talk more about the effect on work-life balance?
I think the things that make teledermatology appealing are the same things that could end up disrupting your work-life balance. On the positive side, you can vacation in Hawaii, work for 2 hours each morning, and pay for the whole thing. That’s very appealing to me! The downside is that there are always patients in the queue. In some sense, your waiting room is always half-full, 24/7. Mentally, you have to become comfortable with that, and you have to develop boundaries. I have very specific times I do teledermatology and then I log off. This helps me establish boundaries and creates balance.
You touched on it earlier regarding isotretinoin visits, but what other facets of practice do you think are particularly well-suited to teledermatology?
There are a few that I’ve incorporated into my practice quite aggressively. Almost all acne is going to go to a teledermatology visit. That’s in large part due to payer parity. For the most part, you make the same doing an acne visit online as you will doing it in person. Your patients will be getting the same level of care, better follow-up, and you’ll make the same amount of money. Another thing I do as a patient courtesy is wound checks postsurgery or post-Mohs [micrographic surgery]. There is a huge benefit there to seeing your patients because you can identify infections early, answer simple questions, and reduce in-person clinic visits. That’s a win.
What are visit types you feel are not well-suited to teledermatology or that you approach with more caution?
This will be different for everyone to some degree. I think practitioners need to be alert and use their best judgement when approaching any new patient or new concern. Pigmented lesions certainly give me pause. Although the technology is getting better every day, I believe there is still a gap between seeing a photo of a lesion and seeing a pigmented lesion in person, being able to get up close and examine it dermoscopically. Teledermoscopy, however, is an emerging business model as well, and it will be interesting to see what role this can play as it gets incorporated.
You mentioned having medical licenses in several states. Can you describe the process you went through to obtain these licenses?
It’s a painful process. I started realizing this was something I wanted to incorporate after residency, so I started looking into applying for medical licenses early. Teledermatology companies often will reimburse you and help you to get licenses. I was lucky enough to get assistance, which was essential because it is an onerous process. If you can work that into your contract during negotiations that would be ideal. Not everyone will be as lucky as I was, though. If that doesn’t pertain to you, pick a few states that have larger populations around you, where you know that they have a lot of need and start applying there. Be aware that medical licensure takes about 6 months. Having this started around mid–third year is important.
Employers want someone they can use right away, so I found it very beneficial to approach an employer and be able to explain to them tangibly where you are in the process. For example, “I’ve got my DEA license, Medicare, Medicaid number, and I have licensure in your state and all the surrounding states.” You then have a leg to stand on with your negotiating. If you do the legwork and can then negotiate a higher percentage, you’ll make up the licensure fees in a half day of work. It’s an investment toward your professional career.
Any final thoughts?
I think that insurers are very interested in teledermatology because there’s a potential for huge cost savings. As the dust settles with COVID-19 and we see how telemedicine has changed medicine in general, I really think that payers are going to be more aggressive about requiring teledermatology from their dermatologists. I think residents need to anticipate that teledermatology will be some part of their practice in the future and should start planning now to be prepared for this brave new world going forward.
For the US health care system, the year 2020 was one of great change as well as extreme pain and hardship: some physical, but much emotional and financial. Dermatologists nationwide have not been sheltered from the winds of change. Yet as with most great challenges, one also can discern great change for the better if you look for it. One area of major growth in the wake of the COVID-19 pandemic is the expansion of telehealth, specifically teledermatology.
Prior to the pandemic, teledermatology was in a phase of modest expansion.1 Since the start of the pandemic, however, the adoption of telemedicine services in the United States has been beyond exponential. Before the pandemic, an estimated 15,000 Medicare recipients received telehealth services on a weekly basis. Yet by the end of April 2020, only 3 months after the first reported case of COVID-19 in the United States, nearly 1.3 million Medicare beneficiaries were utilizing telehealth services on a weekly basis.2 The Centers for Medicare & Medicaid Services has recognized the vast increase in need and responded with the addition of 144 new telehealth services covered by Medicare in the last year. In December 2020, the Centers for Medicare & Medicaid Services moved to make many of the previously provisional policies permanent, expanding long-term coverage for telehealth services,2 and use of teledermatology has expanded in parallel. Although the impetus for this change was simple necessity, the benefits of expanded teledermatology are likely to drive its continued incorporation into our daily practices.
Kevin Wright, MD, is a staff dermatologist at the Naval Medical Center San Diego (San Diego, California) and an Associate Professor of Dermatology at the Uniformed Services University of the Health Sciences (Bethesda, Maryland). In this interview, we discussed his experience incorporating a teledermatology component into his postresidency practice, the pros and cons of teledermatology practice, and ways that residents can prepare for a future in teledermatology.
Would you start by briefly describing your work model now?
My primary job is a Monday-through-Friday classic dermatology clinic job. On the weekends or days off, I see asynchronous and synchronous teledermatology through a specialized platform. On weekends, I tend to see anywhere between 20 and 40 patients in about a 6-hour period with breaks in between.
What does a typical “weekend” day of work look like?
In general, I’ll wake up early before my family and spend maybe an hour working. Oftentimes, that will be in my truck parked down by the beach, where I will go for a run or surf before logging on. If I have 40 visits scheduled that day, I can spend a few hours, message most of them, clarify some aspects of the visit, then go and have breakfast with my family before logging back on and completing the encounters.
