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Antigen tests: After pandemic success, time for bigger role?
Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.
Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.
As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.
Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.
Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
Medical community on board
Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.
Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”
Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
How LFTs work
LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.
First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
Global market outlook
By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.
The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
LFTs: Pros and cons
Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.
Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.
However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”
One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.
The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.
Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
FDA’s perspective on LFTs
The FDA has no one-size-fits-all standard for evaluating LFTs.
“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”
EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.
And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
LFTs: The potential, the challenges
Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”
He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.
“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”
Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”
A version of this article first appeared on Medscape.com.
Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.
Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.
As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.
Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.
Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
Medical community on board
Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.
Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”
Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
How LFTs work
LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.
First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
Global market outlook
By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.
The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
LFTs: Pros and cons
Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.
Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.
However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”
One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.
The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.
Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
FDA’s perspective on LFTs
The FDA has no one-size-fits-all standard for evaluating LFTs.
“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”
EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.
And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
LFTs: The potential, the challenges
Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”
He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.
“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”
Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”
A version of this article first appeared on Medscape.com.
Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.
Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.
As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.
Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.
Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
Medical community on board
Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.
Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”
Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
How LFTs work
LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.
First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
Global market outlook
By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.
The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
LFTs: Pros and cons
Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.
Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.
However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”
One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.
The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.
Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
FDA’s perspective on LFTs
The FDA has no one-size-fits-all standard for evaluating LFTs.
“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”
EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.
And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
LFTs: The potential, the challenges
Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”
He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.
“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”
Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”
A version of this article first appeared on Medscape.com.
Lupus may overlap in many patients with systemic sclerosis
TOPLINE:
Patients with both systemic sclerosis (SSc) and systemic lupus erythematosus (SLE) are more likely to be female, Black, and diagnosed with limited cutaneous SSc.
METHODOLOGY:
- Researchers used the 2019 SLE classification criteria from the European Alliance of Associations for Rheumatology and American College of Rheumatology to identify patients with SSc who also met criteria for SLE at a single academic center.
- The study population included 402 adults with SSc.
- The researchers compared demographics, laboratory data, clinical features, and mortality between patients with SSc-SLE and patients with SSc only.
TAKEAWAY:
- Among the 402 patients with SSc who were analyzed, 40 (10%) met the 2019 EULAR/ACR Classification Criteria for SLE.
- Patients with both SSc and SLE were significantly more likely to be female and Black, which is consistent with previous studies; patients with both conditions also were more likely than those with SSc alone to have limited cutaneous SSc (75% vs. 52.2%; P = .006).
- The prevalence of anti-U1-RNP antibody positivity, a classic marker for mixed connective tissue disease, was 30% in SSc-SLE patients and 6.6% in those with SSc only (P < .001).
- Mortality was similar between the two groups, and similar rates were also seen between the two for severe SSc-related end-organ damage, including pulmonary fibrosis, pulmonary hypertension, and scleroderma renal crisis.
IN PRACTICE:
The results highlight the need for clinicians to recognize the SSc-SLE overlap syndrome and to watch for scleroderma organ involvement in patients with features of SLE, Raynaud syndrome, anti-U1-RNP antibody positivity, or an isolated nucleolar pattern of antinuclear antibodies.
SOURCE:
First author Ronald D. Bass, MD, MBA, of Georgetown University, Washington, and colleagues published their report online in Arthritis Care & Research.
LIMITATIONS:
The primary cohort was designed to compare Black to non-Black patients with SSc, and the process of matching these patients may have introduced unmeasured selection bias. Also, since the study was based on classification criteria and not diagnostic criteria, the overlapping patients may not reflect patients with true overlapping of both conditions.
DISCLOSURES:
No outside funding source was listed by the authors. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with both systemic sclerosis (SSc) and systemic lupus erythematosus (SLE) are more likely to be female, Black, and diagnosed with limited cutaneous SSc.
METHODOLOGY:
- Researchers used the 2019 SLE classification criteria from the European Alliance of Associations for Rheumatology and American College of Rheumatology to identify patients with SSc who also met criteria for SLE at a single academic center.
- The study population included 402 adults with SSc.
- The researchers compared demographics, laboratory data, clinical features, and mortality between patients with SSc-SLE and patients with SSc only.
TAKEAWAY:
- Among the 402 patients with SSc who were analyzed, 40 (10%) met the 2019 EULAR/ACR Classification Criteria for SLE.
- Patients with both SSc and SLE were significantly more likely to be female and Black, which is consistent with previous studies; patients with both conditions also were more likely than those with SSc alone to have limited cutaneous SSc (75% vs. 52.2%; P = .006).
