Spondyloarthropathies

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

Rheumatologist Zachary S. Wallace, MD, knew just how prior authorization requirements were impacting his staff time and work flow when he embarked on a study several years ago. Managing authorizations for infusible medications alone was about to become a full-time job for one of the administrative assistants in the rheumatology unit at Massachusetts General Hospital in Boston.

His research questions concerned patients. “There’s a lot of talk about how much onus prior authorization requirements put on providers and the practice,” Dr. Wallace said. ”I was interested in understanding what impact [these requirements] have on patients themselves.”

Dr. Wallace led a review of the EHRs of 225 patients for whom an infusible medication such as rituximab and infliximab was ordered by 1 of the 16 physicians in the rheumatology unit between July 2016 and June 2018. The findings – that patients who needed prior authorizations for infusible medications had a significantly longer time to treatment initiation and higher prednisone-equivalent glucocorticoid exposure – were reported online in Arthritis Care & Research.

Among patients whose authorizations were initially denied, these differences were “pretty drastic,” Dr. Wallace said. The median time to receiving a first infusion was 50 days, compared with 27 days when permission was not required, and glucocorticoid exposure during the 3 months following the request was 605 mg versus 160 mg.

Among patients whose authorizations were not denied, the median time to first infusion was 31 days, compared with 27 days when authorization was not required, and the mean glucocorticoid exposure over 3 months was 364 mg versus 160 mg.

“I hope that our findings will help facilitate discussions with insurance providers, pharmacy benefit managers, and state and federal legislators about the need to address the impact that prior authorization requirements have on patients and providers,” said Dr. Wallace, also of the clinical epidemiology program in the division of rheumatology, allergy and immunology at Massachusetts General, and an assistant professor of medicine at Harvard Medical School, Boston.

Of the 225 patients for whom an infusible medication was ordered, 71% required preauthorization. Of these, 79% were approved and 21% were denied after the first request. And in a finding that Dr. Wallace called “somewhat surprising,” 82% of the authorizations originally denied were approved after appeal.

All told, prior authorizations for infusible medications were eventually approved in all but a small number of cases. “We go through all this effort to get these prior authorizations approved, and 96% of the time, they were ultimately approved,” he said in an interview.

Christopher Phillips, MD, a community rheumatologist in Paducah, Ky., who serves as chair of the insurance subcommittee of the American College of Rheumatology’s committee on rheumatologic care, said the findings “give further credence” to rheumatologists’ concerns. “We know [from our own experiences] that prior authorizations delay care, and we know that delays can cause harm to patients. We now have hard data backing up this assertion.”

Regarding the high number of authorization approvals, “there’s an argument to be made that for certain treatments and certain conditions where the success rate of appeals is high enough, you shouldn’t be subjecting these treatments to these [preauthorization] policies,” he said.

Calls for prior authorization reform

Most patients in the study (71%) had private insurance. But the findings also have implications for Medicare, Dr. Wallace said, as recent federal policies have expanded Medicare Advantage plans’ authority to use prior authorization in conjunction with step therapy for medications administered under Part B. Step therapy favors primary use of what insurers deem the most cost-effective therapies.

The ACR is one of almost 370 physician, patient, and health care organizations that are urging Congress to pass a bipartisan bill aimed at streamlining and standardizing prior authorization under the Medicare Advantage program. The legislation – Improving Seniors’ Timely Access to Care Act of 2019 (H.R. 3107) – was introduced by Reps. Suzan DelBene (D-Wash.), Mike Kelly (R-Pa.), Roger Marshall, MD (R-Kan.), and Ami Bera, MD (D-Calif.).

The bill calls for the creation of an electronic prior authorization program and a “real-time process for items and services that are routinely approved,” as well as greater Centers for Medicare & Medicaid Services oversight on how Medicare Advantage plans use prior authorization. Plans would be required to report to the CMS on the extent of their use of prior authorization and the rate of approvals or denials. They would also be held accountable for making timely prior authorization determinations and providing rationales for denials, according to a letter to Congress cosigned by the ACR.

In a press release about the legislation, Paula Marchetta, MD, president of the ACR, said that “the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies.” She added that “many health care plans now use prior authorization indiscriminately.”

Cathryn Donaldson, director of communications for America’s Health Insurance Plans (AHIP), said in an email that prior authorization is used for less than 15% of covered services, and that, along with step therapy, it “helps ensure that patients receive care that is safe, effective, and necessary.” AHIP “knows that prior authorization can be improved,” she said, and is committed to streamlining the process.

A demonstration project on the automation of various parts of prior authorization is being coordinated with health information technology companies, plans, and providers, she noted.

The federal legislation is based at least partly on a consensus statement drafted by AHIP, the American Medical Association, and four other organizations representing hospitals, medical groups, and health plans on ways to improve the prior authorization process. Among the items mentioned in the statement is that “regular review” of services subject to prior authorization could help identify therapies that “no longer warrant” prior authorization because of low denial rates.

Outside of Medicare Advantage, the AMA is aware of at least 85 bills being introduced in states this year that address utilization management in commercial plans. Nearly all these bills attempt to reform prior authorization programs in some way, according to R. J. Mills, media relations coordinator for the AMA.

Rheumatologic patients hard hit

Off-label medication use was the most common reason (82%) for a prior authorization denial in the Massachusetts General study, even though 78% of the patients for whom infusible medications were prescribed had a condition with no Food and Drug Administration–approved treatment. Having such a condition was associated with 120% or 190% higher odds of having a denial in unadjusted and adjusted (for age and sex) analyses, Dr. Wallace and colleagues reported.

Moreover, nearly half (48%) of the patients with denials had already tried or were currently taking an oral disease-modifying antirheumatic drug, such as methotrexate.

The majority of denials were for the use of rituximab (70%), followed by infliximab (12%) and tocilizumab (12%). Most of the denials (79%) were appealed successfully through a peer-to-peer discussion. In five cases, the insurer’s preferred drug (for example, adalimumab) had to be used rather than the requested infusion (for example, infliximab).

Infused medications, many of which are biologics, are among the most expensive drugs prescribed for patients with rheumatic diseases. They were easiest for Dr. Wallace to study because of the way prior authorizations are handled in his unit, but prior authorization requirements are “widespread” in rheumatology practices across treatment types, he and Dr. Phillips said.

“Some of our relatively inexpensive treatments are subject to prior authorization requirements,” Dr. Phillips said. “We hear stories about prednisone needing a prior authorization sometimes.”

