Rheumatoid Arthritis

Key clinical point: Compared with biological disease-modifying anti-rheumatic drugs (bDMARD), tofacitinib increased the risk for serious infections (SI) in older patients with rheumatoid arthritis (RA; age ≥ 69 years).

Major finding: The risk for non-fatal SI in the tofacitinib vs bDMARD treatment group was ~2 times higher in patients age 69 years (hazard ratio [HR] ~2.00; 95% CI ~1.02 to ~4.00) and ~2.8 times higher in those age ≥ 76 years (HR ~2.8; 95% CI 1.3 to ~6.4).

Study details: This observational cohort study included 1687 patients with RA enrolled in 2238 different treatment courses (TC), of which 345 and 1893 TC involved tofacitinib and bDMARD, respectively.

Disclosures: This study was supported by Pfizer. Several authors declared receiving speaker fees, consulting fees, research grants, or conference expenditures from or having other ties with various sources, including Pfizer.

Source: Riek M et al. Serious infection risk of tofacitinib compared to biologics in patients with rheumatoid arthritis treated in routine clinical care. Sci Rep. 2023;13:17776 (Oct 18). doi: 10.1038/s41598-023-44841-w

Key clinical point: Compared with biological disease-modifying anti-rheumatic drugs (bDMARD), tofacitinib increased the risk for serious infections (SI) in older patients with rheumatoid arthritis (RA; age ≥ 69 years).

Major finding: The risk for non-fatal SI in the tofacitinib vs bDMARD treatment group was ~2 times higher in patients age 69 years (hazard ratio [HR] ~2.00; 95% CI ~1.02 to ~4.00) and ~2.8 times higher in those age ≥ 76 years (HR ~2.8; 95% CI 1.3 to ~6.4).

Study details: This observational cohort study included 1687 patients with RA enrolled in 2238 different treatment courses (TC), of which 345 and 1893 TC involved tofacitinib and bDMARD, respectively.

Disclosures: This study was supported by Pfizer. Several authors declared receiving speaker fees, consulting fees, research grants, or conference expenditures from or having other ties with various sources, including Pfizer.

Source: Riek M et al. Serious infection risk of tofacitinib compared to biologics in patients with rheumatoid arthritis treated in routine clinical care. Sci Rep. 2023;13:17776 (Oct 18). doi: 10.1038/s41598-023-44841-w

Key clinical point: Compared with biological disease-modifying anti-rheumatic drugs (bDMARD), tofacitinib increased the risk for serious infections (SI) in older patients with rheumatoid arthritis (RA; age ≥ 69 years).

Major finding: The risk for non-fatal SI in the tofacitinib vs bDMARD treatment group was ~2 times higher in patients age 69 years (hazard ratio [HR] ~2.00; 95% CI ~1.02 to ~4.00) and ~2.8 times higher in those age ≥ 76 years (HR ~2.8; 95% CI 1.3 to ~6.4).

Study details: This observational cohort study included 1687 patients with RA enrolled in 2238 different treatment courses (TC), of which 345 and 1893 TC involved tofacitinib and bDMARD, respectively.

Disclosures: This study was supported by Pfizer. Several authors declared receiving speaker fees, consulting fees, research grants, or conference expenditures from or having other ties with various sources, including Pfizer.

Source: Riek M et al. Serious infection risk of tofacitinib compared to biologics in patients with rheumatoid arthritis treated in routine clinical care. Sci Rep. 2023;13:17776 (Oct 18). doi: 10.1038/s41598-023-44841-w

Key clinical point: Tapering biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or both b/tsDMARD and conventional synthetic (cs) DMARD increased the risk for disease flares in patients with well-controlled rheumatoid arthritis (RA).

Major finding: Compared with patients whose medication was not tapered, the risk for flares was 31 times higher in the b/tsDMARD taper group (hazard ratio [HR] 31.43; P < .0001) and 18 times higher in the b/tsDMARD and csDMARD taper group (HR 18.45; P = .0039).

Study details: This 2-year prospective cohort study included 131 patients with RA who were on stable b/tsDMARD with or without csDMARD and achieved remission or low disease activity, of whom 39.7% underwent a DMARD taper.

Disclosures: This study was supported by the Autoimmune Association - Young Investigator Grant Award. The authors declared no conflicts of interest.

Source: Tageldin M et al. A real-world 2-year prospective study of medication tapering in patients with well-controlled rheumatoid arthritis within the rheumatoid arthritis medication tapering (RHEUMTAP) cohort. Rheumatology (Oxford). 2023;62(Suppl 4):iv8-iv13 (Oct 19). doi: 10.1093/rheumatology/kead430

Key clinical point: Tapering biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or both b/tsDMARD and conventional synthetic (cs) DMARD increased the risk for disease flares in patients with well-controlled rheumatoid arthritis (RA).

Major finding: Compared with patients whose medication was not tapered, the risk for flares was 31 times higher in the b/tsDMARD taper group (hazard ratio [HR] 31.43; P < .0001) and 18 times higher in the b/tsDMARD and csDMARD taper group (HR 18.45; P = .0039).

Study details: This 2-year prospective cohort study included 131 patients with RA who were on stable b/tsDMARD with or without csDMARD and achieved remission or low disease activity, of whom 39.7% underwent a DMARD taper.

Disclosures: This study was supported by the Autoimmune Association - Young Investigator Grant Award. The authors declared no conflicts of interest.

Source: Tageldin M et al. A real-world 2-year prospective study of medication tapering in patients with well-controlled rheumatoid arthritis within the rheumatoid arthritis medication tapering (RHEUMTAP) cohort. Rheumatology (Oxford). 2023;62(Suppl 4):iv8-iv13 (Oct 19). doi: 10.1093/rheumatology/kead430

Key clinical point: Tapering biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or both b/tsDMARD and conventional synthetic (cs) DMARD increased the risk for disease flares in patients with well-controlled rheumatoid arthritis (RA).

Major finding: Compared with patients whose medication was not tapered, the risk for flares was 31 times higher in the b/tsDMARD taper group (hazard ratio [HR] 31.43; P < .0001) and 18 times higher in the b/tsDMARD and csDMARD taper group (HR 18.45; P = .0039).

Study details: This 2-year prospective cohort study included 131 patients with RA who were on stable b/tsDMARD with or without csDMARD and achieved remission or low disease activity, of whom 39.7% underwent a DMARD taper.

Disclosures: This study was supported by the Autoimmune Association - Young Investigator Grant Award. The authors declared no conflicts of interest.

Source: Tageldin M et al. A real-world 2-year prospective study of medication tapering in patients with well-controlled rheumatoid arthritis within the rheumatoid arthritis medication tapering (RHEUMTAP) cohort. Rheumatology (Oxford). 2023;62(Suppl 4):iv8-iv13 (Oct 19). doi: 10.1093/rheumatology/kead430

Key clinical point: In a vulnerable population of individuals with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi), the herpes zoster subunit (HZ/su) vaccine elicited a serological immune response in most patients and had an acceptable safety profile.

Major finding: The geometric mean concentration of vaccine-specific antibody levels increased from 2317 ng/mL prevaccination to 26,916 ng/mL postvaccination (P < .0001) in patients with RA, with 80.5% of patients showing a ≥4-fold increase in antibody levels. After vaccination, only 6.5% of patients reported an increase in RA disease activity, and adverse events were mostly mild or moderate.

Study details: Findings are from a phase 4 trial including 82 patients with RA treated using JAKi and 51 control individuals without rheumatic diseases, all of whom received two doses of the HZ/su vaccine.

Disclosures: Two authors declared receiving support or research funds for the present study from various sources. T Bergström declared receiving payments or honoraria from GlaxoSmithKline. The other authors declared no conflicts of interest.

Source: Källmark H et al. Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2023 (Oct 18). Doi: 10.1093/rheumatology/kead552.

Key clinical point: In a vulnerable population of individuals with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi), the herpes zoster subunit (HZ/su) vaccine elicited a serological immune response in most patients and had an acceptable safety profile.

Major finding: The geometric mean concentration of vaccine-specific antibody levels increased from 2317 ng/mL prevaccination to 26,916 ng/mL postvaccination (P < .0001) in patients with RA, with 80.5% of patients showing a ≥4-fold increase in antibody levels. After vaccination, only 6.5% of patients reported an increase in RA disease activity, and adverse events were mostly mild or moderate.

Study details: Findings are from a phase 4 trial including 82 patients with RA treated using JAKi and 51 control individuals without rheumatic diseases, all of whom received two doses of the HZ/su vaccine.

Disclosures: Two authors declared receiving support or research funds for the present study from various sources. T Bergström declared receiving payments or honoraria from GlaxoSmithKline. The other authors declared no conflicts of interest.

Source: Källmark H et al. Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2023 (Oct 18). Doi: 10.1093/rheumatology/kead552.

Key clinical point: In a vulnerable population of individuals with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi), the herpes zoster subunit (HZ/su) vaccine elicited a serological immune response in most patients and had an acceptable safety profile.

Major finding: The geometric mean concentration of vaccine-specific antibody levels increased from 2317 ng/mL prevaccination to 26,916 ng/mL postvaccination (P < .0001) in patients with RA, with 80.5% of patients showing a ≥4-fold increase in antibody levels. After vaccination, only 6.5% of patients reported an increase in RA disease activity, and adverse events were mostly mild or moderate.

Study details: Findings are from a phase 4 trial including 82 patients with RA treated using JAKi and 51 control individuals without rheumatic diseases, all of whom received two doses of the HZ/su vaccine.

