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AxSpA remission on TNFi seen in half of patients with comorbid IBD
CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.
The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.
Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
Short IBD duration, adalimumab linked with higher remission odds
They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.
Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.
“But it’s an interesting question that should be addressed in a bigger study,” he said.
Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.
He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
Study details
Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.
Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.
The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.
“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.
There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.
Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.
“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.
Conclusions called ‘reassuring’
Jean Liew, MD, a spondyloarthritis specialist at Boston University, who was not part of the study, noted that the team reported univariate associations of clinical factors with achievement of clinical axSpA remission, but no multivariable analyses with adjustment for potential confounders.
She said the finding of half the patients achieving clinical remission is “reassuring, as anecdotally we may find that patients with IBD-associated spondyloarthritis tend to have more difficult-to-treat symptoms as well as more limited treatment options. For example, they cannot use [interleukin]-17 inhibitors.”
She noted the study is small and descriptive and further analyses are limited by the small number of patients.
“I think if a study of the same type could be performed at a larger scale with larger numbers, it could generate more data on which type of patient with IBD-associated spondyloarthritis is more likely to have a good response after starting a TNF inhibitor,” she said. “Of course, the other question is how long those patients would have good disease control while on the TNF inhibitor. What is the persistence of the medication? This study doesn’t ask or answer that question.”
Dr. Dalal added that in future research it will be important to look at response to medications beyond TNFis, especially Janus kinase inhibitors.
That will help show “whether there is a treatment algorithm that can be tailored to this population in terms of what agents to choose first,” he said. “I think we need multicenter studies to do this.”
Dr. Dalal has received grant funding from Pfizer and Janssen and has served as a consultant for Centaur Labs and Janssen. Dr. Liew has no relevant financial relationships.
CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.
The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.
Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
Short IBD duration, adalimumab linked with higher remission odds
They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.
Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.
“But it’s an interesting question that should be addressed in a bigger study,” he said.
Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.
He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
Study details
Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.
Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.
The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.
“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.
There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.
Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.
“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.
Conclusions called ‘reassuring’
Jean Liew, MD, a spondyloarthritis specialist at Boston University, who was not part of the study, noted that the team reported univariate associations of clinical factors with achievement of clinical axSpA remission, but no multivariable analyses with adjustment for potential confounders.
She said the finding of half the patients achieving clinical remission is “reassuring, as anecdotally we may find that patients with IBD-associated spondyloarthritis tend to have more difficult-to-treat symptoms as well as more limited treatment options. For example, they cannot use [interleukin]-17 inhibitors.”
She noted the study is small and descriptive and further analyses are limited by the small number of patients.
“I think if a study of the same type could be performed at a larger scale with larger numbers, it could generate more data on which type of patient with IBD-associated spondyloarthritis is more likely to have a good response after starting a TNF inhibitor,” she said. “Of course, the other question is how long those patients would have good disease control while on the TNF inhibitor. What is the persistence of the medication? This study doesn’t ask or answer that question.”
Dr. Dalal added that in future research it will be important to look at response to medications beyond TNFis, especially Janus kinase inhibitors.
That will help show “whether there is a treatment algorithm that can be tailored to this population in terms of what agents to choose first,” he said. “I think we need multicenter studies to do this.”
Dr. Dalal has received grant funding from Pfizer and Janssen and has served as a consultant for Centaur Labs and Janssen. Dr. Liew has no relevant financial relationships.
CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.
The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.
Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
Short IBD duration, adalimumab linked with higher remission odds
They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.
Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.
“But it’s an interesting question that should be addressed in a bigger study,” he said.
Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.
He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
Study details
Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.
Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.
The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.
“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.
There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.
Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.
“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.
Conclusions called ‘reassuring’
Jean Liew, MD, a spondyloarthritis specialist at Boston University, who was not part of the study, noted that the team reported univariate associations of clinical factors with achievement of clinical axSpA remission, but no multivariable analyses with adjustment for potential confounders.
She said the finding of half the patients achieving clinical remission is “reassuring, as anecdotally we may find that patients with IBD-associated spondyloarthritis tend to have more difficult-to-treat symptoms as well as more limited treatment options. For example, they cannot use [interleukin]-17 inhibitors.”
She noted the study is small and descriptive and further analyses are limited by the small number of patients.
“I think if a study of the same type could be performed at a larger scale with larger numbers, it could generate more data on which type of patient with IBD-associated spondyloarthritis is more likely to have a good response after starting a TNF inhibitor,” she said. “Of course, the other question is how long those patients would have good disease control while on the TNF inhibitor. What is the persistence of the medication? This study doesn’t ask or answer that question.”
Dr. Dalal added that in future research it will be important to look at response to medications beyond TNFis, especially Janus kinase inhibitors.
That will help show “whether there is a treatment algorithm that can be tailored to this population in terms of what agents to choose first,” he said. “I think we need multicenter studies to do this.”
Dr. Dalal has received grant funding from Pfizer and Janssen and has served as a consultant for Centaur Labs and Janssen. Dr. Liew has no relevant financial relationships.
AT SPARTAN 2023
AxSpA effects may be more severe for Black patients
CLEVELAND – Documenting the prevalence of axial spondyloarthritis (axSpA) among Black Americans has been difficult because of little published data, but new research suggests that when Black Americans do have the disease, it seems to be more severe.
Iman Abutineh, MD, of the University of Tennessee, Memphis, discussed her team’s work at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
A total of 244 patients with axSpA were identified, including 168 (69%) males, 78 (32%) Black patients, and 143 (59%) White patients.