With respect to infusible medications, the insurance subcommittee is hearing from ACR members about seemingly increasing numbers of both clinical coverage reviews – for example, reviews of prior treatments – and site-of-care restrictions, Dr. Phillips noted. “Some carriers are insisting on infusions in non-hospital-based settings, for cost savings, or on home infusions, which are concerning because of [possible] infusion reactions and medical service availability.”

The application of step therapy to rheumatologic patients is troubling because of the “often unique medical circumstances of the patient,” Dr. Phillips said. “There are enough differences among the [tumor necrosis factor] antagonists, for instance, that make one more appropriate for a certain patient than another. Those differences are not brought into consideration with these policies.”

There are other ways in which prior authorization processes “are not well informed medically,” he said, recalling a case brought to the attention of the subcommittee in which a patient prescribed a biologic drug for psoriatic arthritis was denied authorization because “the documentation did not include a [disease activity measure] that is specific to RA and not used for psoriatic arthritis.”

It is not uncommon for authorizations for infusible medications to take 2 weeks or longer to secure – even when initially approved. In the AMA’s 2018 Prior Authorization Physician Survey, 65% reported waiting at least 1 business day for a decision and 26% reported waiting at least 3 business days for responses. “With infusibles, we’re absolutely dealing with a much longer time,” Dr. Phillips said.

In Dr. Wallace’s study, the finding that prior authorizations facilitated greater prednisone-equivalent glucocorticoid exposure is important, he and his colleagues wrote, because these medications may put patients at higher risk of infection, cardiovascular disease, and diabetes – even in low doses and with short-term use. Notably, the median delay to the initiation of treatment was 29 days, regardless of prior authorization requirements. Dr. Wallace said the delays “likely reflect a combination of factors” – including infusion center waiting lists and patient-level factors – and that his team is “thinking about how to facilitate better access [to their practice’s infusion center] for those who are approved for treatment.”

The most common conditions for which infused medication was ordered were inflammatory arthritis (32%), vasculitis (23%), and IgG4-related disease (17%). The 225 patients in the study had an average age of 53 years.

Dr. Wallace reported that he has no relevant financial disclosures.

SOURCE: Wallace ZS et al. Arthritis Care Res. 2019 Sep 10. doi: 10.1002/acr.24062.

While ankylosing spondylitis may be more common among whites, black patients have more comorbidities and express higher disease activity, Dilpreet Kaur Singh, MD, and Marina Magrey, MBBS, reported in The Journal of Rheumatology.

A retrospective review of a large U.S. medical database conducted by Dr. Singh and Dr. Magrey of MetroHealth Medical Center, Cleveland, found that black patients had higher erythrocyte sedimentation rates and C-reactive protein, and a higher prevalence of anterior uveitis, hypertension, diabetes, and depression, compared with white patients. (Dr. Singh, who was a rheumatology fellow at MetroHealth at the time of the study, is now a practicing rheumatologist in Springfield, Mass.)

Disease severity in AS is “thought to be genetically mediated but cultural, social, or economic factors may also be contributing to this racial disparity,” the investigators wrote. “Further research is needed to determine the role of factors other than genetic factors like HLA-B27 positivity that contribute to worsening disease severity.”

The authors extracted data recorded during 1999-2017 from the Explorys platform, a clinical research informatics tool with data from more than 50 million patients in 26 major integrated health care systems in the United States.

The current study comprised 10,990 AS patients with at least two visits to a rheumatologist. Most (84%) were white; 8% were black. Sex was equally distributed in both groups. Positivity for HLA-B27 was similar among whites (26%) and blacks (20%). A majority of patients smoked (65%), and smoking was more common among whites than among blacks (67% vs. 59%).

Disease characteristics suggested that AS was more severe among blacks. Significantly greater proportions of black patients had elevated erythrocyte sedimentation rate (62% vs. 48% of whites) and C-reactive protein (68% vs. 54%). Blacks also experienced significantly greater rates of anterior uveitis (8% vs. 4%), hypertension (29% vs. 22%), diabetes (27% vs. 17%), and depression (36% vs. 32%).

Blacks experienced higher rates of peripheral arthritis, enthesopathy, dactylitis, and inflammatory bowel disease, although these differences were not statistically significant when compared with whites.

Whites, however, had significantly higher rates of psoriasis (10% vs. 6.5%).

Most of the cohort (87%) received NSAIDs; 39% used tumor necrosis factor inhibitors. There were no significant between-group treatment differences.

The authors reported no potential conflicts of interest and no source of financial support.

[email protected]

SOURCE: Singh DK et al. J Rheumatol. 2019 Sep 1. doi: 10.3899/jrheum.181019.

While ankylosing spondylitis may be more common among whites, black patients have more comorbidities and express higher disease activity, Dilpreet Kaur Singh, MD, and Marina Magrey, MBBS, reported in The Journal of Rheumatology.

A retrospective review of a large U.S. medical database conducted by Dr. Singh and Dr. Magrey of MetroHealth Medical Center, Cleveland, found that black patients had higher erythrocyte sedimentation rates and C-reactive protein, and a higher prevalence of anterior uveitis, hypertension, diabetes, and depression, compared with white patients. (Dr. Singh, who was a rheumatology fellow at MetroHealth at the time of the study, is now a practicing rheumatologist in Springfield, Mass.)

Disease severity in AS is “thought to be genetically mediated but cultural, social, or economic factors may also be contributing to this racial disparity,” the investigators wrote. “Further research is needed to determine the role of factors other than genetic factors like HLA-B27 positivity that contribute to worsening disease severity.”

The authors extracted data recorded during 1999-2017 from the Explorys platform, a clinical research informatics tool with data from more than 50 million patients in 26 major integrated health care systems in the United States.

The current study comprised 10,990 AS patients with at least two visits to a rheumatologist. Most (84%) were white; 8% were black. Sex was equally distributed in both groups. Positivity for HLA-B27 was similar among whites (26%) and blacks (20%). A majority of patients smoked (65%), and smoking was more common among whites than among blacks (67% vs. 59%).

Disease characteristics suggested that AS was more severe among blacks. Significantly greater proportions of black patients had elevated erythrocyte sedimentation rate (62% vs. 48% of whites) and C-reactive protein (68% vs. 54%). Blacks also experienced significantly greater rates of anterior uveitis (8% vs. 4%), hypertension (29% vs. 22%), diabetes (27% vs. 17%), and depression (36% vs. 32%).