Disclosures: Two authors declared receiving support or research funds for the present study from various sources. T Bergström declared receiving payments or honoraria from GlaxoSmithKline. The other authors declared no conflicts of interest.

Source: Källmark H et al. Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2023 (Oct 18). Doi: 10.1093/rheumatology/kead552.

Key clinical point: Compared with the general population, the risk for cancer was significantly higher in patients with rheumatoid arthritis (RA) treated with disease-modifying antirheumatic drugs (DMARD).

Major finding: The all-cancer risk was 20% higher in patients with RA than in the general population (standardized incidence ratio [SIR] 1.20; 95% CI 1.17-1.23). The risk was particularly higher for solid cancers like bladder cancer (SIR 2.38; 95% CI 2.25-2.51), cervical cancer (SIR 1.80; 95% CI 1.62-2.01), and lung cancer (SIR 1.41; 95% CI 1.36-1.46) and for hematological malignancies like Hodgkin’s lymphoma (SIR 2.73; 95% CI 2.31-3.23).

Study details: This population-based observational study included 257,074 patients with RA and without a history of cancer, who received DMARD and were compared with the general population.

Disclosures: This study was supported by unrestricted grants from the French National Cancer Institute and the Assistance Publique des Hôpitaux de Paris. Four authors declared receiving research grants, consulting fees, or support for meetings or travel from various sources.

Source: Beydon M et al. Risk of cancer for patients with rheumatoid arthritis versus general population: A national claims database cohort study. Lancet Reg Health Eur. 2023;35:100768 (Oct 29). doi: 10.1016/j.lanepe.2023.100768

Key clinical point: Compared with the general population, the risk for cancer was significantly higher in patients with rheumatoid arthritis (RA) treated with disease-modifying antirheumatic drugs (DMARD).

Major finding: The all-cancer risk was 20% higher in patients with RA than in the general population (standardized incidence ratio [SIR] 1.20; 95% CI 1.17-1.23). The risk was particularly higher for solid cancers like bladder cancer (SIR 2.38; 95% CI 2.25-2.51), cervical cancer (SIR 1.80; 95% CI 1.62-2.01), and lung cancer (SIR 1.41; 95% CI 1.36-1.46) and for hematological malignancies like Hodgkin’s lymphoma (SIR 2.73; 95% CI 2.31-3.23).

Study details: This population-based observational study included 257,074 patients with RA and without a history of cancer, who received DMARD and were compared with the general population.

Disclosures: This study was supported by unrestricted grants from the French National Cancer Institute and the Assistance Publique des Hôpitaux de Paris. Four authors declared receiving research grants, consulting fees, or support for meetings or travel from various sources.

Source: Beydon M et al. Risk of cancer for patients with rheumatoid arthritis versus general population: A national claims database cohort study. Lancet Reg Health Eur. 2023;35:100768 (Oct 29). doi: 10.1016/j.lanepe.2023.100768

Key clinical point: Compared with the general population, the risk for cancer was significantly higher in patients with rheumatoid arthritis (RA) treated with disease-modifying antirheumatic drugs (DMARD).

Major finding: The all-cancer risk was 20% higher in patients with RA than in the general population (standardized incidence ratio [SIR] 1.20; 95% CI 1.17-1.23). The risk was particularly higher for solid cancers like bladder cancer (SIR 2.38; 95% CI 2.25-2.51), cervical cancer (SIR 1.80; 95% CI 1.62-2.01), and lung cancer (SIR 1.41; 95% CI 1.36-1.46) and for hematological malignancies like Hodgkin’s lymphoma (SIR 2.73; 95% CI 2.31-3.23).

Study details: This population-based observational study included 257,074 patients with RA and without a history of cancer, who received DMARD and were compared with the general population.

Disclosures: This study was supported by unrestricted grants from the French National Cancer Institute and the Assistance Publique des Hôpitaux de Paris. Four authors declared receiving research grants, consulting fees, or support for meetings or travel from various sources.

Source: Beydon M et al. Risk of cancer for patients with rheumatoid arthritis versus general population: A national claims database cohort study. Lancet Reg Health Eur. 2023;35:100768 (Oct 29). doi: 10.1016/j.lanepe.2023.100768

Key clinical point: Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, peficitinib, and upadacitinib showed comparable efficacy, and all of these drugs had impressive remission rates in patients with rheumatoid arthritis (RA).

Major finding: At 6 months of treatment with JAKi, the average Clinical Disease Activity Index (CDAI) scores improved significantly (P < .001), with 1 out of 3 patients achieving CDAI-remission and ≥82% of patients achieving CDAI-low disease activity (LDA). The achievement rates of CDAI-remission and CDAI-LDA were comparable across the four treatment groups.

Study details: Findings are from analysis of a retrospective study including 361 patients with RA from the ANSWER cohort who received tofacitinib (n = 127), baricitinib (n = 153), peficitinib (n = 29), or upadacitinib (n = 52).

Disclosures: This study did not receive any specific funding. Some authors declared receiving research grants, payments for lectures, or speaking or consulting fees from various sources.

Source: Hayashi S et al. Real-world comparative study of the efficacy of Janus kinase inhibitors in patients with rheumatoid arthritis: The ANSWER cohort study. Rheumatology (Oxford). 2023 (Nov 1). doi: 10.1093/rheumatology/kead543

Key clinical point: Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, peficitinib, and upadacitinib showed comparable efficacy, and all of these drugs had impressive remission rates in patients with rheumatoid arthritis (RA).

Major finding: At 6 months of treatment with JAKi, the average Clinical Disease Activity Index (CDAI) scores improved significantly (P < .001), with 1 out of 3 patients achieving CDAI-remission and ≥82% of patients achieving CDAI-low disease activity (LDA). The achievement rates of CDAI-remission and CDAI-LDA were comparable across the four treatment groups.

Study details: Findings are from analysis of a retrospective study including 361 patients with RA from the ANSWER cohort who received tofacitinib (n = 127), baricitinib (n = 153), peficitinib (n = 29), or upadacitinib (n = 52).

Disclosures: This study did not receive any specific funding. Some authors declared receiving research grants, payments for lectures, or speaking or consulting fees from various sources.

Source: Hayashi S et al. Real-world comparative study of the efficacy of Janus kinase inhibitors in patients with rheumatoid arthritis: The ANSWER cohort study. Rheumatology (Oxford). 2023 (Nov 1). doi: 10.1093/rheumatology/kead543

Key clinical point: Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, peficitinib, and upadacitinib showed comparable efficacy, and all of these drugs had impressive remission rates in patients with rheumatoid arthritis (RA).

Major finding: At 6 months of treatment with JAKi, the average Clinical Disease Activity Index (CDAI) scores improved significantly (P < .001), with 1 out of 3 patients achieving CDAI-remission and ≥82% of patients achieving CDAI-low disease activity (LDA). The achievement rates of CDAI-remission and CDAI-LDA were comparable across the four treatment groups.

Study details: Findings are from analysis of a retrospective study including 361 patients with RA from the ANSWER cohort who received tofacitinib (n = 127), baricitinib (n = 153), peficitinib (n = 29), or upadacitinib (n = 52).

Disclosures: This study did not receive any specific funding. Some authors declared receiving research grants, payments for lectures, or speaking or consulting fees from various sources.

Source: Hayashi S et al. Real-world comparative study of the efficacy of Janus kinase inhibitors in patients with rheumatoid arthritis: The ANSWER cohort study. Rheumatology (Oxford). 2023 (Nov 1). doi: 10.1093/rheumatology/kead543

TOPLINE:

The use of low-dose methotrexate among older adults with chronic kidney disease (CKD) was associated with a significantly increased risk at 90 days for serious adverse events requiring a hospital visit, compared with starting treatment with hydroxychloroquine.

METHODOLOGY:

• In a retrospective, population-based cohort study conducted in Ontario, researchers used linked administrative healthcare data to identify adults aged 66 years and older with CKD who were not undergoing dialysis and were new to medication; CKD was defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m².
• The study population included 2,309 individuals who began treatment with low-dose methotrexate (5-35 mg/week); they were matched with 2,309 individuals who began treatment with hydroxychloroquine (200-400 mg/day). The median age was 76 years, 69% were women, and rheumatoid arthritis was the most common diagnosis (56%).
• The primary outcome was the risk of a hospital visit at 90 days for a composite of serious adverse events that included myelosuppression, sepsis, pneumotoxic effects, or hepatoxic effects.

TAKEAWAY:

• Overall, 3.55% of methotrexate patients and 1.73% of hydroxychloroquine patients met the primary outcome (risk ratio, 2.05); these events occurred at a median of 49 days and 43 days after starting the medications for the two groups, respectively.
• In an analysis by eGFR category, the risk of serious adverse events at 90 days increased among patients with eGFR levels less than 45 mL/min per 1.73 m² (RR, 2.79).
• In a secondary comparison, the 90-day risk of serious adverse events was higher among methotrexate patients who began treatment with doses of 15-35 mg/week in comparison with those whose initial doses were 5 to less than 15 mg/week.

IN PRACTICE:

“Patients with CKD starting low-dose methotrexate should have active surveillance, including blood tests and chest radiographs performed regularly to monitor for signs of myelosuppression, infection, hepatotoxic effects, and pneumotoxic effects,” the researchers wrote.

SOURCE:

The lead author on the study was Flory T. Muanda, MD, of Western University, London, Ont. The study was published online in JAMA Network Open.

