ACR Annual Meeting 2017

 

SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.

The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.

In the sample, 53% received a prescription contraception at any time during the 3-year study period, but only 25% who became pregnant had received a contraception prescription prior to becoming pregnant, lead study author Kimberly Hays, MD, said at the annual meeting of the American College of Rheumatology.

The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.

“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”

“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”

In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.

The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.

About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”

The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.

Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”

In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.

The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.

SOURCE: Hays K et al. ACR 2017 Abstract 1813.

 

SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.

The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.

In the sample, 53% received a prescription contraception at any time during the 3-year study period, but only 25% who became pregnant had received a contraception prescription prior to becoming pregnant, lead study author Kimberly Hays, MD, said at the annual meeting of the American College of Rheumatology.

The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.

“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”

“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”

In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.

The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.

About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”

The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.

Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”

In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.

The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.

SOURCE: Hays K et al. ACR 2017 Abstract 1813.

 

SAN DIEGO – A majority of U.S. teenage girls on Medicaid who were prescribed teratogenic medications for rheumatic diseases did not receive or fill prescriptions for contraception, and some became pregnant while taking the medication, a study showed.

The analysis of a Medicaid database of paid claims from 12 unidentified U.S. states during 2013-2015 found a pregnancy rate of 7.6% in 4,853 females aged 15-19 who were prescribed at least one of eight teratogenic medications, mostly labeled as category D or X: cyclophosphamide, enalapril, leflunomide, lisinopril, losartan, methotrexate, mycophenolate, and cyclosporine (category C). This rate varied from 2.2% in 15-year-olds to 13.6% in 19-year-olds.

In the sample, 53% received a prescription contraception at any time during the 3-year study period, but only 25% who became pregnant had received a contraception prescription prior to becoming pregnant, lead study author Kimberly Hays, MD, said at the annual meeting of the American College of Rheumatology.

The number of filled prescriptions for contraception was low despite the associated risk of the teratogenic medications, said Dr. Hays, a third-year pediatric rheumatology fellow at the Medical University of South Carolina in Charleston.

“Each teratogenic medication carries a different risk,” she said. “Certain teratogenic medications carry a greater risk than other teratogenic medications. The associated risk may vary based on the timing and duration of use.”

“The risks and benefits of using a teratogenic medication for treatment should be discussed with teens and women of reproductive age,” Dr. Hays said. “Disease activity should be low, and the teratogenic medication should be replaced with a safer medication prior to pregnancy if one is available. Highly effective forms of contraception should be offered to patients who are at risk for unintended pregnancy and those who are not trying to conceive.”

In addition to rheumatic diseases, the eight teratogenic medications cited in the study are used to treat other conditions such as inflammatory bowel disease, hypertension, kidney disease, and malignancy, Dr. Hays said.

The study population was made up of 45.0% whites, 36.6% blacks, 4.8% Hispanics, and 13.6% others.

About 10% were defined as having a specific rheumatic disease, mainly systemic lupus erythematosus (70%), Dr. Hays said. “However, more than 10% had a rheumatic condition of some kind. Generalizations in ICD-9 coding made it difficult to identify specific diseases in some cases.”

The study did not examine birth defect outcomes in the babies born to the females in the cohort, but Dr. Hays said researchers are considering whether to track these numbers via claims data. The study also was not able to capture the use of nonprescribed contraception, such as condoms.

Moving forward, Dr. Hays said the researchers “are planning to also look at pregnancy and contraception rates in age-matched teens not taking teratogenic medications using the same Medicaid claims database. We are also hoping to research patient and provider perspectives pertaining to teratogenic medication use/risk and contraception.”

In addition, researchers hope to examine how commonly the individual drugs were prescribed and link them to contraception use and pregnancy, she said.

The study authors had no relevant financial disclosures, and the study had no external funding. The Medical University of South Carolina provided funding for database access.

SOURCE: Hays K et al. ACR 2017 Abstract 1813.

 

The investigational drug sprifermin significantly increased cartilage thickness in the tibiofemoral joint of patients with knee osteoarthritis in the initial 2-year results of the ongoing FORWARD trial.

“Sprifermin appears to be the first investigational medicinal product to show dose-dependent prevention of cartilage loss and an increase in cartilage thickness, not only in the total tibiofemoral joint [TFJ] but also in both the medial and lateral compartments, including the central medial femorotibial region,” said Marc H. Hochberg, MD, primary investigator in the trial and division head of rheumatology and clinical immunology at the University of Maryland, Baltimore. “The recommendation is that these findings should be further evaluated in phase 3 clinical trials.”

FORWARD is a 5-year, multicenter phase 2 investigation of sprifermin, a novel recombinant human fibroblast growth factor–18. One reason the trial is 5 years in duration is to monitor any change in pain function and other clinically relevant outcomes during the third, fourth, and fifth year after injections are completed, Dr. Hochberg said.

He and his colleagues randomized 549 osteoarthritis (OA) patients to double-blind treatment with one of four different dosing regimens of sprifermin or placebo. These patients were aged 40-85 with symptomatic radiographic primary femorotibial knee OA measuring grade 2 or 3 on the Kellgren-Lawrence scale and a medial minimum joint space width (mJSW) 2.5 mm or greater.

At 2 years, researchers observed a significant dose-dependent relationship between the amount of sprifermin given and the increase in total TFJ cartilage thickness. Patients who received three 100-mcg intra-articular injections of sprifermin every 6 months (group 1) showed a gain in TFJ cartilage thickness of 0.03 mm as seen on MRI, while those who received three 100-mcg injections of sprifermin every 12 months (group 2) had a gain of 0.02 mm, Dr. Hochberg said during a late-breaking abstract session at the annual meeting of the American College of Rheumatology. By contrast, those who received placebo had a loss in TFJ cartilage thickness of 0.02 mm (P less than .001). The other two groups received 30 mcg of sprifermin in three weekly injections every 6 months (group 3) or every 12 months (group 4), and these had TFJ cartilage thickness losses of about 0.01 mm or less.

Similar dose-dependent relationships were observed for some of the secondary endpoints, which included changes in cartilage thickness seen in the medial and lateral compartments, changes in cartilage thickness in the compartments’ subregions, and changes in mJSW. Significant differences in cartilage thickness were observed between sprifermin treatment groups and placebo in the medial (group 1, gain of 0.02 mm vs. loss of 0.03 mm; P less than .001) and lateral (groups 1 and 2, gain of 0.04 mm vs. loss of 0.01 mm; P less than .001) TFJ compartments, and in central medial and lateral TFJ subregions.

Changes in mJSW as seen on x-ray between those in group 1 and those on placebo were significant for the lateral compartment, with an increase in mJSW at the higher doses and a decline in the placebo group, but not for the medial compartment.

There were no significant differences in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores among the treatment groups. Dr. Hochberg noted that patients were permitted to take pain medications during the study, which could have affected this result.

The most frequently reported adverse events were musculoskeletal and connective tissue disorders, specifically arthralgias and back pain, Dr. Hochberg said. The incidence of acute inflammatory reactions was higher with sprifermin, compared with placebo, but the increase was only significant after the first injection cycle, he said.

Merck KGaA and the EMD Serono Research Institute funded the study. Dr. Hochberg reported receiving consulting fees from numerous companies that market or are developing OA drugs, including EMD Serono.

SOURCE: Hochberg M et al. ACR 2017 Abstract 1L.

 

The investigational drug sprifermin significantly increased cartilage thickness in the tibiofemoral joint of patients with knee osteoarthritis in the initial 2-year results of the ongoing FORWARD trial.

“Sprifermin appears to be the first investigational medicinal product to show dose-dependent prevention of cartilage loss and an increase in cartilage thickness, not only in the total tibiofemoral joint [TFJ] but also in both the medial and lateral compartments, including the central medial femorotibial region,” said Marc H. Hochberg, MD, primary investigator in the trial and division head of rheumatology and clinical immunology at the University of Maryland, Baltimore. “The recommendation is that these findings should be further evaluated in phase 3 clinical trials.”

FORWARD is a 5-year, multicenter phase 2 investigation of sprifermin, a novel recombinant human fibroblast growth factor–18. One reason the trial is 5 years in duration is to monitor any change in pain function and other clinically relevant outcomes during the third, fourth, and fifth year after injections are completed, Dr. Hochberg said.

He and his colleagues randomized 549 osteoarthritis (OA) patients to double-blind treatment with one of four different dosing regimens of sprifermin or placebo. These patients were aged 40-85 with symptomatic radiographic primary femorotibial knee OA measuring grade 2 or 3 on the Kellgren-Lawrence scale and a medial minimum joint space width (mJSW) 2.5 mm or greater.

At 2 years, researchers observed a significant dose-dependent relationship between the amount of sprifermin given and the increase in total TFJ cartilage thickness. Patients who received three 100-mcg intra-articular injections of sprifermin every 6 months (group 1) showed a gain in TFJ cartilage thickness of 0.03 mm as seen on MRI, while those who received three 100-mcg injections of sprifermin every 12 months (group 2) had a gain of 0.02 mm, Dr. Hochberg said during a late-breaking abstract session at the annual meeting of the American College of Rheumatology. By contrast, those who received placebo had a loss in TFJ cartilage thickness of 0.02 mm (P less than .001). The other two groups received 30 mcg of sprifermin in three weekly injections every 6 months (group 3) or every 12 months (group 4), and these had TFJ cartilage thickness losses of about 0.01 mm or less.

Similar dose-dependent relationships were observed for some of the secondary endpoints, which included changes in cartilage thickness seen in the medial and lateral compartments, changes in cartilage thickness in the compartments’ subregions, and changes in mJSW. Significant differences in cartilage thickness were observed between sprifermin treatment groups and placebo in the medial (group 1, gain of 0.02 mm vs. loss of 0.03 mm; P less than .001) and lateral (groups 1 and 2, gain of 0.04 mm vs. loss of 0.01 mm; P less than .001) TFJ compartments, and in central medial and lateral TFJ subregions.

Changes in mJSW as seen on x-ray between those in group 1 and those on placebo were significant for the lateral compartment, with an increase in mJSW at the higher doses and a decline in the placebo group, but not for the medial compartment.

There were no significant differences in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores among the treatment groups. Dr. Hochberg noted that patients were permitted to take pain medications during the study, which could have affected this result.

