Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Use of analgesics was higher in patients with psoriasis, particularly those with concomitant psoriatic arthritis (PsA), which could be because of increased joint pain.

Major finding: Moderate-to-severe joint pain was reported by 69% vs 45% of patients with vs without PsA (P less than .0001). Patients with psoriasis vs reference individuals used more nonsteroidal anti‐inflammatory drugs (NSAIDS; 21.0% vs 17.3%) and opioids (14.2% vs 9.0%) within 1 year. Use of NSAIDS (30.8%) and opioids (22.7%) was even higher in patients with psoriasis and PsA. Of all symptoms, only joint pain seemed to be associated with the use of analgesics (P less than .05).

Study details: Findings are from a cross-sectional study of 4,016 adults with psoriasis including 847 with concomitant PsA and 3,490 reference individuals.

Disclosures: No source of funding was declared. Dr. Loft, Dr. Kristensen, and Dr. Egeberg declared being speakers, receiving fees for speaking and consultancy, and/or research funding from various sources. Dr. Nguyen and Dr. Thyssen declared no potential conflict of interests.

Source: Loft N et al. J Am Acad Dermatol. 2021 Jul 24. doi: 10.1016/j.jaad.2021.07.028.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Patients with moderate-to-severe psoriasis who were new users of infliximab and adalimumab vs etanercept had a higher risk for serious infections. The risk was lower with ustekinumab and comparable with secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Major finding: Compared with etanercept, the risk for serious infections was higher for patients who initiated adalimumab (estimated weighted hazard ratio [wHR], 1.22; 95% confidence interval [CI], 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16), whereas the risk was lower with ustekinumab (wHR, 0.79; 95% CI, 0.67-0.94). The risk for serious infections was not higher for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept.

Study details: Findings are from the analysis of a real-world cohort of 44,239 adults with psoriasis who were new users of biologic/biosimilar or targeted synthetic antipsoriatic agents and had no history of serious infection.

Disclosures: The authors did not report any source of funding. No conflict of interests was reported.

Source: Penso L et al. JAMA Dermatol. 2021 Jul 21. doi: 10.1001/jamadermatol.2021.2599.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

Key clinical point: Apremilast demonstrated a significant and clinically meaningful improvement in overall psoriasis severity compared with placebo in patients with mild-to-moderate psoriasis with no new safety signals identified.

Major finding: At week 16, a significantly greater proportion of patients treated with apremilast vs placebo achieved static Physician Global Assessment score of 0 or 1 with 2-point or more reduction from baseline (21.6% vs 4.1%; P < .0001). Most common treatment-emergent adverse events with apremilast vs placebo were diarrhea (16.4% vs 5.1%), headache (13.1% vs 5.1%), and nausea (12.8% vs 4.4%).

Study details: ADVANCE, a phase 3 trial included 595 adults with mild-to-moderate psoriasis inadequately controlled or intolerant to 1 or more topical therapy who were randomly assigned to either apremilast or placebo.

Disclosures: This study was sponsored by Amgen Inc. Some of the authors reported receiving honoraria, grants, and/or research funding and serving as a speaker, investigator, and/or advisory board member for various sources including Amgen Inc. M Chen, M Paris, and Y Wang declared being current/former employees at Amgen Inc.

Source: Gold LS et al. J Am Acad Dermatol. 2021 Aug 2. doi: 10.1016/j.jaad.2021.07.040.

Key clinical point: High resistin levels predict radiologically more rapidly progressing disease in patients with early active rheumatoid arthritis (RA) despite treatment with intensified disease-modifying antirheumatic drug (DMARD) combination. Adding infliximab delayed radiological progression in these patients.

Major finding: Plasma resistin levels at baseline showed positive linearity with disease activity score based on 28-joint count (P = .0072). The addition of infliximab to the DMARD combination delayed radiological progression, with no difference observed between resistin tertiles at 5 years (P = .73).

Study details: This was a post hoc analysis of the NEO-RACo trial, which enrolled 99 patients with early RA treated with intensified FIN-RACo regimen (methotrexate, sulfasalazine, hydroxychloroquine, and prednisolone). Subsequently, patients were randomly assigned to receive placebo or infliximab infusions added to the combination for 6 months.

Disclosures: The Scandinavian Rheumatology Research Foundation, the Maire Lisko Foundation, the Tampere University Hospital's Competitive Research, and others funded this study. None of the authors disclosed any potential conflict of interests.

Source: Vuolteenaho K et al. Scand J Rheumatol. 2021 Jul 15. doi: 10.1080/03009742.2021.1929456.

Key clinical point: High resistin levels predict radiologically more rapidly progressing disease in patients with early active rheumatoid arthritis (RA) despite treatment with intensified disease-modifying antirheumatic drug (DMARD) combination. Adding infliximab delayed radiological progression in these patients.