- The prevalence of anti-U1-RNP antibody positivity, a classic marker for mixed connective tissue disease, was 30% in SSc-SLE patients and 6.6% in those with SSc only (P < .001).
- Mortality was similar between the two groups, and similar rates were also seen between the two for severe SSc-related end-organ damage, including pulmonary fibrosis, pulmonary hypertension, and scleroderma renal crisis.
IN PRACTICE:
The results highlight the need for clinicians to recognize the SSc-SLE overlap syndrome and to watch for scleroderma organ involvement in patients with features of SLE, Raynaud syndrome, anti-U1-RNP antibody positivity, or an isolated nucleolar pattern of antinuclear antibodies.
SOURCE:
First author Ronald D. Bass, MD, MBA, of Georgetown University, Washington, and colleagues published their report online in Arthritis Care & Research.
LIMITATIONS:
The primary cohort was designed to compare Black to non-Black patients with SSc, and the process of matching these patients may have introduced unmeasured selection bias. Also, since the study was based on classification criteria and not diagnostic criteria, the overlapping patients may not reflect patients with true overlapping of both conditions.
DISCLOSURES:
No outside funding source was listed by the authors. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with both systemic sclerosis (SSc) and systemic lupus erythematosus (SLE) are more likely to be female, Black, and diagnosed with limited cutaneous SSc.
METHODOLOGY:
- Researchers used the 2019 SLE classification criteria from the European Alliance of Associations for Rheumatology and American College of Rheumatology to identify patients with SSc who also met criteria for SLE at a single academic center.
- The study population included 402 adults with SSc.
- The researchers compared demographics, laboratory data, clinical features, and mortality between patients with SSc-SLE and patients with SSc only.
TAKEAWAY:
- Among the 402 patients with SSc who were analyzed, 40 (10%) met the 2019 EULAR/ACR Classification Criteria for SLE.
- Patients with both SSc and SLE were significantly more likely to be female and Black, which is consistent with previous studies; patients with both conditions also were more likely than those with SSc alone to have limited cutaneous SSc (75% vs. 52.2%; P = .006).
- The prevalence of anti-U1-RNP antibody positivity, a classic marker for mixed connective tissue disease, was 30% in SSc-SLE patients and 6.6% in those with SSc only (P < .001).
- Mortality was similar between the two groups, and similar rates were also seen between the two for severe SSc-related end-organ damage, including pulmonary fibrosis, pulmonary hypertension, and scleroderma renal crisis.
IN PRACTICE:
The results highlight the need for clinicians to recognize the SSc-SLE overlap syndrome and to watch for scleroderma organ involvement in patients with features of SLE, Raynaud syndrome, anti-U1-RNP antibody positivity, or an isolated nucleolar pattern of antinuclear antibodies.
SOURCE:
First author Ronald D. Bass, MD, MBA, of Georgetown University, Washington, and colleagues published their report online in Arthritis Care & Research.
LIMITATIONS:
The primary cohort was designed to compare Black to non-Black patients with SSc, and the process of matching these patients may have introduced unmeasured selection bias. Also, since the study was based on classification criteria and not diagnostic criteria, the overlapping patients may not reflect patients with true overlapping of both conditions.
DISCLOSURES:
No outside funding source was listed by the authors. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The safety of vaginal estrogen in breast cancer survivors
Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.
When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.
Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.
In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.
Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.
No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.
However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.
Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that
Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.
Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.
When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.
Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.
In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.
Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.
No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.
However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.
Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that
Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.
Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.
When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.
Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.
In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.
Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.
No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.
However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.
Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that
Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.
Extra-articular RA manifestations are in decline, but mortality is still a problem
TOPLINE:
The incidence of extra-articular manifestations of rheumatoid arthritis (ExRA) has declined over time, but the manifestations’ association with increased mortality risk has not changed.
METHODOLOGY:
- A retrospective, population-based cohort study that included 907 adults with incident RA diagnosed during 1985-1999 (n = 296) or 2000-2014 (n = 611) in Olmsted County, Minn.
- Researchers assessed the cumulative incidence of ExRA in groups from both time periods.
- Cox proportional hazard models were used to identify associations between mortality and ExRA.
TAKEAWAY:
- Patients with ExRA had double the risk for premature mortality compared with those without ExRA (hazard ratio, 2.0), with increased mortality for both severe and nonsevere cases of ExRA (HR, 3.05 and 1.83, respectively).
- The 10-year cumulative incidence of developing any ExRA decreased significantly between the 1985-1999 group and the 2000-2014 group (45.1% vs. 31.6%; P = .001).