Average age of onset for patients overall was 27.7 years, and age at diagnosis was 36.1 years with a 7-year delay in diagnosis. Sixty-six (27%) patients had nonradiographic axSpA, 83% were on tumor necrosis factor inhibitors, and 38% were prescribed glucocorticoids.
The researchers found several differences by race.
White patients were more likely to be HLA-B27 positive (77% vs. 59%; P = .010). White patients also had higher prevalence of psoriasis, coronary artery disease, and family history of SpA. White females had a higher prevalence of inflammatory bowel disease, fibromyalgia, depression, and lower grades of sacroiliitis.
Black patients had more hip involvement
A higher percentage of Black patients had elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and hip involvement. In comparing hip involvement, the researchers found that 39 (39%) White males had hip involvement as did 9 (21%) White females. In comparison, 22 (45%) Black men in the study and 14 (54%) Black women showed hip involvement (P = .035).
After adjustment for age, sex, HLA-B27, and insurance status, Black patients had higher grades of sacroiliitis with an odds ratio of 2.32 (95% confidence interval, 1.23-4.44). Black patients had a numerically longer delay in diagnosis, compared with Whites (7.93 vs. 6.64 years), but this did not achieve statistical significance (P = .454), the researchers wrote.
Study addresses racial disparities
“Traditionally we think of axial spondyloarthritis largely in Caucasian males who are HLA-B27 positive,” Dr. Abutineh said, “and we found that there is still a significant portion of patients who don’t meet the criteria that do have disease that is very significant.”
Although actual prevalence was not clear from this study, Dr. Abutineh said their data suggest a 3-to-1 ratio of White-to-Black patients with spondyloarthritis, “but of the Black patients who are diagnosed, their disease is almost always more severe. That points to why it’s important to have a high index of suspicion for this disease in that patient population because if you miss it, it could be detrimental to the patients.”
Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who was not part of the study, said in an interview, “It is an excellent and timely study addressing the racial disparities and inequities surrounding axSpA diagnosis. It highlights the delay in diagnosis and increased burden of disease among Black Americans.”
She said the study may prompt a further look into barriers to care for Black Americans and their beliefs regarding seeking health care for their pain.
Higher rates of nonradiographic axSpA among Black patients
The rate of nonradiographic axSpA among Black Americans was more than twice that of their White counterparts, which, Dr. Alexander noted, could make it more difficult to diagnose axSpA in that population.
The odds ratio for Black patients having nonradiographic axSpA, compared with Whites, was 2.265 (95% CI, 1.082-4.999; P = .035), after adjustment for age, sex, and HLA-B27 status.
Adult patients with axSpA were identified from rheumatology clinics at four major hospital systems and one private clinic in Shelby County, Tenn., between 2011 and 2021. Patients met modified New York (mNY) or Assessment of Spondyloarthritis International Society (ASAS) criteria as assessed by reviewers.
The authors and Dr. Alexander reported no relevant financial relationships.
CLEVELAND – Documenting the prevalence of axial spondyloarthritis (axSpA) among Black Americans has been difficult because of little published data, but new research suggests that when Black Americans do have the disease, it seems to be more severe.
Iman Abutineh, MD, of the University of Tennessee, Memphis, discussed her team’s work at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
A total of 244 patients with axSpA were identified, including 168 (69%) males, 78 (32%) Black patients, and 143 (59%) White patients.
Average age of onset for patients overall was 27.7 years, and age at diagnosis was 36.1 years with a 7-year delay in diagnosis. Sixty-six (27%) patients had nonradiographic axSpA, 83% were on tumor necrosis factor inhibitors, and 38% were prescribed glucocorticoids.
The researchers found several differences by race.
White patients were more likely to be HLA-B27 positive (77% vs. 59%; P = .010). White patients also had higher prevalence of psoriasis, coronary artery disease, and family history of SpA. White females had a higher prevalence of inflammatory bowel disease, fibromyalgia, depression, and lower grades of sacroiliitis.
Black patients had more hip involvement
A higher percentage of Black patients had elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and hip involvement. In comparing hip involvement, the researchers found that 39 (39%) White males had hip involvement as did 9 (21%) White females. In comparison, 22 (45%) Black men in the study and 14 (54%) Black women showed hip involvement (P = .035).
After adjustment for age, sex, HLA-B27, and insurance status, Black patients had higher grades of sacroiliitis with an odds ratio of 2.32 (95% confidence interval, 1.23-4.44). Black patients had a numerically longer delay in diagnosis, compared with Whites (7.93 vs. 6.64 years), but this did not achieve statistical significance (P = .454), the researchers wrote.
Study addresses racial disparities
“Traditionally we think of axial spondyloarthritis largely in Caucasian males who are HLA-B27 positive,” Dr. Abutineh said, “and we found that there is still a significant portion of patients who don’t meet the criteria that do have disease that is very significant.”
Although actual prevalence was not clear from this study, Dr. Abutineh said their data suggest a 3-to-1 ratio of White-to-Black patients with spondyloarthritis, “but of the Black patients who are diagnosed, their disease is almost always more severe. That points to why it’s important to have a high index of suspicion for this disease in that patient population because if you miss it, it could be detrimental to the patients.”
Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who was not part of the study, said in an interview, “It is an excellent and timely study addressing the racial disparities and inequities surrounding axSpA diagnosis. It highlights the delay in diagnosis and increased burden of disease among Black Americans.”
She said the study may prompt a further look into barriers to care for Black Americans and their beliefs regarding seeking health care for their pain.