Major finding: Plasma resistin levels at baseline showed positive linearity with disease activity score based on 28-joint count (P = .0072). The addition of infliximab to the DMARD combination delayed radiological progression, with no difference observed between resistin tertiles at 5 years (P = .73).

Study details: This was a post hoc analysis of the NEO-RACo trial, which enrolled 99 patients with early RA treated with intensified FIN-RACo regimen (methotrexate, sulfasalazine, hydroxychloroquine, and prednisolone). Subsequently, patients were randomly assigned to receive placebo or infliximab infusions added to the combination for 6 months.

Disclosures: The Scandinavian Rheumatology Research Foundation, the Maire Lisko Foundation, the Tampere University Hospital's Competitive Research, and others funded this study. None of the authors disclosed any potential conflict of interests.

Source: Vuolteenaho K et al. Scand J Rheumatol. 2021 Jul 15. doi: 10.1080/03009742.2021.1929456.

Key clinical point: High resistin levels predict radiologically more rapidly progressing disease in patients with early active rheumatoid arthritis (RA) despite treatment with intensified disease-modifying antirheumatic drug (DMARD) combination. Adding infliximab delayed radiological progression in these patients.

Major finding: Plasma resistin levels at baseline showed positive linearity with disease activity score based on 28-joint count (P = .0072). The addition of infliximab to the DMARD combination delayed radiological progression, with no difference observed between resistin tertiles at 5 years (P = .73).

Study details: This was a post hoc analysis of the NEO-RACo trial, which enrolled 99 patients with early RA treated with intensified FIN-RACo regimen (methotrexate, sulfasalazine, hydroxychloroquine, and prednisolone). Subsequently, patients were randomly assigned to receive placebo or infliximab infusions added to the combination for 6 months.

Disclosures: The Scandinavian Rheumatology Research Foundation, the Maire Lisko Foundation, the Tampere University Hospital's Competitive Research, and others funded this study. None of the authors disclosed any potential conflict of interests.

Source: Vuolteenaho K et al. Scand J Rheumatol. 2021 Jul 15. doi: 10.1080/03009742.2021.1929456.

Key clinical point: Iguratimod as monotherapy or combined therapy was remarkably effective and safe in patients with active rheumatoid arthritis (RA) compared with other disease-modifying antirheumatic drugs (DMARDs) monotherapy, primarily consisting of methotrexate.

Major finding: Compared with other DMARDs monotherapy, iguratimod monotherapy or combined therapy was associated with significantly higher American College of Rheumatology 20% response (odds ratio, 1.97; P = .002), lower Disease Activity Score in 28 joints-C-reactive protein (standard mean difference [SMD], −3.49), and a shorter duration of morning stiffness (SMD, −2.06; all P less than .001). The incidence of gastrointestinal events (P = .070), leucopenia (P = .309), transaminase elevation (P = .321), and liver damage (P = .182) was comparable between methotrexate and iguratimod monotherapy.

Study details: This was a meta-analysis of 23 randomized clinical trials involving 2,533 patients with RA.

Disclosures: This study was supported by the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Science & Technology Commission. The authors declared no conflict of interests.

Source: Hu CJ et al. J Orthop Surg Res. 2021 Jul 16. doi: 10.1186/s13018-021-02603-2.

Key clinical point: Iguratimod as monotherapy or combined therapy was remarkably effective and safe in patients with active rheumatoid arthritis (RA) compared with other disease-modifying antirheumatic drugs (DMARDs) monotherapy, primarily consisting of methotrexate.

Major finding: Compared with other DMARDs monotherapy, iguratimod monotherapy or combined therapy was associated with significantly higher American College of Rheumatology 20% response (odds ratio, 1.97; P = .002), lower Disease Activity Score in 28 joints-C-reactive protein (standard mean difference [SMD], −3.49), and a shorter duration of morning stiffness (SMD, −2.06; all P less than .001). The incidence of gastrointestinal events (P = .070), leucopenia (P = .309), transaminase elevation (P = .321), and liver damage (P = .182) was comparable between methotrexate and iguratimod monotherapy.

Study details: This was a meta-analysis of 23 randomized clinical trials involving 2,533 patients with RA.

Disclosures: This study was supported by the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Science & Technology Commission. The authors declared no conflict of interests.

Source: Hu CJ et al. J Orthop Surg Res. 2021 Jul 16. doi: 10.1186/s13018-021-02603-2.

Key clinical point: Iguratimod as monotherapy or combined therapy was remarkably effective and safe in patients with active rheumatoid arthritis (RA) compared with other disease-modifying antirheumatic drugs (DMARDs) monotherapy, primarily consisting of methotrexate.