Is most of your interaction with patients asynchronous, messaging back and forth to take history?
A few states require a phone call, so those are synchronous, and every Medicaid patient requires a video call. I do synchronous visits with all of my isotretinoin patients at first. It’s a mixed bag, but a lot of my visits are done entirely asynchronously.
What attracted you to this model?
During residency, I always felt that many of the ways we saw patients seemed extraordinarily inefficient. My best example of this is isotretinoin follow-ups. Before this year, most of my colleagues were uncomfortable with virtual isotretinoin follow-ups or thought it was a ridiculous idea. Frankly, I never shared this sentiment. Once I had my own board certification, I knew I was going to pursue teledermatology, because seeing kids take a half day off of school to come in for a 10-minute isotretinoin appointment (that’s mainly just a conversation about sports) just didn’t make sense to me. So I knew I wanted to pursue this idea, I just didn’t know exactly how. One day I was approached by a close friend and mentor of mine who had just purchased a teledermatology platform. She asked me if I would like to moonlight once I graduated and I jumped at the opportunity.
What steps did you take prior to graduating to help prepare you to practice teledermatology?
The most important thing I did—and the most important thing I think for third-year residents to do—is to set myself up for success by starting the US Drug Enforcement Administration (DEA) licensure and certification process. Once you have a DEA number, you can apply for Medicare and Medicaid. The nice thing about Medicare is you can start billing immediately after you apply, which is important. The reimbursement isn’t as high, but they pay faster, which allows you to start seeing patients through teledermatology right away. In a pinch, you could see all Medicare patients and make a living until you’ve completed the rest of the process. Once you have a Medicare and Medicaid number, you can apply for credentialing through private payers. However, the Medicare process takes 3 months, and private-payers credentialing takes about 90 days as well. That’s a lot of time! Before finishing residency, I recommend you make sure you have an unrestricted DEA license and you apply for Medicare/Medicaid credentials. Then, when you’re looking at future employment, you can start getting state licenses almost immediately in whatever states you anticipate needing them.
What are the top 3 benefits of incorporating teledermatology into your practice?
Accessibility is one huge benefit. If you’re practicing in a rural area, you’re basically giving [patients] back their time. Teledermatology takes patients much less time, and they get the same level of care. That’s a big selling point. Your patients will be very happy and loyal because of that.
The other thing I never would have foreseen before starting teledermatology is the amazing follow-up you can get. I think many dermatology residents will agree that there are those patients where you think, “Wow, I wish I could see them back. I wonder how they did,” but you never see them again. That’s not the case with teledermatology. I have a running list of all my interesting cases, and I’ll just shoot them a message 2 or 4 weeks later and at their convenience, they can submit a quick photo. I get that excellent feedback, and that’s huge to me for my own personal education and growth.
The third would be experience. I have 24 state medical licenses, and I see patients of all varieties: all socioeconomic backgrounds and skin types and many with severe skin conditions never managed before by a specialist. That, frankly, has increased my comfort level for seeing patients of all types. It forces me to expand my utilization of certain therapies because some people can’t afford 95% of medications we prescribe commonly. I find that challenge very rewarding. It’s something I’m not sure you can achieve by just practicing within your bubble. Inevitably you are going to see a certain type of patient that your hospital or practice attracts by merit of its geography or catchment area. Teledermatology allows you to see the full spectrum of dermatology.
What are the biggest cons to incorporating teledermatology into your practice?
To start off, some patients have boundary issues. Every 200 patients or so, I’ll have someone who submits a visit at 11:30
The second is reimbursement. In other practice models I can bill more in half the time by seeing a patient in person, doing a skin screening and a few biopsies. I believe there’s always a role for teledermatology in any practice, but ultimately dermatologists are pragmatic people who need to be smart about time management. At some point, it becomes difficult to pay the bills if reimbursement is lacking. That’s one of the bigger downsides to teledermatology. We still need to figure out how to reimburse to incentivize what’s best for the patient.
Could you talk more about the effect on work-life balance?
I think the things that make teledermatology appealing are the same things that could end up disrupting your work-life balance. On the positive side, you can vacation in Hawaii, work for 2 hours each morning, and pay for the whole thing. That’s very appealing to me! The downside is that there are always patients in the queue. In some sense, your waiting room is always half-full, 24/7. Mentally, you have to become comfortable with that, and you have to develop boundaries. I have very specific times I do teledermatology and then I log off. This helps me establish boundaries and creates balance.
You touched on it earlier regarding isotretinoin visits, but what other facets of practice do you think are particularly well-suited to teledermatology?
There are a few that I’ve incorporated into my practice quite aggressively. Almost all acne is going to go to a teledermatology visit. That’s in large part due to payer parity. For the most part, you make the same doing an acne visit online as you will doing it in person. Your patients will be getting the same level of care, better follow-up, and you’ll make the same amount of money. Another thing I do as a patient courtesy is wound checks postsurgery or post-Mohs [micrographic surgery]. There is a huge benefit there to seeing your patients because you can identify infections early, answer simple questions, and reduce in-person clinic visits. That’s a win.
What are visit types you feel are not well-suited to teledermatology or that you approach with more caution?