The most frequently reported adverse events were musculoskeletal and connective tissue disorders, specifically arthralgias and back pain, Dr. Hochberg said. The incidence of acute inflammatory reactions was higher with sprifermin, compared with placebo, but the increase was only significant after the first injection cycle, he said.

Merck KGaA and the EMD Serono Research Institute funded the study. Dr. Hochberg reported receiving consulting fees from numerous companies that market or are developing OA drugs, including EMD Serono.

SOURCE: Hochberg M et al. ACR 2017 Abstract 1L.

 

The investigational drug sprifermin significantly increased cartilage thickness in the tibiofemoral joint of patients with knee osteoarthritis in the initial 2-year results of the ongoing FORWARD trial.

“Sprifermin appears to be the first investigational medicinal product to show dose-dependent prevention of cartilage loss and an increase in cartilage thickness, not only in the total tibiofemoral joint [TFJ] but also in both the medial and lateral compartments, including the central medial femorotibial region,” said Marc H. Hochberg, MD, primary investigator in the trial and division head of rheumatology and clinical immunology at the University of Maryland, Baltimore. “The recommendation is that these findings should be further evaluated in phase 3 clinical trials.”

FORWARD is a 5-year, multicenter phase 2 investigation of sprifermin, a novel recombinant human fibroblast growth factor–18. One reason the trial is 5 years in duration is to monitor any change in pain function and other clinically relevant outcomes during the third, fourth, and fifth year after injections are completed, Dr. Hochberg said.

He and his colleagues randomized 549 osteoarthritis (OA) patients to double-blind treatment with one of four different dosing regimens of sprifermin or placebo. These patients were aged 40-85 with symptomatic radiographic primary femorotibial knee OA measuring grade 2 or 3 on the Kellgren-Lawrence scale and a medial minimum joint space width (mJSW) 2.5 mm or greater.

At 2 years, researchers observed a significant dose-dependent relationship between the amount of sprifermin given and the increase in total TFJ cartilage thickness. Patients who received three 100-mcg intra-articular injections of sprifermin every 6 months (group 1) showed a gain in TFJ cartilage thickness of 0.03 mm as seen on MRI, while those who received three 100-mcg injections of sprifermin every 12 months (group 2) had a gain of 0.02 mm, Dr. Hochberg said during a late-breaking abstract session at the annual meeting of the American College of Rheumatology. By contrast, those who received placebo had a loss in TFJ cartilage thickness of 0.02 mm (P less than .001). The other two groups received 30 mcg of sprifermin in three weekly injections every 6 months (group 3) or every 12 months (group 4), and these had TFJ cartilage thickness losses of about 0.01 mm or less.

Similar dose-dependent relationships were observed for some of the secondary endpoints, which included changes in cartilage thickness seen in the medial and lateral compartments, changes in cartilage thickness in the compartments’ subregions, and changes in mJSW. Significant differences in cartilage thickness were observed between sprifermin treatment groups and placebo in the medial (group 1, gain of 0.02 mm vs. loss of 0.03 mm; P less than .001) and lateral (groups 1 and 2, gain of 0.04 mm vs. loss of 0.01 mm; P less than .001) TFJ compartments, and in central medial and lateral TFJ subregions.

Changes in mJSW as seen on x-ray between those in group 1 and those on placebo were significant for the lateral compartment, with an increase in mJSW at the higher doses and a decline in the placebo group, but not for the medial compartment.

There were no significant differences in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores among the treatment groups. Dr. Hochberg noted that patients were permitted to take pain medications during the study, which could have affected this result.

The most frequently reported adverse events were musculoskeletal and connective tissue disorders, specifically arthralgias and back pain, Dr. Hochberg said. The incidence of acute inflammatory reactions was higher with sprifermin, compared with placebo, but the increase was only significant after the first injection cycle, he said.

Merck KGaA and the EMD Serono Research Institute funded the study. Dr. Hochberg reported receiving consulting fees from numerous companies that market or are developing OA drugs, including EMD Serono.

SOURCE: Hochberg M et al. ACR 2017 Abstract 1L.

 

SAN DIEGO – Real-world, nontrial research confirms the findings of a high-profile study released earlier in 2017: Corticosteroid shots are ineffective in the long term for knee osteoarthritis. In fact, researchers found a greater likelihood of a worsening condition in knees treated with the injections.

“Our findings are consistent with the latest randomized, controlled trial,” said study coauthor Jie Wei, MD, of Central South University in Changsha, China. She spoke in a plenary presentation about the study findings at the annual meeting of the American College of Rheumatology.

The use of corticosteroids for knee OA is a controversial topic. As Dr. Wei noted, there has been wide disagreement among medical societies about whether the treatment is useful in the long term for patients with pain flare-ups.

Thinkstock/Zinkevych

An updated 2015 Cochrane Library systemic review and meta-analysis identified 27 studies into the treatment and reported that “intra-articular corticosteroids may cause a moderate improvement in pain and a small improvement in physical function, but the quality of the evidence is low and results are inconclusive” (Cochrane Database Syst Rev. 2015;10:CD005328).

For the randomized, controlled study released in 2017, researchers tracked 140 patients aged 45 and older with inflammation of the synovial membrane. They were randomly assigned to injections of intra-articular triamcinolone or a placebo.

After 2 years of injections every 12 weeks, there was no difference in reported pain between the intervention and control groups. Also, those who received injections lost more cartilage (JAMA. 2017 May 16;317[19]:1967-75).

Researchers launched the new study to seek insight through a real-life cohort. They examined findings from the Osteoarthritis Initiative, a longitudinal study of 4,796 patients aged 45-79 at four U.S. clinics with knee OA or high risk of knee OA. Patients underwent annual examinations at baseline and annually for 4 years.

In an adjusted marginal structural analysis, knee replacement or worsening of Kellgren Lawrence grade at the tibial femoral joint was more likely in 149 injection knees than 2,191 noninjection knees (odds ratio, 5.74; 95% confidence interval, 2.01-16.42).

Knee replacement or joint space width worsening at the tibial femoral joint was also more likely in 120 injection knees than 2,112 noninjection knees (OR, 1.64; 95% CI, 0.91-2.93).

In another analysis, researchers tracked 134 injection knees (58 whose OA progressed) and 498 noninjection knees (132 whose OA progressed) for up to 8 years. After adjustment, the injection knees were more likely to have progressed (hazard ratio, 1.60; 95% CI, 1.21-2.12,).

“Several explanations may account for our study findings,” Dr. Wei said. One possibility, she said, is that corticosteroids may hurt chondrocytes by, among other things, inducing apoptosis and synovial membrane inflammation.

It’s also possible, she said, that patients may feel pain relief after injections and subsequently boost the risk of OA progression by increasing their physical activity.

“We need to know what types of physical activities may increase the OA progression,” she said. “Did patients who received steroid injection indeed increase this type of physical activity compared to subjects without steroid injection?”

Dr. Wei noted the study’s limitations, including the fact that patients who received injections had more pain at baseline, potentially indicating they had worse structural lesions that are more susceptible to progression.

The study authors reported no relevant disclosures. The National Natural Science Foundation of China funded the study. The Osteoarthritis Initiative is a partnership between the National Institutes of Health and Merck, Novartis, GlaxoSmithKline, and Pfizer.

SOURCE: Lei G et al. ACR 2017 abstract 1788

 

SAN DIEGO – Real-world, nontrial research confirms the findings of a high-profile study released earlier in 2017: Corticosteroid shots are ineffective in the long term for knee osteoarthritis. In fact, researchers found a greater likelihood of a worsening condition in knees treated with the injections.

“Our findings are consistent with the latest randomized, controlled trial,” said study coauthor Jie Wei, MD, of Central South University in Changsha, China. She spoke in a plenary presentation about the study findings at the annual meeting of the American College of Rheumatology.

The use of corticosteroids for knee OA is a controversial topic. As Dr. Wei noted, there has been wide disagreement among medical societies about whether the treatment is useful in the long term for patients with pain flare-ups.

Thinkstock/Zinkevych

An updated 2015 Cochrane Library systemic review and meta-analysis identified 27 studies into the treatment and reported that “intra-articular corticosteroids may cause a moderate improvement in pain and a small improvement in physical function, but the quality of the evidence is low and results are inconclusive” (Cochrane Database Syst Rev. 2015;10:CD005328).

For the randomized, controlled study released in 2017, researchers tracked 140 patients aged 45 and older with inflammation of the synovial membrane. They were randomly assigned to injections of intra-articular triamcinolone or a placebo.

After 2 years of injections every 12 weeks, there was no difference in reported pain between the intervention and control groups. Also, those who received injections lost more cartilage (JAMA. 2017 May 16;317[19]:1967-75).

Researchers launched the new study to seek insight through a real-life cohort. They examined findings from the Osteoarthritis Initiative, a longitudinal study of 4,796 patients aged 45-79 at four U.S. clinics with knee OA or high risk of knee OA. Patients underwent annual examinations at baseline and annually for 4 years.

In an adjusted marginal structural analysis, knee replacement or worsening of Kellgren Lawrence grade at the tibial femoral joint was more likely in 149 injection knees than 2,191 noninjection knees (odds ratio, 5.74; 95% confidence interval, 2.01-16.42).

Knee replacement or joint space width worsening at the tibial femoral joint was also more likely in 120 injection knees than 2,112 noninjection knees (OR, 1.64; 95% CI, 0.91-2.93).

In another analysis, researchers tracked 134 injection knees (58 whose OA progressed) and 498 noninjection knees (132 whose OA progressed) for up to 8 years. After adjustment, the injection knees were more likely to have progressed (hazard ratio, 1.60; 95% CI, 1.21-2.12,).

“Several explanations may account for our study findings,” Dr. Wei said. One possibility, she said, is that corticosteroids may hurt chondrocytes by, among other things, inducing apoptosis and synovial membrane inflammation.

It’s also possible, she said, that patients may feel pain relief after injections and subsequently boost the risk of OA progression by increasing their physical activity.

“We need to know what types of physical activities may increase the OA progression,” she said. “Did patients who received steroid injection indeed increase this type of physical activity compared to subjects without steroid injection?”

