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ACIP approves flu vaccine recommendations for 2020-2021
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
EULAR gives pointers on intra-articular injection best practices
New EULAR recommendations for the intra-articular (IA) treatment of arthropathies aim to facilitate uniformity and quality of care for this mainstay of rheumatologic practice, according to a report on the new guidance that was presented at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Until now there were no official recommendations on how best to use it in everyday practice. “This is the first time that there’s been a joint effort to develop evidence-based recommendations,” Jacqueline Usón, MD, PhD, associate professor medicine at Rey Juan Carlos University in Madrid, said in an interview. “Everything that we are saying is pretty logical, but it’s nice to see it put in recommendations based on evidence.”
IA therapy has been around for decades and is key for treating adults with a number of different conditions where synovitis, effusion, pain, or all three, are present, such as inflammatory arthritis and osteoarthritis, Dr. Usón observed during her presentation.
“Today, commonly used injectables are not only corticosteroids but also local anesthetics, hyaluronic acid, blood products, and maybe pharmaceuticals,” she said, adding that “there is a wide variation in the way intra-articular therapies are used and delivered to patients.” Health professionals also have very different views and habits depending on geographic locations and health care systems, she observed. Ironing out the variation was one of the main objectives of the recommendations.
As one of the two conveners of the EULAR task force behind the recommendations, Dr. Usón, herself a rheumatologist at University Hospital of Móstoles, pointed out that the task force brought together a range of specialties – rheumatologists, orthopedic surgeons, radiologists, nuclear medicine specialists, among others, as well as patients – to ensure that the best advice could be given.
The task force followed EULAR standard operating procedures for developing recommendations, with discussion groups, systematic literature reviews, and Delphi technique-based consensus all being employed. The literature search considered publications from 1946 up until 2019.
“We agreed on the need for more background information from health professionals and patients, so we developed two surveys: One for health professionals with 160 items, [for which] we obtained 186 responses from 26 countries; and the patient survey was made up of 44 items, translated into 10 different languages, and we obtained 200 responses,” she said.
The results of the systematic literature review and surveys were used to help form expert consensus, leading to 5 overarching principles and 11 recommendations that look at before, during, and after intra-articular therapy.
Five overarching principles
The first overarching principle recognizes the widespread use of IA therapies and that their use is specific to the disease that is being treated and “may not be interchangeable across indications,” Dr. Usón said. The second principle concerns improving patient-centered outcomes, which are “those that are relevant to the patient,” and include the benefits, harms, preferences, or implications for self-management.
“Contextual factors are important and contribute to the effect of IAT [intra-articular treatment],” she said, discussing the third principle. “These include effective communication, patient expectations, or settings [where the procedure takes place]. In addition, one should take into account that the route of delivery has in itself a placebo effect. We found that in different RCTs [randomized controlled trials], the pooled placebo effect of IA saline is moderate to large.”
The fourth principle looks at ensuring that patients and clinicians make an informed and shared decision, which is again highlighted by the first recommendation. The fifth, and last, overarching principle acknowledges that IA injections may be given by a range of health care professionals.
Advice for before, during, and after injection
Patients need to be “fully informed of the nature of the procedure, the injectable used, and potential effects – benefits and risks – [and] informed consent should be obtained and documented,” said Dr. Usón, outlining the first recommendation. “That seems common,” she said in the interview, “but when we did the survey, we realize that many patients didn’t [give consent], and the doctors didn’t even ask for it. This is why it’s a very general statement, and it’s our first recommendation. The agreement was 99%!”
The recommendations also look at the optimal settings for performing injections, such as providing a professional and private, well-lighted room, and having a resuscitation kit nearby in case patients faint. Accuracy is important, Dr. Usón said, and imaging, such as ultrasound, should be used where available to ensure accurate injection into the joint. This is an area where further research could be performed, she said, urging young rheumatologists and health professionals to consider this. “Intra-articular therapy is something that you learn and do, but you never really investigate in it,” she said.
One recommendation states that when intra-articular injections are being given to pregnant patients, the safety of injected compound must be considered, both for the mother and for the fetus. There is another recommendation on the need to perform IA injections under aseptic conditions, and another stating that patients should be offered local anesthetics, after explaining the pros and cons.
Special populations of patients are also considered, Dr. Usón said. For example, the guidance advises warning patients with diabetes of the risk of transient glycemia after IA glucocorticoids and the need to monitor their blood glucose levels carefully for a couple of days afterward.
As a rule, “IAT is not a contraindication to people with clotting or bleeding disorders, or taking antithrombotic medications,” she said, unless they are at a high risk of bleeding.
Importantly, the recommendations cover when IAT can be performed after joint replacement surgery (after at least 3 months), and the need to “avoid overuse of injected joints” while also avoiding complete immobilization for at least 24 hours afterward. The recommendations very generally cover re-injections, but not how long intervals between injections should be. When asked about interval duration after her presentation, Dr. Usón said that the usual advice is to give IA injections no more than 2-3 times a year, but it depends on the injectable.
“It wasn’t our intention to review the efficacy and the safety of the different injectables, nor to review the use of IAT in different types of joint diseases,” she said. “We do lack a lot of information, a lot of evidence in this, and I really would hope that new rheumatologists start looking into and start investigating in this topic,” she added.
Recommendations will increase awareness of good clinical practice
“IA injections are commonly administered in the rheumatology setting. This is because [IA injection] is often a useful treatment for acute flare of arthritis, particularly when it is limited to a few joints,” observed Ai Lyn Tan, MD, associate professor and honorary consultant rheumatologist at the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine.
IA injection “also relieves symptoms relatively quickly for patients; however, the response can be variable, and there are side effects associated with IA injections,” Dr. Tan added in an interview.
There is a lack of universally accepted recommendations, Dr. Tan observed, noting that while there might be some local guidelines on how to safely perform IA injections these were often not standardized and were subject to being continually updated to try to improve the experience for patients.
“It is therefore timely to learn about the new EULAR recommendations for IA injections. The advantage of this will be to increase awareness of good clinical practice for performing IA injections.”
Dr. Tan had no relevant conflicts of interest.
SOURCE: EULAR COVID-19 Recommendations. E-congress content available until Sept. 1, 2020.
New EULAR recommendations for the intra-articular (IA) treatment of arthropathies aim to facilitate uniformity and quality of care for this mainstay of rheumatologic practice, according to a report on the new guidance that was presented at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Until now there were no official recommendations on how best to use it in everyday practice. “This is the first time that there’s been a joint effort to develop evidence-based recommendations,” Jacqueline Usón, MD, PhD, associate professor medicine at Rey Juan Carlos University in Madrid, said in an interview. “Everything that we are saying is pretty logical, but it’s nice to see it put in recommendations based on evidence.”
IA therapy has been around for decades and is key for treating adults with a number of different conditions where synovitis, effusion, pain, or all three, are present, such as inflammatory arthritis and osteoarthritis, Dr. Usón observed during her presentation.
“Today, commonly used injectables are not only corticosteroids but also local anesthetics, hyaluronic acid, blood products, and maybe pharmaceuticals,” she said, adding that “there is a wide variation in the way intra-articular therapies are used and delivered to patients.” Health professionals also have very different views and habits depending on geographic locations and health care systems, she observed. Ironing out the variation was one of the main objectives of the recommendations.
As one of the two conveners of the EULAR task force behind the recommendations, Dr. Usón, herself a rheumatologist at University Hospital of Móstoles, pointed out that the task force brought together a range of specialties – rheumatologists, orthopedic surgeons, radiologists, nuclear medicine specialists, among others, as well as patients – to ensure that the best advice could be given.
The task force followed EULAR standard operating procedures for developing recommendations, with discussion groups, systematic literature reviews, and Delphi technique-based consensus all being employed. The literature search considered publications from 1946 up until 2019.
“We agreed on the need for more background information from health professionals and patients, so we developed two surveys: One for health professionals with 160 items, [for which] we obtained 186 responses from 26 countries; and the patient survey was made up of 44 items, translated into 10 different languages, and we obtained 200 responses,” she said.
The results of the systematic literature review and surveys were used to help form expert consensus, leading to 5 overarching principles and 11 recommendations that look at before, during, and after intra-articular therapy.
Five overarching principles
The first overarching principle recognizes the widespread use of IA therapies and that their use is specific to the disease that is being treated and “may not be interchangeable across indications,” Dr. Usón said. The second principle concerns improving patient-centered outcomes, which are “those that are relevant to the patient,” and include the benefits, harms, preferences, or implications for self-management.
“Contextual factors are important and contribute to the effect of IAT [intra-articular treatment],” she said, discussing the third principle. “These include effective communication, patient expectations, or settings [where the procedure takes place]. In addition, one should take into account that the route of delivery has in itself a placebo effect. We found that in different RCTs [randomized controlled trials], the pooled placebo effect of IA saline is moderate to large.”
The fourth principle looks at ensuring that patients and clinicians make an informed and shared decision, which is again highlighted by the first recommendation. The fifth, and last, overarching principle acknowledges that IA injections may be given by a range of health care professionals.
Advice for before, during, and after injection
Patients need to be “fully informed of the nature of the procedure, the injectable used, and potential effects – benefits and risks – [and] informed consent should be obtained and documented,” said Dr. Usón, outlining the first recommendation. “That seems common,” she said in the interview, “but when we did the survey, we realize that many patients didn’t [give consent], and the doctors didn’t even ask for it. This is why it’s a very general statement, and it’s our first recommendation. The agreement was 99%!”
The recommendations also look at the optimal settings for performing injections, such as providing a professional and private, well-lighted room, and having a resuscitation kit nearby in case patients faint. Accuracy is important, Dr. Usón said, and imaging, such as ultrasound, should be used where available to ensure accurate injection into the joint. This is an area where further research could be performed, she said, urging young rheumatologists and health professionals to consider this. “Intra-articular therapy is something that you learn and do, but you never really investigate in it,” she said.
One recommendation states that when intra-articular injections are being given to pregnant patients, the safety of injected compound must be considered, both for the mother and for the fetus. There is another recommendation on the need to perform IA injections under aseptic conditions, and another stating that patients should be offered local anesthetics, after explaining the pros and cons.
Special populations of patients are also considered, Dr. Usón said. For example, the guidance advises warning patients with diabetes of the risk of transient glycemia after IA glucocorticoids and the need to monitor their blood glucose levels carefully for a couple of days afterward.
As a rule, “IAT is not a contraindication to people with clotting or bleeding disorders, or taking antithrombotic medications,” she said, unless they are at a high risk of bleeding.
Importantly, the recommendations cover when IAT can be performed after joint replacement surgery (after at least 3 months), and the need to “avoid overuse of injected joints” while also avoiding complete immobilization for at least 24 hours afterward. The recommendations very generally cover re-injections, but not how long intervals between injections should be. When asked about interval duration after her presentation, Dr. Usón said that the usual advice is to give IA injections no more than 2-3 times a year, but it depends on the injectable.
“It wasn’t our intention to review the efficacy and the safety of the different injectables, nor to review the use of IAT in different types of joint diseases,” she said. “We do lack a lot of information, a lot of evidence in this, and I really would hope that new rheumatologists start looking into and start investigating in this topic,” she added.
Recommendations will increase awareness of good clinical practice
“IA injections are commonly administered in the rheumatology setting. This is because [IA injection] is often a useful treatment for acute flare of arthritis, particularly when it is limited to a few joints,” observed Ai Lyn Tan, MD, associate professor and honorary consultant rheumatologist at the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine.
