Psoriatic Arthritis ICYMI

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: In patients with psoriatic arthritis (PsA), joint swelling was more closely related to and better predicted ultrasound-defined inflammation and active synovitis at 1 year than joint tenderness.

Major finding: Swollen joint count correlated better with greyscale and power Doppler (PD) joint scores (correlation coefficient [r] 0.37 and 0.47, respectively) than tender joint count (PD-joint score; r 0.33). Ultrasound verified active synovitis at 12-month follow-up was better predicted by swelling (odds ratio [OR] 6.33; 95% CI 3.70-10.83) vs. tenderness (OR 3.58; 95% CI 2.29-5.58) at baseline.

Study details: Findings are from a prospective study including 83 patients with PsA who underwent clinical and ultrasound examinations at 2 visits scheduled 12 months apart.

Disclosures: This work was funded by Pfizer. The authors declared no conflict of interests.

Source: Bosch P et al. Rheumatology. 2021;keab764 (Oct 21). Doi: 10.1093/rheumatology/keab764.

Key clinical point: In patients with psoriatic arthritis (PsA), joint swelling was more closely related to and better predicted ultrasound-defined inflammation and active synovitis at 1 year than joint tenderness.

Major finding: Swollen joint count correlated better with greyscale and power Doppler (PD) joint scores (correlation coefficient [r] 0.37 and 0.47, respectively) than tender joint count (PD-joint score; r 0.33). Ultrasound verified active synovitis at 12-month follow-up was better predicted by swelling (odds ratio [OR] 6.33; 95% CI 3.70-10.83) vs. tenderness (OR 3.58; 95% CI 2.29-5.58) at baseline.

Study details: Findings are from a prospective study including 83 patients with PsA who underwent clinical and ultrasound examinations at 2 visits scheduled 12 months apart.

Disclosures: This work was funded by Pfizer. The authors declared no conflict of interests.

Source: Bosch P et al. Rheumatology. 2021;keab764 (Oct 21). Doi: 10.1093/rheumatology/keab764.

Key clinical point: In patients with psoriatic arthritis (PsA), joint swelling was more closely related to and better predicted ultrasound-defined inflammation and active synovitis at 1 year than joint tenderness.

Major finding: Swollen joint count correlated better with greyscale and power Doppler (PD) joint scores (correlation coefficient [r] 0.37 and 0.47, respectively) than tender joint count (PD-joint score; r 0.33). Ultrasound verified active synovitis at 12-month follow-up was better predicted by swelling (odds ratio [OR] 6.33; 95% CI 3.70-10.83) vs. tenderness (OR 3.58; 95% CI 2.29-5.58) at baseline.

Study details: Findings are from a prospective study including 83 patients with PsA who underwent clinical and ultrasound examinations at 2 visits scheduled 12 months apart.

Disclosures: This work was funded by Pfizer. The authors declared no conflict of interests.

Source: Bosch P et al. Rheumatology. 2021;keab764 (Oct 21). Doi: 10.1093/rheumatology/keab764.

Key clinical point: The risk for serious infections (SI) was significantly lower in patients with psoriatic arthritis (PsA) vs. patients with rheumatoid arthritis (RA) who were receiving tumor necrosis factor inhibitors (TNFi).

Major finding: The crude incidence rate for SI was lower in patients with PsA (2.16; 95% CI 1.66-2.81) vs. those with RA (4.17; 95% CI 3.52-4.95). Patients with PsA vs. RA still had a lower risk of contracting SI even after adjusting for multiple factors (adjusted hazard ratio 0.65; P = .025).

Study details: Findings are from a prospective observational multicenter study including 1,352 and 1,007 patients with RA and PsA, respectively, from the Norwegian-Disease Modifying Anti-Rheumatic Drug Registry. A total of 3,169 TNFi treatment courses were included in the study.

Disclosures: This study was funded by South-Eastern Health Authority and received partial support from AbbVie, BMS, MSD, Pfizer, Roche, and UCB. The authors report receiving personal fees and grants from the above-mentioned sources and other pharmaceutical companies.

Source: Christensen IE et al. Ann Rheum Dis. 2021 (Oct 8). Doi: 10.1136/annrheumdis-2021-221007.

Key clinical point: The risk for serious infections (SI) was significantly lower in patients with psoriatic arthritis (PsA) vs. patients with rheumatoid arthritis (RA) who were receiving tumor necrosis factor inhibitors (TNFi).

Major finding: The crude incidence rate for SI was lower in patients with PsA (2.16; 95% CI 1.66-2.81) vs. those with RA (4.17; 95% CI 3.52-4.95). Patients with PsA vs. RA still had a lower risk of contracting SI even after adjusting for multiple factors (adjusted hazard ratio 0.65; P = .025).