Dr. Wei noted the study’s limitations, including the fact that patients who received injections had more pain at baseline, potentially indicating they had worse structural lesions that are more susceptible to progression.

The study authors reported no relevant disclosures. The National Natural Science Foundation of China funded the study. The Osteoarthritis Initiative is a partnership between the National Institutes of Health and Merck, Novartis, GlaxoSmithKline, and Pfizer.

SOURCE: Lei G et al. ACR 2017 abstract 1788

 

SAN DIEGO – Real-world, nontrial research confirms the findings of a high-profile study released earlier in 2017: Corticosteroid shots are ineffective in the long term for knee osteoarthritis. In fact, researchers found a greater likelihood of a worsening condition in knees treated with the injections.

“Our findings are consistent with the latest randomized, controlled trial,” said study coauthor Jie Wei, MD, of Central South University in Changsha, China. She spoke in a plenary presentation about the study findings at the annual meeting of the American College of Rheumatology.

The use of corticosteroids for knee OA is a controversial topic. As Dr. Wei noted, there has been wide disagreement among medical societies about whether the treatment is useful in the long term for patients with pain flare-ups.

Thinkstock/Zinkevych

An updated 2015 Cochrane Library systemic review and meta-analysis identified 27 studies into the treatment and reported that “intra-articular corticosteroids may cause a moderate improvement in pain and a small improvement in physical function, but the quality of the evidence is low and results are inconclusive” (Cochrane Database Syst Rev. 2015;10:CD005328).

For the randomized, controlled study released in 2017, researchers tracked 140 patients aged 45 and older with inflammation of the synovial membrane. They were randomly assigned to injections of intra-articular triamcinolone or a placebo.

After 2 years of injections every 12 weeks, there was no difference in reported pain between the intervention and control groups. Also, those who received injections lost more cartilage (JAMA. 2017 May 16;317[19]:1967-75).

Researchers launched the new study to seek insight through a real-life cohort. They examined findings from the Osteoarthritis Initiative, a longitudinal study of 4,796 patients aged 45-79 at four U.S. clinics with knee OA or high risk of knee OA. Patients underwent annual examinations at baseline and annually for 4 years.

In an adjusted marginal structural analysis, knee replacement or worsening of Kellgren Lawrence grade at the tibial femoral joint was more likely in 149 injection knees than 2,191 noninjection knees (odds ratio, 5.74; 95% confidence interval, 2.01-16.42).

Knee replacement or joint space width worsening at the tibial femoral joint was also more likely in 120 injection knees than 2,112 noninjection knees (OR, 1.64; 95% CI, 0.91-2.93).

In another analysis, researchers tracked 134 injection knees (58 whose OA progressed) and 498 noninjection knees (132 whose OA progressed) for up to 8 years. After adjustment, the injection knees were more likely to have progressed (hazard ratio, 1.60; 95% CI, 1.21-2.12,).

“Several explanations may account for our study findings,” Dr. Wei said. One possibility, she said, is that corticosteroids may hurt chondrocytes by, among other things, inducing apoptosis and synovial membrane inflammation.

It’s also possible, she said, that patients may feel pain relief after injections and subsequently boost the risk of OA progression by increasing their physical activity.

“We need to know what types of physical activities may increase the OA progression,” she said. “Did patients who received steroid injection indeed increase this type of physical activity compared to subjects without steroid injection?”

Dr. Wei noted the study’s limitations, including the fact that patients who received injections had more pain at baseline, potentially indicating they had worse structural lesions that are more susceptible to progression.

The study authors reported no relevant disclosures. The National Natural Science Foundation of China funded the study. The Osteoarthritis Initiative is a partnership between the National Institutes of Health and Merck, Novartis, GlaxoSmithKline, and Pfizer.

SOURCE: Lei G et al. ACR 2017 abstract 1788

 

SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.

Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.

“It’s not just a distraction technique,” Dr. Venuturupalli, a rheumatologist in private practice and clinical associate professor at Cedars-Sinai Medical Center and the University of California, Los Angeles, said in an interview. “There seem to be effects beyond that. The experiences bring on a deep relaxation state, similar to what can be achieved through meditation.”

Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.

“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.

Since the 1990s, researchers have explored the potential of VR in medical areas ranging from pain management to treatment of phobias and posttraumatic stress disorder.

“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).

In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”

In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.

Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).

Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.

He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.

But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.

He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.

As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.

Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.

The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.

“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”

Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.

 

[email protected]

 

SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.

Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.

“It’s not just a distraction technique,” Dr. Venuturupalli, a rheumatologist in private practice and clinical associate professor at Cedars-Sinai Medical Center and the University of California, Los Angeles, said in an interview. “There seem to be effects beyond that. The experiences bring on a deep relaxation state, similar to what can be achieved through meditation.”

Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.

“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.

Since the 1990s, researchers have explored the potential of VR in medical areas ranging from pain management to treatment of phobias and posttraumatic stress disorder.

“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).

In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”

In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.

Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).

Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.

He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.

But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.

He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.

As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.

Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.

The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.

“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”

Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.

 

[email protected]

 

SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.

Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.

“It’s not just a distraction technique,” Dr. Venuturupalli, a rheumatologist in private practice and clinical associate professor at Cedars-Sinai Medical Center and the University of California, Los Angeles, said in an interview. “There seem to be effects beyond that. The experiences bring on a deep relaxation state, similar to what can be achieved through meditation.”

Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.

“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.

Since the 1990s, researchers have explored the potential of VR in medical areas ranging from pain management to treatment of phobias and posttraumatic stress disorder.

“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).

In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”

In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.

Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).

Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.

He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.

But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.

He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.

As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.

Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.

The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.

“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”

Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.

 

[email protected]

 

Patients with nonradiographic axial spondyloarthritis (nr-axSpA) who enter remission on adalimumab are likely to relapse if the medication is withdrawn – and many won’t attain remission again, even if the drug is restarted.

However, the findings of the ABILITY-3 trial do offer an intriguing potential, Robert Landewé, MD, PhD, said at the annual meeting of the American College of Rheumatology. About 30% of the study group did maintain remission after adalimumab (Humira) withdrawal, suggesting that at least a portion of these patients can stay in good clinical shape off TNF inhibition.

“The problem is, we just don’t know who those patients are,” said Dr. Landewé of the University of Amsterdam. “We need better predictors to help us identify this population, and we just don’t have them right now.”

ABILITY-3 is the successor to ABILITY-1, the 2012 placebo-controlled study that established adalimumab as an effective treatment for nr-axSpA. Adalimumab is approved in the United States for the treatment of ankylosing spondylitis (radiographic axSpA), but not for nr-axSpA.

ABILITY-3 assessed the impact of withdrawing adalimumab from nr-axSpA patients who had attained remission on the medication. It enrolled 673 adults with active disease at baseline and an inadequate response to at least two nonsteroidal anti-inflammatory drugs.

The study commenced with open-label adalimumab at 40 mg every other week for 28 weeks. At that point, the 305 patients who had attained disease remission were randomized to either continued adalimumab at the same dose and schedule or to placebo. Randomized treatment continued for 40 more weeks. Any patient who experienced a flare resumed the drug as rescue therapy. The investigators calculated the number of patients with a disease flare at week 68 as the primary endpoint. The study also examined a number of secondary endpoints, including response measures, time to flare, functional status, quality of life, and remission.

At baseline, patients were a mean of 35 years old, with a mean disease duration of about 7 years. Most (88%) were HLA-B27 positive, and about 60% had elevated C-reactive protein levels.

At 68 weeks, patients who discontinued adalimumab were 77% more likely to have experienced a disease flare than were those who stayed on the drug (83% vs. 57% or 70% vs. 47% with nonresponder imputation; relative risk, 1.77). A time-to-flare analysis found a significant 67% reduction in the risk of flare among those continuing to take adalimumab.

While those who experienced a disease flare were allowed to resume adalimumab, it appeared to be far less effective at that point. After 12 weeks of rescue therapy, only 57% had regained remission, leaving 43% with persistent active disease.

Nearly all of the secondary endpoints were in favor of continuing therapy, Dr. Landewé said, including the Ankylosing Spondyloarthritis Disease Activity Score-inactive disease (ASDAS-ID), ASDAS-major improvement, ASDAS-clinically important improvement; the Assessment in Spondyloarthritis International Society (ASAS) 20% and 40% rates; the ASAS 5/6 and ASAS-partial response rates; the Bath Ankylosing Spondylitis Disease Activity Index 50; and the Bath Ankylosing Spondylitis Functional Index. Only health-related quality of life as measured by the Health Assessment Questionnaire for the Spondyloarthropathies did not significantly improve to a greater extent among those staying on adalimumab.

There were no new or concerning safety signals, Dr. Landewé said. In the placebo-controlled period, there were 10 serious adverse events in the placebo group and 1 – a case of ureterolithiasis – in the adalimumab group. There was one malignancy, which occurred in the placebo group. No patient died during the study.

“These results support the continuation of adalimumab therapy after achieving a sustained remission,” Dr. Landewé said. “But it will be an important research goal to identify predictors for the population in whom treatment may be safely discontinued.”

AbbVie sponsored the study. Dr. Landewé reported relationships with numerous pharmaceutical companies, including AbbVie.

[email protected]

SOURCE: Landewé R et al. ACR 2017 Abstract 1787.

 

Patients with nonradiographic axial spondyloarthritis (nr-axSpA) who enter remission on adalimumab are likely to relapse if the medication is withdrawn – and many won’t attain remission again, even if the drug is restarted.

However, the findings of the ABILITY-3 trial do offer an intriguing potential, Robert Landewé, MD, PhD, said at the annual meeting of the American College of Rheumatology. About 30% of the study group did maintain remission after adalimumab (Humira) withdrawal, suggesting that at least a portion of these patients can stay in good clinical shape off TNF inhibition.

“The problem is, we just don’t know who those patients are,” said Dr. Landewé of the University of Amsterdam. “We need better predictors to help us identify this population, and we just don’t have them right now.”

ABILITY-3 is the successor to ABILITY-1, the 2012 placebo-controlled study that established adalimumab as an effective treatment for nr-axSpA. Adalimumab is approved in the United States for the treatment of ankylosing spondylitis (radiographic axSpA), but not for nr-axSpA.