IA injection “also relieves symptoms relatively quickly for patients; however, the response can be variable, and there are side effects associated with IA injections,” Dr. Tan added in an interview.
There is a lack of universally accepted recommendations, Dr. Tan observed, noting that while there might be some local guidelines on how to safely perform IA injections these were often not standardized and were subject to being continually updated to try to improve the experience for patients.
“It is therefore timely to learn about the new EULAR recommendations for IA injections. The advantage of this will be to increase awareness of good clinical practice for performing IA injections.”
Dr. Tan had no relevant conflicts of interest.
SOURCE: EULAR COVID-19 Recommendations. E-congress content available until Sept. 1, 2020.
New EULAR recommendations for the intra-articular (IA) treatment of arthropathies aim to facilitate uniformity and quality of care for this mainstay of rheumatologic practice, according to a report on the new guidance that was presented at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Until now there were no official recommendations on how best to use it in everyday practice. “This is the first time that there’s been a joint effort to develop evidence-based recommendations,” Jacqueline Usón, MD, PhD, associate professor medicine at Rey Juan Carlos University in Madrid, said in an interview. “Everything that we are saying is pretty logical, but it’s nice to see it put in recommendations based on evidence.”
IA therapy has been around for decades and is key for treating adults with a number of different conditions where synovitis, effusion, pain, or all three, are present, such as inflammatory arthritis and osteoarthritis, Dr. Usón observed during her presentation.
“Today, commonly used injectables are not only corticosteroids but also local anesthetics, hyaluronic acid, blood products, and maybe pharmaceuticals,” she said, adding that “there is a wide variation in the way intra-articular therapies are used and delivered to patients.” Health professionals also have very different views and habits depending on geographic locations and health care systems, she observed. Ironing out the variation was one of the main objectives of the recommendations.
As one of the two conveners of the EULAR task force behind the recommendations, Dr. Usón, herself a rheumatologist at University Hospital of Móstoles, pointed out that the task force brought together a range of specialties – rheumatologists, orthopedic surgeons, radiologists, nuclear medicine specialists, among others, as well as patients – to ensure that the best advice could be given.
The task force followed EULAR standard operating procedures for developing recommendations, with discussion groups, systematic literature reviews, and Delphi technique-based consensus all being employed. The literature search considered publications from 1946 up until 2019.
“We agreed on the need for more background information from health professionals and patients, so we developed two surveys: One for health professionals with 160 items, [for which] we obtained 186 responses from 26 countries; and the patient survey was made up of 44 items, translated into 10 different languages, and we obtained 200 responses,” she said.
The results of the systematic literature review and surveys were used to help form expert consensus, leading to 5 overarching principles and 11 recommendations that look at before, during, and after intra-articular therapy.
Five overarching principles
The first overarching principle recognizes the widespread use of IA therapies and that their use is specific to the disease that is being treated and “may not be interchangeable across indications,” Dr. Usón said. The second principle concerns improving patient-centered outcomes, which are “those that are relevant to the patient,” and include the benefits, harms, preferences, or implications for self-management.
“Contextual factors are important and contribute to the effect of IAT [intra-articular treatment],” she said, discussing the third principle. “These include effective communication, patient expectations, or settings [where the procedure takes place]. In addition, one should take into account that the route of delivery has in itself a placebo effect. We found that in different RCTs [randomized controlled trials], the pooled placebo effect of IA saline is moderate to large.”
The fourth principle looks at ensuring that patients and clinicians make an informed and shared decision, which is again highlighted by the first recommendation. The fifth, and last, overarching principle acknowledges that IA injections may be given by a range of health care professionals.
Advice for before, during, and after injection
Patients need to be “fully informed of the nature of the procedure, the injectable used, and potential effects – benefits and risks – [and] informed consent should be obtained and documented,” said Dr. Usón, outlining the first recommendation. “That seems common,” she said in the interview, “but when we did the survey, we realize that many patients didn’t [give consent], and the doctors didn’t even ask for it. This is why it’s a very general statement, and it’s our first recommendation. The agreement was 99%!”
The recommendations also look at the optimal settings for performing injections, such as providing a professional and private, well-lighted room, and having a resuscitation kit nearby in case patients faint. Accuracy is important, Dr. Usón said, and imaging, such as ultrasound, should be used where available to ensure accurate injection into the joint. This is an area where further research could be performed, she said, urging young rheumatologists and health professionals to consider this. “Intra-articular therapy is something that you learn and do, but you never really investigate in it,” she said.
One recommendation states that when intra-articular injections are being given to pregnant patients, the safety of injected compound must be considered, both for the mother and for the fetus. There is another recommendation on the need to perform IA injections under aseptic conditions, and another stating that patients should be offered local anesthetics, after explaining the pros and cons.
Special populations of patients are also considered, Dr. Usón said. For example, the guidance advises warning patients with diabetes of the risk of transient glycemia after IA glucocorticoids and the need to monitor their blood glucose levels carefully for a couple of days afterward.
As a rule, “IAT is not a contraindication to people with clotting or bleeding disorders, or taking antithrombotic medications,” she said, unless they are at a high risk of bleeding.
Importantly, the recommendations cover when IAT can be performed after joint replacement surgery (after at least 3 months), and the need to “avoid overuse of injected joints” while also avoiding complete immobilization for at least 24 hours afterward. The recommendations very generally cover re-injections, but not how long intervals between injections should be. When asked about interval duration after her presentation, Dr. Usón said that the usual advice is to give IA injections no more than 2-3 times a year, but it depends on the injectable.
“It wasn’t our intention to review the efficacy and the safety of the different injectables, nor to review the use of IAT in different types of joint diseases,” she said. “We do lack a lot of information, a lot of evidence in this, and I really would hope that new rheumatologists start looking into and start investigating in this topic,” she added.
Recommendations will increase awareness of good clinical practice
“IA injections are commonly administered in the rheumatology setting. This is because [IA injection] is often a useful treatment for acute flare of arthritis, particularly when it is limited to a few joints,” observed Ai Lyn Tan, MD, associate professor and honorary consultant rheumatologist at the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine.
IA injection “also relieves symptoms relatively quickly for patients; however, the response can be variable, and there are side effects associated with IA injections,” Dr. Tan added in an interview.
There is a lack of universally accepted recommendations, Dr. Tan observed, noting that while there might be some local guidelines on how to safely perform IA injections these were often not standardized and were subject to being continually updated to try to improve the experience for patients.
“It is therefore timely to learn about the new EULAR recommendations for IA injections. The advantage of this will be to increase awareness of good clinical practice for performing IA injections.”
Dr. Tan had no relevant conflicts of interest.
SOURCE: EULAR COVID-19 Recommendations. E-congress content available until Sept. 1, 2020.
FROM THE EULAR 2020 E-CONGRESS
New registry focuses on rheumatic immune-related AEs of cancer therapy
Its first findings were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.
“We have limited knowledge on the interrelationships between malignant and rheumatic diseases on both the clinical and molecular level, and we have a large unmet need for management guidelines in the case of the coincidence of both disease entities,” noted lead author Karolina Benesova, MD, of the department of hematology, oncology, and rheumatology at University Hospital Heidelberg (Germany).
The TRheuMa registry – Therapy-Induced Rheumatic Symptoms in Patients with Malignancy – is one of three registries in a multicenter observational project exploring various contexts between malignant and rheumatic diseases. Over its first 22 months, the registry recruited 69 patients having rheumatic symptoms as a result of immune checkpoint inhibitor therapy or other cancer therapies.
Registry findings
The largest shares of patients had non–small cell lung cancer (38%) or melanoma (33%), Dr. Benesova reported. The immune checkpoint inhibitors most commonly received were pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy).
The immune-related adverse events usually presented with symptoms of de novo spondyloarthritis or psoriatic arthritis (42%), late-onset RA (17%), or polymyalgia rheumatica (14%). But 16% of the patients were experiencing a flare of a preexisting rheumatic and musculoskeletal disease.
Laboratory findings differed somewhat from those of classical rheumatic and musculoskeletal diseases, according to Dr. Benesova. Specific findings were rare; in particular, most patients did not have detectable autoantibodies. However, 76% had an elevated C-reactive protein level and 39% had an elevated soluble CD25 level. In addition, nearly all patients (96%) undergoing joint ultrasound had pathologic findings.
“Based on our experiences from interdisciplinary care together with our local oncologists, we have developed a therapeutic algorithm for rheumatic immune-related adverse events,” she reported, noting that the algorithm is consistent with recently published recommendations in this area.
The large majority of patients were adequately treated with prednisone at a dose greater than 10 mg (40%) or at a dose of 10 mg or less with or without an NSAID (40%), while some received NSAID monotherapy (14%).
“We have a growing proportion of patients on conventional or biological [disease-modifying antirheumatic drugs],” Dr. Benesova noted. “These are mostly patients with preexisting rheumatic and musculoskeletal disease or highly suspected de novo classical rheumatic and musculoskeletal disease under checkpoint inhibitor therapy.”
Patients with melanoma having a rheumatic immune-related adverse event had a better response to their therapy than historical counterparts who did not have such events: 39% of the former had a complete response, relative to merely 4% of the latter.
Only a small proportion of patients overall (9%) had to discontinue immune checkpoint inhibitor therapy because of their adverse event, and some of them may be eligible for rechallenge if their cancer progresses, Dr. Benesova noted.
“There is still a lot to be done,” she stated, such as better elucidating the nature of these adverse events [whether transient side effects or a triggering of chronic rheumatic and musculoskeletal diseases], the need for a defensive treatment strategy, and the advisability of closer monitoring of high-risk patients given immune checkpoint inhibitors. “We are aiming at solving these questions in the next few years,” she concluded.
Findings in context
“Registries are important to gain prospective data on patient outcomes,” Sabina Sandigursky, MD, an instructor in the division of rheumatology at the Laura and Isaac Perlmutter Cancer Center at New York University, commented in an interview. “One must be careful, while interpreting these data, especially since they are not randomized, controlled trials.”
Patterns may differ at other centers, too, she pointed out. “The German registry reported a predominance of spondyloarthritis-like disease; however, our patients have a predominance of small-joint involvement. It is unclear what accounts for this difference.”
Individual institutions in North America are similarly collecting data on this patient population, with efforts underway to compile those data to provide a larger picture, according to Dr. Sandigursky.
“Many of the syndromes that we consider to be rheumatic immune-related adverse events have been well described by groups from the U.S., Canada, Australia, and European Union,” she concluded. “From this registry, we can observe how patients are being treated in real time since this information is largely consensus based.”
The study did not receive any specific funding. Dr. Benesova disclosed grant/research support from AbbVie, Novartis, Rheumaliga Baden-Wurttemberg, and the University of Heidelberg, and consultancies, speaker fees, and/or travel reimbursements from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Medac, Merck Sharp & Dohme, Mundipharma, Novartis, Pfizer, Roche, and UCB. Some of her coauthors also disclosed financial relationships with industry. Dr. Sandigursky disclosed having no relevant conflicts of interest.
SOURCE: Benesova K et al. Ann Rheum Dis 2020;79[suppl 1]:168-9, Abstract OP0270.
Its first findings were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.
“We have limited knowledge on the interrelationships between malignant and rheumatic diseases on both the clinical and molecular level, and we have a large unmet need for management guidelines in the case of the coincidence of both disease entities,” noted lead author Karolina Benesova, MD, of the department of hematology, oncology, and rheumatology at University Hospital Heidelberg (Germany).