LIMITATIONS:

The observational design and lack of data on patients’ adherence to medications were among the limiting factors, as were the focus on older adults with CKD and the lack of assessment of the risk-benefit ratio of low-dose methotrexate.

DISCLOSURES:

The study was supported by the Institute for Clinical Evaluative Sciences. Dr. Muanda had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

The use of low-dose methotrexate among older adults with chronic kidney disease (CKD) was associated with a significantly increased risk at 90 days for serious adverse events requiring a hospital visit, compared with starting treatment with hydroxychloroquine.

METHODOLOGY:

• In a retrospective, population-based cohort study conducted in Ontario, researchers used linked administrative healthcare data to identify adults aged 66 years and older with CKD who were not undergoing dialysis and were new to medication; CKD was defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m².
• The study population included 2,309 individuals who began treatment with low-dose methotrexate (5-35 mg/week); they were matched with 2,309 individuals who began treatment with hydroxychloroquine (200-400 mg/day). The median age was 76 years, 69% were women, and rheumatoid arthritis was the most common diagnosis (56%).
• The primary outcome was the risk of a hospital visit at 90 days for a composite of serious adverse events that included myelosuppression, sepsis, pneumotoxic effects, or hepatoxic effects.

TAKEAWAY:

• Overall, 3.55% of methotrexate patients and 1.73% of hydroxychloroquine patients met the primary outcome (risk ratio, 2.05); these events occurred at a median of 49 days and 43 days after starting the medications for the two groups, respectively.
• In an analysis by eGFR category, the risk of serious adverse events at 90 days increased among patients with eGFR levels less than 45 mL/min per 1.73 m² (RR, 2.79).
• In a secondary comparison, the 90-day risk of serious adverse events was higher among methotrexate patients who began treatment with doses of 15-35 mg/week in comparison with those whose initial doses were 5 to less than 15 mg/week.

IN PRACTICE:

“Patients with CKD starting low-dose methotrexate should have active surveillance, including blood tests and chest radiographs performed regularly to monitor for signs of myelosuppression, infection, hepatotoxic effects, and pneumotoxic effects,” the researchers wrote.

SOURCE:

The lead author on the study was Flory T. Muanda, MD, of Western University, London, Ont. The study was published online in JAMA Network Open.

LIMITATIONS:

The observational design and lack of data on patients’ adherence to medications were among the limiting factors, as were the focus on older adults with CKD and the lack of assessment of the risk-benefit ratio of low-dose methotrexate.

DISCLOSURES:

The study was supported by the Institute for Clinical Evaluative Sciences. Dr. Muanda had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

The use of low-dose methotrexate among older adults with chronic kidney disease (CKD) was associated with a significantly increased risk at 90 days for serious adverse events requiring a hospital visit, compared with starting treatment with hydroxychloroquine.

METHODOLOGY:

• In a retrospective, population-based cohort study conducted in Ontario, researchers used linked administrative healthcare data to identify adults aged 66 years and older with CKD who were not undergoing dialysis and were new to medication; CKD was defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m².
• The study population included 2,309 individuals who began treatment with low-dose methotrexate (5-35 mg/week); they were matched with 2,309 individuals who began treatment with hydroxychloroquine (200-400 mg/day). The median age was 76 years, 69% were women, and rheumatoid arthritis was the most common diagnosis (56%).
• The primary outcome was the risk of a hospital visit at 90 days for a composite of serious adverse events that included myelosuppression, sepsis, pneumotoxic effects, or hepatoxic effects.

TAKEAWAY:

• Overall, 3.55% of methotrexate patients and 1.73% of hydroxychloroquine patients met the primary outcome (risk ratio, 2.05); these events occurred at a median of 49 days and 43 days after starting the medications for the two groups, respectively.
• In an analysis by eGFR category, the risk of serious adverse events at 90 days increased among patients with eGFR levels less than 45 mL/min per 1.73 m² (RR, 2.79).
• In a secondary comparison, the 90-day risk of serious adverse events was higher among methotrexate patients who began treatment with doses of 15-35 mg/week in comparison with those whose initial doses were 5 to less than 15 mg/week.

IN PRACTICE:

“Patients with CKD starting low-dose methotrexate should have active surveillance, including blood tests and chest radiographs performed regularly to monitor for signs of myelosuppression, infection, hepatotoxic effects, and pneumotoxic effects,” the researchers wrote.

SOURCE:

The lead author on the study was Flory T. Muanda, MD, of Western University, London, Ont. The study was published online in JAMA Network Open.

LIMITATIONS:

The observational design and lack of data on patients’ adherence to medications were among the limiting factors, as were the focus on older adults with CKD and the lack of assessment of the risk-benefit ratio of low-dose methotrexate.

DISCLOSURES:

The study was supported by the Institute for Clinical Evaluative Sciences. Dr. Muanda had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

SAN DIEGO – In the spring of 2024, the American College of Rheumatology is expected to release guidelines to help inform the screening, monitoring, and treatment of interstitial lung disease (ILD) in people with systemic autoimmune rheumatic diseases (SARDs).

The guidelines, which were previewed during a session at the ACR’s annual meeting, will include 50 recommendations, 3 of which met criteria for a strong rating:

• For people with SARDs at increased risk of developing ILD, the authors strongly recommend against screening with surgical lung biopsy.
• For people with systemic sclerosis (SSc)-related ILD, the authors strongly recommend against glucocorticoids as a first-line ILD treatment.
• For people with SSc-related ILD progression despite an initial ILD treatment, the authors strongly recommend against using long-term glucocorticoids.

Elana J. Bernstein, MD, MSc, a rheumatologist who directs the Columbia/New York-Presbyterian Scleroderma Center, and Sindhu R. Johnson, MD, a rheumatologist who directs the Toronto Scleroderma Program at the University of Toronto, provided a sneak peek of the recommendations to attendees before anticipated publication in Arthritis & Rheumatology and Arthritis Care & Research. For now, guideline summaries for screening and monitoring and treatment are currently available, and three manuscripts are under peer review: one about screening and monitoring, one about treatment, and one about the patient panel that participated in the effort.

Pediatric patients with SARDs excluded

The guidelines’ population of interest was people 17 years of age and older who were diagnosed with SARDs with a high risk of ILD. Pediatric patients with SARDs were excluded from the endeavor, as were those with systemic lupus erythematosus, antineutrophil cytoplasmic antibody–associated vasculitis, sarcoidosis, ankylosing spondylitis, undifferentiated connective tissue disease, interstitial pneumonia with autoimmune features, and those with unclassifiable ILD.

In the realm of screening, the guideline authors conditionally recommend two screening tests for patients considered at increased risk of ILD: pulmonary function tests and high-resolution chest CT (HRCT). Pulmonary function tests should include spirometry, lung volumes, and diffusion capacity. “Office spirometry alone is insufficient,” said Dr. Johnson, who served as lead author of the guidelines. And while a HRCT scan is recommended, “some patients may present to the emergency room with acute onset shortness of breath, and they may receive a CT angiogram to screen for pulmonary embolism,” she said. “It’s important to note that CT angiograms are performed in incomplete inspiration to maximize pulmonary artery enhancement. This may produce atelectasis that may obscure or mimic ILD. As a result, CTA studies are often inadequate to screen for ILD.”

Once a patient is diagnosed with ILD, three tests are recommended for monitoring: pulmonary function testing (every 3-6 months the first year in patients with IIM and SSc, then less frequently once stable, and every 3-12 months in the first year in patients with RA, SjD, and MCTD, then less frequently once stable); ambulatory desaturation testing every 3-12 months; and HRCT as needed. Dr. Johnson noted that while that the screening of ILD lies within the realm of rheumatologists, “once a patient is diagnosed, we are encouraged to comanage these patients with pulmonologists,” she said. “Ambulatory desaturation testing is not an infrequent test in the hands of pulmonologists. This is where co-management can be helpful.” She characterized a 6-minute walk test with continuous oximetry as “insufficient and is not synonymous with ambulatory desaturation testing. Ambulatory desaturation testing includes up titration of oxygen if a patient desaturates.”

The guidelines conditionally recommend against using chest radiography, 6-minute walk test distance, ambulatory desaturation testing, and bronchoscopy for ILD screening, and there is a strong recommendation against surgical lung biopsy. “However, there are unique circumstances where these tests may be considered,” Dr. Johnson said. “For example, ambulatory desaturation testing may be helpful if a patient is unable to perform a pulmonary function test. Bronchoscopy may be used to rule out infection, sarcoidosis, lymphoma, or alveolar hemorrhage, and surgical lung biopsy may be considered if you’re trying to rule out a malignancy.”

Similarly, several tests are conditionally recommended against for the monitoring of ILD, including chest radiography, the 6-minute walk test distance, and bronchoscopy. “But there are unique circumstances where they may be considered,” she said. “The 6-minute walk test may be used if a patient is unable to perform a pulmonary function test or if they’re being assessed for lung transplantation. Bronchoscopy may be used to rule out infection or alveolar hemorrhage.”
 