ABILITY-3 assessed the impact of withdrawing adalimumab from nr-axSpA patients who had attained remission on the medication. It enrolled 673 adults with active disease at baseline and an inadequate response to at least two nonsteroidal anti-inflammatory drugs.

The study commenced with open-label adalimumab at 40 mg every other week for 28 weeks. At that point, the 305 patients who had attained disease remission were randomized to either continued adalimumab at the same dose and schedule or to placebo. Randomized treatment continued for 40 more weeks. Any patient who experienced a flare resumed the drug as rescue therapy. The investigators calculated the number of patients with a disease flare at week 68 as the primary endpoint. The study also examined a number of secondary endpoints, including response measures, time to flare, functional status, quality of life, and remission.

At baseline, patients were a mean of 35 years old, with a mean disease duration of about 7 years. Most (88%) were HLA-B27 positive, and about 60% had elevated C-reactive protein levels.

At 68 weeks, patients who discontinued adalimumab were 77% more likely to have experienced a disease flare than were those who stayed on the drug (83% vs. 57% or 70% vs. 47% with nonresponder imputation; relative risk, 1.77). A time-to-flare analysis found a significant 67% reduction in the risk of flare among those continuing to take adalimumab.

While those who experienced a disease flare were allowed to resume adalimumab, it appeared to be far less effective at that point. After 12 weeks of rescue therapy, only 57% had regained remission, leaving 43% with persistent active disease.

Nearly all of the secondary endpoints were in favor of continuing therapy, Dr. Landewé said, including the Ankylosing Spondyloarthritis Disease Activity Score-inactive disease (ASDAS-ID), ASDAS-major improvement, ASDAS-clinically important improvement; the Assessment in Spondyloarthritis International Society (ASAS) 20% and 40% rates; the ASAS 5/6 and ASAS-partial response rates; the Bath Ankylosing Spondylitis Disease Activity Index 50; and the Bath Ankylosing Spondylitis Functional Index. Only health-related quality of life as measured by the Health Assessment Questionnaire for the Spondyloarthropathies did not significantly improve to a greater extent among those staying on adalimumab.

There were no new or concerning safety signals, Dr. Landewé said. In the placebo-controlled period, there were 10 serious adverse events in the placebo group and 1 – a case of ureterolithiasis – in the adalimumab group. There was one malignancy, which occurred in the placebo group. No patient died during the study.

“These results support the continuation of adalimumab therapy after achieving a sustained remission,” Dr. Landewé said. “But it will be an important research goal to identify predictors for the population in whom treatment may be safely discontinued.”

AbbVie sponsored the study. Dr. Landewé reported relationships with numerous pharmaceutical companies, including AbbVie.

[email protected]

SOURCE: Landewé R et al. ACR 2017 Abstract 1787.

 

Patients with nonradiographic axial spondyloarthritis (nr-axSpA) who enter remission on adalimumab are likely to relapse if the medication is withdrawn – and many won’t attain remission again, even if the drug is restarted.

However, the findings of the ABILITY-3 trial do offer an intriguing potential, Robert Landewé, MD, PhD, said at the annual meeting of the American College of Rheumatology. About 30% of the study group did maintain remission after adalimumab (Humira) withdrawal, suggesting that at least a portion of these patients can stay in good clinical shape off TNF inhibition.

“The problem is, we just don’t know who those patients are,” said Dr. Landewé of the University of Amsterdam. “We need better predictors to help us identify this population, and we just don’t have them right now.”

ABILITY-3 is the successor to ABILITY-1, the 2012 placebo-controlled study that established adalimumab as an effective treatment for nr-axSpA. Adalimumab is approved in the United States for the treatment of ankylosing spondylitis (radiographic axSpA), but not for nr-axSpA.

ABILITY-3 assessed the impact of withdrawing adalimumab from nr-axSpA patients who had attained remission on the medication. It enrolled 673 adults with active disease at baseline and an inadequate response to at least two nonsteroidal anti-inflammatory drugs.

The study commenced with open-label adalimumab at 40 mg every other week for 28 weeks. At that point, the 305 patients who had attained disease remission were randomized to either continued adalimumab at the same dose and schedule or to placebo. Randomized treatment continued for 40 more weeks. Any patient who experienced a flare resumed the drug as rescue therapy. The investigators calculated the number of patients with a disease flare at week 68 as the primary endpoint. The study also examined a number of secondary endpoints, including response measures, time to flare, functional status, quality of life, and remission.

At baseline, patients were a mean of 35 years old, with a mean disease duration of about 7 years. Most (88%) were HLA-B27 positive, and about 60% had elevated C-reactive protein levels.

At 68 weeks, patients who discontinued adalimumab were 77% more likely to have experienced a disease flare than were those who stayed on the drug (83% vs. 57% or 70% vs. 47% with nonresponder imputation; relative risk, 1.77). A time-to-flare analysis found a significant 67% reduction in the risk of flare among those continuing to take adalimumab.

While those who experienced a disease flare were allowed to resume adalimumab, it appeared to be far less effective at that point. After 12 weeks of rescue therapy, only 57% had regained remission, leaving 43% with persistent active disease.

Nearly all of the secondary endpoints were in favor of continuing therapy, Dr. Landewé said, including the Ankylosing Spondyloarthritis Disease Activity Score-inactive disease (ASDAS-ID), ASDAS-major improvement, ASDAS-clinically important improvement; the Assessment in Spondyloarthritis International Society (ASAS) 20% and 40% rates; the ASAS 5/6 and ASAS-partial response rates; the Bath Ankylosing Spondylitis Disease Activity Index 50; and the Bath Ankylosing Spondylitis Functional Index. Only health-related quality of life as measured by the Health Assessment Questionnaire for the Spondyloarthropathies did not significantly improve to a greater extent among those staying on adalimumab.

There were no new or concerning safety signals, Dr. Landewé said. In the placebo-controlled period, there were 10 serious adverse events in the placebo group and 1 – a case of ureterolithiasis – in the adalimumab group. There was one malignancy, which occurred in the placebo group. No patient died during the study.

“These results support the continuation of adalimumab therapy after achieving a sustained remission,” Dr. Landewé said. “But it will be an important research goal to identify predictors for the population in whom treatment may be safely discontinued.”

AbbVie sponsored the study. Dr. Landewé reported relationships with numerous pharmaceutical companies, including AbbVie.

[email protected]

SOURCE: Landewé R et al. ACR 2017 Abstract 1787.

SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.

Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.

“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.

Earlier this year, Dr. Anandarajah and his colleagues reported on the findings of a 2-year analysis of SLE admissions at Strong Memorial Hospital, part of the University of Rochester (N.Y.) Medical Center, where he serves as associate professor of rheumatology and clinical director of the allergy, immunology, and rheumatology division.

The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).

Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).

As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).

Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.

For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.

They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).

Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.

As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.

The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.

The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).

“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.

How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.

“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”

Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.

The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.

SOURCE: C. Thirukuraman et al. ACR 2017 abstract 223.

SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.

Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.

“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.

Earlier this year, Dr. Anandarajah and his colleagues reported on the findings of a 2-year analysis of SLE admissions at Strong Memorial Hospital, part of the University of Rochester (N.Y.) Medical Center, where he serves as associate professor of rheumatology and clinical director of the allergy, immunology, and rheumatology division.

The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).

Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).

As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).

Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.

For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.

They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).

Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.

As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.

The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.

The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).

“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.

How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.

“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”

Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.

The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.

SOURCE: C. Thirukuraman et al. ACR 2017 abstract 223.

SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.

Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.

“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.

Earlier this year, Dr. Anandarajah and his colleagues reported on the findings of a 2-year analysis of SLE admissions at Strong Memorial Hospital, part of the University of Rochester (N.Y.) Medical Center, where he serves as associate professor of rheumatology and clinical director of the allergy, immunology, and rheumatology division.

The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).

Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).

As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).

Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.

For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.

They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).

Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.

As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.

The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.

The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).

“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.

How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.

“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”

Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.

The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.

SOURCE: C. Thirukuraman et al. ACR 2017 abstract 223.

SAN DIEGO – At first glance, rheumatology may seem like the perfect specialty for physicians who don’t want to be bothered by medical emergencies. But the reality can be more complicated.

As Bharat Kumar, MD, explained to an audience at the annual meeting of the American College of Rheumatology, rheumatologists will at times encounter patients in urgent need of their care due to dire medical conditions. In these situations, he said, there may be no time for careful and cautious diagnostics.

“You have to have an awareness of how you think about things,” advised Dr. Kumar, a rheumatologist/immunologist and clinical assistant professor of internal medicine at the University of Iowa, Iowa City. “During emergencies, you have to rely more on intuition to quickly get at answers.”

In a follow-up interview, Dr. Kumar described common rheumatologic emergencies, recalled his own scary encounter with a patient in crisis, and offered guidance about dealing with other physicians.

Q: When do rheumatologists have to deal with medical emergencies?

A: Rheumatology is considered mostly an outpatient specialty. Most of the time, rheumatologists don’t receive off-hour emergency calls.

But there are conditions in which rheumatologists have to be at the front lines in diagnosing and managing medical emergencies. These range from issues like septic arthritis to scleroderma renal crisis and vasculitis affecting vital organs such as the heart, lungs, and kidneys. These are more common at academic settings, but even rheumatologists in private practice should be aware of these conditions.

Q: How often do rheumatologists come across true emergencies in normal practice?

A: It depends on where the rheumatologist is practicing. In our academic setting, we have to see patients in the hospital several times per week.

Rarer are the emergencies that show up to clinic and require evaluation in the emergency department or hospitalization. Over the past year, that has happened perhaps three times to me.

This is likely much less in the private setting, where patients tend to be less sick and less complicated. But that is no guarantee that an emergency won’t crop up.

Q: What is the scariest emergency situation that you’ve come across?

A: It occurred when I entered a room to see a patient of mine with adult-onset Still’s disease.

She was huddled, shivering, barely answering questions. Her eyes were glazed. Her blood pressure was below 90/60 mm Hg, and her pulse was 130 beats per minute. I was petrified that she was in the midst of a cytokine storm secondary to either hemophagocytic lymphohistiocytosis (HLH) or sepsis. Given the high mortality of both, we immediately called our colleagues in the emergency department and sent her for hospitalization. It turned out that she did have HLH, and we had to pursue intensive immunosuppression to abate that cytokine storm.