The TRheuMa registry – Therapy-Induced Rheumatic Symptoms in Patients with Malignancy – is one of three registries in a multicenter observational project exploring various contexts between malignant and rheumatic diseases. Over its first 22 months, the registry recruited 69 patients having rheumatic symptoms as a result of immune checkpoint inhibitor therapy or other cancer therapies.
Registry findings
The largest shares of patients had non–small cell lung cancer (38%) or melanoma (33%), Dr. Benesova reported. The immune checkpoint inhibitors most commonly received were pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy).
The immune-related adverse events usually presented with symptoms of de novo spondyloarthritis or psoriatic arthritis (42%), late-onset RA (17%), or polymyalgia rheumatica (14%). But 16% of the patients were experiencing a flare of a preexisting rheumatic and musculoskeletal disease.
Laboratory findings differed somewhat from those of classical rheumatic and musculoskeletal diseases, according to Dr. Benesova. Specific findings were rare; in particular, most patients did not have detectable autoantibodies. However, 76% had an elevated C-reactive protein level and 39% had an elevated soluble CD25 level. In addition, nearly all patients (96%) undergoing joint ultrasound had pathologic findings.
“Based on our experiences from interdisciplinary care together with our local oncologists, we have developed a therapeutic algorithm for rheumatic immune-related adverse events,” she reported, noting that the algorithm is consistent with recently published recommendations in this area.
The large majority of patients were adequately treated with prednisone at a dose greater than 10 mg (40%) or at a dose of 10 mg or less with or without an NSAID (40%), while some received NSAID monotherapy (14%).
“We have a growing proportion of patients on conventional or biological [disease-modifying antirheumatic drugs],” Dr. Benesova noted. “These are mostly patients with preexisting rheumatic and musculoskeletal disease or highly suspected de novo classical rheumatic and musculoskeletal disease under checkpoint inhibitor therapy.”
Patients with melanoma having a rheumatic immune-related adverse event had a better response to their therapy than historical counterparts who did not have such events: 39% of the former had a complete response, relative to merely 4% of the latter.
Only a small proportion of patients overall (9%) had to discontinue immune checkpoint inhibitor therapy because of their adverse event, and some of them may be eligible for rechallenge if their cancer progresses, Dr. Benesova noted.
“There is still a lot to be done,” she stated, such as better elucidating the nature of these adverse events [whether transient side effects or a triggering of chronic rheumatic and musculoskeletal diseases], the need for a defensive treatment strategy, and the advisability of closer monitoring of high-risk patients given immune checkpoint inhibitors. “We are aiming at solving these questions in the next few years,” she concluded.
Findings in context
“Registries are important to gain prospective data on patient outcomes,” Sabina Sandigursky, MD, an instructor in the division of rheumatology at the Laura and Isaac Perlmutter Cancer Center at New York University, commented in an interview. “One must be careful, while interpreting these data, especially since they are not randomized, controlled trials.”
Patterns may differ at other centers, too, she pointed out. “The German registry reported a predominance of spondyloarthritis-like disease; however, our patients have a predominance of small-joint involvement. It is unclear what accounts for this difference.”
Individual institutions in North America are similarly collecting data on this patient population, with efforts underway to compile those data to provide a larger picture, according to Dr. Sandigursky.
“Many of the syndromes that we consider to be rheumatic immune-related adverse events have been well described by groups from the U.S., Canada, Australia, and European Union,” she concluded. “From this registry, we can observe how patients are being treated in real time since this information is largely consensus based.”
The study did not receive any specific funding. Dr. Benesova disclosed grant/research support from AbbVie, Novartis, Rheumaliga Baden-Wurttemberg, and the University of Heidelberg, and consultancies, speaker fees, and/or travel reimbursements from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Medac, Merck Sharp & Dohme, Mundipharma, Novartis, Pfizer, Roche, and UCB. Some of her coauthors also disclosed financial relationships with industry. Dr. Sandigursky disclosed having no relevant conflicts of interest.
SOURCE: Benesova K et al. Ann Rheum Dis 2020;79[suppl 1]:168-9, Abstract OP0270.
Its first findings were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.
“We have limited knowledge on the interrelationships between malignant and rheumatic diseases on both the clinical and molecular level, and we have a large unmet need for management guidelines in the case of the coincidence of both disease entities,” noted lead author Karolina Benesova, MD, of the department of hematology, oncology, and rheumatology at University Hospital Heidelberg (Germany).
The TRheuMa registry – Therapy-Induced Rheumatic Symptoms in Patients with Malignancy – is one of three registries in a multicenter observational project exploring various contexts between malignant and rheumatic diseases. Over its first 22 months, the registry recruited 69 patients having rheumatic symptoms as a result of immune checkpoint inhibitor therapy or other cancer therapies.
Registry findings
The largest shares of patients had non–small cell lung cancer (38%) or melanoma (33%), Dr. Benesova reported. The immune checkpoint inhibitors most commonly received were pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy).
The immune-related adverse events usually presented with symptoms of de novo spondyloarthritis or psoriatic arthritis (42%), late-onset RA (17%), or polymyalgia rheumatica (14%). But 16% of the patients were experiencing a flare of a preexisting rheumatic and musculoskeletal disease.
Laboratory findings differed somewhat from those of classical rheumatic and musculoskeletal diseases, according to Dr. Benesova. Specific findings were rare; in particular, most patients did not have detectable autoantibodies. However, 76% had an elevated C-reactive protein level and 39% had an elevated soluble CD25 level. In addition, nearly all patients (96%) undergoing joint ultrasound had pathologic findings.
“Based on our experiences from interdisciplinary care together with our local oncologists, we have developed a therapeutic algorithm for rheumatic immune-related adverse events,” she reported, noting that the algorithm is consistent with recently published recommendations in this area.
The large majority of patients were adequately treated with prednisone at a dose greater than 10 mg (40%) or at a dose of 10 mg or less with or without an NSAID (40%), while some received NSAID monotherapy (14%).
“We have a growing proportion of patients on conventional or biological [disease-modifying antirheumatic drugs],” Dr. Benesova noted. “These are mostly patients with preexisting rheumatic and musculoskeletal disease or highly suspected de novo classical rheumatic and musculoskeletal disease under checkpoint inhibitor therapy.”
Patients with melanoma having a rheumatic immune-related adverse event had a better response to their therapy than historical counterparts who did not have such events: 39% of the former had a complete response, relative to merely 4% of the latter.
Only a small proportion of patients overall (9%) had to discontinue immune checkpoint inhibitor therapy because of their adverse event, and some of them may be eligible for rechallenge if their cancer progresses, Dr. Benesova noted.
“There is still a lot to be done,” she stated, such as better elucidating the nature of these adverse events [whether transient side effects or a triggering of chronic rheumatic and musculoskeletal diseases], the need for a defensive treatment strategy, and the advisability of closer monitoring of high-risk patients given immune checkpoint inhibitors. “We are aiming at solving these questions in the next few years,” she concluded.
Findings in context
“Registries are important to gain prospective data on patient outcomes,” Sabina Sandigursky, MD, an instructor in the division of rheumatology at the Laura and Isaac Perlmutter Cancer Center at New York University, commented in an interview. “One must be careful, while interpreting these data, especially since they are not randomized, controlled trials.”
Patterns may differ at other centers, too, she pointed out. “The German registry reported a predominance of spondyloarthritis-like disease; however, our patients have a predominance of small-joint involvement. It is unclear what accounts for this difference.”
Individual institutions in North America are similarly collecting data on this patient population, with efforts underway to compile those data to provide a larger picture, according to Dr. Sandigursky.
“Many of the syndromes that we consider to be rheumatic immune-related adverse events have been well described by groups from the U.S., Canada, Australia, and European Union,” she concluded. “From this registry, we can observe how patients are being treated in real time since this information is largely consensus based.”
The study did not receive any specific funding. Dr. Benesova disclosed grant/research support from AbbVie, Novartis, Rheumaliga Baden-Wurttemberg, and the University of Heidelberg, and consultancies, speaker fees, and/or travel reimbursements from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Medac, Merck Sharp & Dohme, Mundipharma, Novartis, Pfizer, Roche, and UCB. Some of her coauthors also disclosed financial relationships with industry. Dr. Sandigursky disclosed having no relevant conflicts of interest.
SOURCE: Benesova K et al. Ann Rheum Dis 2020;79[suppl 1]:168-9, Abstract OP0270.
FROM THE EULAR 2020 E-CONGRESS
FDA approves Cosentyx for treatment of active nr-axSpA
The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.
FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.
A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.
The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.
Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.
FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.
A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.
The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.
Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.
FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.
A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.
The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.
Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Studies give new insight on starting, stopping etanercept in nonradiographic axSpA
The results from a pair of clinical trials should help to take the guesswork out of starting and stopping the tumor necrosis factor inhibitor etanercept (Enbrel) in patients with nonradiographic axial spondyloarthritis (nr-axSpA). The trials were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Optimal use of etanercept in this disease is still being defined, according to the investigators. Its effects, if any, when given very early in the disease course is unclear, and guidance is conflicting when it comes to stopping the drug after inactive disease is achieved.
In the Dutch randomized controlled PrevAS trial of 80 patients with suspected very early nr-axSpA, initiating etanercept instead of placebo did not significantly improve the odds of achieving a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16.
And in the multinational, open-label, phase 4 RE-EMBARK trial, three-quarters of the 119 patients with nr-axSpA who achieved inactive disease on etanercept and stopped the drug experienced a flare within 40 weeks. However, the majority were able to regain disease inactivity after restarting the drug.
Findings in context
“We all have some patients like this [PrevAS population] where we strongly believe they have axial spondyloarthritis but do not fully qualify,” Nigil Haroon MD, PhD, said in an interview. “From a clinical decision-making process, we may diagnose these patients with axial spondyloarthritis, but due to restrictions in access to medications, we have difficulty accessing biologic medications for them. Hence, this study has practical implications.”
“It has already been shown in other, much larger studies that, even in patients who satisfy the criteria of axial spondyloarthritis, those who are MRI and CRP [C-reactive protein] negative are unlikely to respond, so the results are not surprising,” commented Dr. Haroon, who is codirector of the spondylitis program at the University Health Network and associate professor of medicine and rheumatology at the University of Toronto.
Although intended to be a population with suspected very early disease, several of the PrevAS patients would have met ASAS criteria for the disease at baseline, Dr. Haroon cautioned. In addition, the small sample size precluded subgroup analyses.
“The overall conclusion should be, this is a negative study, rather than state there was a trend to better improvement on etanercept. Although there are practical implications, as mentioned, I don’t think this study, with the numbers and the results presented, will change clinical practice,” he said.
The question of stopping biologics in nr-axSpA was previously addressed in the ABILITY-3 randomized trial of adalimumab (Humira), which found that flares were significantly more common with stopping versus continuing the drug and only about half of patients were able to get back in remission by restarting the drug, according to Dr. Haroon.
However, the RE-EMBARK and ABILITY-3 studies differed in both design and patient population, he noted. For example, the mean disease duration was only about 2 years in the former study, compared with 7 years in the latter.
The initial 59% rate of attaining inactive disease on etanercept in RE-EMBARK was “impressive,” Dr. Haroon said, “but as this was an open-label study, higher values are expected.”