- The incidence of subcutaneous rheumatoid nodules decreased significantly between the two time periods (30.9% vs. 15.8%, respectively; P < .001), as did the incidence of nonsevere ExRA (41.4% vs. 28.8%, respectively; P < .001).
- Rheumatoid nodules were associated with increased mortality risk, and rheumatoid factor positivity was the strongest risk factor for developing ExRA and rheumatoid nodules.
IN PRACTICE:
The results illustrate the need to recognize the increased mortality risk for patients with severe or nonsevere ExRA.
SOURCE:
First author Bradly A. Kimbrough, MD, and colleagues at the Mayo Clinic, Rochester, Minn., published their report online in Arthritis Care & Research.
LIMITATIONS:
The single geographic region and demographics of the study limit its generalizability, and its interpretation is affected by a lack of data on disease activity and the impact of improved therapeutics and management strategies.
DISCLOSURES:
The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and SkinDiseases, the National Institute on Aging, and the National Center for Advancing Translational Sciences. Dr. Kimbrough had no financial conflicts to disclose. Two coauthors reported financial relationships with one or more pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
The incidence of extra-articular manifestations of rheumatoid arthritis (ExRA) has declined over time, but the manifestations’ association with increased mortality risk has not changed.
METHODOLOGY:
- A retrospective, population-based cohort study that included 907 adults with incident RA diagnosed during 1985-1999 (n = 296) or 2000-2014 (n = 611) in Olmsted County, Minn.
- Researchers assessed the cumulative incidence of ExRA in groups from both time periods.
- Cox proportional hazard models were used to identify associations between mortality and ExRA.
TAKEAWAY:
- Patients with ExRA had double the risk for premature mortality compared with those without ExRA (hazard ratio, 2.0), with increased mortality for both severe and nonsevere cases of ExRA (HR, 3.05 and 1.83, respectively).
- The 10-year cumulative incidence of developing any ExRA decreased significantly between the 1985-1999 group and the 2000-2014 group (45.1% vs. 31.6%; P = .001).
- The incidence of subcutaneous rheumatoid nodules decreased significantly between the two time periods (30.9% vs. 15.8%, respectively; P < .001), as did the incidence of nonsevere ExRA (41.4% vs. 28.8%, respectively; P < .001).
- Rheumatoid nodules were associated with increased mortality risk, and rheumatoid factor positivity was the strongest risk factor for developing ExRA and rheumatoid nodules.
IN PRACTICE:
The results illustrate the need to recognize the increased mortality risk for patients with severe or nonsevere ExRA.
SOURCE:
First author Bradly A. Kimbrough, MD, and colleagues at the Mayo Clinic, Rochester, Minn., published their report online in Arthritis Care & Research.
LIMITATIONS:
The single geographic region and demographics of the study limit its generalizability, and its interpretation is affected by a lack of data on disease activity and the impact of improved therapeutics and management strategies.
DISCLOSURES:
The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and SkinDiseases, the National Institute on Aging, and the National Center for Advancing Translational Sciences. Dr. Kimbrough had no financial conflicts to disclose. Two coauthors reported financial relationships with one or more pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
The incidence of extra-articular manifestations of rheumatoid arthritis (ExRA) has declined over time, but the manifestations’ association with increased mortality risk has not changed.
METHODOLOGY:
- A retrospective, population-based cohort study that included 907 adults with incident RA diagnosed during 1985-1999 (n = 296) or 2000-2014 (n = 611) in Olmsted County, Minn.
- Researchers assessed the cumulative incidence of ExRA in groups from both time periods.
- Cox proportional hazard models were used to identify associations between mortality and ExRA.
TAKEAWAY:
- Patients with ExRA had double the risk for premature mortality compared with those without ExRA (hazard ratio, 2.0), with increased mortality for both severe and nonsevere cases of ExRA (HR, 3.05 and 1.83, respectively).
- The 10-year cumulative incidence of developing any ExRA decreased significantly between the 1985-1999 group and the 2000-2014 group (45.1% vs. 31.6%; P = .001).
- The incidence of subcutaneous rheumatoid nodules decreased significantly between the two time periods (30.9% vs. 15.8%, respectively; P < .001), as did the incidence of nonsevere ExRA (41.4% vs. 28.8%, respectively; P < .001).
- Rheumatoid nodules were associated with increased mortality risk, and rheumatoid factor positivity was the strongest risk factor for developing ExRA and rheumatoid nodules.