This will be different for everyone to some degree. I think practitioners need to be alert and use their best judgement when approaching any new patient or new concern. Pigmented lesions certainly give me pause. Although the technology is getting better every day, I believe there is still a gap between seeing a photo of a lesion and seeing a pigmented lesion in person, being able to get up close and examine it dermoscopically. Teledermoscopy, however, is an emerging business model as well, and it will be interesting to see what role this can play as it gets incorporated.
You mentioned having medical licenses in several states. Can you describe the process you went through to obtain these licenses?
It’s a painful process. I started realizing this was something I wanted to incorporate after residency, so I started looking into applying for medical licenses early. Teledermatology companies often will reimburse you and help you to get licenses. I was lucky enough to get assistance, which was essential because it is an onerous process. If you can work that into your contract during negotiations that would be ideal. Not everyone will be as lucky as I was, though. If that doesn’t pertain to you, pick a few states that have larger populations around you, where you know that they have a lot of need and start applying there. Be aware that medical licensure takes about 6 months. Having this started around mid–third year is important.
Employers want someone they can use right away, so I found it very beneficial to approach an employer and be able to explain to them tangibly where you are in the process. For example, “I’ve got my DEA license, Medicare, Medicaid number, and I have licensure in your state and all the surrounding states.” You then have a leg to stand on with your negotiating. If you do the legwork and can then negotiate a higher percentage, you’ll make up the licensure fees in a half day of work. It’s an investment toward your professional career.
Any final thoughts?
I think that insurers are very interested in teledermatology because there’s a potential for huge cost savings. As the dust settles with COVID-19 and we see how telemedicine has changed medicine in general, I really think that payers are going to be more aggressive about requiring teledermatology from their dermatologists. I think residents need to anticipate that teledermatology will be some part of their practice in the future and should start planning now to be prepared for this brave new world going forward.
- Yim KM, Florek AG, Oh DH, et al. Teledermatology in the United States: an update in a dynamic era. Telemed J E Health. 2018;24:691-697.
- Shatzkes MM, Borha EL. Permanent expansion of Medicare telehealth services. The National Law Review website. Published December 7, 2020. Accessed April 13, 2021. https://www.natlawreview.com/article/permanent-expansion-medicare-telehealth-services
- Yim KM, Florek AG, Oh DH, et al. Teledermatology in the United States: an update in a dynamic era. Telemed J E Health. 2018;24:691-697.
- Shatzkes MM, Borha EL. Permanent expansion of Medicare telehealth services. The National Law Review website. Published December 7, 2020. Accessed April 13, 2021. https://www.natlawreview.com/article/permanent-expansion-medicare-telehealth-services
Resident Pearl
- One result of the COVID-19 pandemic is the aggressive adoption of teledermatology across the United States. Graduating residents should be preparing for a scope of practice that incorporates teledermatology.
Diagnostic tests may miss invasive aspergillosis in children
Key clinical point: The small number of invasive aspergillosis cases may contribute to the low specificity of several tests in children after stem cell transplants and should be interpreted with caution.
Major finding: The sensitivity and specificity for probable invasive aspergillosis and potential invasive fungal disease was 80% and 55% for (1→3)-β-D-glucan (BDG); 40% and 100% for galactomannan; and 60% (and 95% (95% CI: 75–100%) for Aspergillus-specific real-time PCR.
Study details: The data come from 404 blood samples taken from 26 pediatric patients who underwent allogeneic hematopoietic stem cell transplantation between April 2016 and March 2018 at a single center.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Springer J et al. J Fungi (Basel). 2021 Mar 22. doi: 10.3390/jof7030238.
Key clinical point: The small number of invasive aspergillosis cases may contribute to the low specificity of several tests in children after stem cell transplants and should be interpreted with caution.
Major finding: The sensitivity and specificity for probable invasive aspergillosis and potential invasive fungal disease was 80% and 55% for (1→3)-β-D-glucan (BDG); 40% and 100% for galactomannan; and 60% (and 95% (95% CI: 75–100%) for Aspergillus-specific real-time PCR.
Study details: The data come from 404 blood samples taken from 26 pediatric patients who underwent allogeneic hematopoietic stem cell transplantation between April 2016 and March 2018 at a single center.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Springer J et al. J Fungi (Basel). 2021 Mar 22. doi: 10.3390/jof7030238.
Key clinical point: The small number of invasive aspergillosis cases may contribute to the low specificity of several tests in children after stem cell transplants and should be interpreted with caution.
Major finding: The sensitivity and specificity for probable invasive aspergillosis and potential invasive fungal disease was 80% and 55% for (1→3)-β-D-glucan (BDG); 40% and 100% for galactomannan; and 60% (and 95% (95% CI: 75–100%) for Aspergillus-specific real-time PCR.
Study details: The data come from 404 blood samples taken from 26 pediatric patients who underwent allogeneic hematopoietic stem cell transplantation between April 2016 and March 2018 at a single center.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Springer J et al. J Fungi (Basel). 2021 Mar 22. doi: 10.3390/jof7030238.
Coinfections raise mortality rates in COVID-19 patients
Key clinical point: Patients with severe COVID-19 and secondary coinfections had higher mortality rates and longer hospital stays compared to patients without secondary infections.