“The message in both studies is that stopping biologics completely is not a good idea as the majority of patients, 70%-75%, will relapse within a short period,” he concluded. “However, it should be kept in mind that these [RE-EMBARK] patients received biologic only for a short 24-week period. This study does not answer the question of whether nonradiographic axial spondyloarthritis patients with sustained inactive disease can be taken off biologics abruptly without a taper over time.”
Details of the studies
In the PrevAS trial, Tamara Rusman, a PhD candidate in Rheumatology at the VU University Medical Center Amsterdam and coinvestigators studied patients meeting Calin criteria for inflammatory back pain who had high disease activity plus either HLA-B27 positivity with at least one feature of axial spondyloarthritis or HLA-B27 negativity with two features.
This population is of interest because “most studies have included only patients with nonradiographic axial spondyloarthritis with a positive MRI of the sacroiliac joints and/or an elevated C-reactive protein level,” she noted.
Results showed that, during 16 weeks of treatment, etanercept users had a nonsignficantly higher rate of achieving an ASAS 20 response with etanercept versus placebo users (17% vs. 11%; hazard ratio, 2.1; P = .2). The etanercept group also had a somewhat higher rate of response as defined by the Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) criterion (25% vs. 13%; hazard ratio, 1.1; P = .8).
“Based on these data, early treatment in inflammatory back pain patients prone to develop axial spondyloarthritis seems not to be useful,” Ms. Rusman concluded. “However, monitoring of these patients should be continued since they remain a risk group for developing axial spondyloarthritis.”
In the RE-EMBARK trial, investigators led by Filip Van den Bosch, MD, PhD, Rheumatology Head-of-Clinic at Ghent (Belgium) University Hospital, started with a cohort of 208 patients with nr-axSpA who were given etanercept and background NSAIDs for 24 weeks.
“Current guidelines do not agree on whether a TNF-blocking agent or another biological DMARD should be tapered once a status of low disease activity or remission is achieved,” he noted.
Overall, 59% of the patients achieved inactive disease (defined as an ASDAS-CRP < 1.3) and discontinued etanercept.
During the next 40 weeks, 24% of these patients maintained inactive disease with only the background NSAID therapy. Among the 75% who experienced a flare, defined as an ASDAS with erythrocyte sedimentation rate (ASDAS-ESR) score of 2.1 or greater, the median time to flare was 16.1 weeks. Fully 62% of this group were able to regain disease inactivity within 12 weeks of restarting etanercept.
In a comparative analysis, relative to the RE-EMBARK patients discontinuing etanercept, similar patients who continued etanercept on the companion EMBARK trial had a longer time to flare (P < .0001) and an 85% lower risk of this outcome.
“There were no new safety signals identified, and as expected, the number of treatment-emergent adverse events dropped during the drug-free period and, interestingly, remained stable over retreatment,” Dr. Van den Bosch noted.
“Temporarily discontinuing etanercept may be an option for some patients with stable inactive nonradiographic axial spondyloarthritis,” he concluded.
The PrevAS trial was financially supported by Pfizer and ReumaNederland. Ms. Rusman declared no relevant conflicts of interest; four coauthors reported financial relationship(s) with Pfizer and other pharmaceutical companies. The RE-EMBARK trial was sponsored by Pfizer. Dr. Van den Bosch disclosed receiving grant/research support from AbbVie, Merck, and UCB, and consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Four coauthors reported financial ties to Pfizer and other pharmaceutical companies, and five coauthors were employees and shareholders of Pfizer.
SOURCES: Rusman T et al. Ann Rheum Dis. 2020;79[suppl 1]:72-3; and Van den Bosch F et al. Ann Rheum Dis. 2020;79[suppl 1]:70.
The results from a pair of clinical trials should help to take the guesswork out of starting and stopping the tumor necrosis factor inhibitor etanercept (Enbrel) in patients with nonradiographic axial spondyloarthritis (nr-axSpA). The trials were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Optimal use of etanercept in this disease is still being defined, according to the investigators. Its effects, if any, when given very early in the disease course is unclear, and guidance is conflicting when it comes to stopping the drug after inactive disease is achieved.
In the Dutch randomized controlled PrevAS trial of 80 patients with suspected very early nr-axSpA, initiating etanercept instead of placebo did not significantly improve the odds of achieving a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16.
And in the multinational, open-label, phase 4 RE-EMBARK trial, three-quarters of the 119 patients with nr-axSpA who achieved inactive disease on etanercept and stopped the drug experienced a flare within 40 weeks. However, the majority were able to regain disease inactivity after restarting the drug.
Findings in context
“We all have some patients like this [PrevAS population] where we strongly believe they have axial spondyloarthritis but do not fully qualify,” Nigil Haroon MD, PhD, said in an interview. “From a clinical decision-making process, we may diagnose these patients with axial spondyloarthritis, but due to restrictions in access to medications, we have difficulty accessing biologic medications for them. Hence, this study has practical implications.”
“It has already been shown in other, much larger studies that, even in patients who satisfy the criteria of axial spondyloarthritis, those who are MRI and CRP [C-reactive protein] negative are unlikely to respond, so the results are not surprising,” commented Dr. Haroon, who is codirector of the spondylitis program at the University Health Network and associate professor of medicine and rheumatology at the University of Toronto.
Although intended to be a population with suspected very early disease, several of the PrevAS patients would have met ASAS criteria for the disease at baseline, Dr. Haroon cautioned. In addition, the small sample size precluded subgroup analyses.
“The overall conclusion should be, this is a negative study, rather than state there was a trend to better improvement on etanercept. Although there are practical implications, as mentioned, I don’t think this study, with the numbers and the results presented, will change clinical practice,” he said.
The question of stopping biologics in nr-axSpA was previously addressed in the ABILITY-3 randomized trial of adalimumab (Humira), which found that flares were significantly more common with stopping versus continuing the drug and only about half of patients were able to get back in remission by restarting the drug, according to Dr. Haroon.
However, the RE-EMBARK and ABILITY-3 studies differed in both design and patient population, he noted. For example, the mean disease duration was only about 2 years in the former study, compared with 7 years in the latter.
The initial 59% rate of attaining inactive disease on etanercept in RE-EMBARK was “impressive,” Dr. Haroon said, “but as this was an open-label study, higher values are expected.”
“The message in both studies is that stopping biologics completely is not a good idea as the majority of patients, 70%-75%, will relapse within a short period,” he concluded. “However, it should be kept in mind that these [RE-EMBARK] patients received biologic only for a short 24-week period. This study does not answer the question of whether nonradiographic axial spondyloarthritis patients with sustained inactive disease can be taken off biologics abruptly without a taper over time.”
Details of the studies
In the PrevAS trial, Tamara Rusman, a PhD candidate in Rheumatology at the VU University Medical Center Amsterdam and coinvestigators studied patients meeting Calin criteria for inflammatory back pain who had high disease activity plus either HLA-B27 positivity with at least one feature of axial spondyloarthritis or HLA-B27 negativity with two features.
This population is of interest because “most studies have included only patients with nonradiographic axial spondyloarthritis with a positive MRI of the sacroiliac joints and/or an elevated C-reactive protein level,” she noted.
Results showed that, during 16 weeks of treatment, etanercept users had a nonsignficantly higher rate of achieving an ASAS 20 response with etanercept versus placebo users (17% vs. 11%; hazard ratio, 2.1; P = .2). The etanercept group also had a somewhat higher rate of response as defined by the Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) criterion (25% vs. 13%; hazard ratio, 1.1; P = .8).
“Based on these data, early treatment in inflammatory back pain patients prone to develop axial spondyloarthritis seems not to be useful,” Ms. Rusman concluded. “However, monitoring of these patients should be continued since they remain a risk group for developing axial spondyloarthritis.”
In the RE-EMBARK trial, investigators led by Filip Van den Bosch, MD, PhD, Rheumatology Head-of-Clinic at Ghent (Belgium) University Hospital, started with a cohort of 208 patients with nr-axSpA who were given etanercept and background NSAIDs for 24 weeks.
“Current guidelines do not agree on whether a TNF-blocking agent or another biological DMARD should be tapered once a status of low disease activity or remission is achieved,” he noted.
Overall, 59% of the patients achieved inactive disease (defined as an ASDAS-CRP < 1.3) and discontinued etanercept.
During the next 40 weeks, 24% of these patients maintained inactive disease with only the background NSAID therapy. Among the 75% who experienced a flare, defined as an ASDAS with erythrocyte sedimentation rate (ASDAS-ESR) score of 2.1 or greater, the median time to flare was 16.1 weeks. Fully 62% of this group were able to regain disease inactivity within 12 weeks of restarting etanercept.
In a comparative analysis, relative to the RE-EMBARK patients discontinuing etanercept, similar patients who continued etanercept on the companion EMBARK trial had a longer time to flare (P < .0001) and an 85% lower risk of this outcome.
“There were no new safety signals identified, and as expected, the number of treatment-emergent adverse events dropped during the drug-free period and, interestingly, remained stable over retreatment,” Dr. Van den Bosch noted.
“Temporarily discontinuing etanercept may be an option for some patients with stable inactive nonradiographic axial spondyloarthritis,” he concluded.
The PrevAS trial was financially supported by Pfizer and ReumaNederland. Ms. Rusman declared no relevant conflicts of interest; four coauthors reported financial relationship(s) with Pfizer and other pharmaceutical companies. The RE-EMBARK trial was sponsored by Pfizer. Dr. Van den Bosch disclosed receiving grant/research support from AbbVie, Merck, and UCB, and consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Four coauthors reported financial ties to Pfizer and other pharmaceutical companies, and five coauthors were employees and shareholders of Pfizer.
SOURCES: Rusman T et al. Ann Rheum Dis. 2020;79[suppl 1]:72-3; and Van den Bosch F et al. Ann Rheum Dis. 2020;79[suppl 1]:70.
The results from a pair of clinical trials should help to take the guesswork out of starting and stopping the tumor necrosis factor inhibitor etanercept (Enbrel) in patients with nonradiographic axial spondyloarthritis (nr-axSpA). The trials were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.
Optimal use of etanercept in this disease is still being defined, according to the investigators. Its effects, if any, when given very early in the disease course is unclear, and guidance is conflicting when it comes to stopping the drug after inactive disease is achieved.
In the Dutch randomized controlled PrevAS trial of 80 patients with suspected very early nr-axSpA, initiating etanercept instead of placebo did not significantly improve the odds of achieving a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16.
And in the multinational, open-label, phase 4 RE-EMBARK trial, three-quarters of the 119 patients with nr-axSpA who achieved inactive disease on etanercept and stopped the drug experienced a flare within 40 weeks. However, the majority were able to regain disease inactivity after restarting the drug.
Findings in context
“We all have some patients like this [PrevAS population] where we strongly believe they have axial spondyloarthritis but do not fully qualify,” Nigil Haroon MD, PhD, said in an interview. “From a clinical decision-making process, we may diagnose these patients with axial spondyloarthritis, but due to restrictions in access to medications, we have difficulty accessing biologic medications for them. Hence, this study has practical implications.”
“It has already been shown in other, much larger studies that, even in patients who satisfy the criteria of axial spondyloarthritis, those who are MRI and CRP [C-reactive protein] negative are unlikely to respond, so the results are not surprising,” commented Dr. Haroon, who is codirector of the spondylitis program at the University Health Network and associate professor of medicine and rheumatology at the University of Toronto.