Preferred treatment options described

First-line treatment recommendations for ILD were based on the best available published evidence, voting panel expertise, and patient preferences. For SSc, the preferred treatment options include mycophenolate (CellCept), tocilizumab (Actemra), or rituximab (Rituxan and biosimilars), while additional options include cyclophosphamide, nintedanib (Ofev), and azathioprine. For myositis, the preferred treatment options include mycophenolate, azathioprine, rituximab, or calcineurin inhibitors, while additional options include a Janus kinase (JAK) inhibitor or cyclophosphamide. For MCTD, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include tocilizumab or cyclophosphamide. For RA and Sjögren’s, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include cyclophosphamide. Dr. Johnson emphasized that there was low certainty evidence to recommend one treatment over another. “Many situations might lead a provider to choose a different option for ILD treatment, such as the presence of comorbidities or extra-pulmonary disease,” she said. “So, while our guidelines were focused on effectiveness for ILD, providers may choose therapies that will help ILD and other disease manifestations.”

The guidelines conditionally recommend a short course of glucocorticoids as a bridging therapy or for treatment of a flare of ILD in patients with myositis, MCTD, RA, and Sjögren’s. The panel strongly recommends against the use of glucocorticoids in patients with SSc due to the concern for inducing a scleroderma renal crisis. “While this may be common knowledge for rheumatologists, it may not be common knowledge for pulmonologists,” she said. “So here is an opportunity to educate our pulmonology colleagues in our consultation notes.”

The guidelines also include recommendations for progression of ILD, which was defined using the INBUILD trial criteria. Mycophenolate is conditionally recommended to be the first ILD treatment for all SARDs when progression occurs, if it wasn’t the first ILD treatment used. “If it was, then other medications that rheumatologists are used to can be considered as the next ILD treatment in the face of progression: rituximab, nintedanib, tocilizumab, and cyclophosphamide,” she said. The guidelines include a conditional recommendation against long-term glucocorticoid use in myositis, MCTD, RA, and Sjögren’s, plus a strong recommendation against long-term glucocorticoid use in SSc. Finally, there is a conditional recommendation of referral for lung transplant evaluation at the appropriate time at experienced centers.

University of Toronto

A patient panel provided input

For the undertaking, a core team that included six rheumatologists; one pulmonologist; one thoracic radiologist; one expert on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology; and two literature review experts developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. The literature review team included 13 rheumatologists, 8 pulmonologists, and 3 methodologists. Finally, a 21-member patient panel was convened to share their values and preferences regarding screening, monitoring, and treatment of SARD-related ILD. Of these, Dr. Bernstein said that 4 were at risk for ILD and 17 had been diagnosed with ILD. Next, the literature review team conducted a systematic review and used the GRADE methodology to rate the available evidence as high, moderate, low, or very low. Then, a voting panel comprising 13 rheumatologists, 10 pulmonologists, 1 radiologist, and 3 patients from the patient panel cast votes for each PICO question and made final recommendations.

The review of evidence left the guidelines authors with 241 PICO questions, “which is a lot,” Dr. Bernstein said. “To put this in perspective, some guidelines address only 10 or 15 PICO questions. Fortunately, we had a dedicated group of experts who were up to the challenge.” Dr. Johnson emphasized that the forthcoming guidelines should not be used by insurers to mandate a specific order of prescribing. “Clinicians must retain the latitude to prescribe medications based on individual patient factors and preferences,” she said.

Dr. Bernstein disclosed that she is an adviser to, a consultant for, and has received grant or research support from Boehringer Ingelheim and has also received grant or research support from Kadmon and Pfizer. Dr. Johnson disclosed that she has received research support from the American College of Rheumatology to develop these guidelines. She has also been an investigator for trials sponsored by Bristol-Myers Squibb, Roche, and Boehringer Ingelheim and has mitigated these relevant conflicts of interest 1 year prior to the development of these guidelines, and will continue to do so for the foreseeable future.

SAN DIEGO – In the spring of 2024, the American College of Rheumatology is expected to release guidelines to help inform the screening, monitoring, and treatment of interstitial lung disease (ILD) in people with systemic autoimmune rheumatic diseases (SARDs).

The guidelines, which were previewed during a session at the ACR’s annual meeting, will include 50 recommendations, 3 of which met criteria for a strong rating:

• For people with SARDs at increased risk of developing ILD, the authors strongly recommend against screening with surgical lung biopsy.
• For people with systemic sclerosis (SSc)-related ILD, the authors strongly recommend against glucocorticoids as a first-line ILD treatment.
• For people with SSc-related ILD progression despite an initial ILD treatment, the authors strongly recommend against using long-term glucocorticoids.

Elana J. Bernstein, MD, MSc, a rheumatologist who directs the Columbia/New York-Presbyterian Scleroderma Center, and Sindhu R. Johnson, MD, a rheumatologist who directs the Toronto Scleroderma Program at the University of Toronto, provided a sneak peek of the recommendations to attendees before anticipated publication in Arthritis & Rheumatology and Arthritis Care & Research. For now, guideline summaries for screening and monitoring and treatment are currently available, and three manuscripts are under peer review: one about screening and monitoring, one about treatment, and one about the patient panel that participated in the effort.

Pediatric patients with SARDs excluded

The guidelines’ population of interest was people 17 years of age and older who were diagnosed with SARDs with a high risk of ILD. Pediatric patients with SARDs were excluded from the endeavor, as were those with systemic lupus erythematosus, antineutrophil cytoplasmic antibody–associated vasculitis, sarcoidosis, ankylosing spondylitis, undifferentiated connective tissue disease, interstitial pneumonia with autoimmune features, and those with unclassifiable ILD.

In the realm of screening, the guideline authors conditionally recommend two screening tests for patients considered at increased risk of ILD: pulmonary function tests and high-resolution chest CT (HRCT). Pulmonary function tests should include spirometry, lung volumes, and diffusion capacity. “Office spirometry alone is insufficient,” said Dr. Johnson, who served as lead author of the guidelines. And while a HRCT scan is recommended, “some patients may present to the emergency room with acute onset shortness of breath, and they may receive a CT angiogram to screen for pulmonary embolism,” she said. “It’s important to note that CT angiograms are performed in incomplete inspiration to maximize pulmonary artery enhancement. This may produce atelectasis that may obscure or mimic ILD. As a result, CTA studies are often inadequate to screen for ILD.”

Once a patient is diagnosed with ILD, three tests are recommended for monitoring: pulmonary function testing (every 3-6 months the first year in patients with IIM and SSc, then less frequently once stable, and every 3-12 months in the first year in patients with RA, SjD, and MCTD, then less frequently once stable); ambulatory desaturation testing every 3-12 months; and HRCT as needed. Dr. Johnson noted that while that the screening of ILD lies within the realm of rheumatologists, “once a patient is diagnosed, we are encouraged to comanage these patients with pulmonologists,” she said. “Ambulatory desaturation testing is not an infrequent test in the hands of pulmonologists. This is where co-management can be helpful.” She characterized a 6-minute walk test with continuous oximetry as “insufficient and is not synonymous with ambulatory desaturation testing. Ambulatory desaturation testing includes up titration of oxygen if a patient desaturates.”

The guidelines conditionally recommend against using chest radiography, 6-minute walk test distance, ambulatory desaturation testing, and bronchoscopy for ILD screening, and there is a strong recommendation against surgical lung biopsy. “However, there are unique circumstances where these tests may be considered,” Dr. Johnson said. “For example, ambulatory desaturation testing may be helpful if a patient is unable to perform a pulmonary function test. Bronchoscopy may be used to rule out infection, sarcoidosis, lymphoma, or alveolar hemorrhage, and surgical lung biopsy may be considered if you’re trying to rule out a malignancy.”

Similarly, several tests are conditionally recommended against for the monitoring of ILD, including chest radiography, the 6-minute walk test distance, and bronchoscopy. “But there are unique circumstances where they may be considered,” she said. “The 6-minute walk test may be used if a patient is unable to perform a pulmonary function test or if they’re being assessed for lung transplantation. Bronchoscopy may be used to rule out infection or alveolar hemorrhage.”
 

Preferred treatment options described

First-line treatment recommendations for ILD were based on the best available published evidence, voting panel expertise, and patient preferences. For SSc, the preferred treatment options include mycophenolate (CellCept), tocilizumab (Actemra), or rituximab (Rituxan and biosimilars), while additional options include cyclophosphamide, nintedanib (Ofev), and azathioprine. For myositis, the preferred treatment options include mycophenolate, azathioprine, rituximab, or calcineurin inhibitors, while additional options include a Janus kinase (JAK) inhibitor or cyclophosphamide. For MCTD, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include tocilizumab or cyclophosphamide. For RA and Sjögren’s, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include cyclophosphamide. Dr. Johnson emphasized that there was low certainty evidence to recommend one treatment over another. “Many situations might lead a provider to choose a different option for ILD treatment, such as the presence of comorbidities or extra-pulmonary disease,” she said. “So, while our guidelines were focused on effectiveness for ILD, providers may choose therapies that will help ILD and other disease manifestations.”

The guidelines conditionally recommend a short course of glucocorticoids as a bridging therapy or for treatment of a flare of ILD in patients with myositis, MCTD, RA, and Sjögren’s. The panel strongly recommends against the use of glucocorticoids in patients with SSc due to the concern for inducing a scleroderma renal crisis. “While this may be common knowledge for rheumatologists, it may not be common knowledge for pulmonologists,” she said. “So here is an opportunity to educate our pulmonology colleagues in our consultation notes.”

The guidelines also include recommendations for progression of ILD, which was defined using the INBUILD trial criteria. Mycophenolate is conditionally recommended to be the first ILD treatment for all SARDs when progression occurs, if it wasn’t the first ILD treatment used. “If it was, then other medications that rheumatologists are used to can be considered as the next ILD treatment in the face of progression: rituximab, nintedanib, tocilizumab, and cyclophosphamide,” she said. The guidelines include a conditional recommendation against long-term glucocorticoid use in myositis, MCTD, RA, and Sjögren’s, plus a strong recommendation against long-term glucocorticoid use in SSc. Finally, there is a conditional recommendation of referral for lung transplant evaluation at the appropriate time at experienced centers.