Major finding: The overall mortality rate was approximately 50%, but 83.14% of the patients with fungal or bacterial isolation died. The risk of death was significantly higher in patients with bacterial and fungal coinfections (odds ratios 11.28 and 5.97, respectively).
Study details: The data come from an analysis of 212 severely ill patients with COVID-19; 89 of these had fungal or bacterial secondary coinfections.
Disclosures: The study was supported by the Fundação de Amparo a Pesquisa do Estado de Minas Gerais - FAPEMIG and the Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq and Brazilian Ministry of Health. The researchers had no financial conflicts to disclose.
Source: Silva DL et al. J Hosp Infect. 2021 Apr 11. doi: 10.1016/j.jhin.2021.04.001.
Key clinical point: Patients with severe COVID-19 and secondary coinfections had higher mortality rates and longer hospital stays compared to patients without secondary infections.
Major finding: The overall mortality rate was approximately 50%, but 83.14% of the patients with fungal or bacterial isolation died. The risk of death was significantly higher in patients with bacterial and fungal coinfections (odds ratios 11.28 and 5.97, respectively).
Study details: The data come from an analysis of 212 severely ill patients with COVID-19; 89 of these had fungal or bacterial secondary coinfections.
Disclosures: The study was supported by the Fundação de Amparo a Pesquisa do Estado de Minas Gerais - FAPEMIG and the Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq and Brazilian Ministry of Health. The researchers had no financial conflicts to disclose.
Source: Silva DL et al. J Hosp Infect. 2021 Apr 11. doi: 10.1016/j.jhin.2021.04.001.
Key clinical point: Patients with severe COVID-19 and secondary coinfections had higher mortality rates and longer hospital stays compared to patients without secondary infections.
Major finding: The overall mortality rate was approximately 50%, but 83.14% of the patients with fungal or bacterial isolation died. The risk of death was significantly higher in patients with bacterial and fungal coinfections (odds ratios 11.28 and 5.97, respectively).
Study details: The data come from an analysis of 212 severely ill patients with COVID-19; 89 of these had fungal or bacterial secondary coinfections.
Disclosures: The study was supported by the Fundação de Amparo a Pesquisa do Estado de Minas Gerais - FAPEMIG and the Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq and Brazilian Ministry of Health. The researchers had no financial conflicts to disclose.
Source: Silva DL et al. J Hosp Infect. 2021 Apr 11. doi: 10.1016/j.jhin.2021.04.001.
Posaconazole posts strong results against invasive fungal infections in cancer patients
Key clinical point: Triazole antifungal agents, as well as amphotericin B and caspofungin, reduced rates of invasive fungal infections in patients with hematological malginancies; notably, posaconazole also was more effective at reducing all-cause mortality and adverse events compared with other triazoles.
Major finding: Posaconazole was superior to fluconazole (odds ratio 0.30), itraconazole (OR 0.40), and amphotericin B (OR 4.97) in reducing the incidence of both suspected and confirmed invasive fungal infections.
Study details: The data come from a meta-analysis of 35 studies including 37 randomized, controlled trials of the effectiveness of triazoles, polyene, and echinocandin antifungals for infection control in patients with hematological malignancies.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Zeng H et al. BMC Cancer. 2021 Apr 14. doi: 10.1186/s12885-021-07973-8.
Key clinical point: Triazole antifungal agents, as well as amphotericin B and caspofungin, reduced rates of invasive fungal infections in patients with hematological malginancies; notably, posaconazole also was more effective at reducing all-cause mortality and adverse events compared with other triazoles.
Major finding: Posaconazole was superior to fluconazole (odds ratio 0.30), itraconazole (OR 0.40), and amphotericin B (OR 4.97) in reducing the incidence of both suspected and confirmed invasive fungal infections.
Study details: The data come from a meta-analysis of 35 studies including 37 randomized, controlled trials of the effectiveness of triazoles, polyene, and echinocandin antifungals for infection control in patients with hematological malignancies.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Zeng H et al. BMC Cancer. 2021 Apr 14. doi: 10.1186/s12885-021-07973-8.
Key clinical point: Triazole antifungal agents, as well as amphotericin B and caspofungin, reduced rates of invasive fungal infections in patients with hematological malginancies; notably, posaconazole also was more effective at reducing all-cause mortality and adverse events compared with other triazoles.
Major finding: Posaconazole was superior to fluconazole (odds ratio 0.30), itraconazole (OR 0.40), and amphotericin B (OR 4.97) in reducing the incidence of both suspected and confirmed invasive fungal infections.
Study details: The data come from a meta-analysis of 35 studies including 37 randomized, controlled trials of the effectiveness of triazoles, polyene, and echinocandin antifungals for infection control in patients with hematological malignancies.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Zeng H et al. BMC Cancer. 2021 Apr 14. doi: 10.1186/s12885-021-07973-8.
Echinocandins fail against wounds caused by Candida
Key clinical point: Concentrations of echinocandin penetration into wound secretions may be sub-therapeutic in some patients, and the relevance to clinical outcomes in patients with severe invasive candidiasis infections remains unclear.
Major finding: Concentrations of echinocandins in wound secretions were significantly lower than simultaneous plasma concentrations, and measured less than 0.025 mg/L-2.25 mg/L for anidulafungin; 0.025 mg/L-2.53 mg/L for micafungin; and 0.18 mg/L-4.04 mg/L for caspofungin.