Although intended to be a population with suspected very early disease, several of the PrevAS patients would have met ASAS criteria for the disease at baseline, Dr. Haroon cautioned. In addition, the small sample size precluded subgroup analyses.
“The overall conclusion should be, this is a negative study, rather than state there was a trend to better improvement on etanercept. Although there are practical implications, as mentioned, I don’t think this study, with the numbers and the results presented, will change clinical practice,” he said.
The question of stopping biologics in nr-axSpA was previously addressed in the ABILITY-3 randomized trial of adalimumab (Humira), which found that flares were significantly more common with stopping versus continuing the drug and only about half of patients were able to get back in remission by restarting the drug, according to Dr. Haroon.
However, the RE-EMBARK and ABILITY-3 studies differed in both design and patient population, he noted. For example, the mean disease duration was only about 2 years in the former study, compared with 7 years in the latter.
The initial 59% rate of attaining inactive disease on etanercept in RE-EMBARK was “impressive,” Dr. Haroon said, “but as this was an open-label study, higher values are expected.”
“The message in both studies is that stopping biologics completely is not a good idea as the majority of patients, 70%-75%, will relapse within a short period,” he concluded. “However, it should be kept in mind that these [RE-EMBARK] patients received biologic only for a short 24-week period. This study does not answer the question of whether nonradiographic axial spondyloarthritis patients with sustained inactive disease can be taken off biologics abruptly without a taper over time.”
Details of the studies
In the PrevAS trial, Tamara Rusman, a PhD candidate in Rheumatology at the VU University Medical Center Amsterdam and coinvestigators studied patients meeting Calin criteria for inflammatory back pain who had high disease activity plus either HLA-B27 positivity with at least one feature of axial spondyloarthritis or HLA-B27 negativity with two features.
This population is of interest because “most studies have included only patients with nonradiographic axial spondyloarthritis with a positive MRI of the sacroiliac joints and/or an elevated C-reactive protein level,” she noted.
Results showed that, during 16 weeks of treatment, etanercept users had a nonsignficantly higher rate of achieving an ASAS 20 response with etanercept versus placebo users (17% vs. 11%; hazard ratio, 2.1; P = .2). The etanercept group also had a somewhat higher rate of response as defined by the Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) criterion (25% vs. 13%; hazard ratio, 1.1; P = .8).
“Based on these data, early treatment in inflammatory back pain patients prone to develop axial spondyloarthritis seems not to be useful,” Ms. Rusman concluded. “However, monitoring of these patients should be continued since they remain a risk group for developing axial spondyloarthritis.”
In the RE-EMBARK trial, investigators led by Filip Van den Bosch, MD, PhD, Rheumatology Head-of-Clinic at Ghent (Belgium) University Hospital, started with a cohort of 208 patients with nr-axSpA who were given etanercept and background NSAIDs for 24 weeks.
“Current guidelines do not agree on whether a TNF-blocking agent or another biological DMARD should be tapered once a status of low disease activity or remission is achieved,” he noted.
Overall, 59% of the patients achieved inactive disease (defined as an ASDAS-CRP < 1.3) and discontinued etanercept.
During the next 40 weeks, 24% of these patients maintained inactive disease with only the background NSAID therapy. Among the 75% who experienced a flare, defined as an ASDAS with erythrocyte sedimentation rate (ASDAS-ESR) score of 2.1 or greater, the median time to flare was 16.1 weeks. Fully 62% of this group were able to regain disease inactivity within 12 weeks of restarting etanercept.
In a comparative analysis, relative to the RE-EMBARK patients discontinuing etanercept, similar patients who continued etanercept on the companion EMBARK trial had a longer time to flare (P < .0001) and an 85% lower risk of this outcome.
“There were no new safety signals identified, and as expected, the number of treatment-emergent adverse events dropped during the drug-free period and, interestingly, remained stable over retreatment,” Dr. Van den Bosch noted.
“Temporarily discontinuing etanercept may be an option for some patients with stable inactive nonradiographic axial spondyloarthritis,” he concluded.
The PrevAS trial was financially supported by Pfizer and ReumaNederland. Ms. Rusman declared no relevant conflicts of interest; four coauthors reported financial relationship(s) with Pfizer and other pharmaceutical companies. The RE-EMBARK trial was sponsored by Pfizer. Dr. Van den Bosch disclosed receiving grant/research support from AbbVie, Merck, and UCB, and consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Four coauthors reported financial ties to Pfizer and other pharmaceutical companies, and five coauthors were employees and shareholders of Pfizer.
SOURCES: Rusman T et al. Ann Rheum Dis. 2020;79[suppl 1]:72-3; and Van den Bosch F et al. Ann Rheum Dis. 2020;79[suppl 1]:70.
FROM THE EULAR 2020 E-CONGRESS
Key clinical point: In nonradiographic axial spondyloarthritis (nr-axSpA), etanercept does not have significant benefit by 16 weeks when started in very early disease, and the majority of patients who achieved inactive disease on the drug and then stopped it experienced a flare within 40 weeks.
Major finding: Patients with suspected very early disease who took etanercept did not have a significantly greater rate of achieving a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16 than did those taking placebo (17% vs. 11%; hazard ratio, 2.1; P = .2). In a separate trial, 75% of patients who achieved inactive disease with etanercept and then stopped the drug had a flare within 40 weeks, but 62% of this group were able to regain disease inactivity within 12 weeks of restarting etanercept.
Study details: A randomized, placebo-controlled PrevAS trial involved 80 patients with suspected very early nr-axSpA who started either etanercept or placebo, and the multicenter, open-label, phase 4 RE-EMBARK trial involved 119 patients achieving inactive nr-axSpA on etanercept.
Disclosures: The PrevAS trial was financially supported by Pfizer and ReumaNederland. Ms. Rusman declared no relevant conflicts of interest; four coauthors reported financial relationship(s) with Pfizer and other pharmaceutical companies. The RE-EMBARK trial was sponsored by Pfizer. Dr. Van den Bosch disclosed receiving grant/research support from AbbVie, Merck, and UCB and consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Four coauthors reported financial ties to Pfizer and other pharmaceutical companies, and five coauthors were employees and shareholders of Pfizer.
Sources: Rusman T et al. Ann Rheum Dis. 2020;79[suppl 1]:72-3; and Van den Bosch F et al. Ann Rheum Dis. 2020;79[suppl 1]:70.
EULAR’s COVID-19 recommendations offer no surprises
As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.
Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.
“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”
The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”
The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”
From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.
The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.
There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.
Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.
The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.
If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.
On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.
“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.
“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”
Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”
One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.
Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.
“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”
SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.
As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.
Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.
“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”
The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”
The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”
From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.
The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.
There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.
Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.
The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.
If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.
On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.
“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.
“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”
Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”
One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.
Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.
“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”
SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.
As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.
Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.
“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”
The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”
The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”
From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.
The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.
There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.
Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.
The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.
If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.
On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.
“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.
“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”
Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”
One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.
Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.
“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”
SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.
FROM THE EULAR 2020 E-CONGRESS
TICOSPA: Efficacy of treat-to-target strategy suggested in axial spondyloarthritis
A treat-to-target strategy for managing patients with axial spondyloarthritis failed to meet its primary efficacy endpoint but still showed several suggestive indications of benefit compared with usual care in a multicenter, randomized study with 160 patients.
The treat-to-target management strategy tested aimed to get patients to an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1, as recommended for patients with axial spondyloarthritis (axSpA) by an international task force. Also notable about the study was its primary endpoint, at least a 30% improvement in the Assessment of Spondyloarthritis International Society Health Index (ASAS HI), a measure of health-related quality-of-life that the study organizers selected in part because of its distinction from the treatment target.
“For the first time in rheumatology, we targeted inflammation to have an impact on another domain of the disease. Despite not reaching statistical significance, we see a difference between the groups,” Anna Moltó, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.
After 12 months in the study, the 80 axSpA patients assigned to the treat-to-target regimen had a 47% rate of attainment of the primary endpoint, compared with 36% of the 80 patients assigned to usual care, an 11% absolute between-group difference with a P value that came close to but failed to achieve the conventional standard of statistical significance after adjustment for potential confounders (P = .09). Six secondary outcomes showed statistically significant improvements compared with the control patients, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the ASAS 20, and ASAS 40. Five additional metrics showed nominal between-group improvements with the treat-to-target strategy that were not statistically significant, including various forms of the ASDAS.
One additional notable finding came from a cost-efficacy analysis run by Dr. Moltó and associates, which showed that the treat-to-target strategy was “dominant” over usual care by producing both better outcomes as well as a lower total cost, compared with control patients, even though twice as many patients on the treat-to-target strategy received a biologic disease-modifying antirheumatic drug (bDMARD) compared with patients in the usual care group. The incremental cost utility ratio for treat-to-target was 19,430 euros (about $22,000) per quality-adjusted life-year gained, putting the strategy into the range of a “cost effective” approach, and the two treatment arms also had comparable safety, said Dr. Moltó, a rheumatologist at Cochin Hospital in Paris.
The 11% increase in treat-to-target patients achieving at least a 30% improvement in their ASAS HI score “is potentially clinically relevant” because the comparator arm in the study received “very active” usual care and was not by any measure a true placebo control group, noted Maxime Dougados, MD, a rheumatologist and professor or medicine at Cochin Hospital and senior investigator for the study. In general, in treatment studies of rheumatologic diseases a 10% or greater absolute increase in the incidence of a beneficial outcome is considered clinically meaningful when compared with an actively-treated control arm, he noted.
“Using the ASAS HI score was very ambitious for the study, and it’s a very relevant outcome,” said Sofia Ramiro, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center who was not associated with the study and chaired the session where Dr. Moltó gave her report. “We have had treat-to-target trials that showed benefit when disease activity was the endpoint.” But when a study “targets treatment to [reducing] disease activity and then uses disease activity as the outcome measure you expect to see an effect, but it is circular reasoning and we are left with challenges in interpreting the results. Now we have a trial that is formally [neutral] but with a different, more ambitious endpoint. All the indications are for benefit from treat-to-target for both the primary endpoint and for all the other endpoints.”
“We were in a difficult situation when choosing the outcome. We didn’t know whether a 30% improvement in the ASAS HI was really relevant, but it seems to be,” said Désirée van der Heijde, MD, a rheumatologist and professor of medicine at Leiden University Medical Center and a collaborator on Dr. Moltó’s study. “I’d choose ASAS HI again as a primary endpoint” for a treat-to-target study in patients with axSpA, she said, but added that a 30% improvement in this score as the response threshold may warrant reconsideration. Both Dr. van der Heijde and Dr. Dougados agreed that at least one additional study with a somewhat similar design is needed to better document and confirm a role for a treat-to-target strategy in axSpA patients.
The Tight Control in Spondyloarthritis (TICOSPA) study ran at 10 French centers and 4 centers each in Belgium and the Netherlands. The study enrolled adults with rheumatologist-diagnosed axSpA with an ASDAS score greater than 2.1 who had not yet received a bDMARD, had not yet maxed out on their dosage of NSAIDs, and had certain baseline immunologic and imaging findings available. The researchers randomized 160 patients to either treat-to-target or usual care management by the center they attended to prevent cross contamination of management strategies. The treat-to-target regimen involved office examinations and consultations every 4 weeks rather than every 3 months with usual care, and also required a predefined management strategy with treatment prompts based on the strategy sent to the treating clinicians via the EMR. The average age of the patients was 38 years, they had been diagnosed with axSpA for an average of just under 4 years, and their mean ASDAS score at entry was 3. During the 12 months of management, 56% of the patients in the treat-to-target arm initiated treatment with a bDMARD, compared with 28% among the controls. Use of NSAIDs was similar between the two study subgroups.