University of Toronto

A patient panel provided input

For the undertaking, a core team that included six rheumatologists; one pulmonologist; one thoracic radiologist; one expert on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology; and two literature review experts developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. The literature review team included 13 rheumatologists, 8 pulmonologists, and 3 methodologists. Finally, a 21-member patient panel was convened to share their values and preferences regarding screening, monitoring, and treatment of SARD-related ILD. Of these, Dr. Bernstein said that 4 were at risk for ILD and 17 had been diagnosed with ILD. Next, the literature review team conducted a systematic review and used the GRADE methodology to rate the available evidence as high, moderate, low, or very low. Then, a voting panel comprising 13 rheumatologists, 10 pulmonologists, 1 radiologist, and 3 patients from the patient panel cast votes for each PICO question and made final recommendations.

The review of evidence left the guidelines authors with 241 PICO questions, “which is a lot,” Dr. Bernstein said. “To put this in perspective, some guidelines address only 10 or 15 PICO questions. Fortunately, we had a dedicated group of experts who were up to the challenge.” Dr. Johnson emphasized that the forthcoming guidelines should not be used by insurers to mandate a specific order of prescribing. “Clinicians must retain the latitude to prescribe medications based on individual patient factors and preferences,” she said.

Dr. Bernstein disclosed that she is an adviser to, a consultant for, and has received grant or research support from Boehringer Ingelheim and has also received grant or research support from Kadmon and Pfizer. Dr. Johnson disclosed that she has received research support from the American College of Rheumatology to develop these guidelines. She has also been an investigator for trials sponsored by Bristol-Myers Squibb, Roche, and Boehringer Ingelheim and has mitigated these relevant conflicts of interest 1 year prior to the development of these guidelines, and will continue to do so for the foreseeable future.

SAN DIEGO – In the spring of 2024, the American College of Rheumatology is expected to release guidelines to help inform the screening, monitoring, and treatment of interstitial lung disease (ILD) in people with systemic autoimmune rheumatic diseases (SARDs).

The guidelines, which were previewed during a session at the ACR’s annual meeting, will include 50 recommendations, 3 of which met criteria for a strong rating:

• For people with SARDs at increased risk of developing ILD, the authors strongly recommend against screening with surgical lung biopsy.
• For people with systemic sclerosis (SSc)-related ILD, the authors strongly recommend against glucocorticoids as a first-line ILD treatment.
• For people with SSc-related ILD progression despite an initial ILD treatment, the authors strongly recommend against using long-term glucocorticoids.

Elana J. Bernstein, MD, MSc, a rheumatologist who directs the Columbia/New York-Presbyterian Scleroderma Center, and Sindhu R. Johnson, MD, a rheumatologist who directs the Toronto Scleroderma Program at the University of Toronto, provided a sneak peek of the recommendations to attendees before anticipated publication in Arthritis & Rheumatology and Arthritis Care & Research. For now, guideline summaries for screening and monitoring and treatment are currently available, and three manuscripts are under peer review: one about screening and monitoring, one about treatment, and one about the patient panel that participated in the effort.

Pediatric patients with SARDs excluded

The guidelines’ population of interest was people 17 years of age and older who were diagnosed with SARDs with a high risk of ILD. Pediatric patients with SARDs were excluded from the endeavor, as were those with systemic lupus erythematosus, antineutrophil cytoplasmic antibody–associated vasculitis, sarcoidosis, ankylosing spondylitis, undifferentiated connective tissue disease, interstitial pneumonia with autoimmune features, and those with unclassifiable ILD.

In the realm of screening, the guideline authors conditionally recommend two screening tests for patients considered at increased risk of ILD: pulmonary function tests and high-resolution chest CT (HRCT). Pulmonary function tests should include spirometry, lung volumes, and diffusion capacity. “Office spirometry alone is insufficient,” said Dr. Johnson, who served as lead author of the guidelines. And while a HRCT scan is recommended, “some patients may present to the emergency room with acute onset shortness of breath, and they may receive a CT angiogram to screen for pulmonary embolism,” she said. “It’s important to note that CT angiograms are performed in incomplete inspiration to maximize pulmonary artery enhancement. This may produce atelectasis that may obscure or mimic ILD. As a result, CTA studies are often inadequate to screen for ILD.”

Once a patient is diagnosed with ILD, three tests are recommended for monitoring: pulmonary function testing (every 3-6 months the first year in patients with IIM and SSc, then less frequently once stable, and every 3-12 months in the first year in patients with RA, SjD, and MCTD, then less frequently once stable); ambulatory desaturation testing every 3-12 months; and HRCT as needed. Dr. Johnson noted that while that the screening of ILD lies within the realm of rheumatologists, “once a patient is diagnosed, we are encouraged to comanage these patients with pulmonologists,” she said. “Ambulatory desaturation testing is not an infrequent test in the hands of pulmonologists. This is where co-management can be helpful.” She characterized a 6-minute walk test with continuous oximetry as “insufficient and is not synonymous with ambulatory desaturation testing. Ambulatory desaturation testing includes up titration of oxygen if a patient desaturates.”

The guidelines conditionally recommend against using chest radiography, 6-minute walk test distance, ambulatory desaturation testing, and bronchoscopy for ILD screening, and there is a strong recommendation against surgical lung biopsy. “However, there are unique circumstances where these tests may be considered,” Dr. Johnson said. “For example, ambulatory desaturation testing may be helpful if a patient is unable to perform a pulmonary function test. Bronchoscopy may be used to rule out infection, sarcoidosis, lymphoma, or alveolar hemorrhage, and surgical lung biopsy may be considered if you’re trying to rule out a malignancy.”

Similarly, several tests are conditionally recommended against for the monitoring of ILD, including chest radiography, the 6-minute walk test distance, and bronchoscopy. “But there are unique circumstances where they may be considered,” she said. “The 6-minute walk test may be used if a patient is unable to perform a pulmonary function test or if they’re being assessed for lung transplantation. Bronchoscopy may be used to rule out infection or alveolar hemorrhage.”
 

Preferred treatment options described

First-line treatment recommendations for ILD were based on the best available published evidence, voting panel expertise, and patient preferences. For SSc, the preferred treatment options include mycophenolate (CellCept), tocilizumab (Actemra), or rituximab (Rituxan and biosimilars), while additional options include cyclophosphamide, nintedanib (Ofev), and azathioprine. For myositis, the preferred treatment options include mycophenolate, azathioprine, rituximab, or calcineurin inhibitors, while additional options include a Janus kinase (JAK) inhibitor or cyclophosphamide. For MCTD, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include tocilizumab or cyclophosphamide. For RA and Sjögren’s, the preferred treatment options include mycophenolate, azathioprine, or rituximab, while additional options include cyclophosphamide. Dr. Johnson emphasized that there was low certainty evidence to recommend one treatment over another. “Many situations might lead a provider to choose a different option for ILD treatment, such as the presence of comorbidities or extra-pulmonary disease,” she said. “So, while our guidelines were focused on effectiveness for ILD, providers may choose therapies that will help ILD and other disease manifestations.”

The guidelines conditionally recommend a short course of glucocorticoids as a bridging therapy or for treatment of a flare of ILD in patients with myositis, MCTD, RA, and Sjögren’s. The panel strongly recommends against the use of glucocorticoids in patients with SSc due to the concern for inducing a scleroderma renal crisis. “While this may be common knowledge for rheumatologists, it may not be common knowledge for pulmonologists,” she said. “So here is an opportunity to educate our pulmonology colleagues in our consultation notes.”

The guidelines also include recommendations for progression of ILD, which was defined using the INBUILD trial criteria. Mycophenolate is conditionally recommended to be the first ILD treatment for all SARDs when progression occurs, if it wasn’t the first ILD treatment used. “If it was, then other medications that rheumatologists are used to can be considered as the next ILD treatment in the face of progression: rituximab, nintedanib, tocilizumab, and cyclophosphamide,” she said. The guidelines include a conditional recommendation against long-term glucocorticoid use in myositis, MCTD, RA, and Sjögren’s, plus a strong recommendation against long-term glucocorticoid use in SSc. Finally, there is a conditional recommendation of referral for lung transplant evaluation at the appropriate time at experienced centers.

University of Toronto

A patient panel provided input

For the undertaking, a core team that included six rheumatologists; one pulmonologist; one thoracic radiologist; one expert on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology; and two literature review experts developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. The literature review team included 13 rheumatologists, 8 pulmonologists, and 3 methodologists. Finally, a 21-member patient panel was convened to share their values and preferences regarding screening, monitoring, and treatment of SARD-related ILD. Of these, Dr. Bernstein said that 4 were at risk for ILD and 17 had been diagnosed with ILD. Next, the literature review team conducted a systematic review and used the GRADE methodology to rate the available evidence as high, moderate, low, or very low. Then, a voting panel comprising 13 rheumatologists, 10 pulmonologists, 1 radiologist, and 3 patients from the patient panel cast votes for each PICO question and made final recommendations.