IN PRACTICE:
The results illustrate the need to recognize the increased mortality risk for patients with severe or nonsevere ExRA.
SOURCE:
First author Bradly A. Kimbrough, MD, and colleagues at the Mayo Clinic, Rochester, Minn., published their report online in Arthritis Care & Research.
LIMITATIONS:
The single geographic region and demographics of the study limit its generalizability, and its interpretation is affected by a lack of data on disease activity and the impact of improved therapeutics and management strategies.
DISCLOSURES:
The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and SkinDiseases, the National Institute on Aging, and the National Center for Advancing Translational Sciences. Dr. Kimbrough had no financial conflicts to disclose. Two coauthors reported financial relationships with one or more pharmaceutical companies.
A version of this article first appeared on Medscape.com.
Rise in incidences of RA among patients who developed COVID-19
Key clinical point: The incidence of rheumatoid arthritis (RA) during the pandemic period was significantly higher in individuals who did vs did not develop COVID-19, with patients age 51-60 years having the seemingly highest risk.
Major finding: The incidence rates of developing seropositive RA (incidence rate ratio [IRR] 1.60; 95% CI 1.16-2.22) and unspecified RA (IRR 2.93; 95% CI 2.04-4.19) during the pandemic period (2020-2022) were significantly higher in patients with vs without previous COVID-19, with the incidence rates being the highest in the age group of 51-60 years vs the age group of 18-30 years (hazard ratio 9.16; 95% CI 7.24-11.59).
Study details: This retrospective, population-based cohort study analyzed the data of 3,335,084 individuals from the COOSALUD EPS registry (Columbia).
Disclosures: This study was supported by funds from COOSALUD EPS, Columbia. JS Marín and J-M Anaya declared employment with and receiving financial support from COOSALUD EPS, respectively.
Source: Marín JS et al. Increased incidence of rheumatoid arthritis after COVID-19. Autoimmun Rev. 2023;22(10):103409 (Aug 18). doi: 10.1016/j.autrev.2023.103409
Key clinical point: The incidence of rheumatoid arthritis (RA) during the pandemic period was significantly higher in individuals who did vs did not develop COVID-19, with patients age 51-60 years having the seemingly highest risk.
Major finding: The incidence rates of developing seropositive RA (incidence rate ratio [IRR] 1.60; 95% CI 1.16-2.22) and unspecified RA (IRR 2.93; 95% CI 2.04-4.19) during the pandemic period (2020-2022) were significantly higher in patients with vs without previous COVID-19, with the incidence rates being the highest in the age group of 51-60 years vs the age group of 18-30 years (hazard ratio 9.16; 95% CI 7.24-11.59).
Study details: This retrospective, population-based cohort study analyzed the data of 3,335,084 individuals from the COOSALUD EPS registry (Columbia).
Disclosures: This study was supported by funds from COOSALUD EPS, Columbia. JS Marín and J-M Anaya declared employment with and receiving financial support from COOSALUD EPS, respectively.
Source: Marín JS et al. Increased incidence of rheumatoid arthritis after COVID-19. Autoimmun Rev. 2023;22(10):103409 (Aug 18). doi: 10.1016/j.autrev.2023.103409
Key clinical point: The incidence of rheumatoid arthritis (RA) during the pandemic period was significantly higher in individuals who did vs did not develop COVID-19, with patients age 51-60 years having the seemingly highest risk.
Major finding: The incidence rates of developing seropositive RA (incidence rate ratio [IRR] 1.60; 95% CI 1.16-2.22) and unspecified RA (IRR 2.93; 95% CI 2.04-4.19) during the pandemic period (2020-2022) were significantly higher in patients with vs without previous COVID-19, with the incidence rates being the highest in the age group of 51-60 years vs the age group of 18-30 years (hazard ratio 9.16; 95% CI 7.24-11.59).
Study details: This retrospective, population-based cohort study analyzed the data of 3,335,084 individuals from the COOSALUD EPS registry (Columbia).
Disclosures: This study was supported by funds from COOSALUD EPS, Columbia. JS Marín and J-M Anaya declared employment with and receiving financial support from COOSALUD EPS, respectively.
Source: Marín JS et al. Increased incidence of rheumatoid arthritis after COVID-19. Autoimmun Rev. 2023;22(10):103409 (Aug 18). doi: 10.1016/j.autrev.2023.103409
Multimorbidity disproportionately impacts women with RA
Key clinical point: Multimorbidity was more prevalent in women vs men with rheumatoid arthritis (RA), with psychological and musculoskeletal conditions being more prevalent in women and cardiovascular-related conditions being more prevalent in men, thus highlighting the need for individualized treatment plans.
