Rheumatoid Arthritis

Daily treatment with tofacitinib (Xeljanz) led to more malignancies and adverse cardiovascular events in older rheumatoid arthritis patients compared with treatment with a tumor necrosis factor (TNF) inhibitor, according to the partial results of a safety study announced last week by Pfizer.

The postmarketing study known as ORAL Surveillance began in 2014 to evaluate the safety of the Janus kinase (JAK) inhibitor tofacitinib compared to a TNF inhibitor in RA patients 50 years of age or older with at least one additional cardiovascular risk factor. Its 4,362 participants were randomized to either daily doses of 5 mg (n = 1,455) or 10 mg (n = 1,456) of tofacitinib or the TNFi (n = 1,451), which was adalimumab for patients in the United States, Canada, and Puerto Rico, and etanercept elsewhere. During analysis, adverse events were pooled for all patients on tofacitinib.

Overall, 135 patients developed major adverse cardiovascular events (MACE) and 164 developed malignancies – excluding nonmelanoma skin cancer. The incidence of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNFi group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09). The rate of MACE was also higher in the combined tofacitinib group (0.98 vs. 0.73 per 100 person-years; HR, 1.33; 95% CI, 0.91-1.94). Both rates for tofacitinib did not meet the trial’s noninferiority criteria.

Among the patients on tofacitinib, the most reported MACE was myocardial infarction and the most reported malignancy was lung cancer. Study participants with noted risk factors – including older age and smoking – were more likely to experience adverse events.

In February 2019, patients in the 10-mg tofacitinib group were switched to the 5-mg because of a safety signal indicating increased risk of pulmonary embolism and death.

Tofacitinib was approved for RA in November 2012, though concerns about serious side effects had been noted during clinical trials and a boxed warning was ultimately added to the drug’s label. Tofacitinib is also approved for adults with active psoriatic arthritis, adults with moderately to severely active ulcerative colitis, and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis. Other JAK inhibitors such as baricitinib and upadacitinib have been approved for RA in the interim as well, though the higher dose of baricitinib was rejected in committee because of safety concerns and both their boxes also warn against infections, thrombosis, and cancer.

A postmarketing safety study on baricitinib is expected to be completed in 2025.

The full results of the ORAL Surveillance study – which should address safety regarding pulmonary embolism and mortality, as well as efficacy data – have not yet been released. “Pfizer is working with the [FDA] and other regulatory agencies to review the full results and analyses as they become available,” the press release said.

Daily treatment with tofacitinib (Xeljanz) led to more malignancies and adverse cardiovascular events in older rheumatoid arthritis patients compared with treatment with a tumor necrosis factor (TNF) inhibitor, according to the partial results of a safety study announced last week by Pfizer.

The postmarketing study known as ORAL Surveillance began in 2014 to evaluate the safety of the Janus kinase (JAK) inhibitor tofacitinib compared to a TNF inhibitor in RA patients 50 years of age or older with at least one additional cardiovascular risk factor. Its 4,362 participants were randomized to either daily doses of 5 mg (n = 1,455) or 10 mg (n = 1,456) of tofacitinib or the TNFi (n = 1,451), which was adalimumab for patients in the United States, Canada, and Puerto Rico, and etanercept elsewhere. During analysis, adverse events were pooled for all patients on tofacitinib.

Overall, 135 patients developed major adverse cardiovascular events (MACE) and 164 developed malignancies – excluding nonmelanoma skin cancer. The incidence of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNFi group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09). The rate of MACE was also higher in the combined tofacitinib group (0.98 vs. 0.73 per 100 person-years; HR, 1.33; 95% CI, 0.91-1.94). Both rates for tofacitinib did not meet the trial’s noninferiority criteria.

Among the patients on tofacitinib, the most reported MACE was myocardial infarction and the most reported malignancy was lung cancer. Study participants with noted risk factors – including older age and smoking – were more likely to experience adverse events.

In February 2019, patients in the 10-mg tofacitinib group were switched to the 5-mg because of a safety signal indicating increased risk of pulmonary embolism and death.

Tofacitinib was approved for RA in November 2012, though concerns about serious side effects had been noted during clinical trials and a boxed warning was ultimately added to the drug’s label. Tofacitinib is also approved for adults with active psoriatic arthritis, adults with moderately to severely active ulcerative colitis, and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis. Other JAK inhibitors such as baricitinib and upadacitinib have been approved for RA in the interim as well, though the higher dose of baricitinib was rejected in committee because of safety concerns and both their boxes also warn against infections, thrombosis, and cancer.

A postmarketing safety study on baricitinib is expected to be completed in 2025.