Higher rates of nonradiographic axSpA among Black patients
The rate of nonradiographic axSpA among Black Americans was more than twice that of their White counterparts, which, Dr. Alexander noted, could make it more difficult to diagnose axSpA in that population.
The odds ratio for Black patients having nonradiographic axSpA, compared with Whites, was 2.265 (95% CI, 1.082-4.999; P = .035), after adjustment for age, sex, and HLA-B27 status.
Adult patients with axSpA were identified from rheumatology clinics at four major hospital systems and one private clinic in Shelby County, Tenn., between 2011 and 2021. Patients met modified New York (mNY) or Assessment of Spondyloarthritis International Society (ASAS) criteria as assessed by reviewers.
The authors and Dr. Alexander reported no relevant financial relationships.
CLEVELAND – Documenting the prevalence of axial spondyloarthritis (axSpA) among Black Americans has been difficult because of little published data, but new research suggests that when Black Americans do have the disease, it seems to be more severe.
Iman Abutineh, MD, of the University of Tennessee, Memphis, discussed her team’s work at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
A total of 244 patients with axSpA were identified, including 168 (69%) males, 78 (32%) Black patients, and 143 (59%) White patients.
Average age of onset for patients overall was 27.7 years, and age at diagnosis was 36.1 years with a 7-year delay in diagnosis. Sixty-six (27%) patients had nonradiographic axSpA, 83% were on tumor necrosis factor inhibitors, and 38% were prescribed glucocorticoids.
The researchers found several differences by race.
White patients were more likely to be HLA-B27 positive (77% vs. 59%; P = .010). White patients also had higher prevalence of psoriasis, coronary artery disease, and family history of SpA. White females had a higher prevalence of inflammatory bowel disease, fibromyalgia, depression, and lower grades of sacroiliitis.
Black patients had more hip involvement
A higher percentage of Black patients had elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and hip involvement. In comparing hip involvement, the researchers found that 39 (39%) White males had hip involvement as did 9 (21%) White females. In comparison, 22 (45%) Black men in the study and 14 (54%) Black women showed hip involvement (P = .035).
After adjustment for age, sex, HLA-B27, and insurance status, Black patients had higher grades of sacroiliitis with an odds ratio of 2.32 (95% confidence interval, 1.23-4.44). Black patients had a numerically longer delay in diagnosis, compared with Whites (7.93 vs. 6.64 years), but this did not achieve statistical significance (P = .454), the researchers wrote.
Study addresses racial disparities
“Traditionally we think of axial spondyloarthritis largely in Caucasian males who are HLA-B27 positive,” Dr. Abutineh said, “and we found that there is still a significant portion of patients who don’t meet the criteria that do have disease that is very significant.”
Although actual prevalence was not clear from this study, Dr. Abutineh said their data suggest a 3-to-1 ratio of White-to-Black patients with spondyloarthritis, “but of the Black patients who are diagnosed, their disease is almost always more severe. That points to why it’s important to have a high index of suspicion for this disease in that patient population because if you miss it, it could be detrimental to the patients.”
Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who was not part of the study, said in an interview, “It is an excellent and timely study addressing the racial disparities and inequities surrounding axSpA diagnosis. It highlights the delay in diagnosis and increased burden of disease among Black Americans.”
She said the study may prompt a further look into barriers to care for Black Americans and their beliefs regarding seeking health care for their pain.
Higher rates of nonradiographic axSpA among Black patients
The rate of nonradiographic axSpA among Black Americans was more than twice that of their White counterparts, which, Dr. Alexander noted, could make it more difficult to diagnose axSpA in that population.
The odds ratio for Black patients having nonradiographic axSpA, compared with Whites, was 2.265 (95% CI, 1.082-4.999; P = .035), after adjustment for age, sex, and HLA-B27 status.
Adult patients with axSpA were identified from rheumatology clinics at four major hospital systems and one private clinic in Shelby County, Tenn., between 2011 and 2021. Patients met modified New York (mNY) or Assessment of Spondyloarthritis International Society (ASAS) criteria as assessed by reviewers.
The authors and Dr. Alexander reported no relevant financial relationships.
AT SPARTAN 2023
Researchers make headway in understanding axSpA diagnostic delay
CLEVELAND – With early diagnosis an ongoing complex target for axial spondyloarthritis (axSpA), new research may help to answer where the biggest delays lie.
Gregory McDermott, MD, a research fellow at Brigham and Women’s Hospital in Boston, led a pilot study with data from Mass General Brigham electronic health records. He shared top results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN) , where addressing delay in diagnosis was a major theme.
Included in the cohort were 554 patients who had three ICD-9 or ICD-10 codes and an imaging report of sacroiliitis, ankylosis, or syndesmophytes, and were screened via manual chart review for modified New York and Assessment of Spondyloarthritis International Society criteria.
The average diagnostic delay for axSpA was 6.8 years in this study (median, 3.8 years), relatively consistent with findings in previous studies globally, and the average age of onset was 29.5.
The researchers also factored in history of specialty care for back pain (orthopedics, physical medicine and rehabilitation, pain medicine) or extra-articular manifestations (ophthalmology, dermatology, gastroenterology) before axSpA diagnosis. Other factors included smoking and insurance status, along with age, sex, race, and other demographic data.
The results showed shorter delays in diagnosing axSpA were associated with older age at symptom onset and peripheral arthritis, whereas longer delays (more than 4 years) were associated with a history of uveitis, ankylosing spondylitis at diagnosis, and being among those in the 80-99th percentile on the social vulnerability index (SVI). The SVI includes U.S. census data on factors including housing type, household composition and disability status, employment status, minority status, non-English speaking, educational attainment, transportation, and mean income level.