Study details: Findings are from a prospective observational multicenter study including 1,352 and 1,007 patients with RA and PsA, respectively, from the Norwegian-Disease Modifying Anti-Rheumatic Drug Registry. A total of 3,169 TNFi treatment courses were included in the study.

Disclosures: This study was funded by South-Eastern Health Authority and received partial support from AbbVie, BMS, MSD, Pfizer, Roche, and UCB. The authors report receiving personal fees and grants from the above-mentioned sources and other pharmaceutical companies.

Source: Christensen IE et al. Ann Rheum Dis. 2021 (Oct 8). Doi: 10.1136/annrheumdis-2021-221007.

Key clinical point: The risk for serious infections (SI) was significantly lower in patients with psoriatic arthritis (PsA) vs. patients with rheumatoid arthritis (RA) who were receiving tumor necrosis factor inhibitors (TNFi).

Major finding: The crude incidence rate for SI was lower in patients with PsA (2.16; 95% CI 1.66-2.81) vs. those with RA (4.17; 95% CI 3.52-4.95). Patients with PsA vs. RA still had a lower risk of contracting SI even after adjusting for multiple factors (adjusted hazard ratio 0.65; P = .025).

Study details: Findings are from a prospective observational multicenter study including 1,352 and 1,007 patients with RA and PsA, respectively, from the Norwegian-Disease Modifying Anti-Rheumatic Drug Registry. A total of 3,169 TNFi treatment courses were included in the study.

Disclosures: This study was funded by South-Eastern Health Authority and received partial support from AbbVie, BMS, MSD, Pfizer, Roche, and UCB. The authors report receiving personal fees and grants from the above-mentioned sources and other pharmaceutical companies.

Source: Christensen IE et al. Ann Rheum Dis. 2021 (Oct 8). Doi: 10.1136/annrheumdis-2021-221007.

Key clinical point: Upadacitinib continued to demonstrate improvement in clinical manifestations of psoriatic arthritis (PsA) through week 56 in patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs) with no new adverse events.

Major finding: Consistent with week 24, a higher proportion of patients achieved at least 20% improvement in the American College of Rheumatology criteria with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Study details: Findings are from an analysis of 1,419 patients with active PsA and inadequate response to at least 1 non-bDMARD who completed 56 weeks of treatment in the phase 3 SELECT-PsA 1 study.

Disclosures: This study was sponsored by AbbVie. The authors reported receiving research grants, honoraria, and consulting fees from or serving as an advisory board member, being an employee, or being shareholders in various companies, including AbbVie.

Source: McInnes IB et al. RMD Open. 2021;7:e001838 (Oct 18). Doi:  10.1136/rmdopen-2021-001838.

Key clinical point: Upadacitinib continued to demonstrate improvement in clinical manifestations of psoriatic arthritis (PsA) through week 56 in patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs) with no new adverse events.

Major finding: Consistent with week 24, a higher proportion of patients achieved at least 20% improvement in the American College of Rheumatology criteria with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Study details: Findings are from an analysis of 1,419 patients with active PsA and inadequate response to at least 1 non-bDMARD who completed 56 weeks of treatment in the phase 3 SELECT-PsA 1 study.

Disclosures: This study was sponsored by AbbVie. The authors reported receiving research grants, honoraria, and consulting fees from or serving as an advisory board member, being an employee, or being shareholders in various companies, including AbbVie.

Source: McInnes IB et al. RMD Open. 2021;7:e001838 (Oct 18). Doi:  10.1136/rmdopen-2021-001838.

Key clinical point: Upadacitinib continued to demonstrate improvement in clinical manifestations of psoriatic arthritis (PsA) through week 56 in patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs) with no new adverse events.

Major finding: Consistent with week 24, a higher proportion of patients achieved at least 20% improvement in the American College of Rheumatology criteria with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Study details: Findings are from an analysis of 1,419 patients with active PsA and inadequate response to at least 1 non-bDMARD who completed 56 weeks of treatment in the phase 3 SELECT-PsA 1 study.

Disclosures: This study was sponsored by AbbVie. The authors reported receiving research grants, honoraria, and consulting fees from or serving as an advisory board member, being an employee, or being shareholders in various companies, including AbbVie.

Source: McInnes IB et al. RMD Open. 2021;7:e001838 (Oct 18). Doi:  10.1136/rmdopen-2021-001838.

The rate of U.S. hospitalizations for three types of serious infections in patients with psoriatic arthritis (PsA) appears to have declined from 2012 to 2017, according to research presented at the virtual annual meeting of the American College of Rheumatology.

Several of the standard treatments for PsA have an increased risk of infections, but the rates vary amongst conventional disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, and other therapies.