Study details: The data come from 21 critically ill adults with suspected or confirmed invasive fungal infections who were treated with an echinocandins anidulafungin (AFG), micafungin (MFG), and caspofungin (CAS); concentrations in wound secretion were measured using liquid chromatography or tandem mass spectrometry detection.
Disclosures: The study was supported by the University of Innsbruck and Medical University of Innsbruck, and by the Austrian Science Fund. The researchers had no financial conflicts to disclose.
Source: Gasperetti T et al. Infection. 2021 Apr 20. doi: 10.1007/s15010-021-01604-x.
Key clinical point: Concentrations of echinocandin penetration into wound secretions may be sub-therapeutic in some patients, and the relevance to clinical outcomes in patients with severe invasive candidiasis infections remains unclear.
Major finding: Concentrations of echinocandins in wound secretions were significantly lower than simultaneous plasma concentrations, and measured less than 0.025 mg/L-2.25 mg/L for anidulafungin; 0.025 mg/L-2.53 mg/L for micafungin; and 0.18 mg/L-4.04 mg/L for caspofungin.
Study details: The data come from 21 critically ill adults with suspected or confirmed invasive fungal infections who were treated with an echinocandins anidulafungin (AFG), micafungin (MFG), and caspofungin (CAS); concentrations in wound secretion were measured using liquid chromatography or tandem mass spectrometry detection.
Disclosures: The study was supported by the University of Innsbruck and Medical University of Innsbruck, and by the Austrian Science Fund. The researchers had no financial conflicts to disclose.
Source: Gasperetti T et al. Infection. 2021 Apr 20. doi: 10.1007/s15010-021-01604-x.
Key clinical point: Concentrations of echinocandin penetration into wound secretions may be sub-therapeutic in some patients, and the relevance to clinical outcomes in patients with severe invasive candidiasis infections remains unclear.
Major finding: Concentrations of echinocandins in wound secretions were significantly lower than simultaneous plasma concentrations, and measured less than 0.025 mg/L-2.25 mg/L for anidulafungin; 0.025 mg/L-2.53 mg/L for micafungin; and 0.18 mg/L-4.04 mg/L for caspofungin.
Study details: The data come from 21 critically ill adults with suspected or confirmed invasive fungal infections who were treated with an echinocandins anidulafungin (AFG), micafungin (MFG), and caspofungin (CAS); concentrations in wound secretion were measured using liquid chromatography or tandem mass spectrometry detection.
Disclosures: The study was supported by the University of Innsbruck and Medical University of Innsbruck, and by the Austrian Science Fund. The researchers had no financial conflicts to disclose.
Source: Gasperetti T et al. Infection. 2021 Apr 20. doi: 10.1007/s15010-021-01604-x.
Multiple sclerosis patients may develop fungal infections on disease-modifying drugs
Key clinical point: Invasive fungal infections, though rare, have been observed in multiple sclerosis patients using a range of disease-modifying treatments and should be suspected in patients presenting with signs of infection.
Major finding: The overall occurrence of invasive fungal infections in patients with multiple sclerosis on disease-modifying treatments was low, but monoclonal antibodies were associated with higher rates of infection. The most common infection sources were Aspergillosis and cryptococcal meningitidis.
Study details: The data come from a meta-analysis of patients treated with rituximab, ocrelizumab, alemtuzumab, fingolimod, natalizumab, dimethyl fumarate, interferon, glatiramer acetate, cladribine, teriflunomide.
Disclosures: The study received no outside funding. Lead author Dr. Scotto had no financial conflicts to disclose; several coauthors disclosed relationships with companies including Almirall, Bayer, Biogen, Merck, Novartis, Roche, and Sanofi-Genzyme.
Source: Scotto R et al. Expert Opin Drug Saf. 2021 Apr 21. doi: 10.1080/14740338.2021.1918673.
Key clinical point: Invasive fungal infections, though rare, have been observed in multiple sclerosis patients using a range of disease-modifying treatments and should be suspected in patients presenting with signs of infection.
Major finding: The overall occurrence of invasive fungal infections in patients with multiple sclerosis on disease-modifying treatments was low, but monoclonal antibodies were associated with higher rates of infection. The most common infection sources were Aspergillosis and cryptococcal meningitidis.
Study details: The data come from a meta-analysis of patients treated with rituximab, ocrelizumab, alemtuzumab, fingolimod, natalizumab, dimethyl fumarate, interferon, glatiramer acetate, cladribine, teriflunomide.
Disclosures: The study received no outside funding. Lead author Dr. Scotto had no financial conflicts to disclose; several coauthors disclosed relationships with companies including Almirall, Bayer, Biogen, Merck, Novartis, Roche, and Sanofi-Genzyme.
Source: Scotto R et al. Expert Opin Drug Saf. 2021 Apr 21. doi: 10.1080/14740338.2021.1918673.
Key clinical point: Invasive fungal infections, though rare, have been observed in multiple sclerosis patients using a range of disease-modifying treatments and should be suspected in patients presenting with signs of infection.