Blacks experienced higher rates of peripheral arthritis, enthesopathy, dactylitis, and inflammatory bowel disease, although these differences were not statistically significant when compared with whites.

Whites, however, had significantly higher rates of psoriasis (10% vs. 6.5%).

Most of the cohort (87%) received NSAIDs; 39% used tumor necrosis factor inhibitors. There were no significant between-group treatment differences.

The authors reported no potential conflicts of interest and no source of financial support.

[email protected]

SOURCE: Singh DK et al. J Rheumatol. 2019 Sep 1. doi: 10.3899/jrheum.181019.

While ankylosing spondylitis may be more common among whites, black patients have more comorbidities and express higher disease activity, Dilpreet Kaur Singh, MD, and Marina Magrey, MBBS, reported in The Journal of Rheumatology.

A retrospective review of a large U.S. medical database conducted by Dr. Singh and Dr. Magrey of MetroHealth Medical Center, Cleveland, found that black patients had higher erythrocyte sedimentation rates and C-reactive protein, and a higher prevalence of anterior uveitis, hypertension, diabetes, and depression, compared with white patients. (Dr. Singh, who was a rheumatology fellow at MetroHealth at the time of the study, is now a practicing rheumatologist in Springfield, Mass.)

Disease severity in AS is “thought to be genetically mediated but cultural, social, or economic factors may also be contributing to this racial disparity,” the investigators wrote. “Further research is needed to determine the role of factors other than genetic factors like HLA-B27 positivity that contribute to worsening disease severity.”

The authors extracted data recorded during 1999-2017 from the Explorys platform, a clinical research informatics tool with data from more than 50 million patients in 26 major integrated health care systems in the United States.

The current study comprised 10,990 AS patients with at least two visits to a rheumatologist. Most (84%) were white; 8% were black. Sex was equally distributed in both groups. Positivity for HLA-B27 was similar among whites (26%) and blacks (20%). A majority of patients smoked (65%), and smoking was more common among whites than among blacks (67% vs. 59%).

Disease characteristics suggested that AS was more severe among blacks. Significantly greater proportions of black patients had elevated erythrocyte sedimentation rate (62% vs. 48% of whites) and C-reactive protein (68% vs. 54%). Blacks also experienced significantly greater rates of anterior uveitis (8% vs. 4%), hypertension (29% vs. 22%), diabetes (27% vs. 17%), and depression (36% vs. 32%).

Blacks experienced higher rates of peripheral arthritis, enthesopathy, dactylitis, and inflammatory bowel disease, although these differences were not statistically significant when compared with whites.

Whites, however, had significantly higher rates of psoriasis (10% vs. 6.5%).

Most of the cohort (87%) received NSAIDs; 39% used tumor necrosis factor inhibitors. There were no significant between-group treatment differences.

The authors reported no potential conflicts of interest and no source of financial support.

[email protected]

SOURCE: Singh DK et al. J Rheumatol. 2019 Sep 1. doi: 10.3899/jrheum.181019.

Approximately two-thirds of adults with uveitis achieved inflammation control after 6 months on either methotrexate or mycophenolate alongside a reduction in corticosteroid use in an international, multicenter, open-label, randomized trial.

“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.

Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.

Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.

SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.

Approximately two-thirds of adults with uveitis achieved inflammation control after 6 months on either methotrexate or mycophenolate alongside a reduction in corticosteroid use in an international, multicenter, open-label, randomized trial.

“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.

Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.

Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.

SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.

Approximately two-thirds of adults with uveitis achieved inflammation control after 6 months on either methotrexate or mycophenolate alongside a reduction in corticosteroid use in an international, multicenter, open-label, randomized trial.

“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.

Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.

Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.

SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.

A number of medications commonly prescribed by rheumatologists may interact with cannabidiol oil, investigators at the Imperial College Healthcare NHS Trust, London, reported.

“Patients are increasingly requesting information concerning the safety of CBD oil,” Taryn Youngstein, MD, and associates said in letter to the editor in Rheumatology, but current guidelines on the use of medical cannabis do “not address the potential interactions between CBD oil and medicines frequently used in the rheumatology clinic.”

The most important potential CBD interaction, they suggested, may be with corticosteroids. Hydrocortisone and prednisolone both inhibit the cytochrome P450 enzyme CYP3A, but CBD is a potent inhibitor of CYP3A, so “concomitant use may decrease glucocorticoid clearance and increase risk of systemic [corticosteroid] side effects,” the investigators wrote.

CBD also is known to inhibit the cytochrome P450 isozymes CYP2C9, CYP2D6, CYP2C19, CYP3A4, and CYP1A2, which, alone or in combination, are involved in the metabolization of naproxen, tramadol, amitriptyline, and tofacitinib (Xeljanz), according to a literature search done via the college’s medicine information department that also used the British National Formulary and the Natural Medicines online interaction checker.

The Janus kinase inhibitor tofacitinib is included among the possible interactions, but the other Food and Drug Administration–approved JAK inhibitor, baricitinib (Olumiant), is primarily metabolized by the kidneys and should not have significant interaction with CBD, Dr. Youngstein and associates said. Most of the conventional synthetic and biologic disease-modifying antirheumatic drugs, including methotrexate, hydroxychloroquine, adalimumab (Humira), and abatacept (Orencia), also are expected to be relatively free from CBD interactions.

This first published report on interactions between CBD oil and common rheumatology medications “highlights the importance of taking comprehensive drug histories, by asking directly about drugs considered alternative medicines and food supplements,” they said.

The investigators declared no conflicts of interest, and there was no specific funding for the study.

[email protected]

SOURCE: Wilson-Morkeh H et al. Rheumatology. 2019 July 29. doi: 10.1093/rheumatology/kez304.

A number of medications commonly prescribed by rheumatologists may interact with cannabidiol oil, investigators at the Imperial College Healthcare NHS Trust, London, reported.

“Patients are increasingly requesting information concerning the safety of CBD oil,” Taryn Youngstein, MD, and associates said in letter to the editor in Rheumatology, but current guidelines on the use of medical cannabis do “not address the potential interactions between CBD oil and medicines frequently used in the rheumatology clinic.”

The most important potential CBD interaction, they suggested, may be with corticosteroids. Hydrocortisone and prednisolone both inhibit the cytochrome P450 enzyme CYP3A, but CBD is a potent inhibitor of CYP3A, so “concomitant use may decrease glucocorticoid clearance and increase risk of systemic [corticosteroid] side effects,” the investigators wrote.