“Given the uptake of biological therapies has increased over recent years, we sought to investigate the national trends in serious infections in patients with psoriatic arthritis from the years 2012 to 2017,” Vagishwari Murugesan, MBBS, a psoriatic arthritis clinical fellow at the University of Toronto, told attendees in a prerecorded poster presentation. Dr. Murugesan was a fellow at Boston University when she conducted the research.

The researchers analyzed data from 2012 to 2017 in the U.S. National Inpatient Sample (NIS), which includes approximately 20% of all discharges from U.S. community hospitals except rehabilitation and long-term acute care institutions. Using ICD-9 and ICD-10 codes, the researchers identified all discharge records containing a diagnosis of PsA as well as pneumonia, sepsis, urinary tract infection (UTI), and skin and soft-tissue infections. After making adjustments to match U.S. population age distributions over the years, they examined trends in serious infections among patients with PsA for that 6-year period.

Demographics over those years changed little: The average age of discharged patients was 59.5 in 2012 and 60.8 in 2017. Similarly, the patient population was 56% women and 88.5% Whites in 2012 and 57.7% women and 88.4% Whites in 2017. The average length of stay was also similar: 4.7 days in 2012, compared with 4.9 days in 2017.

Among 50,700 discharges of patients with PsA in 2012, the researchers identified 125 with pneumonia, 230 with sepsis, 312 with skin and soft-tissue infections, and 174 with a UTI. Among the 179,400 discharges in 2017 of patients with PsA, 344 had pneumonia, 374 had sepsis, 681 had skin and soft-tissue infections, and 348 had a UTI. After statistical analysis, the researchers found no significant differences in pneumonia diagnoses during the years studied, but they did find a statistically significant decline in sepsis, skin and soft tissue infections, and UTI discharges (P < .001).

A notable limitation of the study is the NIS database’s lack of data on treatments or outpatient data, making it impossible to determine if more infections were occurring but simply being treated in outpatient settings, although it’s not clear why such a substantial shift would occur in just 5 years. It’s also possible that coding practices differ across hospital, but, presumably, the ways they might differ in 2012 would be similar to any differences in 2017.

Bruce Jancin/MDedge News

Arthur Kavanaugh, MD, a professor of medicine and director of the Center for Innovative Therapy at the University of California, San Diego, found the results interesting for what he considers an important topic.

“What makes these data interesting is the same thing that limits their reliability: The authors note that infections decreased ‘despite the increase in use of biologics over this time,’ ” Dr. Kavanaugh said in an interview. “These are claims data, so there is no way to support any association between those serious infections and biologic use. Indeed, multiple factors could have also impacted these data. It is not possible to tell from claims data.”

Dr. Kavanaugh said the question is worth investigating further with data from other sources.

The research was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One study coauthor reported ties to UCB; Dr. Murugesan and her other coauthors reported no disclosures. Dr. Kavanaugh had no disclosures.

The rate of U.S. hospitalizations for three types of serious infections in patients with psoriatic arthritis (PsA) appears to have declined from 2012 to 2017, according to research presented at the virtual annual meeting of the American College of Rheumatology.

Several of the standard treatments for PsA have an increased risk of infections, but the rates vary amongst conventional disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, and other therapies.

“Given the uptake of biological therapies has increased over recent years, we sought to investigate the national trends in serious infections in patients with psoriatic arthritis from the years 2012 to 2017,” Vagishwari Murugesan, MBBS, a psoriatic arthritis clinical fellow at the University of Toronto, told attendees in a prerecorded poster presentation. Dr. Murugesan was a fellow at Boston University when she conducted the research.

The researchers analyzed data from 2012 to 2017 in the U.S. National Inpatient Sample (NIS), which includes approximately 20% of all discharges from U.S. community hospitals except rehabilitation and long-term acute care institutions. Using ICD-9 and ICD-10 codes, the researchers identified all discharge records containing a diagnosis of PsA as well as pneumonia, sepsis, urinary tract infection (UTI), and skin and soft-tissue infections. After making adjustments to match U.S. population age distributions over the years, they examined trends in serious infections among patients with PsA for that 6-year period.

Demographics over those years changed little: The average age of discharged patients was 59.5 in 2012 and 60.8 in 2017. Similarly, the patient population was 56% women and 88.5% Whites in 2012 and 57.7% women and 88.4% Whites in 2017. The average length of stay was also similar: 4.7 days in 2012, compared with 4.9 days in 2017.