The full results of the ORAL Surveillance study – which should address safety regarding pulmonary embolism and mortality, as well as efficacy data – have not yet been released. “Pfizer is working with the [FDA] and other regulatory agencies to review the full results and analyses as they become available,” the press release said.

Daily treatment with tofacitinib (Xeljanz) led to more malignancies and adverse cardiovascular events in older rheumatoid arthritis patients compared with treatment with a tumor necrosis factor (TNF) inhibitor, according to the partial results of a safety study announced last week by Pfizer.

The postmarketing study known as ORAL Surveillance began in 2014 to evaluate the safety of the Janus kinase (JAK) inhibitor tofacitinib compared to a TNF inhibitor in RA patients 50 years of age or older with at least one additional cardiovascular risk factor. Its 4,362 participants were randomized to either daily doses of 5 mg (n = 1,455) or 10 mg (n = 1,456) of tofacitinib or the TNFi (n = 1,451), which was adalimumab for patients in the United States, Canada, and Puerto Rico, and etanercept elsewhere. During analysis, adverse events were pooled for all patients on tofacitinib.

Overall, 135 patients developed major adverse cardiovascular events (MACE) and 164 developed malignancies – excluding nonmelanoma skin cancer. The incidence of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNFi group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09). The rate of MACE was also higher in the combined tofacitinib group (0.98 vs. 0.73 per 100 person-years; HR, 1.33; 95% CI, 0.91-1.94). Both rates for tofacitinib did not meet the trial’s noninferiority criteria.

Among the patients on tofacitinib, the most reported MACE was myocardial infarction and the most reported malignancy was lung cancer. Study participants with noted risk factors – including older age and smoking – were more likely to experience adverse events.

In February 2019, patients in the 10-mg tofacitinib group were switched to the 5-mg because of a safety signal indicating increased risk of pulmonary embolism and death.

Tofacitinib was approved for RA in November 2012, though concerns about serious side effects had been noted during clinical trials and a boxed warning was ultimately added to the drug’s label. Tofacitinib is also approved for adults with active psoriatic arthritis, adults with moderately to severely active ulcerative colitis, and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis. Other JAK inhibitors such as baricitinib and upadacitinib have been approved for RA in the interim as well, though the higher dose of baricitinib was rejected in committee because of safety concerns and both their boxes also warn against infections, thrombosis, and cancer.

A postmarketing safety study on baricitinib is expected to be completed in 2025.

The full results of the ORAL Surveillance study – which should address safety regarding pulmonary embolism and mortality, as well as efficacy data – have not yet been released. “Pfizer is working with the [FDA] and other regulatory agencies to review the full results and analyses as they become available,” the press release said.

Key clinical point: Increased prevalence for temporomandibular (TMD) pain is reported in individuals at risk for rheumatoid arthritis (RA). It is recommended to be alert to TMD pain disorders in such cases.

Major finding: The prevalence of TMD pain was higher in individuals at risk for RA vs. controls (P = .046). However, patients with early RA showed no difference in the prevalence of TMD pain vs. control individuals.

Study details: The data come from a cross-sectional study involving 50 individuals each with early RA, those at risk for RA, and controls.

Disclosures: The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors. The authors declared no conflicts of interest.

Source: Kroese JM et al. RMD Open. 2021 Jan 11. doi: 10.1136/rmdopen-2020-001485.

Key clinical point: Increased prevalence for temporomandibular (TMD) pain is reported in individuals at risk for rheumatoid arthritis (RA). It is recommended to be alert to TMD pain disorders in such cases.

Major finding: The prevalence of TMD pain was higher in individuals at risk for RA vs. controls (P = .046). However, patients with early RA showed no difference in the prevalence of TMD pain vs. control individuals.

Study details: The data come from a cross-sectional study involving 50 individuals each with early RA, those at risk for RA, and controls.

Disclosures: The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors. The authors declared no conflicts of interest.

Source: Kroese JM et al. RMD Open. 2021 Jan 11. doi: 10.1136/rmdopen-2020-001485.

Key clinical point: Increased prevalence for temporomandibular (TMD) pain is reported in individuals at risk for rheumatoid arthritis (RA). It is recommended to be alert to TMD pain disorders in such cases.

Major finding: The prevalence of TMD pain was higher in individuals at risk for RA vs. controls (P = .046). However, patients with early RA showed no difference in the prevalence of TMD pain vs. control individuals.

Study details: The data come from a cross-sectional study involving 50 individuals each with early RA, those at risk for RA, and controls.

Disclosures: The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors. The authors declared no conflicts of interest.