Major finding: Compared with other DMARDs monotherapy, iguratimod monotherapy or combined therapy was associated with significantly higher American College of Rheumatology 20% response (odds ratio, 1.97; P = .002), lower Disease Activity Score in 28 joints-C-reactive protein (standard mean difference [SMD], −3.49), and a shorter duration of morning stiffness (SMD, −2.06; all P less than .001). The incidence of gastrointestinal events (P = .070), leucopenia (P = .309), transaminase elevation (P = .321), and liver damage (P = .182) was comparable between methotrexate and iguratimod monotherapy.

Study details: This was a meta-analysis of 23 randomized clinical trials involving 2,533 patients with RA.

Disclosures: This study was supported by the Ministry of Science and Technology of China, the Chinese Academy of Medical Sciences, and the Beijing Municipal Science & Technology Commission. The authors declared no conflict of interests.

Source: Hu CJ et al. J Orthop Surg Res. 2021 Jul 16. doi: 10.1186/s13018-021-02603-2.

Key clinical point: Meta-analysis showed a significant association between the use of fostamatinib and a higher risk for hypertension in patients with rheumatoid arthritis (RA); however, no association was observed with elevated risk for cardiovascular events.

Major findings: Fostamatinib was associated with significantly higher risk for hypertension compared with placebo (relative risk, 3.82; 95% confidence interval [CI], 2.88-5.05); however, it was not associated with the higher risk for all-cause death (Peto odds ratio [pOR], 0.16; 95% CI, 0.02-1.24), major adverse cardiovascular events (pOR, 1.24; 95% CI, 0.26-5.97), and other forms of heart disease (pOR, 1.96; 95% CI, 0.72-5.38).

Study details: This was a meta-analysis of 12 trials including 5,618 patients with RA who were treated with oral fostamatinib.

Disclosures: This study was supported by the Post-doctoral Research and Development Fund of West China Hospital, the Clinical Research Incubation Project of West China Hospital, and the Sichuan Science and Technology Program. The authors declared no conflict of interests.

Source: Chen Y et al. Front Pharmacol. 2021 Jul 19. doi: 10.3389/fphar.2021.632551.

Key clinical point: Meta-analysis showed a significant association between the use of fostamatinib and a higher risk for hypertension in patients with rheumatoid arthritis (RA); however, no association was observed with elevated risk for cardiovascular events.

Major findings: Fostamatinib was associated with significantly higher risk for hypertension compared with placebo (relative risk, 3.82; 95% confidence interval [CI], 2.88-5.05); however, it was not associated with the higher risk for all-cause death (Peto odds ratio [pOR], 0.16; 95% CI, 0.02-1.24), major adverse cardiovascular events (pOR, 1.24; 95% CI, 0.26-5.97), and other forms of heart disease (pOR, 1.96; 95% CI, 0.72-5.38).

Study details: This was a meta-analysis of 12 trials including 5,618 patients with RA who were treated with oral fostamatinib.

Disclosures: This study was supported by the Post-doctoral Research and Development Fund of West China Hospital, the Clinical Research Incubation Project of West China Hospital, and the Sichuan Science and Technology Program. The authors declared no conflict of interests.

Source: Chen Y et al. Front Pharmacol. 2021 Jul 19. doi: 10.3389/fphar.2021.632551.

Key clinical point: Meta-analysis showed a significant association between the use of fostamatinib and a higher risk for hypertension in patients with rheumatoid arthritis (RA); however, no association was observed with elevated risk for cardiovascular events.

Major findings: Fostamatinib was associated with significantly higher risk for hypertension compared with placebo (relative risk, 3.82; 95% confidence interval [CI], 2.88-5.05); however, it was not associated with the higher risk for all-cause death (Peto odds ratio [pOR], 0.16; 95% CI, 0.02-1.24), major adverse cardiovascular events (pOR, 1.24; 95% CI, 0.26-5.97), and other forms of heart disease (pOR, 1.96; 95% CI, 0.72-5.38).

Study details: This was a meta-analysis of 12 trials including 5,618 patients with RA who were treated with oral fostamatinib.

Disclosures: This study was supported by the Post-doctoral Research and Development Fund of West China Hospital, the Clinical Research Incubation Project of West China Hospital, and the Sichuan Science and Technology Program. The authors declared no conflict of interests.

Source: Chen Y et al. Front Pharmacol. 2021 Jul 19. doi: 10.3389/fphar.2021.632551.

In patients with coronary artery disease scheduled for a percutaneous intervention (PCI), fractional flow reserve (FFR) assessment at the time of angiography significantly improves outcome, but it has no apparent value as a routine study in all CAD patients, according to the randomized RIPCORD 2 trial.

When compared to angiography alone in an all comer-strategy, the addition of FFR did not significantly change management or lower costs, but it was associated with a longer time for diagnostic assessment and more complications, Nicholas P. Curzen, BM, PhD, reported at the annual congress of the European Society of Cardiology.