Major finding: The overall occurrence of invasive fungal infections in patients with multiple sclerosis on disease-modifying treatments was low, but monoclonal antibodies were associated with higher rates of infection. The most common infection sources were Aspergillosis and cryptococcal meningitidis.
Study details: The data come from a meta-analysis of patients treated with rituximab, ocrelizumab, alemtuzumab, fingolimod, natalizumab, dimethyl fumarate, interferon, glatiramer acetate, cladribine, teriflunomide.
Disclosures: The study received no outside funding. Lead author Dr. Scotto had no financial conflicts to disclose; several coauthors disclosed relationships with companies including Almirall, Bayer, Biogen, Merck, Novartis, Roche, and Sanofi-Genzyme.
Source: Scotto R et al. Expert Opin Drug Saf. 2021 Apr 21. doi: 10.1080/14740338.2021.1918673.
Short-term oxygen prescriptions lead to inappropriate long-term use
In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.
Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.
A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.
The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.
There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.
In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.
Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.
A version of this article first appeared on Medscape.com.
In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.
Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.
A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.
The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.
There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.
In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.
Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.
A version of this article first appeared on Medscape.com.
In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.
Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.
A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.
The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.
There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.
In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.
Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.
A version of this article first appeared on Medscape.com.
Psoriasis associated with an increased risk of COVID-19 in real-world study
in patients, compared with those on topical therapy, a new study finds.
“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”
Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.
The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.
After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).
In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).
Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.
Reduced risk, compared with topical therapies
After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).
Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).
Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.
One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.
However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).
Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”
In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”
It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”
Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”
As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”
No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.
in patients, compared with those on topical therapy, a new study finds.
“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”
Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.
The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.
After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).
In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).
Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.
Reduced risk, compared with topical therapies
After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).
Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).
Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.
One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.
However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).
Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”
In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”
It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”
Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”
As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”
No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.
in patients, compared with those on topical therapy, a new study finds.
“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”
Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.
The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.
After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).
In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).
Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.
Reduced risk, compared with topical therapies
After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).
Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).
Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.
One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.
However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).
Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”
In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”
It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”
Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”
As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”
No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.
FROM AAD VMX 2021
Line of therapy matters for assessing biologic’s serious infection risk in RA
The order in which tocilizumab (Actemra) is used in the sequence of treatments for rheumatoid arthritis could be muddying the waters when it comes to evaluating patients’ risk for serious infection.
According to new data emerging from the British Society for Rheumatology Biologics Register – Rheumatoid Arthritis (BSRBR-RA), the line of therapy is a confounding factor when examining the risk for serious infection with not only tocilizumab but also other biologic agents.
The good news for patients, however, is that there doesn’t appear to be any overall greater risk for serious infection with one biologic over another when the line of therapy is taken into account.
“We don’t have any strong signal that there is an increased risk of serious infections with tocilizumab, compared to TNF inhibitors,” rheumatologist Kim Lauper, MD, of Geneva University Hospitals, said in an interview after presenting the data at the annual conference of the British Society for Rheumatology.
This is in contrast to studies where an increased risk of infections with tocilizumab has been seen when compared to TNF inhibitors. However, those studies did not account for the line of therapy, explained Dr. Lauper, who is also a clinical research fellow in the Centre for Epidemiology Versus Arthritis at the University of Manchester (England), where the BSRBR-RA is managed.
“Tocilizumab is a treatment that we often give to patients after several other treatments, so they’re really different patients,” Dr. Lauper observed. Indeed, in the “real-world” setting, patients taking tocilizumab tend to be older, have longer disease duration, and have worse functional status than do those who might receive other biologics.
To look at the effect of line of therapy on the serious infection risk associated with commonly used biologic drugs, Dr. Lauper and associates examined data on more than 33,000 treatment courses, representing more than 62,500 patient-years.
Using etanercept as the comparator – because it represents the largest group of patients in the BSRBR-RA – the serious infection risk for tocilizumab, rituximab, adalimumab, infliximab, certolizumab pegol, and abatacept were calculated as an overall rate, and for their use as first-, second-, third-, fourth-, or fifth-line therapy.
The researchers adjusted their analysis for some clear baseline differences between the treatment groups, including age, prior treatment, disease duration, and comorbidities. Seropositivity, smoking status, general health status, and disease activity scores were also adjusted for in the analysis.
Crude hazard ratios (HRs), compared with etanercept, before and after adjusting for these already-known confounding factors were 1.0 and 1.2 for tocilizumab, 1.1 and 1.1 for adalimumab, 1.4 and 1.3 for infliximab, 0.6 and 0.8 for certolizumab pegol, 0.9 and 1.0 for rituximab, and 0.9 and 1.2 for abatacept.
Stratifying by line of therapy, however, changed the results: HRs were no longer significantly different, compared with etanercept, for tocilizumab, adalimumab, and infliximab for most lines of therapy.
Indeed, while the risk for serious infection occurring with tocilizumab was 20% higher overall, compared with etanercept, that risk was actually lower if tocilizumab had been used as first- or fifth-line therapy (HRs for both, 0.9) but higher if it had been used as a third- or fourth-line therapy (HR of 1.4 for both).
“We often use tocilizumab as a second-line, third-line, or even fourth-line therapy, and if we don’t adjust for anything, we can have the impression that there are more infections with tocilizumab. But then, when we adjust for confounding factors and the line of therapy, we don’t have this anymore,” Dr. Lauper said.