Source: Kroese JM et al. RMD Open. 2021 Jan 11. doi: 10.1136/rmdopen-2020-001485.

Key clinical point: Treat-to-target strategy (T2T) was associated with higher probability of achieving the treatment target in patients with rheumatoid arthritis (RA) who could not reach treatment target within 6 months.

Major finding: RA patients following T2T had a 2.8 times higher likelihood for remission/low disease activity at 12 months than those not following the T2T strategy (P = .005).

Study details: Data from ATTRA registry were assessed. Seventy-five patients with RA following T2T were matched with 75 patients who continued initial treatment despite not reaching the treatment target within 6 months.

Disclosures: The work was supported by the project (Ministry of Health, Czech Republic) for conceptual development of research organization (Institute of

Rheumatology). The authors declared no conflicts of interest.

Source: Nekvindová L et al. Arthritis Res Ther. 2021 Jan 6. doi: 10.1186/s13075-020-02393-8.

Key clinical point: Treat-to-target strategy (T2T) was associated with higher probability of achieving the treatment target in patients with rheumatoid arthritis (RA) who could not reach treatment target within 6 months.

Major finding: RA patients following T2T had a 2.8 times higher likelihood for remission/low disease activity at 12 months than those not following the T2T strategy (P = .005).

Study details: Data from ATTRA registry were assessed. Seventy-five patients with RA following T2T were matched with 75 patients who continued initial treatment despite not reaching the treatment target within 6 months.

Disclosures: The work was supported by the project (Ministry of Health, Czech Republic) for conceptual development of research organization (Institute of

Rheumatology). The authors declared no conflicts of interest.

Source: Nekvindová L et al. Arthritis Res Ther. 2021 Jan 6. doi: 10.1186/s13075-020-02393-8.

Key clinical point: Treat-to-target strategy (T2T) was associated with higher probability of achieving the treatment target in patients with rheumatoid arthritis (RA) who could not reach treatment target within 6 months.

Major finding: RA patients following T2T had a 2.8 times higher likelihood for remission/low disease activity at 12 months than those not following the T2T strategy (P = .005).

Study details: Data from ATTRA registry were assessed. Seventy-five patients with RA following T2T were matched with 75 patients who continued initial treatment despite not reaching the treatment target within 6 months.

Disclosures: The work was supported by the project (Ministry of Health, Czech Republic) for conceptual development of research organization (Institute of

Rheumatology). The authors declared no conflicts of interest.

Source: Nekvindová L et al. Arthritis Res Ther. 2021 Jan 6. doi: 10.1186/s13075-020-02393-8.

Key clinical point: In patients with rheumatoid arthritis (RA), baseline magnetic resonance imaging (MRI) osteitis and tenosynovitis independently predicted 2-year MRI damage. Following the MRI-targeted treatment strategy was a positive predictor for stringent remission.

Major finding: Baseline osteitis independently predicted MRI erosion (odds ratio [OR], 1.13), joint space narrowing (OR, 1.15), and combined damage progression (OR, 1.23; P less than .001 for all). Tenosynovitis independently predicted MRI erosion progression (OR, 1.13; P = .01). MRI-targeted treatment strategy predicted Clinical Disease Activity Index remission (OR, 2.94; P = .01), Simplified Disease Activity Index remission (OR, 2.50; P = .047), and Boolean remission (OR, 5.47; P less than .001).

Study details: The data come from the IMAGINE-RA study, a 2-year, investigator-initiated, randomized clinical Danish multicenter trial on 200 RA patients.

Disclosures: The work was supported by AbbVie, who supported the IMAGINE-RA primary study. Some authors received grants/personal fees/nonfinancial support from various research organizations and/or pharmaceutical companies, including AbbVie.

Source: Møller-Bisgaard S et al. Rheumatology (Oxford). 2021 Jan 5. doi: 10.1093/rheumatology/keaa496.

Key clinical point: In patients with rheumatoid arthritis (RA), baseline magnetic resonance imaging (MRI) osteitis and tenosynovitis independently predicted 2-year MRI damage. Following the MRI-targeted treatment strategy was a positive predictor for stringent remission.

Major finding: Baseline osteitis independently predicted MRI erosion (odds ratio [OR], 1.13), joint space narrowing (OR, 1.15), and combined damage progression (OR, 1.23; P less than .001 for all). Tenosynovitis independently predicted MRI erosion progression (OR, 1.13; P = .01). MRI-targeted treatment strategy predicted Clinical Disease Activity Index remission (OR, 2.94; P = .01), Simplified Disease Activity Index remission (OR, 2.50; P = .047), and Boolean remission (OR, 5.47; P less than .001).