Major finding: Among patients with RA age 18-50 years, women vs men were at higher risk for ≥ 2 morbidities (difference in adjusted absolute risk [Δ] 7.5 percentage points; P < .001) and ≥ 5 morbidities (Δ 4.4 percentage points; P < .001). Moreover, the prevalence of psychological and musculoskeletal conditions was higher in women vs men with RA, whereas the prevalence of cardiovascular-related conditions was higher in men vs women with RA (all P < .05).
Study details: This cross-sectional analysis of national administrative claims data from the OptumLabs Data Warehouse included 154,391 patients with RA who were matched with 154,391 comparator individuals without RA.
Disclosures: This study was supported by grants from the US National Institutes of Health and other sources. The authors declared no conflicts of interest. Two authors declared receiving unrelated funding support from various sources.
Source: Stevens MA et al. Disparities in multimorbidity and comorbidities in rheumatoid arthritis by sex acrossthe lifespan. Rheumatology (Oxford). 2023 (Aug 31). doi: 10.1093/rheumatology/kead454
Key clinical point: Multimorbidity was more prevalent in women vs men with rheumatoid arthritis (RA), with psychological and musculoskeletal conditions being more prevalent in women and cardiovascular-related conditions being more prevalent in men, thus highlighting the need for individualized treatment plans.
Major finding: Among patients with RA age 18-50 years, women vs men were at higher risk for ≥ 2 morbidities (difference in adjusted absolute risk [Δ] 7.5 percentage points; P < .001) and ≥ 5 morbidities (Δ 4.4 percentage points; P < .001). Moreover, the prevalence of psychological and musculoskeletal conditions was higher in women vs men with RA, whereas the prevalence of cardiovascular-related conditions was higher in men vs women with RA (all P < .05).
Study details: This cross-sectional analysis of national administrative claims data from the OptumLabs Data Warehouse included 154,391 patients with RA who were matched with 154,391 comparator individuals without RA.
Disclosures: This study was supported by grants from the US National Institutes of Health and other sources. The authors declared no conflicts of interest. Two authors declared receiving unrelated funding support from various sources.
Source: Stevens MA et al. Disparities in multimorbidity and comorbidities in rheumatoid arthritis by sex acrossthe lifespan. Rheumatology (Oxford). 2023 (Aug 31). doi: 10.1093/rheumatology/kead454
Key clinical point: Multimorbidity was more prevalent in women vs men with rheumatoid arthritis (RA), with psychological and musculoskeletal conditions being more prevalent in women and cardiovascular-related conditions being more prevalent in men, thus highlighting the need for individualized treatment plans.
Major finding: Among patients with RA age 18-50 years, women vs men were at higher risk for ≥ 2 morbidities (difference in adjusted absolute risk [Δ] 7.5 percentage points; P < .001) and ≥ 5 morbidities (Δ 4.4 percentage points; P < .001). Moreover, the prevalence of psychological and musculoskeletal conditions was higher in women vs men with RA, whereas the prevalence of cardiovascular-related conditions was higher in men vs women with RA (all P < .05).
Study details: This cross-sectional analysis of national administrative claims data from the OptumLabs Data Warehouse included 154,391 patients with RA who were matched with 154,391 comparator individuals without RA.
Disclosures: This study was supported by grants from the US National Institutes of Health and other sources. The authors declared no conflicts of interest. Two authors declared receiving unrelated funding support from various sources.
Source: Stevens MA et al. Disparities in multimorbidity and comorbidities in rheumatoid arthritis by sex acrossthe lifespan. Rheumatology (Oxford). 2023 (Aug 31). doi: 10.1093/rheumatology/kead454
JAKi offer a potential therapeutic option for mitigating bone loss in RA
Key clinical point: Janus kinase inhibitors (JAKi) were more potent in inhibiting bone mineral density (BMD) loss compared with other targeted therapies in patients with rheumatoid arthritis (RA), specifically in those with anti-cyclic citrullinated peptide antibody (ACPA)-positive RA.
Major finding: JAKi therapy led to greater gains in bilateral femoral BMD than conventional synthetic disease-modifying antirheumatic drugs (csDMARD; P < .05), tumor necrosis factor inhibitors (TNFi), and non-TNFi biologics, with the improvements in femoral BMD being significant in patients with ACPA-positive RA (P < .01) but not in those with ACPA-negative RA. Similar trends were observed for BMD values at the lumbar spine.