Notable uveitis finding
Dr. McDermott said the team was surprised by the association between having had uveitis and delayed axSpA diagnosis.
Among patients with uveitis, 12% had a short delay from symptom onset to axSpA diagnosis of 0-1 years, but more than twice that percentage (27%) had a delay of more than 4 years (P < .001).
“We thought the finding related to uveitis was interesting and potentially clinically meaningful as 27% of axSpA patients in our cohort with more than 4 years of diagnostic delay sought ophthalmology care prior to their diagnosis, [compared with 13% of patients with a diagnosis within 1 year],” Dr. McDermott said. “This practice setting in particular may be a place where we can intervene with simple screening or increased education in order to get people appropriately referred to rheumatology care.”
Longer delays can lead to more functional impairment, radiographic progression, and work disability, as well as poorer quality of life, increased depression, and higher unemployment and health care costs, Dr. McDermott said.
Patients may miss key treatment window
Maureen Dubreuil, MD, MSc, assistant professor at Boston University and a rheumatologist with the VA Boston Healthcare System, who was not part of the study, said: “This study addressed a critically important problem in the field – that diagnosis of axSpA is delayed by 7 years, which is much longer than the average time to diagnosis for other forms of arthritis, such as rheumatoid arthritis, which is under 6 months.
“It is critical that diagnostic delay is reduced in axSpA because undiagnosed individuals may miss an important window of opportunity to receive treatment that prevents permanent structural damage and functional declines. This work, if confirmed in other data, would allow development of interventions to improve timely evaluation of individuals with chronic back pain who may have axSpA, particularly among those with within lower socioeconomic strata, and those who are older or have uveitis.”
Study tests screening tool
Among the ideas proposed for reducing the delay was a referral strategy with a screening tool.
Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who presented her team’s poster, noted that, in the United States, patients with chronic back pain often come first to a primary care doctor or another specialty and not to a rheumatologist.
As an internal medicine resident at Yale University, New Haven, Conn., Dr. Alexander and colleagues there conducted the Finding Axial Spondyloarthritis (FaxSpA) study to test whether patient self-referral or referral by other physicians, guided by answers to a screening tool, could help to speed the process of getting patients more likely to have axSpA to a rheumatologist.
Dr. Alexander said they found that using the screening tool was better than having no referral strategy, explaining that screening helped diagnose about 34% of the study population with axSpA, whereas if a patient came in with chronic back pain to a primary care physician without any screening and ultimately to a rheumatologist, “you’re only capturing about 20%,” she said, citing estimates in the literature.
Questions may need rewording
However, the researchers found that patient interpretation of the screening questions was different depending on whether they were answering online or directly from a rheumatologist’s in-person questions. For more success, Dr. Alexander said, the questions may need to be reworded or more education may be needed for both patients and physicians to get more valid information.
For instance, she said, when the screening tool asks about inflammation, the patient may assume the physician is asking about pain and answer one way, but when a rheumatologist asks the question a slightly different way in the clinic, the patient may give a different answer.
First questions in portal, on social media
In the screening intervention (called A-tool) patients first answered three questions via the MyChart portal or Facebook. If they answered all three questions positively, they would move on to another round of questions and the answers would decide whether they would be eligible to come into the rheumatologist to get evaluated for axSpA.
At the study visit, rheumatologists asked the same questions as the online A-tool, which focus on SpA features with reasonable sensitivity and specificity for axSpA (no labs or imaging included). Clinicians’ judgment was considered the gold standard for diagnosis of axSpA.
The authors reported that 1,274 patients answered questions with the screening tool via Facebook (50%) and MyChart (50%) from April 2019 to February 2022. Among the responders, 507 (40%) were eligible for a rheumatologist visit.
As of May 2022, 100 patients were enrolled. Of the enrolled patients, 86 patients completed all the study procedures, including study visit, labs, and imaging (x-ray and MRI of the pelvis). Of the 86 patients, 29 (34%) were diagnosed with axSpA.
The tool appears to help narrow the chronic back pain patients who need to be seen by a rheumatologist for potential axSpA, Dr. Alexander said, which may help to speed diagnosis and also save time and resources.
Dr. McDermott, Dr. Dubreuil, and Dr. Alexander reported no relevant financial relationships. The FaxSpA study was supported with funding from Novartis and the Spondylitis Association of America.
CLEVELAND – With early diagnosis an ongoing complex target for axial spondyloarthritis (axSpA), new research may help to answer where the biggest delays lie.
Gregory McDermott, MD, a research fellow at Brigham and Women’s Hospital in Boston, led a pilot study with data from Mass General Brigham electronic health records. He shared top results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN) , where addressing delay in diagnosis was a major theme.
Included in the cohort were 554 patients who had three ICD-9 or ICD-10 codes and an imaging report of sacroiliitis, ankylosis, or syndesmophytes, and were screened via manual chart review for modified New York and Assessment of Spondyloarthritis International Society criteria.
The average diagnostic delay for axSpA was 6.8 years in this study (median, 3.8 years), relatively consistent with findings in previous studies globally, and the average age of onset was 29.5.
The researchers also factored in history of specialty care for back pain (orthopedics, physical medicine and rehabilitation, pain medicine) or extra-articular manifestations (ophthalmology, dermatology, gastroenterology) before axSpA diagnosis. Other factors included smoking and insurance status, along with age, sex, race, and other demographic data.