As a tool for evaluating stenotic lesions in diseased vessels, FFR, also known as pressure wire assessment, allows interventionalists to target those vessels that induce ischemia without unnecessarily treating vessels with lesions that are hemodynamically nonsignificant. It is guideline recommended for patients with scheduled PCI on the basis of several randomized trials, including the landmark FAME trial.

“The results of these trials were spectacular. The clinical outcomes were significantly better in the FFR group despite less stents being placed and fewer vessels being stented. And there was significantly less resource utilization in the FFR group,” said Dr. Curzen, professor of interventional cardiology, University of Southampton, England.
 

Hypothesis: All-comers benefit from FFR

This prompted the new trial, called RIPCORD 2. The hypothesis was that systematic FFR early in the diagnosis of CAD would reduce resource utilization and improve quality of life relative to angiography alone. Both were addressed as primary endpoints. A reduction in clinical events at 12 months was a secondary endpoint.

The 1,136 participants, all scheduled for angiographic evaluation for stable angina or non-ST elevated myocardial infarction (NSTEMI), were randomized at 17 participating centers in the United Kingdom. All underwent angiography, but the experimental arm also underwent FFR for all arteries of a size suitable for revascularization.

Resource utilization evaluated through hospital costs at 12 months was somewhat higher in the FFR group, but the difference was not significant (P =.137). There was also no significant difference (P = 0.88) between the groups in quality of life, which was measured with EQ-5D-5L, an instrument for expressing five dimensions of health on a visual analog scale.
 

No impact from FFR on clinical events

Furthermore, there was no difference in the rate of clinical events, whether measured by a composite endpoint of major adverse cardiac events (MACE) (P = .64) or by the components of death, stroke, myocardial infarction, and unplanned revascularization, according to Dr. Curzen.

Finally, FFR did not appear to influence subsequent management. When the intervention and control groups were compared, the proportions triaged to optimal medical therapy, optimal medical therapy plus PCI, or optimal medical therapy plus bypass grafting did not differ significantly.  

Given the lack of significant differences for FFR plus angiography relative to angiography alone for any clinically relevant outcome, the addition of FFR provides "no overall advantage" in this all comer study population, Dr. Curzen concluded.

However, FFR was associated with some relative disadvantages. These included significantly longer mean procedure times (69 vs. 42.4 minutes; P < .001), significantly greater mean use of contrast (206 vs. 146.3 mL; P < .001), and a significantly higher mean radiation dose (6608.7 vs. 5029.7 cGY/cm²; P < .001). There were 10 complications (1.8%) associated with FFR.

RIPCORD 1 results provided study rationale

In the previously published nonrandomized RIPCORD 1 study, interventionalists were asked to develop a management plan on the basis of angiography alone in 200 patients with stable chest pain. When these interventionalists were then provided with FFR results, the new information resulted in a change of management plan in 36% of cases.

According to Dr. Curzen, it was this study that raised all-comer FFR as a “logical and clinically plausible question.” RIPCORD 2 provided the answer.

While he is now conducting an evaluation of a subgroup of RIPCORD 2 patients with more severe disease, “it appears that the atheroma burden on angiography is adequate” to make an appropriate management determination in most or all cases.

The invited discussant for this study, Robert Byrne, MD, BCh, PhD, director of cardiology, Mater Private Hospital, Dublin, pointed out that more angiography-alone patients in RIPCORD 2 required additional evaluation to develop a management strategy (14.7% vs. 1.8%), but he agreed that FFR offered “no reasonable benefit” in the relatively low-risk patients who were enrolled.
 

Results do not alter FFR indications

However, he emphasized that the lack of an advantage in this trial should in no way diminish the evidence of benefit for selective FFR use as currently recommended in guidelines. This was echoed strongly in remarks by two other interventionalists who served on the same panel after the RIPCORD 2 results were presented.

“I want to make sure that our audience does not walk away thinking that FFR is useless. This is not what was shown,” said Roxana Mehran, MD, director of interventional cardiovascular research at Icahn School of Medicine at Mount Sinai, New York. She emphasized that this was a study that found no value in a low-risk, all-comer population and is not relevant to the populations where it now has an indication.

Marco Roffi, MD, director of the interventional cardiology unit, Geneva University Hospitals, made the same point.

“These results do not take away the value of FFR in a more selected population [than that enrolled in RIPCORD 2],” Dr. Roffi said. He did not rule out the potential for benefit from adding FFR to angiography even in early disease assessment if a benefit can be demonstrated in a higher-risk population.

Dr. Curzen reports financial relationships with Abbott, Beckman Coulter, HeartFlow, and Boston Scientific, which provided funding for RIPCORD 2. Dr. Byrne reported financial relationships with the trial sponsor as well as Abbott, Biosensors, and Biotronik. Dr. Mehran reports financial relationships with more than 15 medical product companies including the sponsor of this trial. Dr. Roffi reports no relevant financial disclosures.