Study details: The data come from the IMAGINE-RA study, a 2-year, investigator-initiated, randomized clinical Danish multicenter trial on 200 RA patients.

Disclosures: The work was supported by AbbVie, who supported the IMAGINE-RA primary study. Some authors received grants/personal fees/nonfinancial support from various research organizations and/or pharmaceutical companies, including AbbVie.

Source: Møller-Bisgaard S et al. Rheumatology (Oxford). 2021 Jan 5. doi: 10.1093/rheumatology/keaa496.

Key clinical point: In patients with rheumatoid arthritis (RA), baseline magnetic resonance imaging (MRI) osteitis and tenosynovitis independently predicted 2-year MRI damage. Following the MRI-targeted treatment strategy was a positive predictor for stringent remission.

Major finding: Baseline osteitis independently predicted MRI erosion (odds ratio [OR], 1.13), joint space narrowing (OR, 1.15), and combined damage progression (OR, 1.23; P less than .001 for all). Tenosynovitis independently predicted MRI erosion progression (OR, 1.13; P = .01). MRI-targeted treatment strategy predicted Clinical Disease Activity Index remission (OR, 2.94; P = .01), Simplified Disease Activity Index remission (OR, 2.50; P = .047), and Boolean remission (OR, 5.47; P less than .001).

Study details: The data come from the IMAGINE-RA study, a 2-year, investigator-initiated, randomized clinical Danish multicenter trial on 200 RA patients.

Disclosures: The work was supported by AbbVie, who supported the IMAGINE-RA primary study. Some authors received grants/personal fees/nonfinancial support from various research organizations and/or pharmaceutical companies, including AbbVie.

Source: Møller-Bisgaard S et al. Rheumatology (Oxford). 2021 Jan 5. doi: 10.1093/rheumatology/keaa496.

Key clinical point: Patients with incident rheumatoid arthritis (RA) have increased risks for venous thromboembolism (VTE), pulmonary embolism (PE), and deep vein thrombosis (DVT) than the general population.

Major finding: RA patients showed higher overall risks for VTE (adjusted hazard ratio [aHR], 1.28; 95% confidence interval [CI], 1.20-1.36), PE (aHR, 1.25; 95% CI, 1.13-1.39), and DVT (aHR, 1.30; 95% CI, 1.21-1.40) after adjusting for VTE risk factors.

Study details: The data come from a population-based study involving 39,142 patients with incident RA and 78,078 matched non-RA controls.

Disclosures: The study was supported by the Canadian Institutes of Health Research. The authors declared no conflicts of interest.

Source: Li L et al. Rheumatology (Oxford). 2021 Jan 5. doi: 10.1093/rheumatology/keaa262.

Key clinical point: Patients with incident rheumatoid arthritis (RA) have increased risks for venous thromboembolism (VTE), pulmonary embolism (PE), and deep vein thrombosis (DVT) than the general population.

Major finding: RA patients showed higher overall risks for VTE (adjusted hazard ratio [aHR], 1.28; 95% confidence interval [CI], 1.20-1.36), PE (aHR, 1.25; 95% CI, 1.13-1.39), and DVT (aHR, 1.30; 95% CI, 1.21-1.40) after adjusting for VTE risk factors.

Study details: The data come from a population-based study involving 39,142 patients with incident RA and 78,078 matched non-RA controls.

Disclosures: The study was supported by the Canadian Institutes of Health Research. The authors declared no conflicts of interest.

Source: Li L et al. Rheumatology (Oxford). 2021 Jan 5. doi: 10.1093/rheumatology/keaa262.

Key clinical point: Patients with incident rheumatoid arthritis (RA) have increased risks for venous thromboembolism (VTE), pulmonary embolism (PE), and deep vein thrombosis (DVT) than the general population.

Major finding: RA patients showed higher overall risks for VTE (adjusted hazard ratio [aHR], 1.28; 95% confidence interval [CI], 1.20-1.36), PE (aHR, 1.25; 95% CI, 1.13-1.39), and DVT (aHR, 1.30; 95% CI, 1.21-1.40) after adjusting for VTE risk factors.

Study details: The data come from a population-based study involving 39,142 patients with incident RA and 78,078 matched non-RA controls.

Disclosures: The study was supported by the Canadian Institutes of Health Research. The authors declared no conflicts of interest.

Source: Li L et al. Rheumatology (Oxford). 2021 Jan 5. doi: 10.1093/rheumatology/keaa262.