TICOSPA was sponsored by UCB. Dr. Moltó has been a consultant to and received research funding from AbbVie, Bristol-Myers Squibb, Merck, Pfizer, and UCB. Dr. Dougados has had financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Merck, Pfizer, and UCB. Dr. van der Heijde has had financial relationships with more than 20 companies including UCB. Dr. Ramiro had been a consultant to or received research funding from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Sanofi.
SOURCE: Moltó A et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:413.
A treat-to-target strategy for managing patients with axial spondyloarthritis failed to meet its primary efficacy endpoint but still showed several suggestive indications of benefit compared with usual care in a multicenter, randomized study with 160 patients.
The treat-to-target management strategy tested aimed to get patients to an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1, as recommended for patients with axial spondyloarthritis (axSpA) by an international task force. Also notable about the study was its primary endpoint, at least a 30% improvement in the Assessment of Spondyloarthritis International Society Health Index (ASAS HI), a measure of health-related quality-of-life that the study organizers selected in part because of its distinction from the treatment target.
“For the first time in rheumatology, we targeted inflammation to have an impact on another domain of the disease. Despite not reaching statistical significance, we see a difference between the groups,” Anna Moltó, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.
After 12 months in the study, the 80 axSpA patients assigned to the treat-to-target regimen had a 47% rate of attainment of the primary endpoint, compared with 36% of the 80 patients assigned to usual care, an 11% absolute between-group difference with a P value that came close to but failed to achieve the conventional standard of statistical significance after adjustment for potential confounders (P = .09). Six secondary outcomes showed statistically significant improvements compared with the control patients, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the ASAS 20, and ASAS 40. Five additional metrics showed nominal between-group improvements with the treat-to-target strategy that were not statistically significant, including various forms of the ASDAS.
One additional notable finding came from a cost-efficacy analysis run by Dr. Moltó and associates, which showed that the treat-to-target strategy was “dominant” over usual care by producing both better outcomes as well as a lower total cost, compared with control patients, even though twice as many patients on the treat-to-target strategy received a biologic disease-modifying antirheumatic drug (bDMARD) compared with patients in the usual care group. The incremental cost utility ratio for treat-to-target was 19,430 euros (about $22,000) per quality-adjusted life-year gained, putting the strategy into the range of a “cost effective” approach, and the two treatment arms also had comparable safety, said Dr. Moltó, a rheumatologist at Cochin Hospital in Paris.
The 11% increase in treat-to-target patients achieving at least a 30% improvement in their ASAS HI score “is potentially clinically relevant” because the comparator arm in the study received “very active” usual care and was not by any measure a true placebo control group, noted Maxime Dougados, MD, a rheumatologist and professor or medicine at Cochin Hospital and senior investigator for the study. In general, in treatment studies of rheumatologic diseases a 10% or greater absolute increase in the incidence of a beneficial outcome is considered clinically meaningful when compared with an actively-treated control arm, he noted.
“Using the ASAS HI score was very ambitious for the study, and it’s a very relevant outcome,” said Sofia Ramiro, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center who was not associated with the study and chaired the session where Dr. Moltó gave her report. “We have had treat-to-target trials that showed benefit when disease activity was the endpoint.” But when a study “targets treatment to [reducing] disease activity and then uses disease activity as the outcome measure you expect to see an effect, but it is circular reasoning and we are left with challenges in interpreting the results. Now we have a trial that is formally [neutral] but with a different, more ambitious endpoint. All the indications are for benefit from treat-to-target for both the primary endpoint and for all the other endpoints.”
“We were in a difficult situation when choosing the outcome. We didn’t know whether a 30% improvement in the ASAS HI was really relevant, but it seems to be,” said Désirée van der Heijde, MD, a rheumatologist and professor of medicine at Leiden University Medical Center and a collaborator on Dr. Moltó’s study. “I’d choose ASAS HI again as a primary endpoint” for a treat-to-target study in patients with axSpA, she said, but added that a 30% improvement in this score as the response threshold may warrant reconsideration. Both Dr. van der Heijde and Dr. Dougados agreed that at least one additional study with a somewhat similar design is needed to better document and confirm a role for a treat-to-target strategy in axSpA patients.
The Tight Control in Spondyloarthritis (TICOSPA) study ran at 10 French centers and 4 centers each in Belgium and the Netherlands. The study enrolled adults with rheumatologist-diagnosed axSpA with an ASDAS score greater than 2.1 who had not yet received a bDMARD, had not yet maxed out on their dosage of NSAIDs, and had certain baseline immunologic and imaging findings available. The researchers randomized 160 patients to either treat-to-target or usual care management by the center they attended to prevent cross contamination of management strategies. The treat-to-target regimen involved office examinations and consultations every 4 weeks rather than every 3 months with usual care, and also required a predefined management strategy with treatment prompts based on the strategy sent to the treating clinicians via the EMR. The average age of the patients was 38 years, they had been diagnosed with axSpA for an average of just under 4 years, and their mean ASDAS score at entry was 3. During the 12 months of management, 56% of the patients in the treat-to-target arm initiated treatment with a bDMARD, compared with 28% among the controls. Use of NSAIDs was similar between the two study subgroups.
TICOSPA was sponsored by UCB. Dr. Moltó has been a consultant to and received research funding from AbbVie, Bristol-Myers Squibb, Merck, Pfizer, and UCB. Dr. Dougados has had financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Merck, Pfizer, and UCB. Dr. van der Heijde has had financial relationships with more than 20 companies including UCB. Dr. Ramiro had been a consultant to or received research funding from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Sanofi.
SOURCE: Moltó A et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:413.
A treat-to-target strategy for managing patients with axial spondyloarthritis failed to meet its primary efficacy endpoint but still showed several suggestive indications of benefit compared with usual care in a multicenter, randomized study with 160 patients.
The treat-to-target management strategy tested aimed to get patients to an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1, as recommended for patients with axial spondyloarthritis (axSpA) by an international task force. Also notable about the study was its primary endpoint, at least a 30% improvement in the Assessment of Spondyloarthritis International Society Health Index (ASAS HI), a measure of health-related quality-of-life that the study organizers selected in part because of its distinction from the treatment target.
“For the first time in rheumatology, we targeted inflammation to have an impact on another domain of the disease. Despite not reaching statistical significance, we see a difference between the groups,” Anna Moltó, MD, said at the annual European Congress of Rheumatology, held online this year due to COVID-19.
After 12 months in the study, the 80 axSpA patients assigned to the treat-to-target regimen had a 47% rate of attainment of the primary endpoint, compared with 36% of the 80 patients assigned to usual care, an 11% absolute between-group difference with a P value that came close to but failed to achieve the conventional standard of statistical significance after adjustment for potential confounders (P = .09). Six secondary outcomes showed statistically significant improvements compared with the control patients, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the ASAS 20, and ASAS 40. Five additional metrics showed nominal between-group improvements with the treat-to-target strategy that were not statistically significant, including various forms of the ASDAS.
One additional notable finding came from a cost-efficacy analysis run by Dr. Moltó and associates, which showed that the treat-to-target strategy was “dominant” over usual care by producing both better outcomes as well as a lower total cost, compared with control patients, even though twice as many patients on the treat-to-target strategy received a biologic disease-modifying antirheumatic drug (bDMARD) compared with patients in the usual care group. The incremental cost utility ratio for treat-to-target was 19,430 euros (about $22,000) per quality-adjusted life-year gained, putting the strategy into the range of a “cost effective” approach, and the two treatment arms also had comparable safety, said Dr. Moltó, a rheumatologist at Cochin Hospital in Paris.
The 11% increase in treat-to-target patients achieving at least a 30% improvement in their ASAS HI score “is potentially clinically relevant” because the comparator arm in the study received “very active” usual care and was not by any measure a true placebo control group, noted Maxime Dougados, MD, a rheumatologist and professor or medicine at Cochin Hospital and senior investigator for the study. In general, in treatment studies of rheumatologic diseases a 10% or greater absolute increase in the incidence of a beneficial outcome is considered clinically meaningful when compared with an actively-treated control arm, he noted.
“Using the ASAS HI score was very ambitious for the study, and it’s a very relevant outcome,” said Sofia Ramiro, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center who was not associated with the study and chaired the session where Dr. Moltó gave her report. “We have had treat-to-target trials that showed benefit when disease activity was the endpoint.” But when a study “targets treatment to [reducing] disease activity and then uses disease activity as the outcome measure you expect to see an effect, but it is circular reasoning and we are left with challenges in interpreting the results. Now we have a trial that is formally [neutral] but with a different, more ambitious endpoint. All the indications are for benefit from treat-to-target for both the primary endpoint and for all the other endpoints.”
“We were in a difficult situation when choosing the outcome. We didn’t know whether a 30% improvement in the ASAS HI was really relevant, but it seems to be,” said Désirée van der Heijde, MD, a rheumatologist and professor of medicine at Leiden University Medical Center and a collaborator on Dr. Moltó’s study. “I’d choose ASAS HI again as a primary endpoint” for a treat-to-target study in patients with axSpA, she said, but added that a 30% improvement in this score as the response threshold may warrant reconsideration. Both Dr. van der Heijde and Dr. Dougados agreed that at least one additional study with a somewhat similar design is needed to better document and confirm a role for a treat-to-target strategy in axSpA patients.
The Tight Control in Spondyloarthritis (TICOSPA) study ran at 10 French centers and 4 centers each in Belgium and the Netherlands. The study enrolled adults with rheumatologist-diagnosed axSpA with an ASDAS score greater than 2.1 who had not yet received a bDMARD, had not yet maxed out on their dosage of NSAIDs, and had certain baseline immunologic and imaging findings available. The researchers randomized 160 patients to either treat-to-target or usual care management by the center they attended to prevent cross contamination of management strategies. The treat-to-target regimen involved office examinations and consultations every 4 weeks rather than every 3 months with usual care, and also required a predefined management strategy with treatment prompts based on the strategy sent to the treating clinicians via the EMR. The average age of the patients was 38 years, they had been diagnosed with axSpA for an average of just under 4 years, and their mean ASDAS score at entry was 3. During the 12 months of management, 56% of the patients in the treat-to-target arm initiated treatment with a bDMARD, compared with 28% among the controls. Use of NSAIDs was similar between the two study subgroups.
TICOSPA was sponsored by UCB. Dr. Moltó has been a consultant to and received research funding from AbbVie, Bristol-Myers Squibb, Merck, Pfizer, and UCB. Dr. Dougados has had financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Merck, Pfizer, and UCB. Dr. van der Heijde has had financial relationships with more than 20 companies including UCB. Dr. Ramiro had been a consultant to or received research funding from AbbVie, Eli Lilly, Merck Sharp & Dohme, Novartis, and Sanofi.
SOURCE: Moltó A et al. Ann Rheum Dis. 2020 Jun;79[suppl 1]:413.
REPORTING FROM THE EULAR 2020 E-CONGRESS
Opioid use up after TNF inhibitor for inflammatory arthritis
Opioid use does not decline after patients with inflammatory arthritis start TNF inhibitor therapy; in fact, average use appears to increase, results from a new study show.