CBD also is known to inhibit the cytochrome P450 isozymes CYP2C9, CYP2D6, CYP2C19, CYP3A4, and CYP1A2, which, alone or in combination, are involved in the metabolization of naproxen, tramadol, amitriptyline, and tofacitinib (Xeljanz), according to a literature search done via the college’s medicine information department that also used the British National Formulary and the Natural Medicines online interaction checker.

The Janus kinase inhibitor tofacitinib is included among the possible interactions, but the other Food and Drug Administration–approved JAK inhibitor, baricitinib (Olumiant), is primarily metabolized by the kidneys and should not have significant interaction with CBD, Dr. Youngstein and associates said. Most of the conventional synthetic and biologic disease-modifying antirheumatic drugs, including methotrexate, hydroxychloroquine, adalimumab (Humira), and abatacept (Orencia), also are expected to be relatively free from CBD interactions.

This first published report on interactions between CBD oil and common rheumatology medications “highlights the importance of taking comprehensive drug histories, by asking directly about drugs considered alternative medicines and food supplements,” they said.

The investigators declared no conflicts of interest, and there was no specific funding for the study.

[email protected]

SOURCE: Wilson-Morkeh H et al. Rheumatology. 2019 July 29. doi: 10.1093/rheumatology/kez304.

A number of medications commonly prescribed by rheumatologists may interact with cannabidiol oil, investigators at the Imperial College Healthcare NHS Trust, London, reported.

“Patients are increasingly requesting information concerning the safety of CBD oil,” Taryn Youngstein, MD, and associates said in letter to the editor in Rheumatology, but current guidelines on the use of medical cannabis do “not address the potential interactions between CBD oil and medicines frequently used in the rheumatology clinic.”

The most important potential CBD interaction, they suggested, may be with corticosteroids. Hydrocortisone and prednisolone both inhibit the cytochrome P450 enzyme CYP3A, but CBD is a potent inhibitor of CYP3A, so “concomitant use may decrease glucocorticoid clearance and increase risk of systemic [corticosteroid] side effects,” the investigators wrote.

CBD also is known to inhibit the cytochrome P450 isozymes CYP2C9, CYP2D6, CYP2C19, CYP3A4, and CYP1A2, which, alone or in combination, are involved in the metabolization of naproxen, tramadol, amitriptyline, and tofacitinib (Xeljanz), according to a literature search done via the college’s medicine information department that also used the British National Formulary and the Natural Medicines online interaction checker.

The Janus kinase inhibitor tofacitinib is included among the possible interactions, but the other Food and Drug Administration–approved JAK inhibitor, baricitinib (Olumiant), is primarily metabolized by the kidneys and should not have significant interaction with CBD, Dr. Youngstein and associates said. Most of the conventional synthetic and biologic disease-modifying antirheumatic drugs, including methotrexate, hydroxychloroquine, adalimumab (Humira), and abatacept (Orencia), also are expected to be relatively free from CBD interactions.

This first published report on interactions between CBD oil and common rheumatology medications “highlights the importance of taking comprehensive drug histories, by asking directly about drugs considered alternative medicines and food supplements,” they said.

The investigators declared no conflicts of interest, and there was no specific funding for the study.

[email protected]

SOURCE: Wilson-Morkeh H et al. Rheumatology. 2019 July 29. doi: 10.1093/rheumatology/kez304.

The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

The Food and Drug Administration has approved a subcutaneous injection formulation of ixekizumab (Taltz) at 80 mg/mL for the treatment of adult patients with active ankylosing spondylitis (AS), according to a press release from Eli Lilly.

Olivier Le Moal/Getty Images

AS is the third indication for ixekizumab, along with moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and active psoriatic arthritis in adults.

Approval of the humanized interleukin-17A antagonist was based on results from a pair of randomized, double-blind, placebo-controlled, phase 3 studies involving 657 adult patients with active AS: the COAST-V trial in those naive to biologic disease-modifying antirheumatic drugs (bDMARDs) and the COAST-W trial in those who were intolerant or had inadequate response to tumor necrosis factor (TNF) inhibitors. The primary endpoint in both trials was achievement of 40% improvement in Assessment of Spondyloarthritis International Society criteria (ASAS40) at 16 weeks, compared with placebo.

In COAST-V, 48% of patients who received ixekizumab achieved ASAS40, compared with 18% of controls (P less than .0001). In COAST-W, 25% of patients who received ixekizumab achieved ASAS40 versus 13% of controls (P less than .05). The adverse events reported during both trials were consistent with the safety profile in patients who receive ixekizumab for the treatment of plaque psoriasis, including injection-site reactions, upper respiratory tract infections, nausea, and tinea infections.

“Results from the phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors. This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS,” said Philip Mease, MD, of Providence St. Joseph Health and the University of Washington, both in Seattle.

[email protected]

The Food and Drug Administration has approved a subcutaneous injection formulation of ixekizumab (Taltz) at 80 mg/mL for the treatment of adult patients with active ankylosing spondylitis (AS), according to a press release from Eli Lilly.

Olivier Le Moal/Getty Images

AS is the third indication for ixekizumab, along with moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and active psoriatic arthritis in adults.

Approval of the humanized interleukin-17A antagonist was based on results from a pair of randomized, double-blind, placebo-controlled, phase 3 studies involving 657 adult patients with active AS: the COAST-V trial in those naive to biologic disease-modifying antirheumatic drugs (bDMARDs) and the COAST-W trial in those who were intolerant or had inadequate response to tumor necrosis factor (TNF) inhibitors. The primary endpoint in both trials was achievement of 40% improvement in Assessment of Spondyloarthritis International Society criteria (ASAS40) at 16 weeks, compared with placebo.

In COAST-V, 48% of patients who received ixekizumab achieved ASAS40, compared with 18% of controls (P less than .0001). In COAST-W, 25% of patients who received ixekizumab achieved ASAS40 versus 13% of controls (P less than .05). The adverse events reported during both trials were consistent with the safety profile in patients who receive ixekizumab for the treatment of plaque psoriasis, including injection-site reactions, upper respiratory tract infections, nausea, and tinea infections.

“Results from the phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors. This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS,” said Philip Mease, MD, of Providence St. Joseph Health and the University of Washington, both in Seattle.

[email protected]

The Food and Drug Administration has approved a subcutaneous injection formulation of ixekizumab (Taltz) at 80 mg/mL for the treatment of adult patients with active ankylosing spondylitis (AS), according to a press release from Eli Lilly.