It was particularly scary because there is no good way to differentiate between the two conditions, apart from going with clinical intuition.
 

Treating a patient who is potentially septic with immunosuppression is extremely dangerous, and ultimately, we would not have known if our intuition was correct until the infection presented itself.

Fortunately, we were correct. She recovered after 1 week of hospitalization, and we have been following her since then. But it still gives me goosebumps to think, “What if we were wrong?”

Q: Do emergencies in rheumatology tend to appear suddenly or are they more likely to occur because of a long-standing and perhaps untreated condition?

A: While it is true that uncontrolled disease activity can predispose patients to emergencies, other emergencies can occur sporadically and out of the blue.

Many times, an emergency is the first manifestation of disease. The literature is littered with cases of renal crisis being the first manifestation of systemic sclerosis. And internists are often baffled by sudden kidney failure due to previously undiagnosed lupus.

In addition, all rheumatologists have great reverence for septic arthritis and know that it can mimic gout very closely. If a swollen joint is mistaken for gout instead of septic arthritis, this can lead to worsening infection and ultimately, loss of joint function.

Q: What are some potentially dire conditions that may test the diagnostic powers of rheumatologists?

A: Rheumatologists are becoming more aware of HLH. Because it may look clinically indistinguishable from severe infection but needs to be treated with immunosuppression instead of antimicrobial therapy, rheumatologists have to keep it in mind and revisit the diagnosis often in case patients are not improving on the prescribed therapy.

 

Pulmonary vasculitis is another concerning condition because an otherwise negligible cough can turn into massive pulmonary hemorrhage very quickly.

Q: Do you have tips about dealing with ER doctors, primary doctors and others who may be involved with an emergency?

A: Rheumatologists think differently from other specialists. We are cognitive specialists and think more in the long term. Emergency medicine doctors are more concerned about the short term and how to deal with more immediate issues.

Signposting concerns is essential to optimizing communication. Education of other physicians is also important because more frequently than not, patients with rheumatologic diseases present very differently.

Lastly, there’s a very fine line between advocating for patients and overstepping your bounds as a consultant rheumatologist. Maintaining close collaboration and establishing clear and open lines of communication can prevent this.

Dr. Kumar has no relevant disclosures.

SAN DIEGO – At first glance, rheumatology may seem like the perfect specialty for physicians who don’t want to be bothered by medical emergencies. But the reality can be more complicated.

As Bharat Kumar, MD, explained to an audience at the annual meeting of the American College of Rheumatology, rheumatologists will at times encounter patients in urgent need of their care due to dire medical conditions. In these situations, he said, there may be no time for careful and cautious diagnostics.

“You have to have an awareness of how you think about things,” advised Dr. Kumar, a rheumatologist/immunologist and clinical assistant professor of internal medicine at the University of Iowa, Iowa City. “During emergencies, you have to rely more on intuition to quickly get at answers.”

In a follow-up interview, Dr. Kumar described common rheumatologic emergencies, recalled his own scary encounter with a patient in crisis, and offered guidance about dealing with other physicians.

Q: When do rheumatologists have to deal with medical emergencies?

A: Rheumatology is considered mostly an outpatient specialty. Most of the time, rheumatologists don’t receive off-hour emergency calls.

But there are conditions in which rheumatologists have to be at the front lines in diagnosing and managing medical emergencies. These range from issues like septic arthritis to scleroderma renal crisis and vasculitis affecting vital organs such as the heart, lungs, and kidneys. These are more common at academic settings, but even rheumatologists in private practice should be aware of these conditions.

Q: How often do rheumatologists come across true emergencies in normal practice?

A: It depends on where the rheumatologist is practicing. In our academic setting, we have to see patients in the hospital several times per week.

Rarer are the emergencies that show up to clinic and require evaluation in the emergency department or hospitalization. Over the past year, that has happened perhaps three times to me.

This is likely much less in the private setting, where patients tend to be less sick and less complicated. But that is no guarantee that an emergency won’t crop up.

Q: What is the scariest emergency situation that you’ve come across?

A: It occurred when I entered a room to see a patient of mine with adult-onset Still’s disease.

She was huddled, shivering, barely answering questions. Her eyes were glazed. Her blood pressure was below 90/60 mm Hg, and her pulse was 130 beats per minute. I was petrified that she was in the midst of a cytokine storm secondary to either hemophagocytic lymphohistiocytosis (HLH) or sepsis. Given the high mortality of both, we immediately called our colleagues in the emergency department and sent her for hospitalization. It turned out that she did have HLH, and we had to pursue intensive immunosuppression to abate that cytokine storm.

It was particularly scary because there is no good way to differentiate between the two conditions, apart from going with clinical intuition.
 

Treating a patient who is potentially septic with immunosuppression is extremely dangerous, and ultimately, we would not have known if our intuition was correct until the infection presented itself.

Fortunately, we were correct. She recovered after 1 week of hospitalization, and we have been following her since then. But it still gives me goosebumps to think, “What if we were wrong?”

Q: Do emergencies in rheumatology tend to appear suddenly or are they more likely to occur because of a long-standing and perhaps untreated condition?

A: While it is true that uncontrolled disease activity can predispose patients to emergencies, other emergencies can occur sporadically and out of the blue.

Many times, an emergency is the first manifestation of disease. The literature is littered with cases of renal crisis being the first manifestation of systemic sclerosis. And internists are often baffled by sudden kidney failure due to previously undiagnosed lupus.

In addition, all rheumatologists have great reverence for septic arthritis and know that it can mimic gout very closely. If a swollen joint is mistaken for gout instead of septic arthritis, this can lead to worsening infection and ultimately, loss of joint function.

Q: What are some potentially dire conditions that may test the diagnostic powers of rheumatologists?

A: Rheumatologists are becoming more aware of HLH. Because it may look clinically indistinguishable from severe infection but needs to be treated with immunosuppression instead of antimicrobial therapy, rheumatologists have to keep it in mind and revisit the diagnosis often in case patients are not improving on the prescribed therapy.

 

Pulmonary vasculitis is another concerning condition because an otherwise negligible cough can turn into massive pulmonary hemorrhage very quickly.

Q: Do you have tips about dealing with ER doctors, primary doctors and others who may be involved with an emergency?

A: Rheumatologists think differently from other specialists. We are cognitive specialists and think more in the long term. Emergency medicine doctors are more concerned about the short term and how to deal with more immediate issues.

Signposting concerns is essential to optimizing communication. Education of other physicians is also important because more frequently than not, patients with rheumatologic diseases present very differently.

Lastly, there’s a very fine line between advocating for patients and overstepping your bounds as a consultant rheumatologist. Maintaining close collaboration and establishing clear and open lines of communication can prevent this.

Dr. Kumar has no relevant disclosures.

SAN DIEGO – At first glance, rheumatology may seem like the perfect specialty for physicians who don’t want to be bothered by medical emergencies. But the reality can be more complicated.

As Bharat Kumar, MD, explained to an audience at the annual meeting of the American College of Rheumatology, rheumatologists will at times encounter patients in urgent need of their care due to dire medical conditions. In these situations, he said, there may be no time for careful and cautious diagnostics.

“You have to have an awareness of how you think about things,” advised Dr. Kumar, a rheumatologist/immunologist and clinical assistant professor of internal medicine at the University of Iowa, Iowa City. “During emergencies, you have to rely more on intuition to quickly get at answers.”

In a follow-up interview, Dr. Kumar described common rheumatologic emergencies, recalled his own scary encounter with a patient in crisis, and offered guidance about dealing with other physicians.

Q: When do rheumatologists have to deal with medical emergencies?

A: Rheumatology is considered mostly an outpatient specialty. Most of the time, rheumatologists don’t receive off-hour emergency calls.

But there are conditions in which rheumatologists have to be at the front lines in diagnosing and managing medical emergencies. These range from issues like septic arthritis to scleroderma renal crisis and vasculitis affecting vital organs such as the heart, lungs, and kidneys. These are more common at academic settings, but even rheumatologists in private practice should be aware of these conditions.

Q: How often do rheumatologists come across true emergencies in normal practice?

A: It depends on where the rheumatologist is practicing. In our academic setting, we have to see patients in the hospital several times per week.

Rarer are the emergencies that show up to clinic and require evaluation in the emergency department or hospitalization. Over the past year, that has happened perhaps three times to me.

This is likely much less in the private setting, where patients tend to be less sick and less complicated. But that is no guarantee that an emergency won’t crop up.

Q: What is the scariest emergency situation that you’ve come across?

A: It occurred when I entered a room to see a patient of mine with adult-onset Still’s disease.

She was huddled, shivering, barely answering questions. Her eyes were glazed. Her blood pressure was below 90/60 mm Hg, and her pulse was 130 beats per minute. I was petrified that she was in the midst of a cytokine storm secondary to either hemophagocytic lymphohistiocytosis (HLH) or sepsis. Given the high mortality of both, we immediately called our colleagues in the emergency department and sent her for hospitalization. It turned out that she did have HLH, and we had to pursue intensive immunosuppression to abate that cytokine storm.

It was particularly scary because there is no good way to differentiate between the two conditions, apart from going with clinical intuition.
 

Treating a patient who is potentially septic with immunosuppression is extremely dangerous, and ultimately, we would not have known if our intuition was correct until the infection presented itself.

Fortunately, we were correct. She recovered after 1 week of hospitalization, and we have been following her since then. But it still gives me goosebumps to think, “What if we were wrong?”

Q: Do emergencies in rheumatology tend to appear suddenly or are they more likely to occur because of a long-standing and perhaps untreated condition?

A: While it is true that uncontrolled disease activity can predispose patients to emergencies, other emergencies can occur sporadically and out of the blue.

Many times, an emergency is the first manifestation of disease. The literature is littered with cases of renal crisis being the first manifestation of systemic sclerosis. And internists are often baffled by sudden kidney failure due to previously undiagnosed lupus.

In addition, all rheumatologists have great reverence for septic arthritis and know that it can mimic gout very closely. If a swollen joint is mistaken for gout instead of septic arthritis, this can lead to worsening infection and ultimately, loss of joint function.

Q: What are some potentially dire conditions that may test the diagnostic powers of rheumatologists?