“Starting a TNF inhibitor, you would think the pain would go down, and we were hoping the dose of opioids would go down with it,” said investigator Olafur Palsson, MD, from the University of Iceland in Reykjavik and Lund University in Sweden.
“But this research shows that the insertion of a TNF inhibitor has only a minor effect on that,” he told Medscape Medical News.
The findings are an “important reminder” to rheumatologists that they should broaden their consideration of other pain treatments and techniques for patients with inflammatory arthritis, Dr. Palsson said. “They should focus on trying other tactics to get patients’ pain and stiffness under control; there may be some underlying factors.”
The investigators compared opioid prescription rates in 940 patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and undifferentiated arthritis with a control group of 4,700 matched subjects. Dr. Palsson presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.
The team assessed nationwide databases that capture all patients taking biologics for rheumatic diseases and more than 90% of all drug prescriptions. They found that patients with inflammatory arthritis in Iceland were more likely to have received at least one opioid prescription than control subjects (75% vs. 43%).
During the study period, average yearly opioid dose rose much more in the patient group than in the control group. And 2 years after the initiation of TNF inhibitors, the number of patients taking opioids was unchanged from baseline, at about 40%.
Overall, the patient group was prescribed nearly six times more opioids than the control group. The investigators used a bootstrapping analysis to obtain a reliable confidence interval.
“In a way, the data are extremely skewed,” Dr. Palsson explained. “Most patients were taking very low doses of opioids and a few were taking extremely high doses. It’s hard to do a statistical analysis.”
“With bootstrapping, you don’t detect small fluctuations in data,” he said, acknowledging this study limitation. Also, “prescription data don’t necessarily reflect consumption” of a drug. People prescribed high doses may not necessarily be consuming high doses.”
Additionally, the risk for addiction is low when opioids are used as intended, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.
To alleviate chronic pain, opioids “should, in any case, only be part of a comprehensive therapy program in which doctors, psychologists, and physiotherapists work together,” Dr. Isaacs said in a EULAR news release.
Dr. Palsson has disclosed no relevant financial relationships. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB.
This article first appeared on Medscape.com.
Opioid use does not decline after patients with inflammatory arthritis start TNF inhibitor therapy; in fact, average use appears to increase, results from a new study show.
“Starting a TNF inhibitor, you would think the pain would go down, and we were hoping the dose of opioids would go down with it,” said investigator Olafur Palsson, MD, from the University of Iceland in Reykjavik and Lund University in Sweden.
“But this research shows that the insertion of a TNF inhibitor has only a minor effect on that,” he told Medscape Medical News.
The findings are an “important reminder” to rheumatologists that they should broaden their consideration of other pain treatments and techniques for patients with inflammatory arthritis, Dr. Palsson said. “They should focus on trying other tactics to get patients’ pain and stiffness under control; there may be some underlying factors.”
The investigators compared opioid prescription rates in 940 patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and undifferentiated arthritis with a control group of 4,700 matched subjects. Dr. Palsson presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.
The team assessed nationwide databases that capture all patients taking biologics for rheumatic diseases and more than 90% of all drug prescriptions. They found that patients with inflammatory arthritis in Iceland were more likely to have received at least one opioid prescription than control subjects (75% vs. 43%).
During the study period, average yearly opioid dose rose much more in the patient group than in the control group. And 2 years after the initiation of TNF inhibitors, the number of patients taking opioids was unchanged from baseline, at about 40%.
Overall, the patient group was prescribed nearly six times more opioids than the control group. The investigators used a bootstrapping analysis to obtain a reliable confidence interval.
“In a way, the data are extremely skewed,” Dr. Palsson explained. “Most patients were taking very low doses of opioids and a few were taking extremely high doses. It’s hard to do a statistical analysis.”
“With bootstrapping, you don’t detect small fluctuations in data,” he said, acknowledging this study limitation. Also, “prescription data don’t necessarily reflect consumption” of a drug. People prescribed high doses may not necessarily be consuming high doses.”
Additionally, the risk for addiction is low when opioids are used as intended, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.
To alleviate chronic pain, opioids “should, in any case, only be part of a comprehensive therapy program in which doctors, psychologists, and physiotherapists work together,” Dr. Isaacs said in a EULAR news release.
Dr. Palsson has disclosed no relevant financial relationships. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB.
This article first appeared on Medscape.com.
Opioid use does not decline after patients with inflammatory arthritis start TNF inhibitor therapy; in fact, average use appears to increase, results from a new study show.
“Starting a TNF inhibitor, you would think the pain would go down, and we were hoping the dose of opioids would go down with it,” said investigator Olafur Palsson, MD, from the University of Iceland in Reykjavik and Lund University in Sweden.
“But this research shows that the insertion of a TNF inhibitor has only a minor effect on that,” he told Medscape Medical News.
The findings are an “important reminder” to rheumatologists that they should broaden their consideration of other pain treatments and techniques for patients with inflammatory arthritis, Dr. Palsson said. “They should focus on trying other tactics to get patients’ pain and stiffness under control; there may be some underlying factors.”
The investigators compared opioid prescription rates in 940 patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and undifferentiated arthritis with a control group of 4,700 matched subjects. Dr. Palsson presented the findings at the virtual European League Against Rheumatism (EULAR) 2020 Congress.
The team assessed nationwide databases that capture all patients taking biologics for rheumatic diseases and more than 90% of all drug prescriptions. They found that patients with inflammatory arthritis in Iceland were more likely to have received at least one opioid prescription than control subjects (75% vs. 43%).
During the study period, average yearly opioid dose rose much more in the patient group than in the control group. And 2 years after the initiation of TNF inhibitors, the number of patients taking opioids was unchanged from baseline, at about 40%.
Overall, the patient group was prescribed nearly six times more opioids than the control group. The investigators used a bootstrapping analysis to obtain a reliable confidence interval.
“In a way, the data are extremely skewed,” Dr. Palsson explained. “Most patients were taking very low doses of opioids and a few were taking extremely high doses. It’s hard to do a statistical analysis.”
“With bootstrapping, you don’t detect small fluctuations in data,” he said, acknowledging this study limitation. Also, “prescription data don’t necessarily reflect consumption” of a drug. People prescribed high doses may not necessarily be consuming high doses.”
Additionally, the risk for addiction is low when opioids are used as intended, said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR scientific program committee.
To alleviate chronic pain, opioids “should, in any case, only be part of a comprehensive therapy program in which doctors, psychologists, and physiotherapists work together,” Dr. Isaacs said in a EULAR news release.
Dr. Palsson has disclosed no relevant financial relationships. Dr. Isaacs is a consultant or has received honoraria or grants from Pfizer, AbbVie, Amgen, Merck, Roche, and UCB.
This article first appeared on Medscape.com.
Age leads COVID-19 hospitalization risk factors in RMDs
Being aged older than 65 years was associated with the highest risk of people with rheumatic and musculoskeletal diseases (RMDs) needing hospital treatment for COVID-19, according to the first results to be reported from ReCoVery, the German national COVID-19 registry.
Older patients with RMDs were five times more likely than younger patients to be hospitalized if they tested positive for SARS‑CoV‑2 and developed COVID-19 (odds ratio, 5.1; 95% confidence interval, 2.3-11.4).
The likelihood of hospitalization was also significantly increased by the current or prior use of glucocorticoids (OR, 2.59; 95% CI, 1.2-5.4) and by the presence of cardiovascular disease (OR, 2.27; 95% CI, 1.2-5.4).
“The register is a joint initiative of the German Society for Rheumatology and the Justus Liebig University in Giessen,” explained Anne Regierer, MD, during a live session of the annual European Congress of Rheumatology, held online this year due to COVID-19.
“The current pandemic has changed all of our lives. For patients it brought a lot of uncertainty and fears,” said Dr. Regierer, of the German Rheumatism Research Center Berlin.
“The risk of SARS-CoV-2 infection in patients with inflammatory rheumatic diseases [IRD] is still largely unknown. We still don’t know whether they have a high risk of getting the infection or whether they have a higher risk of a severer case ... therefore there’s an urgent need to have data to generate evidence for the management of our patients.”
Launched at the end of March 2020, the German registry now includes data on 251 patients – 194 of whom have recovered – provided by more than 200 registered rheumatologists. The registry data have now been integrated into the EULAR COVID-19 Database, which is itself part of a global effort to better understand and optimally manage RMD patients during the pandemic.
“The data presented by Dr. Regierer looked at similar outcomes and found quite similar results, which is reassuring,” Kimme Hyrich, MD, PhD, professor of epidemiology at the University of Manchester (England) and a consultant rheumatologist in the Kellgren Centre for Rheumatology at Manchester University Hospitals NHS Foundation Trust, said in an interview.
“We are very grateful for this collaboration [with the German society and others]. Our first publication has looked at hospitalization, but with more data we may have the opportunity to look at less-common outcomes [e.g. death, other COVID complications] or within individual diseases or treatments. So far I don’t think we will come to a different conclusion,” observed Dr. Hyrich, who is on the steering committee for the EULAR COVID-19 Database.
“These initial data are reassuring in that the majority of cases of COVID reported to our database have recovered, including those who were hospitalized,” she said.
Current EULAR advice is to continue treatment with glucocorticoids in patients who are being chronically treated, but to use them at the lowest possible dose.
The objectives of this first analysis of the German registry was to provide a description of the patients who did and did not require hospitalization and those who needed ventilation, as well as look at possible risk factors for hospitalization.
Dr. Regierer reported that, of 192 patients they included – all with a positive lab test for SARS-CoV-2 – 128 (67%) did not require hospital admission. Of those that did (n = 64), 43 (22%) did not need ventilation and 21 (11%) did. Fifteen patients died, all of whom had been hospitalized, and all but one of them had needed ventilation.
Concerning the characteristics of the patients, those who needed hospital treatment with and without ventilation were older than those who were not admitted (70 vs. 65 vs. 54 years, respectively).
“Looking at the sexes, the gender distribution is also interesting. We see 69% females in the nonhospitalized patients, 65% of the inpatients without ventilation, but only 43% females in the ventilated patients. So in this group, the male patients are the majority,” Dr. Regierer observed.
Just over half of all patients in the nonhospitalized and the hospitalized without ventilation groups had IRD in remission, but those in the hospitalized with ventilation group less than one-fifth had their IRD under control.
“Of course we have to keep in mind the small sample sizes,” Dr. Regierer said, but the distribution of patients by disease type was “what you’d expect in clinical care.” The majority of patients in each of the three groups had RA (47%, 56%, and 57%), followed by psoriatic arthritis (19%, 7%, and 14%), axial spondyloarthritis (11%, 5%, and 0%), systemic lupus erythematosus (6%, 2%, and 0%), and vasculitis (1%, 5%, and 5%).
Patients who were hospitalized with and without ventilation were more likely to have more than one comorbidity than those who were not hospitalized with COVID-19.
“The most frequent comorbidity was cardiovascular disease with 58% and 76% in the inpatient groups,” Dr. Regierer reported. One-third of the nonhospitalized patients had a cardiovascular comorbidity.
“If we look at pulmonary disease, we see that 38% of the ventilator patients had an underlying pulmonary disease,” she added. This was in comparison with 19% of the hospitalized without ventilation and 13% of the nonhospitalized patients. Diabetes was another common comorbidity in hospitalized patients with (16%) and without (19%) ventilation versus just 2% of nonhospitalized patients. While these and other comorbidities such as chronic renal insufficiency were associated with higher odds ratios in the multivariate risk factor analysis, they did not reach statistical significance.