Among 50,700 discharges of patients with PsA in 2012, the researchers identified 125 with pneumonia, 230 with sepsis, 312 with skin and soft-tissue infections, and 174 with a UTI. Among the 179,400 discharges in 2017 of patients with PsA, 344 had pneumonia, 374 had sepsis, 681 had skin and soft-tissue infections, and 348 had a UTI. After statistical analysis, the researchers found no significant differences in pneumonia diagnoses during the years studied, but they did find a statistically significant decline in sepsis, skin and soft tissue infections, and UTI discharges (P < .001).

A notable limitation of the study is the NIS database’s lack of data on treatments or outpatient data, making it impossible to determine if more infections were occurring but simply being treated in outpatient settings, although it’s not clear why such a substantial shift would occur in just 5 years. It’s also possible that coding practices differ across hospital, but, presumably, the ways they might differ in 2012 would be similar to any differences in 2017.

Bruce Jancin/MDedge News

Arthur Kavanaugh, MD, a professor of medicine and director of the Center for Innovative Therapy at the University of California, San Diego, found the results interesting for what he considers an important topic.

“What makes these data interesting is the same thing that limits their reliability: The authors note that infections decreased ‘despite the increase in use of biologics over this time,’ ” Dr. Kavanaugh said in an interview. “These are claims data, so there is no way to support any association between those serious infections and biologic use. Indeed, multiple factors could have also impacted these data. It is not possible to tell from claims data.”

Dr. Kavanaugh said the question is worth investigating further with data from other sources.

The research was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One study coauthor reported ties to UCB; Dr. Murugesan and her other coauthors reported no disclosures. Dr. Kavanaugh had no disclosures.

The rate of U.S. hospitalizations for three types of serious infections in patients with psoriatic arthritis (PsA) appears to have declined from 2012 to 2017, according to research presented at the virtual annual meeting of the American College of Rheumatology.

Several of the standard treatments for PsA have an increased risk of infections, but the rates vary amongst conventional disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, and other therapies.

“Given the uptake of biological therapies has increased over recent years, we sought to investigate the national trends in serious infections in patients with psoriatic arthritis from the years 2012 to 2017,” Vagishwari Murugesan, MBBS, a psoriatic arthritis clinical fellow at the University of Toronto, told attendees in a prerecorded poster presentation. Dr. Murugesan was a fellow at Boston University when she conducted the research.

The researchers analyzed data from 2012 to 2017 in the U.S. National Inpatient Sample (NIS), which includes approximately 20% of all discharges from U.S. community hospitals except rehabilitation and long-term acute care institutions. Using ICD-9 and ICD-10 codes, the researchers identified all discharge records containing a diagnosis of PsA as well as pneumonia, sepsis, urinary tract infection (UTI), and skin and soft-tissue infections. After making adjustments to match U.S. population age distributions over the years, they examined trends in serious infections among patients with PsA for that 6-year period.

Demographics over those years changed little: The average age of discharged patients was 59.5 in 2012 and 60.8 in 2017. Similarly, the patient population was 56% women and 88.5% Whites in 2012 and 57.7% women and 88.4% Whites in 2017. The average length of stay was also similar: 4.7 days in 2012, compared with 4.9 days in 2017.

Among 50,700 discharges of patients with PsA in 2012, the researchers identified 125 with pneumonia, 230 with sepsis, 312 with skin and soft-tissue infections, and 174 with a UTI. Among the 179,400 discharges in 2017 of patients with PsA, 344 had pneumonia, 374 had sepsis, 681 had skin and soft-tissue infections, and 348 had a UTI. After statistical analysis, the researchers found no significant differences in pneumonia diagnoses during the years studied, but they did find a statistically significant decline in sepsis, skin and soft tissue infections, and UTI discharges (P < .001).

A notable limitation of the study is the NIS database’s lack of data on treatments or outpatient data, making it impossible to determine if more infections were occurring but simply being treated in outpatient settings, although it’s not clear why such a substantial shift would occur in just 5 years. It’s also possible that coding practices differ across hospital, but, presumably, the ways they might differ in 2012 would be similar to any differences in 2017.

Bruce Jancin/MDedge News

Arthur Kavanaugh, MD, a professor of medicine and director of the Center for Innovative Therapy at the University of California, San Diego, found the results interesting for what he considers an important topic.

“What makes these data interesting is the same thing that limits their reliability: The authors note that infections decreased ‘despite the increase in use of biologics over this time,’ ” Dr. Kavanaugh said in an interview. “These are claims data, so there is no way to support any association between those serious infections and biologic use. Indeed, multiple factors could have also impacted these data. It is not possible to tell from claims data.”

Dr. Kavanaugh said the question is worth investigating further with data from other sources.

The research was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. One study coauthor reported ties to UCB; Dr. Murugesan and her other coauthors reported no disclosures. Dr. Kavanaugh had no disclosures.