A: Rheumatologists are becoming more aware of HLH. Because it may look clinically indistinguishable from severe infection but needs to be treated with immunosuppression instead of antimicrobial therapy, rheumatologists have to keep it in mind and revisit the diagnosis often in case patients are not improving on the prescribed therapy.

 

Pulmonary vasculitis is another concerning condition because an otherwise negligible cough can turn into massive pulmonary hemorrhage very quickly.

Q: Do you have tips about dealing with ER doctors, primary doctors and others who may be involved with an emergency?

A: Rheumatologists think differently from other specialists. We are cognitive specialists and think more in the long term. Emergency medicine doctors are more concerned about the short term and how to deal with more immediate issues.

Signposting concerns is essential to optimizing communication. Education of other physicians is also important because more frequently than not, patients with rheumatologic diseases present very differently.

Lastly, there’s a very fine line between advocating for patients and overstepping your bounds as a consultant rheumatologist. Maintaining close collaboration and establishing clear and open lines of communication can prevent this.

Dr. Kumar has no relevant disclosures.

 

SAN DIEGO – While use of the investigational agent blisibimod did not meet the primary endpoint in a phase 3 trial in systemic lupus erythematosus (SLE), it was associated with steroid sparing, decreased urine protein, a trend toward decreased anti–double-stranded DNA antibodies, and significant decreases in anticardiolipin antibodies and immunoglobulin levels.

Those results were reported from CHABLIS-SC1 trial, a randomized (5:4), double-blind, placebo-controlled phase 3 study of 442 patients, and were presented by Joan T. Merrill, MD, at the annual meeting of the American College of Rheumatology. Blisibimod is a subcutaneously injected inhibitor of B-cell activating factor.

Although the study did not reach its primary endpoint of at least a 6-point improvement in the SLE Responder Index–6 (SRI-6) at week 52, “the response rates in the treatment group were as high or even better than response rates we usually see with similar B cell–modifying drugs,” said Dr. Merrill of the Oklahoma Medical Research Foundation, Oklahoma City. “What we’re observing is a trial with a very high placebo response rate.”

The SRI-6 primary endpoint at 52 weeks was met by 44% of patients on blisibimod, compared with 42% on placebo. But the SRI-6 endpoint widened when the most common features at entry were excluded (mucocutaneous and musculoskeletal), suggesting the possibility that blisibimod affects the more objective and potentially organ-threatening renal endpoint.

To be eligible for the trial, patients had to have a Safety of Estrogen in Lupus Erythematosus National Assessment Group–SLE Disease Activity Index (SELENA-SLEDAI) score of 10 or greater and be receiving steroids. The SRI-6 primary endpoint also required no worsening on the British Isles Lupus Assessment Group (BILAG) disease activity index or Physician Global Assessment. Key secondary endpoints included proteinuria and achievement of steroid taper.

Patients in the study were required to be receiving stable doses of prednisone or an equivalent steroid at less than or equal to 0.5 mg/kg or 40 mg daily for at least 28 days prior to randomization. Other permitted standard-of-care oral medications included methotrexate up to 25 mg weekly, azathioprine up to 300 mg daily, mycophenolate mofetil or sodium salt up to 3 mg daily, leflunomide up to 40 mg daily, hydroxychloroquine up to 400 mg daily, and nonsteroidal drugs within locally approved dose ranges.

Of the 442 patients enrolled, 245 received blisibimod, and 197 received placebo. They were well matched in demographics and baseline disease characteristics. “There were very few patients of African descent in this trial,” Dr. Merrill noted. “Also, about 30% of patients had some renal involvement. In fact, patients with stable, active renal disease were encouraged to participate in this trial.” The mean prednisone dose at entry was between 15 and 16 mg daily, and about 60% of patients were taking an antimalarial. An equal proportion of patients in both groups discontinued the study (22%). “A few more patients withdrew due to adverse events in the blisibimod group, and a few more patients withdrew due to lack of efficacy in the placebo group,” she said.

Of 135 patients with a baseline urine protein-to-creatinine ratio equal to or greater than 0.5, blisibimod treatment led to significantly greater improvement in proteinuria at several time points than did treatment with placebo, which also showed improvement in proteinuria.

Treatment with blisibimod also was associated with a reduction in anti–double-stranded DNA antibodies, as well as significant reductions in peripheral B-cell lineages, anticardiolipin antibodies, and immunoglobulins, and with significant increases in complement C3 and C4. “The expected pharmacodynamic markers were [also] met ... and more patients treated with blisibimod were able to achieve a prednisone milestone of reduction to less than or equal to 7.5 mg/day, compared with those in the placebo group,” she said. “This was statistically significant over time at multiple time points.”

Adverse events were balanced between treatment arms except for injection site reactions, which occurred in 7.3% of blisibimod-treated patients versus 2.6% of placebo patients. There were no major safety issues in the study.

Dr. Merrill hypothesized that the higher mean doses of corticosteroid at baseline could have contributed to the higher-than-usual placebo response rates and failure to meet the primary SRI-6 endpoint.

The study was supported by Anthera. Dr. Merrill disclosed that she has received research support from Anthera, Amgen, EMD Serono, GlaxoSmithKline. and Novartis.

[email protected]

 

SAN DIEGO – While use of the investigational agent blisibimod did not meet the primary endpoint in a phase 3 trial in systemic lupus erythematosus (SLE), it was associated with steroid sparing, decreased urine protein, a trend toward decreased anti–double-stranded DNA antibodies, and significant decreases in anticardiolipin antibodies and immunoglobulin levels.

Those results were reported from CHABLIS-SC1 trial, a randomized (5:4), double-blind, placebo-controlled phase 3 study of 442 patients, and were presented by Joan T. Merrill, MD, at the annual meeting of the American College of Rheumatology. Blisibimod is a subcutaneously injected inhibitor of B-cell activating factor.

Although the study did not reach its primary endpoint of at least a 6-point improvement in the SLE Responder Index–6 (SRI-6) at week 52, “the response rates in the treatment group were as high or even better than response rates we usually see with similar B cell–modifying drugs,” said Dr. Merrill of the Oklahoma Medical Research Foundation, Oklahoma City. “What we’re observing is a trial with a very high placebo response rate.”

The SRI-6 primary endpoint at 52 weeks was met by 44% of patients on blisibimod, compared with 42% on placebo. But the SRI-6 endpoint widened when the most common features at entry were excluded (mucocutaneous and musculoskeletal), suggesting the possibility that blisibimod affects the more objective and potentially organ-threatening renal endpoint.

To be eligible for the trial, patients had to have a Safety of Estrogen in Lupus Erythematosus National Assessment Group–SLE Disease Activity Index (SELENA-SLEDAI) score of 10 or greater and be receiving steroids. The SRI-6 primary endpoint also required no worsening on the British Isles Lupus Assessment Group (BILAG) disease activity index or Physician Global Assessment. Key secondary endpoints included proteinuria and achievement of steroid taper.

Patients in the study were required to be receiving stable doses of prednisone or an equivalent steroid at less than or equal to 0.5 mg/kg or 40 mg daily for at least 28 days prior to randomization. Other permitted standard-of-care oral medications included methotrexate up to 25 mg weekly, azathioprine up to 300 mg daily, mycophenolate mofetil or sodium salt up to 3 mg daily, leflunomide up to 40 mg daily, hydroxychloroquine up to 400 mg daily, and nonsteroidal drugs within locally approved dose ranges.

Of the 442 patients enrolled, 245 received blisibimod, and 197 received placebo. They were well matched in demographics and baseline disease characteristics. “There were very few patients of African descent in this trial,” Dr. Merrill noted. “Also, about 30% of patients had some renal involvement. In fact, patients with stable, active renal disease were encouraged to participate in this trial.” The mean prednisone dose at entry was between 15 and 16 mg daily, and about 60% of patients were taking an antimalarial. An equal proportion of patients in both groups discontinued the study (22%). “A few more patients withdrew due to adverse events in the blisibimod group, and a few more patients withdrew due to lack of efficacy in the placebo group,” she said.

Of 135 patients with a baseline urine protein-to-creatinine ratio equal to or greater than 0.5, blisibimod treatment led to significantly greater improvement in proteinuria at several time points than did treatment with placebo, which also showed improvement in proteinuria.

Treatment with blisibimod also was associated with a reduction in anti–double-stranded DNA antibodies, as well as significant reductions in peripheral B-cell lineages, anticardiolipin antibodies, and immunoglobulins, and with significant increases in complement C3 and C4. “The expected pharmacodynamic markers were [also] met ... and more patients treated with blisibimod were able to achieve a prednisone milestone of reduction to less than or equal to 7.5 mg/day, compared with those in the placebo group,” she said. “This was statistically significant over time at multiple time points.”

Adverse events were balanced between treatment arms except for injection site reactions, which occurred in 7.3% of blisibimod-treated patients versus 2.6% of placebo patients. There were no major safety issues in the study.

Dr. Merrill hypothesized that the higher mean doses of corticosteroid at baseline could have contributed to the higher-than-usual placebo response rates and failure to meet the primary SRI-6 endpoint.

The study was supported by Anthera. Dr. Merrill disclosed that she has received research support from Anthera, Amgen, EMD Serono, GlaxoSmithKline. and Novartis.

[email protected]

 

SAN DIEGO – While use of the investigational agent blisibimod did not meet the primary endpoint in a phase 3 trial in systemic lupus erythematosus (SLE), it was associated with steroid sparing, decreased urine protein, a trend toward decreased anti–double-stranded DNA antibodies, and significant decreases in anticardiolipin antibodies and immunoglobulin levels.

Those results were reported from CHABLIS-SC1 trial, a randomized (5:4), double-blind, placebo-controlled phase 3 study of 442 patients, and were presented by Joan T. Merrill, MD, at the annual meeting of the American College of Rheumatology. Blisibimod is a subcutaneously injected inhibitor of B-cell activating factor.

Although the study did not reach its primary endpoint of at least a 6-point improvement in the SLE Responder Index–6 (SRI-6) at week 52, “the response rates in the treatment group were as high or even better than response rates we usually see with similar B cell–modifying drugs,” said Dr. Merrill of the Oklahoma Medical Research Foundation, Oklahoma City. “What we’re observing is a trial with a very high placebo response rate.”