With regard to RMD treatments, more than 60% of patients in the hospitalized group had received treatment with glucocorticoids versus 37% of those who did not get admitted. No differences were seen for the other treatments.
Interestingly, “female sex, remission, and use of NSAIDs have an odds ratio smaller than 1. So there might be a lower risk of hospitalization associated with these factors,” Dr. Regierer said.
Dr. Regierer has received grant support and is part of speaker’s bureaus for a variety of pharmaceutical companies. Dr. Hyrich disclosed grant income from Bristol-Myers Squibb, UCB, and Pfizer, and receiving speaker fees from AbbVie.
Being aged older than 65 years was associated with the highest risk of people with rheumatic and musculoskeletal diseases (RMDs) needing hospital treatment for COVID-19, according to the first results to be reported from ReCoVery, the German national COVID-19 registry.
Older patients with RMDs were five times more likely than younger patients to be hospitalized if they tested positive for SARS‑CoV‑2 and developed COVID-19 (odds ratio, 5.1; 95% confidence interval, 2.3-11.4).
The likelihood of hospitalization was also significantly increased by the current or prior use of glucocorticoids (OR, 2.59; 95% CI, 1.2-5.4) and by the presence of cardiovascular disease (OR, 2.27; 95% CI, 1.2-5.4).
“The register is a joint initiative of the German Society for Rheumatology and the Justus Liebig University in Giessen,” explained Anne Regierer, MD, during a live session of the annual European Congress of Rheumatology, held online this year due to COVID-19.
“The current pandemic has changed all of our lives. For patients it brought a lot of uncertainty and fears,” said Dr. Regierer, of the German Rheumatism Research Center Berlin.
“The risk of SARS-CoV-2 infection in patients with inflammatory rheumatic diseases [IRD] is still largely unknown. We still don’t know whether they have a high risk of getting the infection or whether they have a higher risk of a severer case ... therefore there’s an urgent need to have data to generate evidence for the management of our patients.”
Launched at the end of March 2020, the German registry now includes data on 251 patients – 194 of whom have recovered – provided by more than 200 registered rheumatologists. The registry data have now been integrated into the EULAR COVID-19 Database, which is itself part of a global effort to better understand and optimally manage RMD patients during the pandemic.
“The data presented by Dr. Regierer looked at similar outcomes and found quite similar results, which is reassuring,” Kimme Hyrich, MD, PhD, professor of epidemiology at the University of Manchester (England) and a consultant rheumatologist in the Kellgren Centre for Rheumatology at Manchester University Hospitals NHS Foundation Trust, said in an interview.
“We are very grateful for this collaboration [with the German society and others]. Our first publication has looked at hospitalization, but with more data we may have the opportunity to look at less-common outcomes [e.g. death, other COVID complications] or within individual diseases or treatments. So far I don’t think we will come to a different conclusion,” observed Dr. Hyrich, who is on the steering committee for the EULAR COVID-19 Database.
“These initial data are reassuring in that the majority of cases of COVID reported to our database have recovered, including those who were hospitalized,” she said.
Current EULAR advice is to continue treatment with glucocorticoids in patients who are being chronically treated, but to use them at the lowest possible dose.
The objectives of this first analysis of the German registry was to provide a description of the patients who did and did not require hospitalization and those who needed ventilation, as well as look at possible risk factors for hospitalization.
Dr. Regierer reported that, of 192 patients they included – all with a positive lab test for SARS-CoV-2 – 128 (67%) did not require hospital admission. Of those that did (n = 64), 43 (22%) did not need ventilation and 21 (11%) did. Fifteen patients died, all of whom had been hospitalized, and all but one of them had needed ventilation.
Concerning the characteristics of the patients, those who needed hospital treatment with and without ventilation were older than those who were not admitted (70 vs. 65 vs. 54 years, respectively).
“Looking at the sexes, the gender distribution is also interesting. We see 69% females in the nonhospitalized patients, 65% of the inpatients without ventilation, but only 43% females in the ventilated patients. So in this group, the male patients are the majority,” Dr. Regierer observed.
Just over half of all patients in the nonhospitalized and the hospitalized without ventilation groups had IRD in remission, but those in the hospitalized with ventilation group less than one-fifth had their IRD under control.
“Of course we have to keep in mind the small sample sizes,” Dr. Regierer said, but the distribution of patients by disease type was “what you’d expect in clinical care.” The majority of patients in each of the three groups had RA (47%, 56%, and 57%), followed by psoriatic arthritis (19%, 7%, and 14%), axial spondyloarthritis (11%, 5%, and 0%), systemic lupus erythematosus (6%, 2%, and 0%), and vasculitis (1%, 5%, and 5%).
Patients who were hospitalized with and without ventilation were more likely to have more than one comorbidity than those who were not hospitalized with COVID-19.
“The most frequent comorbidity was cardiovascular disease with 58% and 76% in the inpatient groups,” Dr. Regierer reported. One-third of the nonhospitalized patients had a cardiovascular comorbidity.
“If we look at pulmonary disease, we see that 38% of the ventilator patients had an underlying pulmonary disease,” she added. This was in comparison with 19% of the hospitalized without ventilation and 13% of the nonhospitalized patients. Diabetes was another common comorbidity in hospitalized patients with (16%) and without (19%) ventilation versus just 2% of nonhospitalized patients. While these and other comorbidities such as chronic renal insufficiency were associated with higher odds ratios in the multivariate risk factor analysis, they did not reach statistical significance.
With regard to RMD treatments, more than 60% of patients in the hospitalized group had received treatment with glucocorticoids versus 37% of those who did not get admitted. No differences were seen for the other treatments.
Interestingly, “female sex, remission, and use of NSAIDs have an odds ratio smaller than 1. So there might be a lower risk of hospitalization associated with these factors,” Dr. Regierer said.
Dr. Regierer has received grant support and is part of speaker’s bureaus for a variety of pharmaceutical companies. Dr. Hyrich disclosed grant income from Bristol-Myers Squibb, UCB, and Pfizer, and receiving speaker fees from AbbVie.
Being aged older than 65 years was associated with the highest risk of people with rheumatic and musculoskeletal diseases (RMDs) needing hospital treatment for COVID-19, according to the first results to be reported from ReCoVery, the German national COVID-19 registry.
Older patients with RMDs were five times more likely than younger patients to be hospitalized if they tested positive for SARS‑CoV‑2 and developed COVID-19 (odds ratio, 5.1; 95% confidence interval, 2.3-11.4).
The likelihood of hospitalization was also significantly increased by the current or prior use of glucocorticoids (OR, 2.59; 95% CI, 1.2-5.4) and by the presence of cardiovascular disease (OR, 2.27; 95% CI, 1.2-5.4).
“The register is a joint initiative of the German Society for Rheumatology and the Justus Liebig University in Giessen,” explained Anne Regierer, MD, during a live session of the annual European Congress of Rheumatology, held online this year due to COVID-19.
“The current pandemic has changed all of our lives. For patients it brought a lot of uncertainty and fears,” said Dr. Regierer, of the German Rheumatism Research Center Berlin.
“The risk of SARS-CoV-2 infection in patients with inflammatory rheumatic diseases [IRD] is still largely unknown. We still don’t know whether they have a high risk of getting the infection or whether they have a higher risk of a severer case ... therefore there’s an urgent need to have data to generate evidence for the management of our patients.”
Launched at the end of March 2020, the German registry now includes data on 251 patients – 194 of whom have recovered – provided by more than 200 registered rheumatologists. The registry data have now been integrated into the EULAR COVID-19 Database, which is itself part of a global effort to better understand and optimally manage RMD patients during the pandemic.
“The data presented by Dr. Regierer looked at similar outcomes and found quite similar results, which is reassuring,” Kimme Hyrich, MD, PhD, professor of epidemiology at the University of Manchester (England) and a consultant rheumatologist in the Kellgren Centre for Rheumatology at Manchester University Hospitals NHS Foundation Trust, said in an interview.
“We are very grateful for this collaboration [with the German society and others]. Our first publication has looked at hospitalization, but with more data we may have the opportunity to look at less-common outcomes [e.g. death, other COVID complications] or within individual diseases or treatments. So far I don’t think we will come to a different conclusion,” observed Dr. Hyrich, who is on the steering committee for the EULAR COVID-19 Database.
“These initial data are reassuring in that the majority of cases of COVID reported to our database have recovered, including those who were hospitalized,” she said.
Current EULAR advice is to continue treatment with glucocorticoids in patients who are being chronically treated, but to use them at the lowest possible dose.
The objectives of this first analysis of the German registry was to provide a description of the patients who did and did not require hospitalization and those who needed ventilation, as well as look at possible risk factors for hospitalization.
Dr. Regierer reported that, of 192 patients they included – all with a positive lab test for SARS-CoV-2 – 128 (67%) did not require hospital admission. Of those that did (n = 64), 43 (22%) did not need ventilation and 21 (11%) did. Fifteen patients died, all of whom had been hospitalized, and all but one of them had needed ventilation.
Concerning the characteristics of the patients, those who needed hospital treatment with and without ventilation were older than those who were not admitted (70 vs. 65 vs. 54 years, respectively).
“Looking at the sexes, the gender distribution is also interesting. We see 69% females in the nonhospitalized patients, 65% of the inpatients without ventilation, but only 43% females in the ventilated patients. So in this group, the male patients are the majority,” Dr. Regierer observed.
Just over half of all patients in the nonhospitalized and the hospitalized without ventilation groups had IRD in remission, but those in the hospitalized with ventilation group less than one-fifth had their IRD under control.
“Of course we have to keep in mind the small sample sizes,” Dr. Regierer said, but the distribution of patients by disease type was “what you’d expect in clinical care.” The majority of patients in each of the three groups had RA (47%, 56%, and 57%), followed by psoriatic arthritis (19%, 7%, and 14%), axial spondyloarthritis (11%, 5%, and 0%), systemic lupus erythematosus (6%, 2%, and 0%), and vasculitis (1%, 5%, and 5%).
Patients who were hospitalized with and without ventilation were more likely to have more than one comorbidity than those who were not hospitalized with COVID-19.
“The most frequent comorbidity was cardiovascular disease with 58% and 76% in the inpatient groups,” Dr. Regierer reported. One-third of the nonhospitalized patients had a cardiovascular comorbidity.
“If we look at pulmonary disease, we see that 38% of the ventilator patients had an underlying pulmonary disease,” she added. This was in comparison with 19% of the hospitalized without ventilation and 13% of the nonhospitalized patients. Diabetes was another common comorbidity in hospitalized patients with (16%) and without (19%) ventilation versus just 2% of nonhospitalized patients. While these and other comorbidities such as chronic renal insufficiency were associated with higher odds ratios in the multivariate risk factor analysis, they did not reach statistical significance.
With regard to RMD treatments, more than 60% of patients in the hospitalized group had received treatment with glucocorticoids versus 37% of those who did not get admitted. No differences were seen for the other treatments.
Interestingly, “female sex, remission, and use of NSAIDs have an odds ratio smaller than 1. So there might be a lower risk of hospitalization associated with these factors,” Dr. Regierer said.
Dr. Regierer has received grant support and is part of speaker’s bureaus for a variety of pharmaceutical companies. Dr. Hyrich disclosed grant income from Bristol-Myers Squibb, UCB, and Pfizer, and receiving speaker fees from AbbVie.
FROM THE EULAR 2020 E-CONGRESS