“Line of therapy in itself is not a risk for serious infections,” she said in qualifying the conclusions that could be drawn from the study. “It may be a marker of the disease or some patient characteristic that is associated with a higher risk of infections.” Nevertheless, it should be taken into account when evaluating serious outcomes and possibly other safety and effectiveness outcomes.
“I understand concentrating on the hospitalized infections because the data are so much more robust,” observed consultant rheumatologist Jon Packham, BM, DM, of Haywood Hospital in Stoke-on-Trent, England, who chaired the session. He queried if there were any data on milder or just antibiotic-treated infections. At present, there aren’t those data to look at, Dr. Lauper responded, as this is something that’s difficult for registers to capture because doctors often do not log them in the databases.
There are also too few data on Janus kinase (JAK) inhibitors currently in the BSRBR-RA at present to be able to look at their rate of serious infection by line of therapy, Dr. Lauper noted. Because JAK inhibitors act on cytokines different from those affected by biologics for RA, there may be a difference there, but more data are needed on the JAK inhibitors before that question can be analyzed.
Dr. Lauper did not state having any disclosures. The BSRBR-RA is funded by the BSR via restricted income grants from several U.K. pharmaceutical companies, which has included or currently includes AbbVie, Celltrion, Hospira, Pfizer, UCB, Roche, Swedish Orphan Biovitrum, and Merck.
The order in which tocilizumab (Actemra) is used in the sequence of treatments for rheumatoid arthritis could be muddying the waters when it comes to evaluating patients’ risk for serious infection.
According to new data emerging from the British Society for Rheumatology Biologics Register – Rheumatoid Arthritis (BSRBR-RA), the line of therapy is a confounding factor when examining the risk for serious infection with not only tocilizumab but also other biologic agents.
The good news for patients, however, is that there doesn’t appear to be any overall greater risk for serious infection with one biologic over another when the line of therapy is taken into account.
“We don’t have any strong signal that there is an increased risk of serious infections with tocilizumab, compared to TNF inhibitors,” rheumatologist Kim Lauper, MD, of Geneva University Hospitals, said in an interview after presenting the data at the annual conference of the British Society for Rheumatology.
This is in contrast to studies where an increased risk of infections with tocilizumab has been seen when compared to TNF inhibitors. However, those studies did not account for the line of therapy, explained Dr. Lauper, who is also a clinical research fellow in the Centre for Epidemiology Versus Arthritis at the University of Manchester (England), where the BSRBR-RA is managed.
“Tocilizumab is a treatment that we often give to patients after several other treatments, so they’re really different patients,” Dr. Lauper observed. Indeed, in the “real-world” setting, patients taking tocilizumab tend to be older, have longer disease duration, and have worse functional status than do those who might receive other biologics.
To look at the effect of line of therapy on the serious infection risk associated with commonly used biologic drugs, Dr. Lauper and associates examined data on more than 33,000 treatment courses, representing more than 62,500 patient-years.
Using etanercept as the comparator – because it represents the largest group of patients in the BSRBR-RA – the serious infection risk for tocilizumab, rituximab, adalimumab, infliximab, certolizumab pegol, and abatacept were calculated as an overall rate, and for their use as first-, second-, third-, fourth-, or fifth-line therapy.
The researchers adjusted their analysis for some clear baseline differences between the treatment groups, including age, prior treatment, disease duration, and comorbidities. Seropositivity, smoking status, general health status, and disease activity scores were also adjusted for in the analysis.
Crude hazard ratios (HRs), compared with etanercept, before and after adjusting for these already-known confounding factors were 1.0 and 1.2 for tocilizumab, 1.1 and 1.1 for adalimumab, 1.4 and 1.3 for infliximab, 0.6 and 0.8 for certolizumab pegol, 0.9 and 1.0 for rituximab, and 0.9 and 1.2 for abatacept.
Stratifying by line of therapy, however, changed the results: HRs were no longer significantly different, compared with etanercept, for tocilizumab, adalimumab, and infliximab for most lines of therapy.
Indeed, while the risk for serious infection occurring with tocilizumab was 20% higher overall, compared with etanercept, that risk was actually lower if tocilizumab had been used as first- or fifth-line therapy (HRs for both, 0.9) but higher if it had been used as a third- or fourth-line therapy (HR of 1.4 for both).
“We often use tocilizumab as a second-line, third-line, or even fourth-line therapy, and if we don’t adjust for anything, we can have the impression that there are more infections with tocilizumab. But then, when we adjust for confounding factors and the line of therapy, we don’t have this anymore,” Dr. Lauper said.
“Line of therapy in itself is not a risk for serious infections,” she said in qualifying the conclusions that could be drawn from the study. “It may be a marker of the disease or some patient characteristic that is associated with a higher risk of infections.” Nevertheless, it should be taken into account when evaluating serious outcomes and possibly other safety and effectiveness outcomes.
“I understand concentrating on the hospitalized infections because the data are so much more robust,” observed consultant rheumatologist Jon Packham, BM, DM, of Haywood Hospital in Stoke-on-Trent, England, who chaired the session. He queried if there were any data on milder or just antibiotic-treated infections. At present, there aren’t those data to look at, Dr. Lauper responded, as this is something that’s difficult for registers to capture because doctors often do not log them in the databases.