Study details: This retrospective observational study included 362 patients with RA who were treated with JAKi, csDMARD, TNFi, and non-TNFi biologics.
Disclosures: This study was supported by the National Science and Technology Council, Taiwan, and other sources. The authors declared no conflicts of interest.
Source: Chen YW et al. Potential alleviation of bone mineral density loss with Janus kinase inhibitors in rheumatoid arthritis. Clin Rheumatol. 2023 (Sep 2). doi: 10.1007/s10067-023-06735-0
Key clinical point: Janus kinase inhibitors (JAKi) were more potent in inhibiting bone mineral density (BMD) loss compared with other targeted therapies in patients with rheumatoid arthritis (RA), specifically in those with anti-cyclic citrullinated peptide antibody (ACPA)-positive RA.
Major finding: JAKi therapy led to greater gains in bilateral femoral BMD than conventional synthetic disease-modifying antirheumatic drugs (csDMARD; P < .05), tumor necrosis factor inhibitors (TNFi), and non-TNFi biologics, with the improvements in femoral BMD being significant in patients with ACPA-positive RA (P < .01) but not in those with ACPA-negative RA. Similar trends were observed for BMD values at the lumbar spine.
Study details: This retrospective observational study included 362 patients with RA who were treated with JAKi, csDMARD, TNFi, and non-TNFi biologics.
Disclosures: This study was supported by the National Science and Technology Council, Taiwan, and other sources. The authors declared no conflicts of interest.
Source: Chen YW et al. Potential alleviation of bone mineral density loss with Janus kinase inhibitors in rheumatoid arthritis. Clin Rheumatol. 2023 (Sep 2). doi: 10.1007/s10067-023-06735-0
Key clinical point: Janus kinase inhibitors (JAKi) were more potent in inhibiting bone mineral density (BMD) loss compared with other targeted therapies in patients with rheumatoid arthritis (RA), specifically in those with anti-cyclic citrullinated peptide antibody (ACPA)-positive RA.
Major finding: JAKi therapy led to greater gains in bilateral femoral BMD than conventional synthetic disease-modifying antirheumatic drugs (csDMARD; P < .05), tumor necrosis factor inhibitors (TNFi), and non-TNFi biologics, with the improvements in femoral BMD being significant in patients with ACPA-positive RA (P < .01) but not in those with ACPA-negative RA. Similar trends were observed for BMD values at the lumbar spine.
Study details: This retrospective observational study included 362 patients with RA who were treated with JAKi, csDMARD, TNFi, and non-TNFi biologics.
Disclosures: This study was supported by the National Science and Technology Council, Taiwan, and other sources. The authors declared no conflicts of interest.
Source: Chen YW et al. Potential alleviation of bone mineral density loss with Janus kinase inhibitors in rheumatoid arthritis. Clin Rheumatol. 2023 (Sep 2). doi: 10.1007/s10067-023-06735-0
Circulating semaphorin 4A shows potential for predicting treatment failure in RA
Key clinical point: Circulating semaphorin 4A (SEMA4A) serum levels predicted treatment failure and showed an association with response to therapy in patients with rheumatoid arthritis (RA).
Major finding: Baseline serum levels of SEMA4A > 94 ng/mL predicted the risk for treatment failure defined by the occurrence of flares and treatment escalation (adjusted hazard ratio [aHR] 2.73; 95% CI 1.24-5.96). The baseline SEMA4A serum levels were significantly higher in patients who experienced no or moderate response than in those with a good response (P = .035).
Study details: The data come from a prospective observational routine care study that included two cohorts; the first cohort comprised 101 patients with established RA and the second comprised 40 patients with RA who initiated new therapy due to insufficient disease control.
Disclosures: E Vandebeuque declared receiving grants from the Société Française de Rhumatologie, Paris, and other sources. The authors declared no conflicts of interest.
Source: Avouac J et al. Relevance of circulating Semaphorin 4A for rheumatoid arthritis response to treatment. Sci Rep. 2023;13:14626 (Sep 5). doi: 10.1038/s41598-023-41943-3
Key clinical point: Circulating semaphorin 4A (SEMA4A) serum levels predicted treatment failure and showed an association with response to therapy in patients with rheumatoid arthritis (RA).
Major finding: Baseline serum levels of SEMA4A > 94 ng/mL predicted the risk for treatment failure defined by the occurrence of flares and treatment escalation (adjusted hazard ratio [aHR] 2.73; 95% CI 1.24-5.96). The baseline SEMA4A serum levels were significantly higher in patients who experienced no or moderate response than in those with a good response (P = .035).