The results showed shorter delays in diagnosing axSpA were associated with older age at symptom onset and peripheral arthritis, whereas longer delays (more than 4 years) were associated with a history of uveitis, ankylosing spondylitis at diagnosis, and being among those in the 80-99th percentile on the social vulnerability index (SVI). The SVI includes U.S. census data on factors including housing type, household composition and disability status, employment status, minority status, non-English speaking, educational attainment, transportation, and mean income level.
Notable uveitis finding
Dr. McDermott said the team was surprised by the association between having had uveitis and delayed axSpA diagnosis.
Among patients with uveitis, 12% had a short delay from symptom onset to axSpA diagnosis of 0-1 years, but more than twice that percentage (27%) had a delay of more than 4 years (P < .001).
“We thought the finding related to uveitis was interesting and potentially clinically meaningful as 27% of axSpA patients in our cohort with more than 4 years of diagnostic delay sought ophthalmology care prior to their diagnosis, [compared with 13% of patients with a diagnosis within 1 year],” Dr. McDermott said. “This practice setting in particular may be a place where we can intervene with simple screening or increased education in order to get people appropriately referred to rheumatology care.”
Longer delays can lead to more functional impairment, radiographic progression, and work disability, as well as poorer quality of life, increased depression, and higher unemployment and health care costs, Dr. McDermott said.
Patients may miss key treatment window
Maureen Dubreuil, MD, MSc, assistant professor at Boston University and a rheumatologist with the VA Boston Healthcare System, who was not part of the study, said: “This study addressed a critically important problem in the field – that diagnosis of axSpA is delayed by 7 years, which is much longer than the average time to diagnosis for other forms of arthritis, such as rheumatoid arthritis, which is under 6 months.
“It is critical that diagnostic delay is reduced in axSpA because undiagnosed individuals may miss an important window of opportunity to receive treatment that prevents permanent structural damage and functional declines. This work, if confirmed in other data, would allow development of interventions to improve timely evaluation of individuals with chronic back pain who may have axSpA, particularly among those with within lower socioeconomic strata, and those who are older or have uveitis.”
Study tests screening tool
Among the ideas proposed for reducing the delay was a referral strategy with a screening tool.
Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who presented her team’s poster, noted that, in the United States, patients with chronic back pain often come first to a primary care doctor or another specialty and not to a rheumatologist.
As an internal medicine resident at Yale University, New Haven, Conn., Dr. Alexander and colleagues there conducted the Finding Axial Spondyloarthritis (FaxSpA) study to test whether patient self-referral or referral by other physicians, guided by answers to a screening tool, could help to speed the process of getting patients more likely to have axSpA to a rheumatologist.
Dr. Alexander said they found that using the screening tool was better than having no referral strategy, explaining that screening helped diagnose about 34% of the study population with axSpA, whereas if a patient came in with chronic back pain to a primary care physician without any screening and ultimately to a rheumatologist, “you’re only capturing about 20%,” she said, citing estimates in the literature.
Questions may need rewording
However, the researchers found that patient interpretation of the screening questions was different depending on whether they were answering online or directly from a rheumatologist’s in-person questions. For more success, Dr. Alexander said, the questions may need to be reworded or more education may be needed for both patients and physicians to get more valid information.
For instance, she said, when the screening tool asks about inflammation, the patient may assume the physician is asking about pain and answer one way, but when a rheumatologist asks the question a slightly different way in the clinic, the patient may give a different answer.
First questions in portal, on social media
In the screening intervention (called A-tool) patients first answered three questions via the MyChart portal or Facebook. If they answered all three questions positively, they would move on to another round of questions and the answers would decide whether they would be eligible to come into the rheumatologist to get evaluated for axSpA.
At the study visit, rheumatologists asked the same questions as the online A-tool, which focus on SpA features with reasonable sensitivity and specificity for axSpA (no labs or imaging included). Clinicians’ judgment was considered the gold standard for diagnosis of axSpA.
The authors reported that 1,274 patients answered questions with the screening tool via Facebook (50%) and MyChart (50%) from April 2019 to February 2022. Among the responders, 507 (40%) were eligible for a rheumatologist visit.
As of May 2022, 100 patients were enrolled. Of the enrolled patients, 86 patients completed all the study procedures, including study visit, labs, and imaging (x-ray and MRI of the pelvis). Of the 86 patients, 29 (34%) were diagnosed with axSpA.
The tool appears to help narrow the chronic back pain patients who need to be seen by a rheumatologist for potential axSpA, Dr. Alexander said, which may help to speed diagnosis and also save time and resources.
Dr. McDermott, Dr. Dubreuil, and Dr. Alexander reported no relevant financial relationships. The FaxSpA study was supported with funding from Novartis and the Spondylitis Association of America.
CLEVELAND – With early diagnosis an ongoing complex target for axial spondyloarthritis (axSpA), new research may help to answer where the biggest delays lie.
Gregory McDermott, MD, a research fellow at Brigham and Women’s Hospital in Boston, led a pilot study with data from Mass General Brigham electronic health records. He shared top results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN) , where addressing delay in diagnosis was a major theme.
Included in the cohort were 554 patients who had three ICD-9 or ICD-10 codes and an imaging report of sacroiliitis, ankylosis, or syndesmophytes, and were screened via manual chart review for modified New York and Assessment of Spondyloarthritis International Society criteria.
The average diagnostic delay for axSpA was 6.8 years in this study (median, 3.8 years), relatively consistent with findings in previous studies globally, and the average age of onset was 29.5.