The review of evidence left the guidelines authors with 241 PICO questions, “which is a lot,” Dr. Bernstein said. “To put this in perspective, some guidelines address only 10 or 15 PICO questions. Fortunately, we had a dedicated group of experts who were up to the challenge.” Dr. Johnson emphasized that the forthcoming guidelines should not be used by insurers to mandate a specific order of prescribing. “Clinicians must retain the latitude to prescribe medications based on individual patient factors and preferences,” she said.

Dr. Bernstein disclosed that she is an adviser to, a consultant for, and has received grant or research support from Boehringer Ingelheim and has also received grant or research support from Kadmon and Pfizer. Dr. Johnson disclosed that she has received research support from the American College of Rheumatology to develop these guidelines. She has also been an investigator for trials sponsored by Bristol-Myers Squibb, Roche, and Boehringer Ingelheim and has mitigated these relevant conflicts of interest 1 year prior to the development of these guidelines, and will continue to do so for the foreseeable future.

SAN DIEGO – The use of abatacept (Orencia) in individuals at risk of developing rheumatoid arthritis is feasible, results from a proof-of-concept, phase 2b study showed.

The findings are encouraging because data from at-risk cohorts have reported rates of progression to RA in excess of 50% over 24 months, Andrew Cope, MBBS, PhD, head of the Center for Rheumatic Diseases at King’s College London, said during an abstract session at the annual meeting of the American College of Rheumatology. “If we’re going to do interception trials, we need to make sure that the risk-benefit is about right, and we also need to have enough events in the placebo arm against which to compare any impact of a drug,” he said.

For the randomized, placebo-controlled study known as the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) trial, Dr. Cope and colleagues at 28 sites in the United Kingdom and 3 in the Netherlands set out to evaluate the feasibility, efficacy, and acceptability of abatacept therapy in subjects at high risk of developing RA and to characterize the effects of T-cell costimulation modulation on the evaluation of immune and inflammatory responses associated with anti–citrullinated protein antibody (ACPA) prior to, during, and after therapy. They enrolled male and female individuals aged 18 and older with arthralgia, considered to be inflammatory in nature, and who were either ACPA and rheumatoid factor (RF) positive, or had high-titer ACPA. The researchers excluded individuals with clinically apparent arthritis, or a history of inflammatory arthritis as assessed by a rheumatologist, as well as those with a history or current use of conventional or targeted synthetic or biologic disease-modifying antirheumatic drugs (DMARDs), or oral or parenteral use of corticosteroids. They also excluded people with comorbidities requiring treatment with immunosuppressive or immune-modulating therapy, those who had received a live vaccine in the prior 3 months, as well as those who were pregnant or breastfeeding.

Study participants were randomized 1:1 to receive 52 weekly subcutaneous injections of placebo or 125 mg abatacept and were followed for another 52 weeks. The primary endpoint was time to development of clinically apparent arthritis in at least three joints, or to fulfillment of the ACR/European Alliance of Associations for Rheumatology 2010 criteria for RA, whichever comes first, during 24 months of follow-up, with joint synovitis confirmed by ultrasound.

Dr. Cope reported results from 103 patients in the placebo arm and 110 patients in the abatacept arm. Their mean age was 49 years and 77% were female. At baseline, 73% of study participants had a power Doppler score of 0, which suggests minimal levels of active subclinical synovitis in a substantial proportion of this at-risk trial population. At 52 weeks, the researchers observed 30 events in the placebo arm (29%) and 7 in the abatacept arm (6%), while at 104 weeks, there were 38 events in the placebo arm (37%) and 27 in the abatacept arm (25%). This reflected a difference in mean arthritis-free survival time between arms of 99.2 days in favor of abatacept (P = .002).

Prespecified exploratory analysis showed that individuals with high levels of ACPA or who had an extended autoantibody profile at baseline were more likely to remain arthritis-free after abatacept therapy. “So, we’re seeing a hint here that there is an abatacept-sensitive population,” Dr. Cope said.

There were 7 serious adverse events in the abatacept group and 11 in the placebo group, including 2 deaths, 1 in each arm. None of the deaths were attributable to the study drug.

In other findings during the treatment phase, subjects in the abatacept arm, when compared to those in the placebo arm, had reduced levels of anxiety on the Hospital Anxiety Depression Scale; reduced fatigue, improved physical and emotional well-being, and improved functional well-being on the Functional Assessment of Chronic Illness Therapy-Fatigue measure; reduced sleep problems on the Symptoms in Persons at Risk of Rheumatoid Arthritis questionnaire; positive impact on work instability on the RA Work Instability Scale, and a positive impact on illness beliefs.

Based on the study findings, Dr. Cope concluded that clinical trials of RA interception are feasible, and that the rates of progression to RA are consistent with cohorts in other studies. “Abatacept reduced rates of progression to RA,” he said. “We also have data to suggest that the drug reduced subclinical inflammation as defined by ultrasound.”

One of the session moderators, Jon T. Giles, MD, MPH, associate professor of medicine at Columbia University, New York, asked Dr. Cope how he and his colleagues assessed the acceptability of abatacept. “Drug adherence is quite a good way to assess that, and we set the adherence level stringently at about 90%,” Dr. Cope said. “The nonadherence was about 26%. Getting people who don’t have disease to inject [the drug] weekly is not a trivial thing.”

Bristol-Myers Squibb funded the study. Dr. Cope disclosed that he has received grant support, consulting, and/or speakers bureau fees from GlaxoSmithKline, AbbVie, Janssen, Bristol-Myers Squibb, UCB, Galapagos, and Lilly. Many coauthors of the APIPPRA trial had financial relationships with multiple pharmaceutical companies, including Bristol-Myers Squibb. Dr. Giles disclosed that he is a consultant for AbbVie, Gilead, Lilly, Novartis, and Pfizer.

SAN DIEGO – The use of abatacept (Orencia) in individuals at risk of developing rheumatoid arthritis is feasible, results from a proof-of-concept, phase 2b study showed.

The findings are encouraging because data from at-risk cohorts have reported rates of progression to RA in excess of 50% over 24 months, Andrew Cope, MBBS, PhD, head of the Center for Rheumatic Diseases at King’s College London, said during an abstract session at the annual meeting of the American College of Rheumatology. “If we’re going to do interception trials, we need to make sure that the risk-benefit is about right, and we also need to have enough events in the placebo arm against which to compare any impact of a drug,” he said.

For the randomized, placebo-controlled study known as the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) trial, Dr. Cope and colleagues at 28 sites in the United Kingdom and 3 in the Netherlands set out to evaluate the feasibility, efficacy, and acceptability of abatacept therapy in subjects at high risk of developing RA and to characterize the effects of T-cell costimulation modulation on the evaluation of immune and inflammatory responses associated with anti–citrullinated protein antibody (ACPA) prior to, during, and after therapy. They enrolled male and female individuals aged 18 and older with arthralgia, considered to be inflammatory in nature, and who were either ACPA and rheumatoid factor (RF) positive, or had high-titer ACPA. The researchers excluded individuals with clinically apparent arthritis, or a history of inflammatory arthritis as assessed by a rheumatologist, as well as those with a history or current use of conventional or targeted synthetic or biologic disease-modifying antirheumatic drugs (DMARDs), or oral or parenteral use of corticosteroids. They also excluded people with comorbidities requiring treatment with immunosuppressive or immune-modulating therapy, those who had received a live vaccine in the prior 3 months, as well as those who were pregnant or breastfeeding.

Study participants were randomized 1:1 to receive 52 weekly subcutaneous injections of placebo or 125 mg abatacept and were followed for another 52 weeks. The primary endpoint was time to development of clinically apparent arthritis in at least three joints, or to fulfillment of the ACR/European Alliance of Associations for Rheumatology 2010 criteria for RA, whichever comes first, during 24 months of follow-up, with joint synovitis confirmed by ultrasound.

Dr. Cope reported results from 103 patients in the placebo arm and 110 patients in the abatacept arm. Their mean age was 49 years and 77% were female. At baseline, 73% of study participants had a power Doppler score of 0, which suggests minimal levels of active subclinical synovitis in a substantial proportion of this at-risk trial population. At 52 weeks, the researchers observed 30 events in the placebo arm (29%) and 7 in the abatacept arm (6%), while at 104 weeks, there were 38 events in the placebo arm (37%) and 27 in the abatacept arm (25%). This reflected a difference in mean arthritis-free survival time between arms of 99.2 days in favor of abatacept (P = .002).

Prespecified exploratory analysis showed that individuals with high levels of ACPA or who had an extended autoantibody profile at baseline were more likely to remain arthritis-free after abatacept therapy. “So, we’re seeing a hint here that there is an abatacept-sensitive population,” Dr. Cope said.

There were 7 serious adverse events in the abatacept group and 11 in the placebo group, including 2 deaths, 1 in each arm. None of the deaths were attributable to the study drug.

In other findings during the treatment phase, subjects in the abatacept arm, when compared to those in the placebo arm, had reduced levels of anxiety on the Hospital Anxiety Depression Scale; reduced fatigue, improved physical and emotional well-being, and improved functional well-being on the Functional Assessment of Chronic Illness Therapy-Fatigue measure; reduced sleep problems on the Symptoms in Persons at Risk of Rheumatoid Arthritis questionnaire; positive impact on work instability on the RA Work Instability Scale, and a positive impact on illness beliefs.

Based on the study findings, Dr. Cope concluded that clinical trials of RA interception are feasible, and that the rates of progression to RA are consistent with cohorts in other studies. “Abatacept reduced rates of progression to RA,” he said. “We also have data to suggest that the drug reduced subclinical inflammation as defined by ultrasound.”