Study details: The data come from a prospective observational routine care study that included two cohorts; the first cohort comprised 101 patients with established RA and the second comprised 40 patients with RA who initiated new therapy due to insufficient disease control.
Disclosures: E Vandebeuque declared receiving grants from the Société Française de Rhumatologie, Paris, and other sources. The authors declared no conflicts of interest.
Source: Avouac J et al. Relevance of circulating Semaphorin 4A for rheumatoid arthritis response to treatment. Sci Rep. 2023;13:14626 (Sep 5). doi: 10.1038/s41598-023-41943-3
Key clinical point: Circulating semaphorin 4A (SEMA4A) serum levels predicted treatment failure and showed an association with response to therapy in patients with rheumatoid arthritis (RA).
Major finding: Baseline serum levels of SEMA4A > 94 ng/mL predicted the risk for treatment failure defined by the occurrence of flares and treatment escalation (adjusted hazard ratio [aHR] 2.73; 95% CI 1.24-5.96). The baseline SEMA4A serum levels were significantly higher in patients who experienced no or moderate response than in those with a good response (P = .035).
Study details: The data come from a prospective observational routine care study that included two cohorts; the first cohort comprised 101 patients with established RA and the second comprised 40 patients with RA who initiated new therapy due to insufficient disease control.
Disclosures: E Vandebeuque declared receiving grants from the Société Française de Rhumatologie, Paris, and other sources. The authors declared no conflicts of interest.
Source: Avouac J et al. Relevance of circulating Semaphorin 4A for rheumatoid arthritis response to treatment. Sci Rep. 2023;13:14626 (Sep 5). doi: 10.1038/s41598-023-41943-3
Tofacitinib + iguratimod offers choice for dual treat-to-target in RA with usual interstitial pneumonia
Key clinical point: Tofacitinib combined with iguratimod relieves clinical symptoms and results in a higher response rate compared with conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in patients with rheumatoid arthritis with usual interstitial pneumonia (RA-UIP).
Major finding: After 6 months, treatment with tofacitinib + iguratimod vs csDMARD significantly improved forced vital capacity percentage (P = .031) and high-resolution computed tomography fibrosis score (P = .015) and resulted in a higher overall response rate (66.7% vs 35.7%; P = .027), with no patients discontinuing tofacitinib or iguratimod due to side effects or poor efficacy.
Study details:This prospective observational cohort study included 78 patients with RA-UIP who received tofacitinib + iguratimod, csDMARD + iguratimod, or csDMARD.
Disclosures: This study did not declare any specific funding source. The authors declared no conflicts of interest.
Source: Wang S et al. A prospective observational cohort study of the efficacy of tofacitinib plus iguratimod on rheumatoid arthritis with usual interstitial pneumonia. Front Immunol. 2023;14:1215450 (Aug 23). doi: 10.3389/fimmu.2023.1215450
Key clinical point: Tofacitinib combined with iguratimod relieves clinical symptoms and results in a higher response rate compared with conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in patients with rheumatoid arthritis with usual interstitial pneumonia (RA-UIP).
Major finding: After 6 months, treatment with tofacitinib + iguratimod vs csDMARD significantly improved forced vital capacity percentage (P = .031) and high-resolution computed tomography fibrosis score (P = .015) and resulted in a higher overall response rate (66.7% vs 35.7%; P = .027), with no patients discontinuing tofacitinib or iguratimod due to side effects or poor efficacy.
Study details:This prospective observational cohort study included 78 patients with RA-UIP who received tofacitinib + iguratimod, csDMARD + iguratimod, or csDMARD.
Disclosures: This study did not declare any specific funding source. The authors declared no conflicts of interest.
Source: Wang S et al. A prospective observational cohort study of the efficacy of tofacitinib plus iguratimod on rheumatoid arthritis with usual interstitial pneumonia. Front Immunol. 2023;14:1215450 (Aug 23). doi: 10.3389/fimmu.2023.1215450
Key clinical point: Tofacitinib combined with iguratimod relieves clinical symptoms and results in a higher response rate compared with conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in patients with rheumatoid arthritis with usual interstitial pneumonia (RA-UIP).
Major finding: After 6 months, treatment with tofacitinib + iguratimod vs csDMARD significantly improved forced vital capacity percentage (P = .031) and high-resolution computed tomography fibrosis score (P = .015) and resulted in a higher overall response rate (66.7% vs 35.7%; P = .027), with no patients discontinuing tofacitinib or iguratimod due to side effects or poor efficacy.