The researchers also factored in history of specialty care for back pain (orthopedics, physical medicine and rehabilitation, pain medicine) or extra-articular manifestations (ophthalmology, dermatology, gastroenterology) before axSpA diagnosis. Other factors included smoking and insurance status, along with age, sex, race, and other demographic data.
The results showed shorter delays in diagnosing axSpA were associated with older age at symptom onset and peripheral arthritis, whereas longer delays (more than 4 years) were associated with a history of uveitis, ankylosing spondylitis at diagnosis, and being among those in the 80-99th percentile on the social vulnerability index (SVI). The SVI includes U.S. census data on factors including housing type, household composition and disability status, employment status, minority status, non-English speaking, educational attainment, transportation, and mean income level.
Notable uveitis finding
Dr. McDermott said the team was surprised by the association between having had uveitis and delayed axSpA diagnosis.
Among patients with uveitis, 12% had a short delay from symptom onset to axSpA diagnosis of 0-1 years, but more than twice that percentage (27%) had a delay of more than 4 years (P < .001).
“We thought the finding related to uveitis was interesting and potentially clinically meaningful as 27% of axSpA patients in our cohort with more than 4 years of diagnostic delay sought ophthalmology care prior to their diagnosis, [compared with 13% of patients with a diagnosis within 1 year],” Dr. McDermott said. “This practice setting in particular may be a place where we can intervene with simple screening or increased education in order to get people appropriately referred to rheumatology care.”
Longer delays can lead to more functional impairment, radiographic progression, and work disability, as well as poorer quality of life, increased depression, and higher unemployment and health care costs, Dr. McDermott said.
Patients may miss key treatment window
Maureen Dubreuil, MD, MSc, assistant professor at Boston University and a rheumatologist with the VA Boston Healthcare System, who was not part of the study, said: “This study addressed a critically important problem in the field – that diagnosis of axSpA is delayed by 7 years, which is much longer than the average time to diagnosis for other forms of arthritis, such as rheumatoid arthritis, which is under 6 months.
“It is critical that diagnostic delay is reduced in axSpA because undiagnosed individuals may miss an important window of opportunity to receive treatment that prevents permanent structural damage and functional declines. This work, if confirmed in other data, would allow development of interventions to improve timely evaluation of individuals with chronic back pain who may have axSpA, particularly among those with within lower socioeconomic strata, and those who are older or have uveitis.”
Study tests screening tool
Among the ideas proposed for reducing the delay was a referral strategy with a screening tool.
Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who presented her team’s poster, noted that, in the United States, patients with chronic back pain often come first to a primary care doctor or another specialty and not to a rheumatologist.
As an internal medicine resident at Yale University, New Haven, Conn., Dr. Alexander and colleagues there conducted the Finding Axial Spondyloarthritis (FaxSpA) study to test whether patient self-referral or referral by other physicians, guided by answers to a screening tool, could help to speed the process of getting patients more likely to have axSpA to a rheumatologist.
Dr. Alexander said they found that using the screening tool was better than having no referral strategy, explaining that screening helped diagnose about 34% of the study population with axSpA, whereas if a patient came in with chronic back pain to a primary care physician without any screening and ultimately to a rheumatologist, “you’re only capturing about 20%,” she said, citing estimates in the literature.
Questions may need rewording
However, the researchers found that patient interpretation of the screening questions was different depending on whether they were answering online or directly from a rheumatologist’s in-person questions. For more success, Dr. Alexander said, the questions may need to be reworded or more education may be needed for both patients and physicians to get more valid information.
For instance, she said, when the screening tool asks about inflammation, the patient may assume the physician is asking about pain and answer one way, but when a rheumatologist asks the question a slightly different way in the clinic, the patient may give a different answer.
First questions in portal, on social media
In the screening intervention (called A-tool) patients first answered three questions via the MyChart portal or Facebook. If they answered all three questions positively, they would move on to another round of questions and the answers would decide whether they would be eligible to come into the rheumatologist to get evaluated for axSpA.
At the study visit, rheumatologists asked the same questions as the online A-tool, which focus on SpA features with reasonable sensitivity and specificity for axSpA (no labs or imaging included). Clinicians’ judgment was considered the gold standard for diagnosis of axSpA.
The authors reported that 1,274 patients answered questions with the screening tool via Facebook (50%) and MyChart (50%) from April 2019 to February 2022. Among the responders, 507 (40%) were eligible for a rheumatologist visit.
As of May 2022, 100 patients were enrolled. Of the enrolled patients, 86 patients completed all the study procedures, including study visit, labs, and imaging (x-ray and MRI of the pelvis). Of the 86 patients, 29 (34%) were diagnosed with axSpA.
The tool appears to help narrow the chronic back pain patients who need to be seen by a rheumatologist for potential axSpA, Dr. Alexander said, which may help to speed diagnosis and also save time and resources.
Dr. McDermott, Dr. Dubreuil, and Dr. Alexander reported no relevant financial relationships. The FaxSpA study was supported with funding from Novartis and the Spondylitis Association of America.
AT SPARTAN 2023
MACE, VTE rates compared between TNF and JAK inhibitors for AxSpA and PsA
CLEVELAND – Patients with axial spondyloarthritis or psoriatic arthritis who used Janus kinase (JAK) inhibitors did not have higher risk of myocardial infarction, stroke, or venous thromboembolism (VTE), compared with those who used tumor necrosis factor inhibitors (TNFi), according to new research.