One of the session moderators, Jon T. Giles, MD, MPH, associate professor of medicine at Columbia University, New York, asked Dr. Cope how he and his colleagues assessed the acceptability of abatacept. “Drug adherence is quite a good way to assess that, and we set the adherence level stringently at about 90%,” Dr. Cope said. “The nonadherence was about 26%. Getting people who don’t have disease to inject [the drug] weekly is not a trivial thing.”

Bristol-Myers Squibb funded the study. Dr. Cope disclosed that he has received grant support, consulting, and/or speakers bureau fees from GlaxoSmithKline, AbbVie, Janssen, Bristol-Myers Squibb, UCB, Galapagos, and Lilly. Many coauthors of the APIPPRA trial had financial relationships with multiple pharmaceutical companies, including Bristol-Myers Squibb. Dr. Giles disclosed that he is a consultant for AbbVie, Gilead, Lilly, Novartis, and Pfizer.

SAN DIEGO – The use of abatacept (Orencia) in individuals at risk of developing rheumatoid arthritis is feasible, results from a proof-of-concept, phase 2b study showed.

The findings are encouraging because data from at-risk cohorts have reported rates of progression to RA in excess of 50% over 24 months, Andrew Cope, MBBS, PhD, head of the Center for Rheumatic Diseases at King’s College London, said during an abstract session at the annual meeting of the American College of Rheumatology. “If we’re going to do interception trials, we need to make sure that the risk-benefit is about right, and we also need to have enough events in the placebo arm against which to compare any impact of a drug,” he said.

For the randomized, placebo-controlled study known as the Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA) trial, Dr. Cope and colleagues at 28 sites in the United Kingdom and 3 in the Netherlands set out to evaluate the feasibility, efficacy, and acceptability of abatacept therapy in subjects at high risk of developing RA and to characterize the effects of T-cell costimulation modulation on the evaluation of immune and inflammatory responses associated with anti–citrullinated protein antibody (ACPA) prior to, during, and after therapy. They enrolled male and female individuals aged 18 and older with arthralgia, considered to be inflammatory in nature, and who were either ACPA and rheumatoid factor (RF) positive, or had high-titer ACPA. The researchers excluded individuals with clinically apparent arthritis, or a history of inflammatory arthritis as assessed by a rheumatologist, as well as those with a history or current use of conventional or targeted synthetic or biologic disease-modifying antirheumatic drugs (DMARDs), or oral or parenteral use of corticosteroids. They also excluded people with comorbidities requiring treatment with immunosuppressive or immune-modulating therapy, those who had received a live vaccine in the prior 3 months, as well as those who were pregnant or breastfeeding.

Study participants were randomized 1:1 to receive 52 weekly subcutaneous injections of placebo or 125 mg abatacept and were followed for another 52 weeks. The primary endpoint was time to development of clinically apparent arthritis in at least three joints, or to fulfillment of the ACR/European Alliance of Associations for Rheumatology 2010 criteria for RA, whichever comes first, during 24 months of follow-up, with joint synovitis confirmed by ultrasound.

Dr. Cope reported results from 103 patients in the placebo arm and 110 patients in the abatacept arm. Their mean age was 49 years and 77% were female. At baseline, 73% of study participants had a power Doppler score of 0, which suggests minimal levels of active subclinical synovitis in a substantial proportion of this at-risk trial population. At 52 weeks, the researchers observed 30 events in the placebo arm (29%) and 7 in the abatacept arm (6%), while at 104 weeks, there were 38 events in the placebo arm (37%) and 27 in the abatacept arm (25%). This reflected a difference in mean arthritis-free survival time between arms of 99.2 days in favor of abatacept (P = .002).

Prespecified exploratory analysis showed that individuals with high levels of ACPA or who had an extended autoantibody profile at baseline were more likely to remain arthritis-free after abatacept therapy. “So, we’re seeing a hint here that there is an abatacept-sensitive population,” Dr. Cope said.

There were 7 serious adverse events in the abatacept group and 11 in the placebo group, including 2 deaths, 1 in each arm. None of the deaths were attributable to the study drug.

In other findings during the treatment phase, subjects in the abatacept arm, when compared to those in the placebo arm, had reduced levels of anxiety on the Hospital Anxiety Depression Scale; reduced fatigue, improved physical and emotional well-being, and improved functional well-being on the Functional Assessment of Chronic Illness Therapy-Fatigue measure; reduced sleep problems on the Symptoms in Persons at Risk of Rheumatoid Arthritis questionnaire; positive impact on work instability on the RA Work Instability Scale, and a positive impact on illness beliefs.

Based on the study findings, Dr. Cope concluded that clinical trials of RA interception are feasible, and that the rates of progression to RA are consistent with cohorts in other studies. “Abatacept reduced rates of progression to RA,” he said. “We also have data to suggest that the drug reduced subclinical inflammation as defined by ultrasound.”

One of the session moderators, Jon T. Giles, MD, MPH, associate professor of medicine at Columbia University, New York, asked Dr. Cope how he and his colleagues assessed the acceptability of abatacept. “Drug adherence is quite a good way to assess that, and we set the adherence level stringently at about 90%,” Dr. Cope said. “The nonadherence was about 26%. Getting people who don’t have disease to inject [the drug] weekly is not a trivial thing.”

Bristol-Myers Squibb funded the study. Dr. Cope disclosed that he has received grant support, consulting, and/or speakers bureau fees from GlaxoSmithKline, AbbVie, Janssen, Bristol-Myers Squibb, UCB, Galapagos, and Lilly. Many coauthors of the APIPPRA trial had financial relationships with multiple pharmaceutical companies, including Bristol-Myers Squibb. Dr. Giles disclosed that he is a consultant for AbbVie, Gilead, Lilly, Novartis, and Pfizer.

SAN DIEGO – A new randomized, double-blind, phase 3 study of the first-in-class drug telitacicept showed efficacy and safety in patients aged 18-65 with rheumatoid arthritis who were resistant to methotrexate, researchers reported at the annual meeting of the American College of Rheumatology.

Telitacicept is a recombinant fusion protein that aims to target and neutralize B lymphocyte stimulator (also known as B-cell activating factor) and a proliferation-inducing ligand (APRIL), both of which are linked to autoimmunity. Per the industry-funded trial, patients who took 160 mg weekly of the drug versus placebo for 24 weeks met the primary endpoint of achieving at least a 20% improvement in ACR response criteria (60.0% vs. 26.9%, respectively, P < .001), researcher Qing Zuraw, MD, MPH, MBA, of drug developer RemeGen, said in her presentation.

Rheumatologist Jeffrey A. Sparks MD, MMSc, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, who did not take part in the study but is familiar with the findings, said in an interview that the results are promising. “The magnitude of effect is impressive, and it seems it was well tolerated with relatively few serious adverse events. I would want to see this replicated in other patient populations. Also, more data are needed to truly establish safety.”

He added that, “once more data emerges, there would be a debate on where to place this in the treatment lines.”

According to Dr. Sparks, nearly half of patients with RA either cannot tolerate methotrexate or have partial or no response. “There are currently several available treatment options. These patients typically use either [tumor necrosis factor] inhibitors, another targeted medication, or combination therapy.”

Telitacicept is approved in China to treat systemic lupus erythematosus, Dr. Zuraw noted.

The researchers randomly assigned patients with moderate to severe RA at a 3:1 ratio to the drug (n = 360) or placebo (n = 119). The participants were aged 18-65 with a mean age of 49-50 depending on group, and 81.1%-87.4% females depending on group. Ethnicity/race was not reported.

At week 24, patients in the telitacicept group were more likely to achieve an ACR 50 response versus placebo (21.4% vs. 5.9%, respectively; P < .001).

“Significantly more patients in the telitacicept 160 mg group showed no radiographic progression (change in modified Total Sharp Score [mTSS] ≤ 0) at week 24, compared with placebo (90.2% vs. 66.4%; P < .001),” the researchers reported. “Additionally, patients in the telitacicept 160-mg group showed significantly less progression of joint damage (as measured by mTSS, joint space narrowing score, erosion score) from baseline to week 24.”

Treatment-emergent adverse effect levels were similar between the two groups (79.7% in the drug group and 77.3% in the placebo group), as were serious adverse events (6.4% and 6.7%, respectively) and infections/infestations (41.1% and 42.0%, respectively).

Dr. Zuraw noted limitations: The trial lacked a comparator treatment, and the study took place in a Chinese population with limited racial diversity.

In a Q&A session following Dr. Zuraw’s presentation, an audience member offered some perspective instead of a question by noting that most biologic drugs reach an ACR 20 response rate of about 60%, and most fail to move patients to low disease activity. “That’s the case for your product,” he told Dr. Zuraw. “That’s true for basically everything.”

He added that failing to discuss clinical importance is “a flaw of many talks.”

Dr. Zuraw responded that the many drugs do indeed have a response rate in the range of 60%, and she said the company will consider providing information about clinical impact in future talks.

No information is available about the potential cost of the drug. “This targets two proteins, so it is possible that it could have additional costs than typical biologics,” Dr. Sparks said.

RemeGen funded the study. Dr. Zuraw and some other authors disclosed financial relationships with RemeGen. Dr. Sparks reported receiving support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Gordon and Llura Gund Foundation; research support from Bristol-Myers Squibb; and consulting for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova, Janssen, Optum, Pfizer, Recor, Sobi, and UCB.