In patients with coronary artery disease scheduled for a percutaneous intervention (PCI), fractional flow reserve (FFR) assessment at the time of angiography significantly improves outcome, but it has no apparent value as a routine study in all CAD patients, according to the randomized RIPCORD 2 trial.

When compared to angiography alone in an all comer-strategy, the addition of FFR did not significantly change management or lower costs, but it was associated with a longer time for diagnostic assessment and more complications, Nicholas P. Curzen, BM, PhD, reported at the annual congress of the European Society of Cardiology.

As a tool for evaluating stenotic lesions in diseased vessels, FFR, also known as pressure wire assessment, allows interventionalists to target those vessels that induce ischemia without unnecessarily treating vessels with lesions that are hemodynamically nonsignificant. It is guideline recommended for patients with scheduled PCI on the basis of several randomized trials, including the landmark FAME trial.

“The results of these trials were spectacular. The clinical outcomes were significantly better in the FFR group despite less stents being placed and fewer vessels being stented. And there was significantly less resource utilization in the FFR group,” said Dr. Curzen, professor of interventional cardiology, University of Southampton, England.
 

Hypothesis: All-comers benefit from FFR

This prompted the new trial, called RIPCORD 2. The hypothesis was that systematic FFR early in the diagnosis of CAD would reduce resource utilization and improve quality of life relative to angiography alone. Both were addressed as primary endpoints. A reduction in clinical events at 12 months was a secondary endpoint.

The 1,136 participants, all scheduled for angiographic evaluation for stable angina or non-ST elevated myocardial infarction (NSTEMI), were randomized at 17 participating centers in the United Kingdom. All underwent angiography, but the experimental arm also underwent FFR for all arteries of a size suitable for revascularization.

Resource utilization evaluated through hospital costs at 12 months was somewhat higher in the FFR group, but the difference was not significant (P =.137). There was also no significant difference (P = 0.88) between the groups in quality of life, which was measured with EQ-5D-5L, an instrument for expressing five dimensions of health on a visual analog scale.
 

No impact from FFR on clinical events

Furthermore, there was no difference in the rate of clinical events, whether measured by a composite endpoint of major adverse cardiac events (MACE) (P = .64) or by the components of death, stroke, myocardial infarction, and unplanned revascularization, according to Dr. Curzen.

Finally, FFR did not appear to influence subsequent management. When the intervention and control groups were compared, the proportions triaged to optimal medical therapy, optimal medical therapy plus PCI, or optimal medical therapy plus bypass grafting did not differ significantly.  

Given the lack of significant differences for FFR plus angiography relative to angiography alone for any clinically relevant outcome, the addition of FFR provides "no overall advantage" in this all comer study population, Dr. Curzen concluded.

However, FFR was associated with some relative disadvantages. These included significantly longer mean procedure times (69 vs. 42.4 minutes; P < .001), significantly greater mean use of contrast (206 vs. 146.3 mL; P < .001), and a significantly higher mean radiation dose (6608.7 vs. 5029.7 cGY/cm²; P < .001). There were 10 complications (1.8%) associated with FFR.

RIPCORD 1 results provided study rationale

In the previously published nonrandomized RIPCORD 1 study, interventionalists were asked to develop a management plan on the basis of angiography alone in 200 patients with stable chest pain. When these interventionalists were then provided with FFR results, the new information resulted in a change of management plan in 36% of cases.

According to Dr. Curzen, it was this study that raised all-comer FFR as a “logical and clinically plausible question.” RIPCORD 2 provided the answer.

While he is now conducting an evaluation of a subgroup of RIPCORD 2 patients with more severe disease, “it appears that the atheroma burden on angiography is adequate” to make an appropriate management determination in most or all cases.

The invited discussant for this study, Robert Byrne, MD, BCh, PhD, director of cardiology, Mater Private Hospital, Dublin, pointed out that more angiography-alone patients in RIPCORD 2 required additional evaluation to develop a management strategy (14.7% vs. 1.8%), but he agreed that FFR offered “no reasonable benefit” in the relatively low-risk patients who were enrolled.
 

Results do not alter FFR indications

However, he emphasized that the lack of an advantage in this trial should in no way diminish the evidence of benefit for selective FFR use as currently recommended in guidelines. This was echoed strongly in remarks by two other interventionalists who served on the same panel after the RIPCORD 2 results were presented.

“I want to make sure that our audience does not walk away thinking that FFR is useless. This is not what was shown,” said Roxana Mehran, MD, director of interventional cardiovascular research at Icahn School of Medicine at Mount Sinai, New York. She emphasized that this was a study that found no value in a low-risk, all-comer population and is not relevant to the populations where it now has an indication.