Study details:This prospective observational cohort study included 78 patients with RA-UIP who received tofacitinib + iguratimod, csDMARD + iguratimod, or csDMARD.
Disclosures: This study did not declare any specific funding source. The authors declared no conflicts of interest.
Source: Wang S et al. A prospective observational cohort study of the efficacy of tofacitinib plus iguratimod on rheumatoid arthritis with usual interstitial pneumonia. Front Immunol. 2023;14:1215450 (Aug 23). doi: 10.3389/fimmu.2023.1215450
Real-world study supports tocilizumab as first-line biologic in DMARD-IR patients with RA
Key clinical point: First-line biologic treatment with tocilizumab significantly reduced disease activity scores and demonstrated a good safety profile in a real-world cohort of patients with rheumatoid arthritis (RA) who had had an inadequate response to disease-modifying antirheumatic drugs (DMARD-IR).
Major finding: At 12 months, tocilizumab treatment led to significant reductions in disease activity scores (all P < .001), with 85.5% of patients receiving tocilizumab achieving remission or low disease activity according to the Disease Activity Score of 28 Joints; however, 22.0% of patients switched to other biologic DMARD either due to inefficacy or side effects.
Study details: Findings are from an analysis of 258 patients with RA from the TReasure Registry who were DMARD-IR and received first-line biologic therapy with tocilizumab as monotherapy (n = 80) or in combination with conventional synthetic DMARD (n = 178).
Disclosures: This study was sponsored by Roche Pharmaceuticals, Turkey, and funded by Hacettepe Rheumatology Society, Ankara. Some authors, including the lead author, declared receiving research support, consulting fees, or honoraria from and having other ties with Roche and other sources.
Source: Karadag O et al. Tocilizumab as a first line biologic agent in rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs: Real life experience from the TReasure Registry. Clin Exp Rheumatol. 2023 (Aug 29). doi: 10.55563/clinexprheumatol/2h6ma1
Key clinical point: First-line biologic treatment with tocilizumab significantly reduced disease activity scores and demonstrated a good safety profile in a real-world cohort of patients with rheumatoid arthritis (RA) who had had an inadequate response to disease-modifying antirheumatic drugs (DMARD-IR).
Major finding: At 12 months, tocilizumab treatment led to significant reductions in disease activity scores (all P < .001), with 85.5% of patients receiving tocilizumab achieving remission or low disease activity according to the Disease Activity Score of 28 Joints; however, 22.0% of patients switched to other biologic DMARD either due to inefficacy or side effects.
Study details: Findings are from an analysis of 258 patients with RA from the TReasure Registry who were DMARD-IR and received first-line biologic therapy with tocilizumab as monotherapy (n = 80) or in combination with conventional synthetic DMARD (n = 178).
Disclosures: This study was sponsored by Roche Pharmaceuticals, Turkey, and funded by Hacettepe Rheumatology Society, Ankara. Some authors, including the lead author, declared receiving research support, consulting fees, or honoraria from and having other ties with Roche and other sources.
Source: Karadag O et al. Tocilizumab as a first line biologic agent in rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs: Real life experience from the TReasure Registry. Clin Exp Rheumatol. 2023 (Aug 29). doi: 10.55563/clinexprheumatol/2h6ma1
Key clinical point: First-line biologic treatment with tocilizumab significantly reduced disease activity scores and demonstrated a good safety profile in a real-world cohort of patients with rheumatoid arthritis (RA) who had had an inadequate response to disease-modifying antirheumatic drugs (DMARD-IR).
Major finding: At 12 months, tocilizumab treatment led to significant reductions in disease activity scores (all P < .001), with 85.5% of patients receiving tocilizumab achieving remission or low disease activity according to the Disease Activity Score of 28 Joints; however, 22.0% of patients switched to other biologic DMARD either due to inefficacy or side effects.
Study details: Findings are from an analysis of 258 patients with RA from the TReasure Registry who were DMARD-IR and received first-line biologic therapy with tocilizumab as monotherapy (n = 80) or in combination with conventional synthetic DMARD (n = 178).
Disclosures: This study was sponsored by Roche Pharmaceuticals, Turkey, and funded by Hacettepe Rheumatology Society, Ankara. Some authors, including the lead author, declared receiving research support, consulting fees, or honoraria from and having other ties with Roche and other sources.
Source: Karadag O et al. Tocilizumab as a first line biologic agent in rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs: Real life experience from the TReasure Registry. Clin Exp Rheumatol. 2023 (Aug 29). doi: 10.55563/clinexprheumatol/2h6ma1