Additional analyses of a postmarketing trial that was required after the Food and Drug Administration’s approval of the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has identified characteristics of older patients with rheumatoid arthritis with at least one cardiovascular risk factor who may be at higher risk for major adverse cardiovascular events (MACE) when taking the drug.

Results from the phase 3b/4 ORAL Surveillance trial presented at the virtual annual meeting of the American College of Rheumatology show that people taking tofacitinib for RA with at least one cardiovascular (CV) risk factor had a nonsignificant higher risk for MACE than did people taking tumor necrosis factor inhibitors (TNFi), with the risk from tofacitinib more pronounced in current smokers, aspirin users, people older than 65 years, and men, compared with women.

“It is the first large, randomized safety study of active RA patients with increased CV risk comparing tofacitinib to TNF inhibition,” study author Christina Charles-Schoeman, MD, said in an interview. “These data emphasize the importance of assessing baseline CV risk when treating patients with RA.” Dr. Charles-Schoeman is chief of rheumatology at the University of California, Los Angeles.

The results shed further light on the trial’s findings, which the FDA used in September 2021 to mandate boxed warnings about the risk of MI or stroke, cancer, venous thromboembolism, and death, as well as updated indications, for tofacitinib and other JAK inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq). The FDA limited all approved uses of these three medications to patients who have not responded well to TNFi to ensure their benefits outweigh their risks.

Tofacitinib is indicated for RA, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA.

While the overall results of the trial results show nonsignificant increased incidence rates for MACE in tofacitinib users versus TNFI users, Katherine Liao, MD, a rheumatologist at Brigham and Women’s Hospital in Boston, noted that more information is needed to determine who is at greatest risk. “Another thing to keep in mind is, while there was evidence of an elevated relative risk for MACE, compared to TNFi, the absolute risk, based on the numbers what we know so far, is small,” she said.

The trial compared two different doses of tofacitinib – 5 mg (1,455 patients) and 10 mg (n = 1,456) twice daily – and TNFi (n = 1,451) in people with moderate to severe RA over age 50. Patient characteristics were similar across all three treatment arms, Dr. Charles-Schoeman said. All patients had inadequate response to methotrexate, and about 57% in all three treatment groups were taking corticosteroids. The 10-mg tofacitinib patients switched to the 5-mg dose in February 2019 but represent the 10-mg group in the study analysis.

ORAL Surveillance demonstrated a 24% greater risk of MACE in the 5-mg tofacitinib patients and a 43% heightened risk the 10-mg group, compared with patients who received a TNFi.

The differentiating factor for MACE incidence was MI. The higher- and lower-dose tofacitinib groups had 69% and 80% greater risk for MI. While the risk for fatal MI were similar across all three treatment groups, the risk for nonfatal MI were more than doubled in the respective tofacitinib groups: hazard ratios of 2.32 and 2.08. The incidence of stroke was similar across all three arms, Dr. Charles-Schoeman said.

The study identified a number of baseline characteristics as independent overall risk factors for MACE across all treatment groups. Current smoking and aspirin use more than doubled the risk (HR, 2.18; P < .0001 and HR, 2.11; P = .004, respectively), while age greater than 65 years and male sex approached that level (HR, 1.81; P = .0011 and HR, 1.81; P = .0015) approached that level. Other factors that elevated the risk of MACE to a lesser extent were a history of diabetes, hypertension or coronary artery procedures, and a total cholesterol to HDL ratio greater than4.

Other ORAL Surveillance subanalyses and tofacitinib real-world data reported

This was one of several analyses presented at ACR 2021 that compared adverse event risks for tofacitinib versus TNFi drugs. A separate analysis of claims data from patients with RA in two U.S. insurance databases plus Medicare found a statistically nonsignificant increased risk of adverse CV outcomes (MI or stroke) with tofacitinib, compared with TNFi users, among patients who met the same inclusion and exclusion criteria of the ORAL Surveillance trial but not in a “real-world evidence” cohort of more than 102,000 patients with RA in routine care from the databases.

Two additional ORAL Surveillance analyses presented at ACR 2021 gave details about risk factors for higher rates of malignancies and venous thromboembolic events found in patients taking tofacitinib with at least one CV risk factor. As would be expected, older age (≥65 vs. 50-64 years) and current or past smoking (vs. never smoking) were independent risk factors for higher malignancy rates across all treatment arms. Pulmonary embolism events across treatment groups were independently associated with a history of venous thromboembolism, baseline use of oral contraceptives or hormone replacement therapy, baseline body mass index of at least 30 kg/m², age 65 or older, and history of hypertension.