Olivier Le Moal/Getty Images

AS is the third indication for ixekizumab, along with moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and active psoriatic arthritis in adults.

Approval of the humanized interleukin-17A antagonist was based on results from a pair of randomized, double-blind, placebo-controlled, phase 3 studies involving 657 adult patients with active AS: the COAST-V trial in those naive to biologic disease-modifying antirheumatic drugs (bDMARDs) and the COAST-W trial in those who were intolerant or had inadequate response to tumor necrosis factor (TNF) inhibitors. The primary endpoint in both trials was achievement of 40% improvement in Assessment of Spondyloarthritis International Society criteria (ASAS40) at 16 weeks, compared with placebo.

In COAST-V, 48% of patients who received ixekizumab achieved ASAS40, compared with 18% of controls (P less than .0001). In COAST-W, 25% of patients who received ixekizumab achieved ASAS40 versus 13% of controls (P less than .05). The adverse events reported during both trials were consistent with the safety profile in patients who receive ixekizumab for the treatment of plaque psoriasis, including injection-site reactions, upper respiratory tract infections, nausea, and tinea infections.

“Results from the phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors. This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS,” said Philip Mease, MD, of Providence St. Joseph Health and the University of Washington, both in Seattle.

[email protected]

Vaccination status should be reviewed annually for patients with autoimmune inflammatory rheumatic diseases, according to updated recommendations from the European League Against Rheumatism.

luiscar/Thinkstock

Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk for infections, and vaccination has been shown to reduce risk by “potentially translating into a lower rate of hospital admissions due to infections, emergency room visits, and the rate of invasive infectious diseases,” wrote Victoria Furer, MD, of Tel Aviv Sourasky Medical Center, and members of the task force that updated the recommendations, which were published in Annals of the Rheumatic Diseases.

However, AIIRD patients often go unvaccinated because of a lack of awareness or concerns about vaccine safety and efficacy, they said (Ann Rheum Dis. 2019 Aug 14. doi: 10.1136/annrheumdis-2019-215882).

The task force consisted of 21 experts, including patients, rheumatologists, immunologists, an infectious disease specialist, and health professionals in rheumatology representing eight countries. They evaluated data from four systematic literature reviews and developed nine recommendations based on six key principles.

“For each recommendation, the level of evidence for the incidence/prevalence of vaccine preventable infection in AIIRD, and efficacy/immunogenicity/safety of vaccination were stated, when available, followed by the strength of recommendation and the level of agreement,” the task force wrote.

These overarching principles start with an annual assessment of vaccination status by the AIIRD patient’s rheumatology team. Other principles include explanation of an individualized vaccination program to the patient as a foundation for joint decision-making, vaccinating patients during quiescent disease periods, vaccinating in advance of planned immunosuppression when possible, considering non-live vaccines for AIIRD patients also treated with systemic glucocorticoids and DMARDs, and considering live-attenuated vaccines with caution.

Several of the nine recommendations developed by the task force are modified from the previous recommendations issued in 2011. The task force made its recommendations with an eye toward optimizing individual risk stratification and avoiding “unnecessary” vaccination in AIIRD patients with low risk of infection as part of the update process. A notable change from the 2011 guidelines is the recommendation of both influenza and pneumococcal vaccinations for the majority of patients with AIIRD as opposed to all patients to emphasize the importance of individualized risk assessment, the task force noted.

The recommendations state that influenza vaccination and pneumococcal vaccination should be “strongly considered” for patients with AIIRD, and patients also should receive tetanus toxoid vaccination according to recommendations for the general population. However, clinicians should consider passive immunization for patients treated with B-cell depleting therapy, the task force wrote.

AIIRD patients at risk for hepatitis A and B should receive vaccinations for those diseases, with boosters or passive immunization if indicated, and high-risk patients may consider herpes zoster vaccination, according to the recommendations.

In addition, AIIRD patients – especially patients with systemic lupus erythematosus – should receive human papilloma virus vaccination according to recommendations for the general population, but AIIRD patients should avoid yellow fever vaccination, the task force stated. However, for AIIRD patients traveling to areas of yellow fever risk, “withholding immunosuppressive therapy to allow a safe vaccination or measuring serology in previously exposed patients may be considered.”

Finally, mothers treated with biologics during the second half of pregnancy should avoid live-attenuated vaccines for their newborns, and immunocompetent household members of AIIRD patients should be encouraged to follow national guidelines for routine vaccination with the exception of the oral polio vaccine, the task force concluded.

Vaccination status should be reviewed annually for patients with autoimmune inflammatory rheumatic diseases, according to updated recommendations from the European League Against Rheumatism.

luiscar/Thinkstock

Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk for infections, and vaccination has been shown to reduce risk by “potentially translating into a lower rate of hospital admissions due to infections, emergency room visits, and the rate of invasive infectious diseases,” wrote Victoria Furer, MD, of Tel Aviv Sourasky Medical Center, and members of the task force that updated the recommendations, which were published in Annals of the Rheumatic Diseases.

However, AIIRD patients often go unvaccinated because of a lack of awareness or concerns about vaccine safety and efficacy, they said (Ann Rheum Dis. 2019 Aug 14. doi: 10.1136/annrheumdis-2019-215882).

The task force consisted of 21 experts, including patients, rheumatologists, immunologists, an infectious disease specialist, and health professionals in rheumatology representing eight countries. They evaluated data from four systematic literature reviews and developed nine recommendations based on six key principles.

“For each recommendation, the level of evidence for the incidence/prevalence of vaccine preventable infection in AIIRD, and efficacy/immunogenicity/safety of vaccination were stated, when available, followed by the strength of recommendation and the level of agreement,” the task force wrote.

These overarching principles start with an annual assessment of vaccination status by the AIIRD patient’s rheumatology team. Other principles include explanation of an individualized vaccination program to the patient as a foundation for joint decision-making, vaccinating patients during quiescent disease periods, vaccinating in advance of planned immunosuppression when possible, considering non-live vaccines for AIIRD patients also treated with systemic glucocorticoids and DMARDs, and considering live-attenuated vaccines with caution.

Several of the nine recommendations developed by the task force are modified from the previous recommendations issued in 2011. The task force made its recommendations with an eye toward optimizing individual risk stratification and avoiding “unnecessary” vaccination in AIIRD patients with low risk of infection as part of the update process. A notable change from the 2011 guidelines is the recommendation of both influenza and pneumococcal vaccinations for the majority of patients with AIIRD as opposed to all patients to emphasize the importance of individualized risk assessment, the task force noted.