The information was presented in a poster at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
Patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) have increased cardiovascular risk compared with the general population. Emerging evidence has suggested that TNFi may protect the cardiovascular system and that there are cardiovascular and thrombotic concerns with JAK inhibitors.
Sali Merjanah, MD, a rheumatology fellow at Boston University, and colleagues, compared how drugs in the two treatment classes affected the likelihood of major adverse cardiovascular events (MACE) or VTE. MACE in this study were myocardial infarction and stroke.
In a search of the Marketscan Database during 2006-2021, the researchers identified 1,621 TNFi and 47 JAK inhibitor users with 273 and 8 cases of MACE, respectively. They identified 2,507 TNFi and 96 JAK users with 452 and 26 cases of VTE, respectively. Patients were aged 18-65 years and had at least one inpatient or two outpatient axSpA or PsA ICD-9 or ICD-10 diagnosis codes separated by at least 7 days.
The likelihood of MACE was 14% lower among JAK inhibitor users than TNFi users (the reference group), whereas the likelihood of VTE was 39% higher for JAK inhibitor users, but neither comparison was statistically significant. JAK/TNFi nonusers had a statistically significant 27% greater likelihood of MACE than did TNFi users. The likelihood for VTE was 12% higher for JAK/TNFi nonusers, compared with TNFi users, but this finding was not statistically significant. The researchers adjusted comparisons for age, medications, and comorbidities.
Small numbers complicate the research
Lianne Gensler, MD, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco, who was not part of the study, said the limitations the authors list are important to note. The researchers said that the study’s small number of JAK inhibitor users, short duration of exposure, and low event rate limit its precision, and there is potential misclassification of TNF/JAK inhibitor exposure, as well as confounding by indication.
Dr. Gensler noted that these same limitations apply to studies of patients with RA as well that try to answer the question of risk for MACE and malignancy when using these drugs,
“MACE is a rare event, malignancy is a rare event. So it’s like finding a needle in a haystack, and the haystack is really big. You either have to enrich the haystack with more needles or you have to make a smaller haystack,” Dr. Gensler said.
Nevertheless, she said, she credits the researchers for bringing the available information to light.
“I think we have to do this many different ways to try to get at the answer in a partial way,” she said.
The data were drawn from 2006 to 2021, but JAK inhibitors have only been approved for axSpA in the last one and a half years and for PsA at the end of 2017.
Additionally, the people taking JAK inhibitors would have likely already failed TNFis, she said, adding that this can make it hard to tell whether an event was linked with the JAK or the TNFi.
Nonusers may have other risk factors
She pointed out that in this study patients who were not using TNF or JAK inhibitors had slightly higher risk numerically for both MACE and VTE than did those using TNFis.
“There, the assumption is always that this is confounding by indication, meaning it is likely that the people who are nonusers have other risk factors for MACE, which is why we’re not giving them these drugs.”
Having heart failure, for instance, is a contraindication for using a TNF inhibitor, she noted. “So it’s not that these are protective compared to nonusers. It’s probably that the nonuser has higher risk and is not getting treated with these drugs to begin with.”
The authors properly concluded from the data that patients using JAK inhibitors did not have higher risk of MACE or VTE, compared with those who used TNFis, she said, but larger studies with more follow-up are needed.
“No evidence doesn’t mean no effect,” she said. “Part of it depends on the [statistical] power and the population you’re studying.”
Dr. Gensler is a consultant for AbbVie, Acceleron, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and has received grant support from Novartis and UCB. The authors’ financial relationships were not available.
CLEVELAND – Patients with axial spondyloarthritis or psoriatic arthritis who used Janus kinase (JAK) inhibitors did not have higher risk of myocardial infarction, stroke, or venous thromboembolism (VTE), compared with those who used tumor necrosis factor inhibitors (TNFi), according to new research.
The information was presented in a poster at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
Patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) have increased cardiovascular risk compared with the general population. Emerging evidence has suggested that TNFi may protect the cardiovascular system and that there are cardiovascular and thrombotic concerns with JAK inhibitors.
Sali Merjanah, MD, a rheumatology fellow at Boston University, and colleagues, compared how drugs in the two treatment classes affected the likelihood of major adverse cardiovascular events (MACE) or VTE. MACE in this study were myocardial infarction and stroke.
In a search of the Marketscan Database during 2006-2021, the researchers identified 1,621 TNFi and 47 JAK inhibitor users with 273 and 8 cases of MACE, respectively. They identified 2,507 TNFi and 96 JAK users with 452 and 26 cases of VTE, respectively. Patients were aged 18-65 years and had at least one inpatient or two outpatient axSpA or PsA ICD-9 or ICD-10 diagnosis codes separated by at least 7 days.
The likelihood of MACE was 14% lower among JAK inhibitor users than TNFi users (the reference group), whereas the likelihood of VTE was 39% higher for JAK inhibitor users, but neither comparison was statistically significant. JAK/TNFi nonusers had a statistically significant 27% greater likelihood of MACE than did TNFi users. The likelihood for VTE was 12% higher for JAK/TNFi nonusers, compared with TNFi users, but this finding was not statistically significant. The researchers adjusted comparisons for age, medications, and comorbidities.
Small numbers complicate the research
Lianne Gensler, MD, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco, who was not part of the study, said the limitations the authors list are important to note. The researchers said that the study’s small number of JAK inhibitor users, short duration of exposure, and low event rate limit its precision, and there is potential misclassification of TNF/JAK inhibitor exposure, as well as confounding by indication.