The ORAL Surveillance findings are worth considering when determining treatments for RA patients with CV risk factors, Dr. Charles-Schoeman said. “Tofacitinib remains an effective RA treatment,” she said. “The choice of specific RA treatment for any patient remains an individual decision between the patient and physician, which is decided based on a number of different factors. This new study provides additional information regarding both tofacitinib as well as traditional CV risk factors for discussion with the patient.”

The ORAL Surveillance results may give rheumatologists reason to rethink use of tofacitinib in some patients with CV risk, said Dr. Liao of Brigham and Women’s Hospital in Boston. “Currently, we have limited data and are still awaiting a report of the full trial results,” she said in an interview. “Based on the data available, I can think of a few patients in my clinic where I would reconsider use of these drugs, i.e., history of heart attack with stable angina, especially if there are other options.” However, she noted that many patients on tofacitinib have already failed on older treatments.

These data emphasize the importance of addressing CV risk with patients, said Brittany N. Weber, MD, PhD, a cardio-rheumatologist at Brigham and Women’s Hospital who works with Dr. Liao. “It is also an opportunity to discuss modification of risk factors and to discuss primary prevention therapies, such as statin therapy, where appropriate,” she added. “Based on the individual’s cardiovascular risk, there may be a role for further risk stratification to further understand an individual’s risk, which can also inform primary prevention cardiovascular therapies and help guide these discussions.” Risk stratification could include cardiac CT for calcium scoring or cardiac coronary CT angiography for determining atherosclerotic burden.

The study was sponsored by Pfizer. Dr. Charles-Schoeman disclosed relationships with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Pfizer, and Regeneron-Sanofi. Dr. Liao and Dr. Weber have no relevant disclosures.

Additional analyses of a postmarketing trial that was required after the Food and Drug Administration’s approval of the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has identified characteristics of older patients with rheumatoid arthritis with at least one cardiovascular risk factor who may be at higher risk for major adverse cardiovascular events (MACE) when taking the drug.

Results from the phase 3b/4 ORAL Surveillance trial presented at the virtual annual meeting of the American College of Rheumatology show that people taking tofacitinib for RA with at least one cardiovascular (CV) risk factor had a nonsignificant higher risk for MACE than did people taking tumor necrosis factor inhibitors (TNFi), with the risk from tofacitinib more pronounced in current smokers, aspirin users, people older than 65 years, and men, compared with women.

“It is the first large, randomized safety study of active RA patients with increased CV risk comparing tofacitinib to TNF inhibition,” study author Christina Charles-Schoeman, MD, said in an interview. “These data emphasize the importance of assessing baseline CV risk when treating patients with RA.” Dr. Charles-Schoeman is chief of rheumatology at the University of California, Los Angeles.

The results shed further light on the trial’s findings, which the FDA used in September 2021 to mandate boxed warnings about the risk of MI or stroke, cancer, venous thromboembolism, and death, as well as updated indications, for tofacitinib and other JAK inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq). The FDA limited all approved uses of these three medications to patients who have not responded well to TNFi to ensure their benefits outweigh their risks.

Tofacitinib is indicated for RA, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA.

While the overall results of the trial results show nonsignificant increased incidence rates for MACE in tofacitinib users versus TNFI users, Katherine Liao, MD, a rheumatologist at Brigham and Women’s Hospital in Boston, noted that more information is needed to determine who is at greatest risk. “Another thing to keep in mind is, while there was evidence of an elevated relative risk for MACE, compared to TNFi, the absolute risk, based on the numbers what we know so far, is small,” she said.

The trial compared two different doses of tofacitinib – 5 mg (1,455 patients) and 10 mg (n = 1,456) twice daily – and TNFi (n = 1,451) in people with moderate to severe RA over age 50. Patient characteristics were similar across all three treatment arms, Dr. Charles-Schoeman said. All patients had inadequate response to methotrexate, and about 57% in all three treatment groups were taking corticosteroids. The 10-mg tofacitinib patients switched to the 5-mg dose in February 2019 but represent the 10-mg group in the study analysis.

ORAL Surveillance demonstrated a 24% greater risk of MACE in the 5-mg tofacitinib patients and a 43% heightened risk the 10-mg group, compared with patients who received a TNFi.

The differentiating factor for MACE incidence was MI. The higher- and lower-dose tofacitinib groups had 69% and 80% greater risk for MI. While the risk for fatal MI were similar across all three treatment groups, the risk for nonfatal MI were more than doubled in the respective tofacitinib groups: hazard ratios of 2.32 and 2.08. The incidence of stroke was similar across all three arms, Dr. Charles-Schoeman said.