The recommendations state that influenza vaccination and pneumococcal vaccination should be “strongly considered” for patients with AIIRD, and patients also should receive tetanus toxoid vaccination according to recommendations for the general population. However, clinicians should consider passive immunization for patients treated with B-cell depleting therapy, the task force wrote.

AIIRD patients at risk for hepatitis A and B should receive vaccinations for those diseases, with boosters or passive immunization if indicated, and high-risk patients may consider herpes zoster vaccination, according to the recommendations.

In addition, AIIRD patients – especially patients with systemic lupus erythematosus – should receive human papilloma virus vaccination according to recommendations for the general population, but AIIRD patients should avoid yellow fever vaccination, the task force stated. However, for AIIRD patients traveling to areas of yellow fever risk, “withholding immunosuppressive therapy to allow a safe vaccination or measuring serology in previously exposed patients may be considered.”

Finally, mothers treated with biologics during the second half of pregnancy should avoid live-attenuated vaccines for their newborns, and immunocompetent household members of AIIRD patients should be encouraged to follow national guidelines for routine vaccination with the exception of the oral polio vaccine, the task force concluded.

Vaccination status should be reviewed annually for patients with autoimmune inflammatory rheumatic diseases, according to updated recommendations from the European League Against Rheumatism.

luiscar/Thinkstock

Patients with autoimmune inflammatory rheumatic diseases (AIIRD) are at increased risk for infections, and vaccination has been shown to reduce risk by “potentially translating into a lower rate of hospital admissions due to infections, emergency room visits, and the rate of invasive infectious diseases,” wrote Victoria Furer, MD, of Tel Aviv Sourasky Medical Center, and members of the task force that updated the recommendations, which were published in Annals of the Rheumatic Diseases.

However, AIIRD patients often go unvaccinated because of a lack of awareness or concerns about vaccine safety and efficacy, they said (Ann Rheum Dis. 2019 Aug 14. doi: 10.1136/annrheumdis-2019-215882).

The task force consisted of 21 experts, including patients, rheumatologists, immunologists, an infectious disease specialist, and health professionals in rheumatology representing eight countries. They evaluated data from four systematic literature reviews and developed nine recommendations based on six key principles.

“For each recommendation, the level of evidence for the incidence/prevalence of vaccine preventable infection in AIIRD, and efficacy/immunogenicity/safety of vaccination were stated, when available, followed by the strength of recommendation and the level of agreement,” the task force wrote.

These overarching principles start with an annual assessment of vaccination status by the AIIRD patient’s rheumatology team. Other principles include explanation of an individualized vaccination program to the patient as a foundation for joint decision-making, vaccinating patients during quiescent disease periods, vaccinating in advance of planned immunosuppression when possible, considering non-live vaccines for AIIRD patients also treated with systemic glucocorticoids and DMARDs, and considering live-attenuated vaccines with caution.

Several of the nine recommendations developed by the task force are modified from the previous recommendations issued in 2011. The task force made its recommendations with an eye toward optimizing individual risk stratification and avoiding “unnecessary” vaccination in AIIRD patients with low risk of infection as part of the update process. A notable change from the 2011 guidelines is the recommendation of both influenza and pneumococcal vaccinations for the majority of patients with AIIRD as opposed to all patients to emphasize the importance of individualized risk assessment, the task force noted.

The recommendations state that influenza vaccination and pneumococcal vaccination should be “strongly considered” for patients with AIIRD, and patients also should receive tetanus toxoid vaccination according to recommendations for the general population. However, clinicians should consider passive immunization for patients treated with B-cell depleting therapy, the task force wrote.

AIIRD patients at risk for hepatitis A and B should receive vaccinations for those diseases, with boosters or passive immunization if indicated, and high-risk patients may consider herpes zoster vaccination, according to the recommendations.

In addition, AIIRD patients – especially patients with systemic lupus erythematosus – should receive human papilloma virus vaccination according to recommendations for the general population, but AIIRD patients should avoid yellow fever vaccination, the task force stated. However, for AIIRD patients traveling to areas of yellow fever risk, “withholding immunosuppressive therapy to allow a safe vaccination or measuring serology in previously exposed patients may be considered.”

Finally, mothers treated with biologics during the second half of pregnancy should avoid live-attenuated vaccines for their newborns, and immunocompetent household members of AIIRD patients should be encouraged to follow national guidelines for routine vaccination with the exception of the oral polio vaccine, the task force concluded.

For the purpose of classifying patients with axial spondyloarthritis with radiographic sacroiliitis, the modified New York (mNY) criteria and the Assessment of Spondyloarthritis international Society (ASAS) criteria should be considered interchangeable, according to a comparative study first presented at the 2019 European League Against Rheumatism and now published.

“The major finding is that patients classified with one set of the criteria are essentially the same as those classified with the other,” according to Anne Boel, a researcher in the department of rheumatology at Leiden (the Netherlands) University Medical Center, and first author of the study.

The study addresses a controversy that has persisted since the introduction of ASAS criteria for defining axial spondyloarthritis (axSpA) with definite structural changes on conventional radiographs. It was unclear whether this ASAS diagnosis, called radiographic axSpA (r-axSpA), was the same as ankylosing spondylitis (AS) as defined by the older modified New York (mNY) criteria.

In this study, patients from eight cohorts were evaluated with the two classification sets. In addition to having radiographic sacroiliitis, all patients had to have back pain for at least 3 months, which is also mandatory for both classification sets.

Of the 3,434 fulfilling the ASAS criteria for r-axSpA, 96% fulfilled the mNY criteria for AS. Of the 3,882 meeting the mNY criteria for AS, 93% fulfilled the ASAS criteria for r-axSpA.

On the basis of this level of agreement, the authors called the terms r-axSpA and AS “interchangeable.” In the small proportion of cases when there was disagreement, the reason was considered to be minor and not to alter the conclusion that the disease entities are the same.

“Patients cannot be classified according to the ASAS criteria if they first develop back pain at age 45 years or older, so this is one difference between the two criteria sets that would affect classification,” Ms. Boel explained in an interview.

When tallied, 7% of the 4,041 patients with axSpA with radiographic sacroiliitis evaluated met only the mNY criteria, 3% met only the ASAS criteria, 89% met both sets of criteria, and 1% met neither, according to the published data.