Marco Roffi, MD, director of the interventional cardiology unit, Geneva University Hospitals, made the same point.

“These results do not take away the value of FFR in a more selected population [than that enrolled in RIPCORD 2],” Dr. Roffi said. He did not rule out the potential for benefit from adding FFR to angiography even in early disease assessment if a benefit can be demonstrated in a higher-risk population.

Dr. Curzen reports financial relationships with Abbott, Beckman Coulter, HeartFlow, and Boston Scientific, which provided funding for RIPCORD 2. Dr. Byrne reported financial relationships with the trial sponsor as well as Abbott, Biosensors, and Biotronik. Dr. Mehran reports financial relationships with more than 15 medical product companies including the sponsor of this trial. Dr. Roffi reports no relevant financial disclosures.

In patients with coronary artery disease scheduled for a percutaneous intervention (PCI), fractional flow reserve (FFR) assessment at the time of angiography significantly improves outcome, but it has no apparent value as a routine study in all CAD patients, according to the randomized RIPCORD 2 trial.

When compared to angiography alone in an all comer-strategy, the addition of FFR did not significantly change management or lower costs, but it was associated with a longer time for diagnostic assessment and more complications, Nicholas P. Curzen, BM, PhD, reported at the annual congress of the European Society of Cardiology.

As a tool for evaluating stenotic lesions in diseased vessels, FFR, also known as pressure wire assessment, allows interventionalists to target those vessels that induce ischemia without unnecessarily treating vessels with lesions that are hemodynamically nonsignificant. It is guideline recommended for patients with scheduled PCI on the basis of several randomized trials, including the landmark FAME trial.

“The results of these trials were spectacular. The clinical outcomes were significantly better in the FFR group despite less stents being placed and fewer vessels being stented. And there was significantly less resource utilization in the FFR group,” said Dr. Curzen, professor of interventional cardiology, University of Southampton, England.
 

Hypothesis: All-comers benefit from FFR

This prompted the new trial, called RIPCORD 2. The hypothesis was that systematic FFR early in the diagnosis of CAD would reduce resource utilization and improve quality of life relative to angiography alone. Both were addressed as primary endpoints. A reduction in clinical events at 12 months was a secondary endpoint.

The 1,136 participants, all scheduled for angiographic evaluation for stable angina or non-ST elevated myocardial infarction (NSTEMI), were randomized at 17 participating centers in the United Kingdom. All underwent angiography, but the experimental arm also underwent FFR for all arteries of a size suitable for revascularization.

Resource utilization evaluated through hospital costs at 12 months was somewhat higher in the FFR group, but the difference was not significant (P =.137). There was also no significant difference (P = 0.88) between the groups in quality of life, which was measured with EQ-5D-5L, an instrument for expressing five dimensions of health on a visual analog scale.
 

No impact from FFR on clinical events

Furthermore, there was no difference in the rate of clinical events, whether measured by a composite endpoint of major adverse cardiac events (MACE) (P = .64) or by the components of death, stroke, myocardial infarction, and unplanned revascularization, according to Dr. Curzen.

Finally, FFR did not appear to influence subsequent management. When the intervention and control groups were compared, the proportions triaged to optimal medical therapy, optimal medical therapy plus PCI, or optimal medical therapy plus bypass grafting did not differ significantly.  

Given the lack of significant differences for FFR plus angiography relative to angiography alone for any clinically relevant outcome, the addition of FFR provides "no overall advantage" in this all comer study population, Dr. Curzen concluded.

However, FFR was associated with some relative disadvantages. These included significantly longer mean procedure times (69 vs. 42.4 minutes; P < .001), significantly greater mean use of contrast (206 vs. 146.3 mL; P < .001), and a significantly higher mean radiation dose (6608.7 vs. 5029.7 cGY/cm²; P < .001). There were 10 complications (1.8%) associated with FFR.

RIPCORD 1 results provided study rationale

In the previously published nonrandomized RIPCORD 1 study, interventionalists were asked to develop a management plan on the basis of angiography alone in 200 patients with stable chest pain. When these interventionalists were then provided with FFR results, the new information resulted in a change of management plan in 36% of cases.

According to Dr. Curzen, it was this study that raised all-comer FFR as a “logical and clinically plausible question.” RIPCORD 2 provided the answer.

While he is now conducting an evaluation of a subgroup of RIPCORD 2 patients with more severe disease, “it appears that the atheroma burden on angiography is adequate” to make an appropriate management determination in most or all cases.

The invited discussant for this study, Robert Byrne, MD, BCh, PhD, director of cardiology, Mater Private Hospital, Dublin, pointed out that more angiography-alone patients in RIPCORD 2 required additional evaluation to develop a management strategy (14.7% vs. 1.8%), but he agreed that FFR offered “no reasonable benefit” in the relatively low-risk patients who were enrolled.
 