The SRI-6 primary endpoint at 52 weeks was met by 44% of patients on blisibimod, compared with 42% on placebo. But the SRI-6 endpoint widened when the most common features at entry were excluded (mucocutaneous and musculoskeletal), suggesting the possibility that blisibimod affects the more objective and potentially organ-threatening renal endpoint.

To be eligible for the trial, patients had to have a Safety of Estrogen in Lupus Erythematosus National Assessment Group–SLE Disease Activity Index (SELENA-SLEDAI) score of 10 or greater and be receiving steroids. The SRI-6 primary endpoint also required no worsening on the British Isles Lupus Assessment Group (BILAG) disease activity index or Physician Global Assessment. Key secondary endpoints included proteinuria and achievement of steroid taper.

Patients in the study were required to be receiving stable doses of prednisone or an equivalent steroid at less than or equal to 0.5 mg/kg or 40 mg daily for at least 28 days prior to randomization. Other permitted standard-of-care oral medications included methotrexate up to 25 mg weekly, azathioprine up to 300 mg daily, mycophenolate mofetil or sodium salt up to 3 mg daily, leflunomide up to 40 mg daily, hydroxychloroquine up to 400 mg daily, and nonsteroidal drugs within locally approved dose ranges.

Of the 442 patients enrolled, 245 received blisibimod, and 197 received placebo. They were well matched in demographics and baseline disease characteristics. “There were very few patients of African descent in this trial,” Dr. Merrill noted. “Also, about 30% of patients had some renal involvement. In fact, patients with stable, active renal disease were encouraged to participate in this trial.” The mean prednisone dose at entry was between 15 and 16 mg daily, and about 60% of patients were taking an antimalarial. An equal proportion of patients in both groups discontinued the study (22%). “A few more patients withdrew due to adverse events in the blisibimod group, and a few more patients withdrew due to lack of efficacy in the placebo group,” she said.

Of 135 patients with a baseline urine protein-to-creatinine ratio equal to or greater than 0.5, blisibimod treatment led to significantly greater improvement in proteinuria at several time points than did treatment with placebo, which also showed improvement in proteinuria.

Treatment with blisibimod also was associated with a reduction in anti–double-stranded DNA antibodies, as well as significant reductions in peripheral B-cell lineages, anticardiolipin antibodies, and immunoglobulins, and with significant increases in complement C3 and C4. “The expected pharmacodynamic markers were [also] met ... and more patients treated with blisibimod were able to achieve a prednisone milestone of reduction to less than or equal to 7.5 mg/day, compared with those in the placebo group,” she said. “This was statistically significant over time at multiple time points.”

Adverse events were balanced between treatment arms except for injection site reactions, which occurred in 7.3% of blisibimod-treated patients versus 2.6% of placebo patients. There were no major safety issues in the study.

Dr. Merrill hypothesized that the higher mean doses of corticosteroid at baseline could have contributed to the higher-than-usual placebo response rates and failure to meet the primary SRI-6 endpoint.

The study was supported by Anthera. Dr. Merrill disclosed that she has received research support from Anthera, Amgen, EMD Serono, GlaxoSmithKline. and Novartis.

[email protected]

 

SAN DIEGO – If you perceive that the use of biosimilars for rheumatic diseases hasn’t gained the traction one would expect, you’re not alone. In the opinion of J. Eugene Huffstutter, MD, the expected risks of biosimilar products have clinicians concerned, especially when it comes to immunologic characteristics.

“We’ve all had patients on biologics for years: Everything’s fine, but then the patient has an infusion reaction,” Dr. Huffstutter said at the annual meeting of the American College of Rheumatology. “I’ve had it happen with the first infusion of a biologic and I’ve had it with the 20th infusion of that same biologic product. It’s impossible to predict.”

Doug Brunk/Frontline Medical News

Dr. Huffstutter, a rheumatologist who is clinical assistant professor of medicine at the University of Tennessee, Chattanooga, went on to note that the potency differences between products are another concern. “One of them has to do with mechanical differences,” he said. “I notice that with various lots, some are easier to mix than others. You are going to get some comments from your infusion nurses depending on how easy or how difficult it may be.”

Other unforeseen risks of biosimilars include the impact on pharmacovigilance, manufacturing, and politics. “What if our government says we want to use this agent or that agent? Or, what if it advises everyone to use the bio-originator? Then there are coverage challenges,” he said. “How are the insurance companies going to look at this? Then there are corporate impacts. The companies that make biosimilars have invested a tremendous amount of resources to bring these to market. We have a huge market in the U.S., but the uptake has been very slow. So are they going to say, ‘We’re going to take our resources and do something else?’ ”

Practice protocols for using biosimilars vary depending on your practice environment. For example, if biosimilars are administered by a freestanding practice, “you have to depend a lot on your state laws in terms of what the pharmacist is able to do,” said Dr. Huffstutter, who is also the past president of the Tennessee Rheumatology Society. “What are the patient support programs available for that biosimilar compared with bio-originator? What do the insurance contracts say in terms of can you get this filled or not? What’s the formulary status? How well do physicians in your community accept biosimilars? More importantly, how do your patients feel about biosimilars? I think they’ve been left out of this whole discussion.”

Dr. Huffstutter disclosed that he has received research support from GlaxoSmithKline, Pfizer, and UCB. He is also a member of the speakers bureau and/or is an adviser to Janssen, Lilly, Pfizer, Genentech, Novartis, Regeneron, and UCB.

[email protected]

 

SAN DIEGO – If you perceive that the use of biosimilars for rheumatic diseases hasn’t gained the traction one would expect, you’re not alone. In the opinion of J. Eugene Huffstutter, MD, the expected risks of biosimilar products have clinicians concerned, especially when it comes to immunologic characteristics.

“We’ve all had patients on biologics for years: Everything’s fine, but then the patient has an infusion reaction,” Dr. Huffstutter said at the annual meeting of the American College of Rheumatology. “I’ve had it happen with the first infusion of a biologic and I’ve had it with the 20th infusion of that same biologic product. It’s impossible to predict.”

Doug Brunk/Frontline Medical News

Dr. Huffstutter, a rheumatologist who is clinical assistant professor of medicine at the University of Tennessee, Chattanooga, went on to note that the potency differences between products are another concern. “One of them has to do with mechanical differences,” he said. “I notice that with various lots, some are easier to mix than others. You are going to get some comments from your infusion nurses depending on how easy or how difficult it may be.”

Other unforeseen risks of biosimilars include the impact on pharmacovigilance, manufacturing, and politics. “What if our government says we want to use this agent or that agent? Or, what if it advises everyone to use the bio-originator? Then there are coverage challenges,” he said. “How are the insurance companies going to look at this? Then there are corporate impacts. The companies that make biosimilars have invested a tremendous amount of resources to bring these to market. We have a huge market in the U.S., but the uptake has been very slow. So are they going to say, ‘We’re going to take our resources and do something else?’ ”

Practice protocols for using biosimilars vary depending on your practice environment. For example, if biosimilars are administered by a freestanding practice, “you have to depend a lot on your state laws in terms of what the pharmacist is able to do,” said Dr. Huffstutter, who is also the past president of the Tennessee Rheumatology Society. “What are the patient support programs available for that biosimilar compared with bio-originator? What do the insurance contracts say in terms of can you get this filled or not? What’s the formulary status? How well do physicians in your community accept biosimilars? More importantly, how do your patients feel about biosimilars? I think they’ve been left out of this whole discussion.”

Dr. Huffstutter disclosed that he has received research support from GlaxoSmithKline, Pfizer, and UCB. He is also a member of the speakers bureau and/or is an adviser to Janssen, Lilly, Pfizer, Genentech, Novartis, Regeneron, and UCB.

[email protected]

 

SAN DIEGO – If you perceive that the use of biosimilars for rheumatic diseases hasn’t gained the traction one would expect, you’re not alone. In the opinion of J. Eugene Huffstutter, MD, the expected risks of biosimilar products have clinicians concerned, especially when it comes to immunologic characteristics.

“We’ve all had patients on biologics for years: Everything’s fine, but then the patient has an infusion reaction,” Dr. Huffstutter said at the annual meeting of the American College of Rheumatology. “I’ve had it happen with the first infusion of a biologic and I’ve had it with the 20th infusion of that same biologic product. It’s impossible to predict.”

Doug Brunk/Frontline Medical News

Dr. Huffstutter, a rheumatologist who is clinical assistant professor of medicine at the University of Tennessee, Chattanooga, went on to note that the potency differences between products are another concern. “One of them has to do with mechanical differences,” he said. “I notice that with various lots, some are easier to mix than others. You are going to get some comments from your infusion nurses depending on how easy or how difficult it may be.”

Other unforeseen risks of biosimilars include the impact on pharmacovigilance, manufacturing, and politics. “What if our government says we want to use this agent or that agent? Or, what if it advises everyone to use the bio-originator? Then there are coverage challenges,” he said. “How are the insurance companies going to look at this? Then there are corporate impacts. The companies that make biosimilars have invested a tremendous amount of resources to bring these to market. We have a huge market in the U.S., but the uptake has been very slow. So are they going to say, ‘We’re going to take our resources and do something else?’ ”

Practice protocols for using biosimilars vary depending on your practice environment. For example, if biosimilars are administered by a freestanding practice, “you have to depend a lot on your state laws in terms of what the pharmacist is able to do,” said Dr. Huffstutter, who is also the past president of the Tennessee Rheumatology Society. “What are the patient support programs available for that biosimilar compared with bio-originator? What do the insurance contracts say in terms of can you get this filled or not? What’s the formulary status? How well do physicians in your community accept biosimilars? More importantly, how do your patients feel about biosimilars? I think they’ve been left out of this whole discussion.”

Dr. Huffstutter disclosed that he has received research support from GlaxoSmithKline, Pfizer, and UCB. He is also a member of the speakers bureau and/or is an adviser to Janssen, Lilly, Pfizer, Genentech, Novartis, Regeneron, and UCB.

[email protected]

 

SAN DIEGO – Receiving a kidney transplant increased the likelihood of survival in patients with end-stage renal disease (ESRD) due to granulomatosis with polyangiitis, a study showed.

“We found that there was a huge survival advantage of having a renal transplant,” lead author Zachary S. Wallace, MD, MS, of Harvard Medical School, Boston, said in an interview. “In addition, this improvement in survival seems to be due to a dramatic reduction in death due to cardiovascular disease.”