Of those who met the mNY criteria but not the ASAS criteria, 99.7% would have potentially fulfilled the ASAS criteria for r-axSpA except for older age at onset. The remainder was attributed to an absence of inflammatory back pain or another spondyloarthritis feature.

Of the 3,434 patients fulfilling the ASAS criteria, 90% fulfilled the mNY criteria because of the presence of inflammatory back pain. Most of those without inflammatory back pain had a mobility restriction and so still met the mNY criteria. A small proportion without inflammatory back pain or mobility restriction fulfilled the ASAS criteria because of other SpA features.

The study resolves a persistent debate over whether AS patients identified by mNY criteria are the same as r-axSpA identified by ASAS criteria, according to the authors, reiterating that these data show that they can be considered the same disease.

This finding is particularly relevant when evaluating studies that have classified patients by either the mNY or the ASAS criteria.

This finding “has important implications for the axSpA research field,” the authors concluded. “Acknowledging that both criteria sets identify the same patients implies that older literature on AS and newer literature on r-axSpA can be directly compared.”

The study had no specific funding source. Ms. Boel reported having no potential conflicts of interest. Coauthors reported ties with pharmaceutical companies outside of this study.

SOURCE: Boel A et al. Ann Rheum Dis. 2019 Jul 30. doi: 10.1136/annrheumdis-2019-215707.

For the purpose of classifying patients with axial spondyloarthritis with radiographic sacroiliitis, the modified New York (mNY) criteria and the Assessment of Spondyloarthritis international Society (ASAS) criteria should be considered interchangeable, according to a comparative study first presented at the 2019 European League Against Rheumatism and now published.

“The major finding is that patients classified with one set of the criteria are essentially the same as those classified with the other,” according to Anne Boel, a researcher in the department of rheumatology at Leiden (the Netherlands) University Medical Center, and first author of the study.

The study addresses a controversy that has persisted since the introduction of ASAS criteria for defining axial spondyloarthritis (axSpA) with definite structural changes on conventional radiographs. It was unclear whether this ASAS diagnosis, called radiographic axSpA (r-axSpA), was the same as ankylosing spondylitis (AS) as defined by the older modified New York (mNY) criteria.

In this study, patients from eight cohorts were evaluated with the two classification sets. In addition to having radiographic sacroiliitis, all patients had to have back pain for at least 3 months, which is also mandatory for both classification sets.

Of the 3,434 fulfilling the ASAS criteria for r-axSpA, 96% fulfilled the mNY criteria for AS. Of the 3,882 meeting the mNY criteria for AS, 93% fulfilled the ASAS criteria for r-axSpA.

On the basis of this level of agreement, the authors called the terms r-axSpA and AS “interchangeable.” In the small proportion of cases when there was disagreement, the reason was considered to be minor and not to alter the conclusion that the disease entities are the same.

“Patients cannot be classified according to the ASAS criteria if they first develop back pain at age 45 years or older, so this is one difference between the two criteria sets that would affect classification,” Ms. Boel explained in an interview.

When tallied, 7% of the 4,041 patients with axSpA with radiographic sacroiliitis evaluated met only the mNY criteria, 3% met only the ASAS criteria, 89% met both sets of criteria, and 1% met neither, according to the published data.

Of those who met the mNY criteria but not the ASAS criteria, 99.7% would have potentially fulfilled the ASAS criteria for r-axSpA except for older age at onset. The remainder was attributed to an absence of inflammatory back pain or another spondyloarthritis feature.

Of the 3,434 patients fulfilling the ASAS criteria, 90% fulfilled the mNY criteria because of the presence of inflammatory back pain. Most of those without inflammatory back pain had a mobility restriction and so still met the mNY criteria. A small proportion without inflammatory back pain or mobility restriction fulfilled the ASAS criteria because of other SpA features.

The study resolves a persistent debate over whether AS patients identified by mNY criteria are the same as r-axSpA identified by ASAS criteria, according to the authors, reiterating that these data show that they can be considered the same disease.

This finding is particularly relevant when evaluating studies that have classified patients by either the mNY or the ASAS criteria.

This finding “has important implications for the axSpA research field,” the authors concluded. “Acknowledging that both criteria sets identify the same patients implies that older literature on AS and newer literature on r-axSpA can be directly compared.”

The study had no specific funding source. Ms. Boel reported having no potential conflicts of interest. Coauthors reported ties with pharmaceutical companies outside of this study.

SOURCE: Boel A et al. Ann Rheum Dis. 2019 Jul 30. doi: 10.1136/annrheumdis-2019-215707.

For the purpose of classifying patients with axial spondyloarthritis with radiographic sacroiliitis, the modified New York (mNY) criteria and the Assessment of Spondyloarthritis international Society (ASAS) criteria should be considered interchangeable, according to a comparative study first presented at the 2019 European League Against Rheumatism and now published.

“The major finding is that patients classified with one set of the criteria are essentially the same as those classified with the other,” according to Anne Boel, a researcher in the department of rheumatology at Leiden (the Netherlands) University Medical Center, and first author of the study.

The study addresses a controversy that has persisted since the introduction of ASAS criteria for defining axial spondyloarthritis (axSpA) with definite structural changes on conventional radiographs. It was unclear whether this ASAS diagnosis, called radiographic axSpA (r-axSpA), was the same as ankylosing spondylitis (AS) as defined by the older modified New York (mNY) criteria.

In this study, patients from eight cohorts were evaluated with the two classification sets. In addition to having radiographic sacroiliitis, all patients had to have back pain for at least 3 months, which is also mandatory for both classification sets.

Of the 3,434 fulfilling the ASAS criteria for r-axSpA, 96% fulfilled the mNY criteria for AS. Of the 3,882 meeting the mNY criteria for AS, 93% fulfilled the ASAS criteria for r-axSpA.

On the basis of this level of agreement, the authors called the terms r-axSpA and AS “interchangeable.” In the small proportion of cases when there was disagreement, the reason was considered to be minor and not to alter the conclusion that the disease entities are the same.

“Patients cannot be classified according to the ASAS criteria if they first develop back pain at age 45 years or older, so this is one difference between the two criteria sets that would affect classification,” Ms. Boel explained in an interview.

When tallied, 7% of the 4,041 patients with axSpA with radiographic sacroiliitis evaluated met only the mNY criteria, 3% met only the ASAS criteria, 89% met both sets of criteria, and 1% met neither, according to the published data.

Of those who met the mNY criteria but not the ASAS criteria, 99.7% would have potentially fulfilled the ASAS criteria for r-axSpA except for older age at onset. The remainder was attributed to an absence of inflammatory back pain or another spondyloarthritis feature.