Results do not alter FFR indications

However, he emphasized that the lack of an advantage in this trial should in no way diminish the evidence of benefit for selective FFR use as currently recommended in guidelines. This was echoed strongly in remarks by two other interventionalists who served on the same panel after the RIPCORD 2 results were presented.

“I want to make sure that our audience does not walk away thinking that FFR is useless. This is not what was shown,” said Roxana Mehran, MD, director of interventional cardiovascular research at Icahn School of Medicine at Mount Sinai, New York. She emphasized that this was a study that found no value in a low-risk, all-comer population and is not relevant to the populations where it now has an indication.

Marco Roffi, MD, director of the interventional cardiology unit, Geneva University Hospitals, made the same point.

“These results do not take away the value of FFR in a more selected population [than that enrolled in RIPCORD 2],” Dr. Roffi said. He did not rule out the potential for benefit from adding FFR to angiography even in early disease assessment if a benefit can be demonstrated in a higher-risk population.

Dr. Curzen reports financial relationships with Abbott, Beckman Coulter, HeartFlow, and Boston Scientific, which provided funding for RIPCORD 2. Dr. Byrne reported financial relationships with the trial sponsor as well as Abbott, Biosensors, and Biotronik. Dr. Mehran reports financial relationships with more than 15 medical product companies including the sponsor of this trial. Dr. Roffi reports no relevant financial disclosures.

Key clinical point: Patients with rheumatoid arthritis (RA) with high baseline fibromyalgianess were more likely to use glucocorticoid persistently at 3 months follow-up, regardless of inflammatory activity.

Major finding: After adjusting for potential confounders including noninflammatory and inflammatory factors, patients with high or very high vs low fibromyalgianess were significantly more likely to be taking prednisone (adjusted odds ratio, 4.99; 95% confidence interval, 1.20-20.73) at 3-month follow-up.

Study details: Findings are from an analysis of 97 patients with active RA from the prospective Central Pain in RA (CPIRA) cohort, who were on oral prednisone for 3 months after starting a new disease-modifying antirheumatic drug.

Disclosures: The CPIRA study was funded by the National Institute of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. YC Lee, MB Bolster, and DJ Clauw reported receiving consulting fees, speaking fees, honoraria, and/or stock ownership from various sources. All the other authors declared no conflict of interests.

Source: Wallace BI et al. Rheumatology (Oxford). 2021 Jul 22. doi: 10.1093/rheumatology/keab583.

Key clinical point: Patients with rheumatoid arthritis (RA) with high baseline fibromyalgianess were more likely to use glucocorticoid persistently at 3 months follow-up, regardless of inflammatory activity.

Major finding: After adjusting for potential confounders including noninflammatory and inflammatory factors, patients with high or very high vs low fibromyalgianess were significantly more likely to be taking prednisone (adjusted odds ratio, 4.99; 95% confidence interval, 1.20-20.73) at 3-month follow-up.

Study details: Findings are from an analysis of 97 patients with active RA from the prospective Central Pain in RA (CPIRA) cohort, who were on oral prednisone for 3 months after starting a new disease-modifying antirheumatic drug.

Disclosures: The CPIRA study was funded by the National Institute of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. YC Lee, MB Bolster, and DJ Clauw reported receiving consulting fees, speaking fees, honoraria, and/or stock ownership from various sources. All the other authors declared no conflict of interests.

Source: Wallace BI et al. Rheumatology (Oxford). 2021 Jul 22. doi: 10.1093/rheumatology/keab583.

Key clinical point: Patients with rheumatoid arthritis (RA) with high baseline fibromyalgianess were more likely to use glucocorticoid persistently at 3 months follow-up, regardless of inflammatory activity.

Major finding: After adjusting for potential confounders including noninflammatory and inflammatory factors, patients with high or very high vs low fibromyalgianess were significantly more likely to be taking prednisone (adjusted odds ratio, 4.99; 95% confidence interval, 1.20-20.73) at 3-month follow-up.

Study details: Findings are from an analysis of 97 patients with active RA from the prospective Central Pain in RA (CPIRA) cohort, who were on oral prednisone for 3 months after starting a new disease-modifying antirheumatic drug.

Disclosures: The CPIRA study was funded by the National Institute of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. YC Lee, MB Bolster, and DJ Clauw reported receiving consulting fees, speaking fees, honoraria, and/or stock ownership from various sources. All the other authors declared no conflict of interests.

Source: Wallace BI et al. Rheumatology (Oxford). 2021 Jul 22. doi: 10.1093/rheumatology/keab583.