The study identified a number of baseline characteristics as independent overall risk factors for MACE across all treatment groups. Current smoking and aspirin use more than doubled the risk (HR, 2.18; P < .0001 and HR, 2.11; P = .004, respectively), while age greater than 65 years and male sex approached that level (HR, 1.81; P = .0011 and HR, 1.81; P = .0015) approached that level. Other factors that elevated the risk of MACE to a lesser extent were a history of diabetes, hypertension or coronary artery procedures, and a total cholesterol to HDL ratio greater than4.

Other ORAL Surveillance subanalyses and tofacitinib real-world data reported

This was one of several analyses presented at ACR 2021 that compared adverse event risks for tofacitinib versus TNFi drugs. A separate analysis of claims data from patients with RA in two U.S. insurance databases plus Medicare found a statistically nonsignificant increased risk of adverse CV outcomes (MI or stroke) with tofacitinib, compared with TNFi users, among patients who met the same inclusion and exclusion criteria of the ORAL Surveillance trial but not in a “real-world evidence” cohort of more than 102,000 patients with RA in routine care from the databases.

Two additional ORAL Surveillance analyses presented at ACR 2021 gave details about risk factors for higher rates of malignancies and venous thromboembolic events found in patients taking tofacitinib with at least one CV risk factor. As would be expected, older age (≥65 vs. 50-64 years) and current or past smoking (vs. never smoking) were independent risk factors for higher malignancy rates across all treatment arms. Pulmonary embolism events across treatment groups were independently associated with a history of venous thromboembolism, baseline use of oral contraceptives or hormone replacement therapy, baseline body mass index of at least 30 kg/m², age 65 or older, and history of hypertension.

The ORAL Surveillance findings are worth considering when determining treatments for RA patients with CV risk factors, Dr. Charles-Schoeman said. “Tofacitinib remains an effective RA treatment,” she said. “The choice of specific RA treatment for any patient remains an individual decision between the patient and physician, which is decided based on a number of different factors. This new study provides additional information regarding both tofacitinib as well as traditional CV risk factors for discussion with the patient.”

The ORAL Surveillance results may give rheumatologists reason to rethink use of tofacitinib in some patients with CV risk, said Dr. Liao of Brigham and Women’s Hospital in Boston. “Currently, we have limited data and are still awaiting a report of the full trial results,” she said in an interview. “Based on the data available, I can think of a few patients in my clinic where I would reconsider use of these drugs, i.e., history of heart attack with stable angina, especially if there are other options.” However, she noted that many patients on tofacitinib have already failed on older treatments.

These data emphasize the importance of addressing CV risk with patients, said Brittany N. Weber, MD, PhD, a cardio-rheumatologist at Brigham and Women’s Hospital who works with Dr. Liao. “It is also an opportunity to discuss modification of risk factors and to discuss primary prevention therapies, such as statin therapy, where appropriate,” she added. “Based on the individual’s cardiovascular risk, there may be a role for further risk stratification to further understand an individual’s risk, which can also inform primary prevention cardiovascular therapies and help guide these discussions.” Risk stratification could include cardiac CT for calcium scoring or cardiac coronary CT angiography for determining atherosclerotic burden.

The study was sponsored by Pfizer. Dr. Charles-Schoeman disclosed relationships with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Pfizer, and Regeneron-Sanofi. Dr. Liao and Dr. Weber have no relevant disclosures.

Additional analyses of a postmarketing trial that was required after the Food and Drug Administration’s approval of the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has identified characteristics of older patients with rheumatoid arthritis with at least one cardiovascular risk factor who may be at higher risk for major adverse cardiovascular events (MACE) when taking the drug.

Results from the phase 3b/4 ORAL Surveillance trial presented at the virtual annual meeting of the American College of Rheumatology show that people taking tofacitinib for RA with at least one cardiovascular (CV) risk factor had a nonsignificant higher risk for MACE than did people taking tumor necrosis factor inhibitors (TNFi), with the risk from tofacitinib more pronounced in current smokers, aspirin users, people older than 65 years, and men, compared with women.

“It is the first large, randomized safety study of active RA patients with increased CV risk comparing tofacitinib to TNF inhibition,” study author Christina Charles-Schoeman, MD, said in an interview. “These data emphasize the importance of assessing baseline CV risk when treating patients with RA.” Dr. Charles-Schoeman is chief of rheumatology at the University of California, Los Angeles.

The results shed further light on the trial’s findings, which the FDA used in September 2021 to mandate boxed warnings about the risk of MI or stroke, cancer, venous thromboembolism, and death, as well as updated indications, for tofacitinib and other JAK inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq). The FDA limited all approved uses of these three medications to patients who have not responded well to TNFi to ensure their benefits outweigh their risks.

Tofacitinib is indicated for RA, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA.