Of the 3,434 patients fulfilling the ASAS criteria, 90% fulfilled the mNY criteria because of the presence of inflammatory back pain. Most of those without inflammatory back pain had a mobility restriction and so still met the mNY criteria. A small proportion without inflammatory back pain or mobility restriction fulfilled the ASAS criteria because of other SpA features.

The study resolves a persistent debate over whether AS patients identified by mNY criteria are the same as r-axSpA identified by ASAS criteria, according to the authors, reiterating that these data show that they can be considered the same disease.

This finding is particularly relevant when evaluating studies that have classified patients by either the mNY or the ASAS criteria.

This finding “has important implications for the axSpA research field,” the authors concluded. “Acknowledging that both criteria sets identify the same patients implies that older literature on AS and newer literature on r-axSpA can be directly compared.”

The study had no specific funding source. Ms. Boel reported having no potential conflicts of interest. Coauthors reported ties with pharmaceutical companies outside of this study.

SOURCE: Boel A et al. Ann Rheum Dis. 2019 Jul 30. doi: 10.1136/annrheumdis-2019-215707.

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

LAKE BUENA VISTA, FLA. – Patient Reported Outcomes Measurement Information System (PROMIS) tools developed by the National Institutes of Health provide particularly useful information for managing rheumatology patients, according to Jeffrey Curtis, MD.

Courtesy UAB Photo

The PROMIS tools – which like most patient-reported outcome (PRO) measurement tools are designed to evaluate and monitor physical, mental, and social health – can be used both for the general population and for individuals living with chronic conditions, Dr. Curtis, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB), said at the annual meeting of the Florida Society of Rheumatology.

The tools take a deeper dive into various symptoms and their effects; for instance, with respect to physical health, they measure fatigue, physical function, sleep disturbance, pain intensity, and pain interference – the extent to which pain “messes your patient’s life up,” explained Dr. Curtis, who also is codirector of the UAB Pharmacoepidemiology and Pharmacoeconomics Unit.

Additional physical health domains that PROs measure include dyspnea, gastrointestinal symptoms, pain behavior, pain quality, sexual function, and sleep-related impairment.

These are “things that, honestly, we don’t talk about much as a field, but absolutely affect patients with autoimmune diseases,” he said. “You know, sexual function – that doesn’t come up in my practice spontaneously very often, but there are ways you can quantify that, and for many patients that’s actually a big deal.”

The domains measured by PROMIS tools for mental health look at anxiety and depression, but also delve into alcohol use, anger, cognitive function, life satisfaction, self-efficacy for managing chronic conditions, substance use, and more. The domains for social health address ability to participate in social roles and activities, as well as companionship, satisfaction with social roles and activity, social isolation, and social support.

“You can’t go on a hike with friends [and] be far from a bathroom, because you have bad arthritis and you have Crohn’s disease. Well, that’s kind of an important thing that may or may not come up in your discussions about inflammatory arthritis associated with [inflammatory bowel disease],” he said.

Another example is a patient who is embarrassed attending social functions or wearing a swimsuit because of really bad psoriasis.

“These are the kinds of things that I’m suggesting you and I probably want to measure if we’re providing holistic care to rheumatology patients,” Dr. Curtis said.

The PROMIS tools provide a simple, user-friendly means for doing so in English, Spanish, and many other languages, he noted.

All the scales use the same 1-100 scoring range, which simplifies measurements. They are available for free by download and can be printed or used electronically for use in the office, at home, on the web, and via smartphone.

The NIH developed the PROMIS tools several years ago and validated them for multiple chronic disease populations, Dr. Curtis said, adding that the tools include multiple individual domains and overall “profiles” of varying lengths.

Most are fixed-length scales that are between 4 and 10 questions and can be completed within 30-60 seconds per scale, so several scales can be completed within 5-10 minutes.

However, some scales are longer and provide greater detail.

“The nice thing is that if you ask a few more questions you can get more precise information – there’s more of a floor and ceiling. You can detect people who do really well. You can distinguish between the marathon runners and the 5K-ers and the people who can walk 2 miles but aren’t going to run a race,” he explained.

Further, the PROMIS tools, like the 36-item Short Form Health Survey (SF-36), are benchmarked against the U.S. adult population, allowing for assessment of how a specific drug or treatment “impacts your arthritis patient on a scale that would also be relevant for somebody who doesn’t have arthritis, they have diabetes.”

The metrics and scales are the same, and that can be helpful when trying to get a payer to pay for a particular drug, he said.

“None of these are rheumatology specific; this puts PROs into a language that can help rheumatology contend for the value of the care that we provide on a scale that would be relevant for any other chronic illness, even for nonrheumatology patients,” he explained.

In addition, minimally important differences (group mean change of about 2-3 units) and minimally clinical important differences for individuals (5 units) have been established.

“So we know what the numbers mean, and this is true for all of the scales,” he said.

PROMIS tools also include computer-adaptive testing (CAT) versions, which helps to personalize the scales to provide more precise information for a given patient and eliminate irrelevant information.

Of note, PROMIS health measures are among the data that can be tracked on a smartphone using Arthritis Power, an arthritis research registry developed with the help of a recent infrastructure grant awarded to the Center for Education and Research and Therapeutics of Musculoskeletal Disorders at UAB, Dr. Curtis said.


The measures were also shown in the AWARE study to track closely with other measures, including the Clinical Disease Activity Index (CDAI), and with patient improvement on therapy.

“So these PROMIS scores are tracking with things that you and I are familiar with ... and it looks like these scores are faithfully tracking, over time, patients getting better on therapies that we would expect them to,” he said. “I think this is additional validation – not just from the National Institutes of Health and a decade of research by lots of different groups, but in our own field – that these actually correlate with disease activity ... and that when you start an effective therapy like a [tumor necrosis factor inhibitor] they’re going to improve as you would anticipate.”

Dr. Curtis reported funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Patient-Centered Outcomes Research Institute. He has also consulted for or received research grants from Amgen, AbbVie, Bristol-Myers Squibb, CORRONA, Lilly, Janssen, Myriad, Novartis, Roche, Pfizer, and Sanofi/Regeneron.

[email protected]

The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.

The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.

Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

*This article was updated on July 24, 2019.

[email protected]

The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.

The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.

Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

*This article was updated on July 24, 2019.

[email protected]

The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.

The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.

Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

*This article was updated on July 24, 2019.

[email protected]