Key clinical point: Hydroxychloroquine for the treatment of rheumatoid arthritis (RA) does not increase the risks for depression, suicidality, or psychosis compared with sulfasalazine.

Major finding: Hydroxychloroquine use was not associated with risks for depression, acute psychosis, or suicidality compared with sulfasalazine. The hazard ratios [HRs] for short-term risks for depression, acute psychosis, and suicidality were 0.96 (95% confidence interval [CI], 0.79-1.16), 1.03 (95% CI, 0.66-1.60), and 0.94 (95% CI, 0.49-1.77), respectively. The corresponding HRs for long-term risks were 0.94 (95% CI, 0.71-1.26), 0.99 (95% CI, 0.72-1.35), and 0.77 (95% CI, 0.56-1.07), respectively.

Study details: Findings from a multinational network cohort study of RA patients using hydroxychloroquine (n=918,144) and sulfasalazine (n=290,383).

Disclosures: This study was supported by the National Institute for Health Research Oxford Biomedical Research Centre, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research & Development, IQVIA, the Korea Health Technology, and the Korea Health Industry Development Institute. Some of the authors reported personal funding/support from pharmaceutical companies and/or research organizations.

Source: Lane JCE et al. Rheumatology (Oxford). 2020 Dec 25. doi: 10.1093/rheumatology/keaa771.

Key clinical point: Hydroxychloroquine for the treatment of rheumatoid arthritis (RA) does not increase the risks for depression, suicidality, or psychosis compared with sulfasalazine.

Major finding: Hydroxychloroquine use was not associated with risks for depression, acute psychosis, or suicidality compared with sulfasalazine. The hazard ratios [HRs] for short-term risks for depression, acute psychosis, and suicidality were 0.96 (95% confidence interval [CI], 0.79-1.16), 1.03 (95% CI, 0.66-1.60), and 0.94 (95% CI, 0.49-1.77), respectively. The corresponding HRs for long-term risks were 0.94 (95% CI, 0.71-1.26), 0.99 (95% CI, 0.72-1.35), and 0.77 (95% CI, 0.56-1.07), respectively.

Study details: Findings from a multinational network cohort study of RA patients using hydroxychloroquine (n=918,144) and sulfasalazine (n=290,383).

Disclosures: This study was supported by the National Institute for Health Research Oxford Biomedical Research Centre, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research & Development, IQVIA, the Korea Health Technology, and the Korea Health Industry Development Institute. Some of the authors reported personal funding/support from pharmaceutical companies and/or research organizations.

Source: Lane JCE et al. Rheumatology (Oxford). 2020 Dec 25. doi: 10.1093/rheumatology/keaa771.

Key clinical point: Hydroxychloroquine for the treatment of rheumatoid arthritis (RA) does not increase the risks for depression, suicidality, or psychosis compared with sulfasalazine.

Major finding: Hydroxychloroquine use was not associated with risks for depression, acute psychosis, or suicidality compared with sulfasalazine. The hazard ratios [HRs] for short-term risks for depression, acute psychosis, and suicidality were 0.96 (95% confidence interval [CI], 0.79-1.16), 1.03 (95% CI, 0.66-1.60), and 0.94 (95% CI, 0.49-1.77), respectively. The corresponding HRs for long-term risks were 0.94 (95% CI, 0.71-1.26), 0.99 (95% CI, 0.72-1.35), and 0.77 (95% CI, 0.56-1.07), respectively.

Study details: Findings from a multinational network cohort study of RA patients using hydroxychloroquine (n=918,144) and sulfasalazine (n=290,383).

Disclosures: This study was supported by the National Institute for Health Research Oxford Biomedical Research Centre, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research & Development, IQVIA, the Korea Health Technology, and the Korea Health Industry Development Institute. Some of the authors reported personal funding/support from pharmaceutical companies and/or research organizations.

Source: Lane JCE et al. Rheumatology (Oxford). 2020 Dec 25. doi: 10.1093/rheumatology/keaa771.

Key clinical point: Patients with endometriosis are at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: The risk of RA was significantly higher in patients with endometriosis (adjusted hazard ratio [aHR], 1.75; 95% confidence interval [CI], 1.27-2.41), those aged 45 years or older (aHR, 1.50; 95% CI, 1.06-2.13), and those with autoimmune disease (aHR, 6.99; 95% CI, 2.84-17.21).

Study details: This 13-year Taiwanese population-based study included 14,463 women with and 14,463 women without endometriosis who were propensity score-matched by age, comorbidities, corticosteroids, nonsteroidal anti-inflammatory drugs, and hormonal medications.