There are also too few data on Janus kinase (JAK) inhibitors currently in the BSRBR-RA at present to be able to look at their rate of serious infection by line of therapy, Dr. Lauper noted. Because JAK inhibitors act on cytokines different from those affected by biologics for RA, there may be a difference there, but more data are needed on the JAK inhibitors before that question can be analyzed.
Dr. Lauper did not state having any disclosures. The BSRBR-RA is funded by the BSR via restricted income grants from several U.K. pharmaceutical companies, which has included or currently includes AbbVie, Celltrion, Hospira, Pfizer, UCB, Roche, Swedish Orphan Biovitrum, and Merck.
The order in which tocilizumab (Actemra) is used in the sequence of treatments for rheumatoid arthritis could be muddying the waters when it comes to evaluating patients’ risk for serious infection.
According to new data emerging from the British Society for Rheumatology Biologics Register – Rheumatoid Arthritis (BSRBR-RA), the line of therapy is a confounding factor when examining the risk for serious infection with not only tocilizumab but also other biologic agents.
The good news for patients, however, is that there doesn’t appear to be any overall greater risk for serious infection with one biologic over another when the line of therapy is taken into account.
“We don’t have any strong signal that there is an increased risk of serious infections with tocilizumab, compared to TNF inhibitors,” rheumatologist Kim Lauper, MD, of Geneva University Hospitals, said in an interview after presenting the data at the annual conference of the British Society for Rheumatology.
This is in contrast to studies where an increased risk of infections with tocilizumab has been seen when compared to TNF inhibitors. However, those studies did not account for the line of therapy, explained Dr. Lauper, who is also a clinical research fellow in the Centre for Epidemiology Versus Arthritis at the University of Manchester (England), where the BSRBR-RA is managed.
“Tocilizumab is a treatment that we often give to patients after several other treatments, so they’re really different patients,” Dr. Lauper observed. Indeed, in the “real-world” setting, patients taking tocilizumab tend to be older, have longer disease duration, and have worse functional status than do those who might receive other biologics.
To look at the effect of line of therapy on the serious infection risk associated with commonly used biologic drugs, Dr. Lauper and associates examined data on more than 33,000 treatment courses, representing more than 62,500 patient-years.
Using etanercept as the comparator – because it represents the largest group of patients in the BSRBR-RA – the serious infection risk for tocilizumab, rituximab, adalimumab, infliximab, certolizumab pegol, and abatacept were calculated as an overall rate, and for their use as first-, second-, third-, fourth-, or fifth-line therapy.
The researchers adjusted their analysis for some clear baseline differences between the treatment groups, including age, prior treatment, disease duration, and comorbidities. Seropositivity, smoking status, general health status, and disease activity scores were also adjusted for in the analysis.
Crude hazard ratios (HRs), compared with etanercept, before and after adjusting for these already-known confounding factors were 1.0 and 1.2 for tocilizumab, 1.1 and 1.1 for adalimumab, 1.4 and 1.3 for infliximab, 0.6 and 0.8 for certolizumab pegol, 0.9 and 1.0 for rituximab, and 0.9 and 1.2 for abatacept.
Stratifying by line of therapy, however, changed the results: HRs were no longer significantly different, compared with etanercept, for tocilizumab, adalimumab, and infliximab for most lines of therapy.
Indeed, while the risk for serious infection occurring with tocilizumab was 20% higher overall, compared with etanercept, that risk was actually lower if tocilizumab had been used as first- or fifth-line therapy (HRs for both, 0.9) but higher if it had been used as a third- or fourth-line therapy (HR of 1.4 for both).
“We often use tocilizumab as a second-line, third-line, or even fourth-line therapy, and if we don’t adjust for anything, we can have the impression that there are more infections with tocilizumab. But then, when we adjust for confounding factors and the line of therapy, we don’t have this anymore,” Dr. Lauper said.
“Line of therapy in itself is not a risk for serious infections,” she said in qualifying the conclusions that could be drawn from the study. “It may be a marker of the disease or some patient characteristic that is associated with a higher risk of infections.” Nevertheless, it should be taken into account when evaluating serious outcomes and possibly other safety and effectiveness outcomes.
“I understand concentrating on the hospitalized infections because the data are so much more robust,” observed consultant rheumatologist Jon Packham, BM, DM, of Haywood Hospital in Stoke-on-Trent, England, who chaired the session. He queried if there were any data on milder or just antibiotic-treated infections. At present, there aren’t those data to look at, Dr. Lauper responded, as this is something that’s difficult for registers to capture because doctors often do not log them in the databases.
There are also too few data on Janus kinase (JAK) inhibitors currently in the BSRBR-RA at present to be able to look at their rate of serious infection by line of therapy, Dr. Lauper noted. Because JAK inhibitors act on cytokines different from those affected by biologics for RA, there may be a difference there, but more data are needed on the JAK inhibitors before that question can be analyzed.
Dr. Lauper did not state having any disclosures. The BSRBR-RA is funded by the BSR via restricted income grants from several U.K. pharmaceutical companies, which has included or currently includes AbbVie, Celltrion, Hospira, Pfizer, UCB, Roche, Swedish Orphan Biovitrum, and Merck.
FROM BSR 2021