SAN DIEGO – A new randomized, double-blind, phase 3 study of the first-in-class drug telitacicept showed efficacy and safety in patients aged 18-65 with rheumatoid arthritis who were resistant to methotrexate, researchers reported at the annual meeting of the American College of Rheumatology.

Telitacicept is a recombinant fusion protein that aims to target and neutralize B lymphocyte stimulator (also known as B-cell activating factor) and a proliferation-inducing ligand (APRIL), both of which are linked to autoimmunity. Per the industry-funded trial, patients who took 160 mg weekly of the drug versus placebo for 24 weeks met the primary endpoint of achieving at least a 20% improvement in ACR response criteria (60.0% vs. 26.9%, respectively, P < .001), researcher Qing Zuraw, MD, MPH, MBA, of drug developer RemeGen, said in her presentation.

Rheumatologist Jeffrey A. Sparks MD, MMSc, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, who did not take part in the study but is familiar with the findings, said in an interview that the results are promising. “The magnitude of effect is impressive, and it seems it was well tolerated with relatively few serious adverse events. I would want to see this replicated in other patient populations. Also, more data are needed to truly establish safety.”

He added that, “once more data emerges, there would be a debate on where to place this in the treatment lines.”

According to Dr. Sparks, nearly half of patients with RA either cannot tolerate methotrexate or have partial or no response. “There are currently several available treatment options. These patients typically use either [tumor necrosis factor] inhibitors, another targeted medication, or combination therapy.”

Telitacicept is approved in China to treat systemic lupus erythematosus, Dr. Zuraw noted.

The researchers randomly assigned patients with moderate to severe RA at a 3:1 ratio to the drug (n = 360) or placebo (n = 119). The participants were aged 18-65 with a mean age of 49-50 depending on group, and 81.1%-87.4% females depending on group. Ethnicity/race was not reported.

At week 24, patients in the telitacicept group were more likely to achieve an ACR 50 response versus placebo (21.4% vs. 5.9%, respectively; P < .001).

“Significantly more patients in the telitacicept 160 mg group showed no radiographic progression (change in modified Total Sharp Score [mTSS] ≤ 0) at week 24, compared with placebo (90.2% vs. 66.4%; P < .001),” the researchers reported. “Additionally, patients in the telitacicept 160-mg group showed significantly less progression of joint damage (as measured by mTSS, joint space narrowing score, erosion score) from baseline to week 24.”

Treatment-emergent adverse effect levels were similar between the two groups (79.7% in the drug group and 77.3% in the placebo group), as were serious adverse events (6.4% and 6.7%, respectively) and infections/infestations (41.1% and 42.0%, respectively).

Dr. Zuraw noted limitations: The trial lacked a comparator treatment, and the study took place in a Chinese population with limited racial diversity.

In a Q&A session following Dr. Zuraw’s presentation, an audience member offered some perspective instead of a question by noting that most biologic drugs reach an ACR 20 response rate of about 60%, and most fail to move patients to low disease activity. “That’s the case for your product,” he told Dr. Zuraw. “That’s true for basically everything.”

He added that failing to discuss clinical importance is “a flaw of many talks.”

Dr. Zuraw responded that the many drugs do indeed have a response rate in the range of 60%, and she said the company will consider providing information about clinical impact in future talks.

No information is available about the potential cost of the drug. “This targets two proteins, so it is possible that it could have additional costs than typical biologics,” Dr. Sparks said.

RemeGen funded the study. Dr. Zuraw and some other authors disclosed financial relationships with RemeGen. Dr. Sparks reported receiving support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Gordon and Llura Gund Foundation; research support from Bristol-Myers Squibb; and consulting for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova, Janssen, Optum, Pfizer, Recor, Sobi, and UCB.

SAN DIEGO – A new randomized, double-blind, phase 3 study of the first-in-class drug telitacicept showed efficacy and safety in patients aged 18-65 with rheumatoid arthritis who were resistant to methotrexate, researchers reported at the annual meeting of the American College of Rheumatology.

Telitacicept is a recombinant fusion protein that aims to target and neutralize B lymphocyte stimulator (also known as B-cell activating factor) and a proliferation-inducing ligand (APRIL), both of which are linked to autoimmunity. Per the industry-funded trial, patients who took 160 mg weekly of the drug versus placebo for 24 weeks met the primary endpoint of achieving at least a 20% improvement in ACR response criteria (60.0% vs. 26.9%, respectively, P < .001), researcher Qing Zuraw, MD, MPH, MBA, of drug developer RemeGen, said in her presentation.

Rheumatologist Jeffrey A. Sparks MD, MMSc, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, who did not take part in the study but is familiar with the findings, said in an interview that the results are promising. “The magnitude of effect is impressive, and it seems it was well tolerated with relatively few serious adverse events. I would want to see this replicated in other patient populations. Also, more data are needed to truly establish safety.”

He added that, “once more data emerges, there would be a debate on where to place this in the treatment lines.”

According to Dr. Sparks, nearly half of patients with RA either cannot tolerate methotrexate or have partial or no response. “There are currently several available treatment options. These patients typically use either [tumor necrosis factor] inhibitors, another targeted medication, or combination therapy.”

Telitacicept is approved in China to treat systemic lupus erythematosus, Dr. Zuraw noted.

The researchers randomly assigned patients with moderate to severe RA at a 3:1 ratio to the drug (n = 360) or placebo (n = 119). The participants were aged 18-65 with a mean age of 49-50 depending on group, and 81.1%-87.4% females depending on group. Ethnicity/race was not reported.

At week 24, patients in the telitacicept group were more likely to achieve an ACR 50 response versus placebo (21.4% vs. 5.9%, respectively; P < .001).

“Significantly more patients in the telitacicept 160 mg group showed no radiographic progression (change in modified Total Sharp Score [mTSS] ≤ 0) at week 24, compared with placebo (90.2% vs. 66.4%; P < .001),” the researchers reported. “Additionally, patients in the telitacicept 160-mg group showed significantly less progression of joint damage (as measured by mTSS, joint space narrowing score, erosion score) from baseline to week 24.”

Treatment-emergent adverse effect levels were similar between the two groups (79.7% in the drug group and 77.3% in the placebo group), as were serious adverse events (6.4% and 6.7%, respectively) and infections/infestations (41.1% and 42.0%, respectively).

Dr. Zuraw noted limitations: The trial lacked a comparator treatment, and the study took place in a Chinese population with limited racial diversity.

In a Q&A session following Dr. Zuraw’s presentation, an audience member offered some perspective instead of a question by noting that most biologic drugs reach an ACR 20 response rate of about 60%, and most fail to move patients to low disease activity. “That’s the case for your product,” he told Dr. Zuraw. “That’s true for basically everything.”

He added that failing to discuss clinical importance is “a flaw of many talks.”

Dr. Zuraw responded that the many drugs do indeed have a response rate in the range of 60%, and she said the company will consider providing information about clinical impact in future talks.

No information is available about the potential cost of the drug. “This targets two proteins, so it is possible that it could have additional costs than typical biologics,” Dr. Sparks said.

RemeGen funded the study. Dr. Zuraw and some other authors disclosed financial relationships with RemeGen. Dr. Sparks reported receiving support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Gordon and Llura Gund Foundation; research support from Bristol-Myers Squibb; and consulting for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova, Janssen, Optum, Pfizer, Recor, Sobi, and UCB.

SAN DIEGO – Researchers say they’ve developed a novel blood-based assay that can differentiate patients with seropositive or seronegative rheumatoid arthritis from healthy people and those with other inflammatory diseases or osteoarthritis.

While cautioning that the results need to be confirmed, University of Oxford (England) rheumatologist Peter Taylor, PhD, MA, told an audience at the annual meeting of the American College of Rheumatology that the test has an overall mean sensitivity of 90.8% (standard deviation, 0.94%; 95% confidence interval, 83.2%-95.4%) and mean specificity of 96.1% (SD, 0.64%; 95% CI, 92.7%-97.9%). The mean area under the curve (AUC) is 0.991 (SD, 0.001; 95% CI, 97.2%-99.6%).

SAN DIEGO – Researchers say they’ve developed a novel blood-based assay that can differentiate patients with seropositive or seronegative rheumatoid arthritis from healthy people and those with other inflammatory diseases or osteoarthritis.

While cautioning that the results need to be confirmed, University of Oxford (England) rheumatologist Peter Taylor, PhD, MA, told an audience at the annual meeting of the American College of Rheumatology that the test has an overall mean sensitivity of 90.8% (standard deviation, 0.94%; 95% confidence interval, 83.2%-95.4%) and mean specificity of 96.1% (SD, 0.64%; 95% CI, 92.7%-97.9%). The mean area under the curve (AUC) is 0.991 (SD, 0.001; 95% CI, 97.2%-99.6%).

SAN DIEGO – Researchers say they’ve developed a novel blood-based assay that can differentiate patients with seropositive or seronegative rheumatoid arthritis from healthy people and those with other inflammatory diseases or osteoarthritis.

While cautioning that the results need to be confirmed, University of Oxford (England) rheumatologist Peter Taylor, PhD, MA, told an audience at the annual meeting of the American College of Rheumatology that the test has an overall mean sensitivity of 90.8% (standard deviation, 0.94%; 95% confidence interval, 83.2%-95.4%) and mean specificity of 96.1% (SD, 0.64%; 95% CI, 92.7%-97.9%). The mean area under the curve (AUC) is 0.991 (SD, 0.001; 95% CI, 97.2%-99.6%).