Disclosures: The study was supported by the Chung Shan Medical University’s DryLab Team and grants awarded to Chung Shan Medical University. The authors declared no conflicts of interest.

Source: Xue YH et al. Rheumatology (Oxford). 2020 Dec 17. doi: 10.1093/rheumatology/keaa784.

Key clinical point: Patients with endometriosis are at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: The risk of RA was significantly higher in patients with endometriosis (adjusted hazard ratio [aHR], 1.75; 95% confidence interval [CI], 1.27-2.41), those aged 45 years or older (aHR, 1.50; 95% CI, 1.06-2.13), and those with autoimmune disease (aHR, 6.99; 95% CI, 2.84-17.21).

Study details: This 13-year Taiwanese population-based study included 14,463 women with and 14,463 women without endometriosis who were propensity score-matched by age, comorbidities, corticosteroids, nonsteroidal anti-inflammatory drugs, and hormonal medications.

Disclosures: The study was supported by the Chung Shan Medical University’s DryLab Team and grants awarded to Chung Shan Medical University. The authors declared no conflicts of interest.

Source: Xue YH et al. Rheumatology (Oxford). 2020 Dec 17. doi: 10.1093/rheumatology/keaa784.

Key clinical point: Patients with endometriosis are at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: The risk of RA was significantly higher in patients with endometriosis (adjusted hazard ratio [aHR], 1.75; 95% confidence interval [CI], 1.27-2.41), those aged 45 years or older (aHR, 1.50; 95% CI, 1.06-2.13), and those with autoimmune disease (aHR, 6.99; 95% CI, 2.84-17.21).

Study details: This 13-year Taiwanese population-based study included 14,463 women with and 14,463 women without endometriosis who were propensity score-matched by age, comorbidities, corticosteroids, nonsteroidal anti-inflammatory drugs, and hormonal medications.

Disclosures: The study was supported by the Chung Shan Medical University’s DryLab Team and grants awarded to Chung Shan Medical University. The authors declared no conflicts of interest.

Source: Xue YH et al. Rheumatology (Oxford). 2020 Dec 17. doi: 10.1093/rheumatology/keaa784.

Key clinical point: In patients with active rheumatoid arthritis (RA) who had limited or no prior methotrexate (MTX) exposure, filgotinib (FIL) with MTX reduced signs and symptoms of RA and improved physical function with an acceptable safety profile up to 52 weeks.

Major finding: At week 24, significantly higher proportions of patients receiving FIL200 + MTX (81%; P less than .001) and FIL100 + MTX (80%; P = .017) achieved 20% improvement in American College of Rheumatology criteria (ACR20) vs. MTX (71%). Significant improvements in Health Assessment Questionnaire-Disability Index and 28-joint Disease Activity Score with C-reactive protein less than 2.6 were seen at week 24. Adverse event rates through week 52 were comparable between all treatments.

Study details: In this 52-week phase 3 FINCH 3 trial, 1,252 patients with RA were randomly assigned in a 2:1:1:2 ratio to receive filgotinib 200 mg with MTX (FIL200 + MTX), filgotinib 100 mg with MTX (FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX.

Disclosures: The study was funded by Gilead Sciences, Inc. The lead author reported receiving grant/research support from and serving as a consultant for Celltrion, Galapagos, and Gilead Sciences.

Source: Westhovens R et al. Ann Rheum Dis. 2021 Jan 15. doi: 10.1136/annrheumdis-2020-219213.

Key clinical point: In patients with active rheumatoid arthritis (RA) who had limited or no prior methotrexate (MTX) exposure, filgotinib (FIL) with MTX reduced signs and symptoms of RA and improved physical function with an acceptable safety profile up to 52 weeks.

Major finding: At week 24, significantly higher proportions of patients receiving FIL200 + MTX (81%; P less than .001) and FIL100 + MTX (80%; P = .017) achieved 20% improvement in American College of Rheumatology criteria (ACR20) vs. MTX (71%). Significant improvements in Health Assessment Questionnaire-Disability Index and 28-joint Disease Activity Score with C-reactive protein less than 2.6 were seen at week 24. Adverse event rates through week 52 were comparable between all treatments.

Study details: In this 52-week phase 3 FINCH 3 trial, 1,252 patients with RA were randomly assigned in a 2:1:1:2 ratio to receive filgotinib 200 mg with MTX (FIL200 + MTX), filgotinib 100 mg with MTX (FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX.

Disclosures: The study was funded by Gilead Sciences, Inc. The lead author reported receiving grant/research support from and serving as a consultant for Celltrion, Galapagos, and Gilead Sciences.