While the overall results of the trial results show nonsignificant increased incidence rates for MACE in tofacitinib users versus TNFI users, Katherine Liao, MD, a rheumatologist at Brigham and Women’s Hospital in Boston, noted that more information is needed to determine who is at greatest risk. “Another thing to keep in mind is, while there was evidence of an elevated relative risk for MACE, compared to TNFi, the absolute risk, based on the numbers what we know so far, is small,” she said.

The trial compared two different doses of tofacitinib – 5 mg (1,455 patients) and 10 mg (n = 1,456) twice daily – and TNFi (n = 1,451) in people with moderate to severe RA over age 50. Patient characteristics were similar across all three treatment arms, Dr. Charles-Schoeman said. All patients had inadequate response to methotrexate, and about 57% in all three treatment groups were taking corticosteroids. The 10-mg tofacitinib patients switched to the 5-mg dose in February 2019 but represent the 10-mg group in the study analysis.

ORAL Surveillance demonstrated a 24% greater risk of MACE in the 5-mg tofacitinib patients and a 43% heightened risk the 10-mg group, compared with patients who received a TNFi.

The differentiating factor for MACE incidence was MI. The higher- and lower-dose tofacitinib groups had 69% and 80% greater risk for MI. While the risk for fatal MI were similar across all three treatment groups, the risk for nonfatal MI were more than doubled in the respective tofacitinib groups: hazard ratios of 2.32 and 2.08. The incidence of stroke was similar across all three arms, Dr. Charles-Schoeman said.

The study identified a number of baseline characteristics as independent overall risk factors for MACE across all treatment groups. Current smoking and aspirin use more than doubled the risk (HR, 2.18; P < .0001 and HR, 2.11; P = .004, respectively), while age greater than 65 years and male sex approached that level (HR, 1.81; P = .0011 and HR, 1.81; P = .0015) approached that level. Other factors that elevated the risk of MACE to a lesser extent were a history of diabetes, hypertension or coronary artery procedures, and a total cholesterol to HDL ratio greater than4.

Other ORAL Surveillance subanalyses and tofacitinib real-world data reported

This was one of several analyses presented at ACR 2021 that compared adverse event risks for tofacitinib versus TNFi drugs. A separate analysis of claims data from patients with RA in two U.S. insurance databases plus Medicare found a statistically nonsignificant increased risk of adverse CV outcomes (MI or stroke) with tofacitinib, compared with TNFi users, among patients who met the same inclusion and exclusion criteria of the ORAL Surveillance trial but not in a “real-world evidence” cohort of more than 102,000 patients with RA in routine care from the databases.

Two additional ORAL Surveillance analyses presented at ACR 2021 gave details about risk factors for higher rates of malignancies and venous thromboembolic events found in patients taking tofacitinib with at least one CV risk factor. As would be expected, older age (≥65 vs. 50-64 years) and current or past smoking (vs. never smoking) were independent risk factors for higher malignancy rates across all treatment arms. Pulmonary embolism events across treatment groups were independently associated with a history of venous thromboembolism, baseline use of oral contraceptives or hormone replacement therapy, baseline body mass index of at least 30 kg/m², age 65 or older, and history of hypertension.

The ORAL Surveillance findings are worth considering when determining treatments for RA patients with CV risk factors, Dr. Charles-Schoeman said. “Tofacitinib remains an effective RA treatment,” she said. “The choice of specific RA treatment for any patient remains an individual decision between the patient and physician, which is decided based on a number of different factors. This new study provides additional information regarding both tofacitinib as well as traditional CV risk factors for discussion with the patient.”

The ORAL Surveillance results may give rheumatologists reason to rethink use of tofacitinib in some patients with CV risk, said Dr. Liao of Brigham and Women’s Hospital in Boston. “Currently, we have limited data and are still awaiting a report of the full trial results,” she said in an interview. “Based on the data available, I can think of a few patients in my clinic where I would reconsider use of these drugs, i.e., history of heart attack with stable angina, especially if there are other options.” However, she noted that many patients on tofacitinib have already failed on older treatments.

These data emphasize the importance of addressing CV risk with patients, said Brittany N. Weber, MD, PhD, a cardio-rheumatologist at Brigham and Women’s Hospital who works with Dr. Liao. “It is also an opportunity to discuss modification of risk factors and to discuss primary prevention therapies, such as statin therapy, where appropriate,” she added. “Based on the individual’s cardiovascular risk, there may be a role for further risk stratification to further understand an individual’s risk, which can also inform primary prevention cardiovascular therapies and help guide these discussions.” Risk stratification could include cardiac CT for calcium scoring or cardiac coronary CT angiography for determining atherosclerotic burden.

The study was sponsored by Pfizer. Dr. Charles-Schoeman disclosed relationships with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Pfizer, and Regeneron-Sanofi. Dr. Liao and Dr. Weber have no relevant disclosures.