The number of people with the potentially deadly, granulomatosis with polyangiitis (GPA), a small-vessel vasculitis, is unclear. However, a 2017 analysis of residents of Olmsted County, Minn., over a 20-year period estimated the annual incidence at about 3.3/100,000 (Arthritis Rheum. 2017 Nov 9. doi: 10.1002/art.40313).

An estimated 25% of patients with GPA develop ESRD, according to Dr. Wallace, who also works at the vasculitis and glomerulonephritis center at Massachusetts General Hospital, Boston. “GPA and ANCA [antineutrophil cytoplasmic autoantibody]–associated vasculitis in general have a propensity to affect the kidneys, and the reason for that is not entirely known,” he said during the interview. “In the kidney, it most commonly causes a rapidly progressive glomerulonephritis which can cause irreversible renal failure if not aggressively treated.”

Dr. Wallace and his colleagues launched their study to better understand the impact of kidney transplants. “We know that patients with ESRD from more common causes – such as diabetes and hypertension – benefit in terms of survival and quality of life from transplantation,” he said in the interview. “It was unknown if GPA patients similarly benefit. Often, GPA patients have fewer comorbidities than patients with ESRD due to diabetes or hypertension. Since they may be relatively healthier, one might wonder if the survival benefit would be as great in ESRD patients with GPA.”

Dr. Wallace and his colleagues tracked 2,471 cases of ESRD due to GPA from the U.S. Renal Data System. All were wait-listed for a kidney transplant from 1995 to 2014, and the researchers tracked them as late as Jan. 1, 2016. Of the patients studied, 946 received a transplant. The study’s participants tended to be male (59%) and white (86-87%), and they rarely had comorbidities outside of diabetes (64-67%).

There were 438 deaths in the entire group. Those who received transplants were much less likely to die than those who didn’t (adjusted hazard ratio, 0.30; 95% confidence interval, 0.25-0.37; P less than .001), he reported at the annual meeting of the American College of Rheumatology.

Also, those who received transplants were much less likely than those who didn’t to die of cardiovascular disease (adjusted HR, 0.13; 95% CI, 0.08-0.22; P less than .001) and infection (adjusted HR, 0.61; 95% CI, 0.34-1.08; P = .09). There was no statistically significant difference between the groups in terms of deaths from cancer.

“The improvement in survival seems to be due to a dramatic reduction in death due to cardiovascular disease,” Dr. Wallace said in the interview. “While cardiovascular disease is a common cause of death in GPA and ESRD due to other causes, this was not known specifically in patients with ESRD due to GPA.”

The findings provide the following messages to rheumatologists: Renal transplantation in patients with ESRD due to GPA offers a significant survival benefit, and it is important to refer patients early to a renal transplant center, he noted.

“[Rheumatologists] should work closely with primary care physicians and nephrologists to make sure that the patient’s cardiovascular disease risk is being assessed – checking lipids, A_1c, etc. – and addressed as necessary,” Dr. Wallace added.

The study authors reported no relevant financial disclosures. Funding included support from the Rheumatology Research Foundation, the Executive Committee on Research at Massachusetts General, and the National Institutes of Health Loan Repayment Program.

 

SAN DIEGO – Receiving a kidney transplant increased the likelihood of survival in patients with end-stage renal disease (ESRD) due to granulomatosis with polyangiitis, a study showed.

“We found that there was a huge survival advantage of having a renal transplant,” lead author Zachary S. Wallace, MD, MS, of Harvard Medical School, Boston, said in an interview. “In addition, this improvement in survival seems to be due to a dramatic reduction in death due to cardiovascular disease.”

The number of people with the potentially deadly, granulomatosis with polyangiitis (GPA), a small-vessel vasculitis, is unclear. However, a 2017 analysis of residents of Olmsted County, Minn., over a 20-year period estimated the annual incidence at about 3.3/100,000 (Arthritis Rheum. 2017 Nov 9. doi: 10.1002/art.40313).

An estimated 25% of patients with GPA develop ESRD, according to Dr. Wallace, who also works at the vasculitis and glomerulonephritis center at Massachusetts General Hospital, Boston. “GPA and ANCA [antineutrophil cytoplasmic autoantibody]–associated vasculitis in general have a propensity to affect the kidneys, and the reason for that is not entirely known,” he said during the interview. “In the kidney, it most commonly causes a rapidly progressive glomerulonephritis which can cause irreversible renal failure if not aggressively treated.”

Dr. Wallace and his colleagues launched their study to better understand the impact of kidney transplants. “We know that patients with ESRD from more common causes – such as diabetes and hypertension – benefit in terms of survival and quality of life from transplantation,” he said in the interview. “It was unknown if GPA patients similarly benefit. Often, GPA patients have fewer comorbidities than patients with ESRD due to diabetes or hypertension. Since they may be relatively healthier, one might wonder if the survival benefit would be as great in ESRD patients with GPA.”

Dr. Wallace and his colleagues tracked 2,471 cases of ESRD due to GPA from the U.S. Renal Data System. All were wait-listed for a kidney transplant from 1995 to 2014, and the researchers tracked them as late as Jan. 1, 2016. Of the patients studied, 946 received a transplant. The study’s participants tended to be male (59%) and white (86-87%), and they rarely had comorbidities outside of diabetes (64-67%).

There were 438 deaths in the entire group. Those who received transplants were much less likely to die than those who didn’t (adjusted hazard ratio, 0.30; 95% confidence interval, 0.25-0.37; P less than .001), he reported at the annual meeting of the American College of Rheumatology.

Also, those who received transplants were much less likely than those who didn’t to die of cardiovascular disease (adjusted HR, 0.13; 95% CI, 0.08-0.22; P less than .001) and infection (adjusted HR, 0.61; 95% CI, 0.34-1.08; P = .09). There was no statistically significant difference between the groups in terms of deaths from cancer.

“The improvement in survival seems to be due to a dramatic reduction in death due to cardiovascular disease,” Dr. Wallace said in the interview. “While cardiovascular disease is a common cause of death in GPA and ESRD due to other causes, this was not known specifically in patients with ESRD due to GPA.”

The findings provide the following messages to rheumatologists: Renal transplantation in patients with ESRD due to GPA offers a significant survival benefit, and it is important to refer patients early to a renal transplant center, he noted.

“[Rheumatologists] should work closely with primary care physicians and nephrologists to make sure that the patient’s cardiovascular disease risk is being assessed – checking lipids, A_1c, etc. – and addressed as necessary,” Dr. Wallace added.

The study authors reported no relevant financial disclosures. Funding included support from the Rheumatology Research Foundation, the Executive Committee on Research at Massachusetts General, and the National Institutes of Health Loan Repayment Program.

 

SAN DIEGO – Receiving a kidney transplant increased the likelihood of survival in patients with end-stage renal disease (ESRD) due to granulomatosis with polyangiitis, a study showed.

“We found that there was a huge survival advantage of having a renal transplant,” lead author Zachary S. Wallace, MD, MS, of Harvard Medical School, Boston, said in an interview. “In addition, this improvement in survival seems to be due to a dramatic reduction in death due to cardiovascular disease.”

The number of people with the potentially deadly, granulomatosis with polyangiitis (GPA), a small-vessel vasculitis, is unclear. However, a 2017 analysis of residents of Olmsted County, Minn., over a 20-year period estimated the annual incidence at about 3.3/100,000 (Arthritis Rheum. 2017 Nov 9. doi: 10.1002/art.40313).

An estimated 25% of patients with GPA develop ESRD, according to Dr. Wallace, who also works at the vasculitis and glomerulonephritis center at Massachusetts General Hospital, Boston. “GPA and ANCA [antineutrophil cytoplasmic autoantibody]–associated vasculitis in general have a propensity to affect the kidneys, and the reason for that is not entirely known,” he said during the interview. “In the kidney, it most commonly causes a rapidly progressive glomerulonephritis which can cause irreversible renal failure if not aggressively treated.”

Dr. Wallace and his colleagues launched their study to better understand the impact of kidney transplants. “We know that patients with ESRD from more common causes – such as diabetes and hypertension – benefit in terms of survival and quality of life from transplantation,” he said in the interview. “It was unknown if GPA patients similarly benefit. Often, GPA patients have fewer comorbidities than patients with ESRD due to diabetes or hypertension. Since they may be relatively healthier, one might wonder if the survival benefit would be as great in ESRD patients with GPA.”

Dr. Wallace and his colleagues tracked 2,471 cases of ESRD due to GPA from the U.S. Renal Data System. All were wait-listed for a kidney transplant from 1995 to 2014, and the researchers tracked them as late as Jan. 1, 2016. Of the patients studied, 946 received a transplant. The study’s participants tended to be male (59%) and white (86-87%), and they rarely had comorbidities outside of diabetes (64-67%).

There were 438 deaths in the entire group. Those who received transplants were much less likely to die than those who didn’t (adjusted hazard ratio, 0.30; 95% confidence interval, 0.25-0.37; P less than .001), he reported at the annual meeting of the American College of Rheumatology.

Also, those who received transplants were much less likely than those who didn’t to die of cardiovascular disease (adjusted HR, 0.13; 95% CI, 0.08-0.22; P less than .001) and infection (adjusted HR, 0.61; 95% CI, 0.34-1.08; P = .09). There was no statistically significant difference between the groups in terms of deaths from cancer.

“The improvement in survival seems to be due to a dramatic reduction in death due to cardiovascular disease,” Dr. Wallace said in the interview. “While cardiovascular disease is a common cause of death in GPA and ESRD due to other causes, this was not known specifically in patients with ESRD due to GPA.”

The findings provide the following messages to rheumatologists: Renal transplantation in patients with ESRD due to GPA offers a significant survival benefit, and it is important to refer patients early to a renal transplant center, he noted.

“[Rheumatologists] should work closely with primary care physicians and nephrologists to make sure that the patient’s cardiovascular disease risk is being assessed – checking lipids, A_1c, etc. – and addressed as necessary,” Dr. Wallace added.

The study authors reported no relevant financial disclosures. Funding included support from the Rheumatology Research Foundation, the Executive Committee on Research at Massachusetts General, and the National Institutes of Health Loan Repayment Program.