Source: Westhovens R et al. Ann Rheum Dis. 2021 Jan 15. doi: 10.1136/annrheumdis-2020-219213.

Key clinical point: In patients with active rheumatoid arthritis (RA) who had limited or no prior methotrexate (MTX) exposure, filgotinib (FIL) with MTX reduced signs and symptoms of RA and improved physical function with an acceptable safety profile up to 52 weeks.

Major finding: At week 24, significantly higher proportions of patients receiving FIL200 + MTX (81%; P less than .001) and FIL100 + MTX (80%; P = .017) achieved 20% improvement in American College of Rheumatology criteria (ACR20) vs. MTX (71%). Significant improvements in Health Assessment Questionnaire-Disability Index and 28-joint Disease Activity Score with C-reactive protein less than 2.6 were seen at week 24. Adverse event rates through week 52 were comparable between all treatments.

Study details: In this 52-week phase 3 FINCH 3 trial, 1,252 patients with RA were randomly assigned in a 2:1:1:2 ratio to receive filgotinib 200 mg with MTX (FIL200 + MTX), filgotinib 100 mg with MTX (FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX.

Disclosures: The study was funded by Gilead Sciences, Inc. The lead author reported receiving grant/research support from and serving as a consultant for Celltrion, Galapagos, and Gilead Sciences.

Source: Westhovens R et al. Ann Rheum Dis. 2021 Jan 15. doi: 10.1136/annrheumdis-2020-219213.

Key clinical point: Cardiovascular (CV) disease (CVD) and CV risk factors were risk factors for incident dementia among rheumatoid arthritis (RA) patients between 65 and 74 years of age; however, this risk attenuated with increasing age.

Major finding: Patients with CVD and CV risk factors between 65 and 74 years of age had an increased risk for dementia vs. those without CVD and CV risk factors (adjusted hazard Ratio [aHR], 1.18; 95% confidence interval [CI], 1.04-1.33; aHR, 1.03; 95% CI, 1.00-1.11, respectively). For patients between 75 and 84 years of age, a trend toward an increased risk of dementia was observed with CVD but was not statistically significant (aHR, 1.03; 95% CI, 0.92-1.14). These associations were not observed among patients aged 85 years and older.

Study details: Longitudinal analysis of 56,567 patients with RA using Center for Medicare & Medicaid claims (CMS) data from 2006 to 2014; 11,789 (20.1%) incident cases of dementia were included in the analysis.

Disclosures: The study was supported by I Navarro-Millan’s IPCI award from Weill Cornell Medicine Division of General Internal Medicine. JR Curtis received research support and consulting fees from AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, and UCB. SB Lieber reported spousal ownership interests in Cigna, Intuitive Surgical, Inc., Merck, and Pfizer. I Navarro-Millán received consulting fees from Sobi. The remaining authors declared no conflicts of interest.

Source: Sattui SE et al. Semin Arthritis Rheum. 2021 Jan 5. doi: 10.1016/j.semarthrit.2020.09.022.

Key clinical point: Cardiovascular (CV) disease (CVD) and CV risk factors were risk factors for incident dementia among rheumatoid arthritis (RA) patients between 65 and 74 years of age; however, this risk attenuated with increasing age.

Major finding: Patients with CVD and CV risk factors between 65 and 74 years of age had an increased risk for dementia vs. those without CVD and CV risk factors (adjusted hazard Ratio [aHR], 1.18; 95% confidence interval [CI], 1.04-1.33; aHR, 1.03; 95% CI, 1.00-1.11, respectively). For patients between 75 and 84 years of age, a trend toward an increased risk of dementia was observed with CVD but was not statistically significant (aHR, 1.03; 95% CI, 0.92-1.14). These associations were not observed among patients aged 85 years and older.

Study details: Longitudinal analysis of 56,567 patients with RA using Center for Medicare & Medicaid claims (CMS) data from 2006 to 2014; 11,789 (20.1%) incident cases of dementia were included in the analysis.

Disclosures: The study was supported by I Navarro-Millan’s IPCI award from Weill Cornell Medicine Division of General Internal Medicine. JR Curtis received research support and consulting fees from AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, and UCB. SB Lieber reported spousal ownership interests in Cigna, Intuitive Surgical, Inc., Merck, and Pfizer. I Navarro-Millán received consulting fees from Sobi. The remaining authors declared no conflicts of interest.

Source: Sattui SE et al. Semin Arthritis Rheum. 2021 Jan 5. doi: 10.1016/j.semarthrit.2020.09.022.

Key clinical point: Cardiovascular (CV) disease (CVD) and CV risk factors were risk factors for incident dementia among rheumatoid arthritis (RA) patients between 65 and 74 years of age; however, this risk attenuated with increasing age.