Dr. Gensler noted that these same limitations apply to studies of patients with RA as well that try to answer the question of risk for MACE and malignancy when using these drugs,
“MACE is a rare event, malignancy is a rare event. So it’s like finding a needle in a haystack, and the haystack is really big. You either have to enrich the haystack with more needles or you have to make a smaller haystack,” Dr. Gensler said.
Nevertheless, she said, she credits the researchers for bringing the available information to light.
“I think we have to do this many different ways to try to get at the answer in a partial way,” she said.
The data were drawn from 2006 to 2021, but JAK inhibitors have only been approved for axSpA in the last one and a half years and for PsA at the end of 2017.
Additionally, the people taking JAK inhibitors would have likely already failed TNFis, she said, adding that this can make it hard to tell whether an event was linked with the JAK or the TNFi.
Nonusers may have other risk factors
She pointed out that in this study patients who were not using TNF or JAK inhibitors had slightly higher risk numerically for both MACE and VTE than did those using TNFis.
“There, the assumption is always that this is confounding by indication, meaning it is likely that the people who are nonusers have other risk factors for MACE, which is why we’re not giving them these drugs.”
Having heart failure, for instance, is a contraindication for using a TNF inhibitor, she noted. “So it’s not that these are protective compared to nonusers. It’s probably that the nonuser has higher risk and is not getting treated with these drugs to begin with.”
The authors properly concluded from the data that patients using JAK inhibitors did not have higher risk of MACE or VTE, compared with those who used TNFis, she said, but larger studies with more follow-up are needed.
“No evidence doesn’t mean no effect,” she said. “Part of it depends on the [statistical] power and the population you’re studying.”
Dr. Gensler is a consultant for AbbVie, Acceleron, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and has received grant support from Novartis and UCB. The authors’ financial relationships were not available.
CLEVELAND – Patients with axial spondyloarthritis or psoriatic arthritis who used Janus kinase (JAK) inhibitors did not have higher risk of myocardial infarction, stroke, or venous thromboembolism (VTE), compared with those who used tumor necrosis factor inhibitors (TNFi), according to new research.
The information was presented in a poster at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).
Patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) have increased cardiovascular risk compared with the general population. Emerging evidence has suggested that TNFi may protect the cardiovascular system and that there are cardiovascular and thrombotic concerns with JAK inhibitors.
Sali Merjanah, MD, a rheumatology fellow at Boston University, and colleagues, compared how drugs in the two treatment classes affected the likelihood of major adverse cardiovascular events (MACE) or VTE. MACE in this study were myocardial infarction and stroke.
In a search of the Marketscan Database during 2006-2021, the researchers identified 1,621 TNFi and 47 JAK inhibitor users with 273 and 8 cases of MACE, respectively. They identified 2,507 TNFi and 96 JAK users with 452 and 26 cases of VTE, respectively. Patients were aged 18-65 years and had at least one inpatient or two outpatient axSpA or PsA ICD-9 or ICD-10 diagnosis codes separated by at least 7 days.
The likelihood of MACE was 14% lower among JAK inhibitor users than TNFi users (the reference group), whereas the likelihood of VTE was 39% higher for JAK inhibitor users, but neither comparison was statistically significant. JAK/TNFi nonusers had a statistically significant 27% greater likelihood of MACE than did TNFi users. The likelihood for VTE was 12% higher for JAK/TNFi nonusers, compared with TNFi users, but this finding was not statistically significant. The researchers adjusted comparisons for age, medications, and comorbidities.
Small numbers complicate the research
Lianne Gensler, MD, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco, who was not part of the study, said the limitations the authors list are important to note. The researchers said that the study’s small number of JAK inhibitor users, short duration of exposure, and low event rate limit its precision, and there is potential misclassification of TNF/JAK inhibitor exposure, as well as confounding by indication.
Dr. Gensler noted that these same limitations apply to studies of patients with RA as well that try to answer the question of risk for MACE and malignancy when using these drugs,
“MACE is a rare event, malignancy is a rare event. So it’s like finding a needle in a haystack, and the haystack is really big. You either have to enrich the haystack with more needles or you have to make a smaller haystack,” Dr. Gensler said.
Nevertheless, she said, she credits the researchers for bringing the available information to light.
“I think we have to do this many different ways to try to get at the answer in a partial way,” she said.
The data were drawn from 2006 to 2021, but JAK inhibitors have only been approved for axSpA in the last one and a half years and for PsA at the end of 2017.
Additionally, the people taking JAK inhibitors would have likely already failed TNFis, she said, adding that this can make it hard to tell whether an event was linked with the JAK or the TNFi.
Nonusers may have other risk factors
She pointed out that in this study patients who were not using TNF or JAK inhibitors had slightly higher risk numerically for both MACE and VTE than did those using TNFis.
“There, the assumption is always that this is confounding by indication, meaning it is likely that the people who are nonusers have other risk factors for MACE, which is why we’re not giving them these drugs.”
Having heart failure, for instance, is a contraindication for using a TNF inhibitor, she noted. “So it’s not that these are protective compared to nonusers. It’s probably that the nonuser has higher risk and is not getting treated with these drugs to begin with.”
The authors properly concluded from the data that patients using JAK inhibitors did not have higher risk of MACE or VTE, compared with those who used TNFis, she said, but larger studies with more follow-up are needed.
“No evidence doesn’t mean no effect,” she said. “Part of it depends on the [statistical] power and the population you’re studying.”
Dr. Gensler is a consultant for AbbVie, Acceleron, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and has received grant support from Novartis and UCB. The authors’ financial relationships were not available.
AT SPARTAN 2023