Major finding: Patients with CVD and CV risk factors between 65 and 74 years of age had an increased risk for dementia vs. those without CVD and CV risk factors (adjusted hazard Ratio [aHR], 1.18; 95% confidence interval [CI], 1.04-1.33; aHR, 1.03; 95% CI, 1.00-1.11, respectively). For patients between 75 and 84 years of age, a trend toward an increased risk of dementia was observed with CVD but was not statistically significant (aHR, 1.03; 95% CI, 0.92-1.14). These associations were not observed among patients aged 85 years and older.

Study details: Longitudinal analysis of 56,567 patients with RA using Center for Medicare & Medicaid claims (CMS) data from 2006 to 2014; 11,789 (20.1%) incident cases of dementia were included in the analysis.

Disclosures: The study was supported by I Navarro-Millan’s IPCI award from Weill Cornell Medicine Division of General Internal Medicine. JR Curtis received research support and consulting fees from AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, and UCB. SB Lieber reported spousal ownership interests in Cigna, Intuitive Surgical, Inc., Merck, and Pfizer. I Navarro-Millán received consulting fees from Sobi. The remaining authors declared no conflicts of interest.

Source: Sattui SE et al. Semin Arthritis Rheum. 2021 Jan 5. doi: 10.1016/j.semarthrit.2020.09.022.

Key clinical point: Higher disease activity and elevated levels of cytokines/chemokines are associated with a greater risk of diabetes mellitus (DM) in patients with rheumatoid arthritis (RA).

Major finding: High Disease activity Score (DAS28)-C reactive protein (CRP) was associated with an increased risk of DM (test for trend: P less than .001). Several cytokines/chemokines analyzed showed independent association with DM risk including interleukin (IL)-1, IL-6, and select macrophage-derived cytokines/chemokines (hazard ratio per standard deviation range, 1.11-1.26). These associations were independent of the DAS28-CRP.

Study details: This longitudinal analysis included 1,866 patients with RA without prevalent DM from Veteran’s Affairs Rheumatoid Arthritis Registry. Thirty cytokines and chemokines were measured in banked serum obtained at the time of enrolment.

Disclosures: No study sponsor was identified. The presenting author has received consulting fees from Bristol-Myers Squibb and Gilead.

Source: Baker JF. Ann Rheum Dis. 2021 Jan 4. doi: 10.1136/annrheumdis-2020-219140

Key clinical point: Higher disease activity and elevated levels of cytokines/chemokines are associated with a greater risk of diabetes mellitus (DM) in patients with rheumatoid arthritis (RA).

Major finding: High Disease activity Score (DAS28)-C reactive protein (CRP) was associated with an increased risk of DM (test for trend: P less than .001). Several cytokines/chemokines analyzed showed independent association with DM risk including interleukin (IL)-1, IL-6, and select macrophage-derived cytokines/chemokines (hazard ratio per standard deviation range, 1.11-1.26). These associations were independent of the DAS28-CRP.

Study details: This longitudinal analysis included 1,866 patients with RA without prevalent DM from Veteran’s Affairs Rheumatoid Arthritis Registry. Thirty cytokines and chemokines were measured in banked serum obtained at the time of enrolment.

Disclosures: No study sponsor was identified. The presenting author has received consulting fees from Bristol-Myers Squibb and Gilead.

Source: Baker JF. Ann Rheum Dis. 2021 Jan 4. doi: 10.1136/annrheumdis-2020-219140

Key clinical point: Higher disease activity and elevated levels of cytokines/chemokines are associated with a greater risk of diabetes mellitus (DM) in patients with rheumatoid arthritis (RA).

Major finding: High Disease activity Score (DAS28)-C reactive protein (CRP) was associated with an increased risk of DM (test for trend: P less than .001). Several cytokines/chemokines analyzed showed independent association with DM risk including interleukin (IL)-1, IL-6, and select macrophage-derived cytokines/chemokines (hazard ratio per standard deviation range, 1.11-1.26). These associations were independent of the DAS28-CRP.

Study details: This longitudinal analysis included 1,866 patients with RA without prevalent DM from Veteran’s Affairs Rheumatoid Arthritis Registry. Thirty cytokines and chemokines were measured in banked serum obtained at the time of enrolment.

Disclosures: No study sponsor was identified. The presenting author has received consulting fees from Bristol-Myers Squibb and Gilead.

Source: Baker JF. Ann Rheum Dis. 2021 Jan 4. doi: 10.1136/annrheumdis-2020-219140