Key clinical point: Long-term use of tumor necrosis factor inhibitors (TNFis) for rheumatoid arthritis (RA) in clinical practice was not associated with an increased incidence of overall cancer. However, a higher risk of developing urinary tract cancer was observed for TNFi, rituximab, and abatacept.

Major finding: Compared with biologic and targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD)-naive patients, the relative risk for overall cancer was not higher among those treated with TNFis for 10 or more years (adjusted hazard ratio [aHR], 1.0; 95% confidence interval [CI], 0.8-1.2). However, the risk for urinary tract cancer was significantly higher with TNFi (aHR, 1.5; 95% CI, 1.1-1.9), rituximab (aHR, 2.1; 95% CI, 1.3-3.7), and abatacept (aHR, 2.3; 95% CI, 1.3-3.9).

Study details: This was an observational cohort study that included patients with RA (n=69,308) who received TNFis or other b/tsDMARDs, b/tsDMARDs-naïve patients with RA (n=56,233), and matched general population referents (n=109,532).

Disclosures: This study was funded by the Karolinska Institute Region Stockholm. J Askling declared research agreements with various sources. The other authors declared no conflict of interests.

Source: Huss V et al. Rheumatology (Oxford). 2021 Jul 29. doi: 10.1093/rheumatology/keab570.

Key clinical point: Long-term use of tumor necrosis factor inhibitors (TNFis) for rheumatoid arthritis (RA) in clinical practice was not associated with an increased incidence of overall cancer. However, a higher risk of developing urinary tract cancer was observed for TNFi, rituximab, and abatacept.

Major finding: Compared with biologic and targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD)-naive patients, the relative risk for overall cancer was not higher among those treated with TNFis for 10 or more years (adjusted hazard ratio [aHR], 1.0; 95% confidence interval [CI], 0.8-1.2). However, the risk for urinary tract cancer was significantly higher with TNFi (aHR, 1.5; 95% CI, 1.1-1.9), rituximab (aHR, 2.1; 95% CI, 1.3-3.7), and abatacept (aHR, 2.3; 95% CI, 1.3-3.9).

Study details: This was an observational cohort study that included patients with RA (n=69,308) who received TNFis or other b/tsDMARDs, b/tsDMARDs-naïve patients with RA (n=56,233), and matched general population referents (n=109,532).

Disclosures: This study was funded by the Karolinska Institute Region Stockholm. J Askling declared research agreements with various sources. The other authors declared no conflict of interests.

Source: Huss V et al. Rheumatology (Oxford). 2021 Jul 29. doi: 10.1093/rheumatology/keab570.

Key clinical point: Long-term use of tumor necrosis factor inhibitors (TNFis) for rheumatoid arthritis (RA) in clinical practice was not associated with an increased incidence of overall cancer. However, a higher risk of developing urinary tract cancer was observed for TNFi, rituximab, and abatacept.

Major finding: Compared with biologic and targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD)-naive patients, the relative risk for overall cancer was not higher among those treated with TNFis for 10 or more years (adjusted hazard ratio [aHR], 1.0; 95% confidence interval [CI], 0.8-1.2). However, the risk for urinary tract cancer was significantly higher with TNFi (aHR, 1.5; 95% CI, 1.1-1.9), rituximab (aHR, 2.1; 95% CI, 1.3-3.7), and abatacept (aHR, 2.3; 95% CI, 1.3-3.9).

Study details: This was an observational cohort study that included patients with RA (n=69,308) who received TNFis or other b/tsDMARDs, b/tsDMARDs-naïve patients with RA (n=56,233), and matched general population referents (n=109,532).

Disclosures: This study was funded by the Karolinska Institute Region Stockholm. J Askling declared research agreements with various sources. The other authors declared no conflict of interests.

Source: Huss V et al. Rheumatology (Oxford). 2021 Jul 29. doi: 10.1093/rheumatology/keab570.

Key clinical point: In patients with rheumatoid arthritis (RA), treatment with targeted synthetic and biologic disease-modifying antirheumatic drugs (tsDMARDs/bDMARDs) vs conventional synthetic DMARDs (csDMARDs) was associated with a significantly higher risk for herpes zoster (HZ).

Major finding: Compared with csDMARDs, Janus kinase inhibitors (adjusted hazard ratio [aHR], 3.66; P less than .0001), monoclonal anti-tumor necrosis factor antibodies (aHR, 1.63; P = .0042), and B-cell targeted treatment (aHR, 1.57; P = .0355) were associated with a significantly higher risk for HZ.

Study details: The data come from an analysis of 13,991 patients with RA from the German RABBIT register, which included patients who initiated tsDMARD/bDMARD or csDMARD treatment after at least 1 prior DMARD.

Disclosures: RABBIT is supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Hexal, Lilly, MSD, Viatris, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. A Strangfeld, A Zink, GR Burmester, and J Braun declared receiving speaker fees, honoraria, consulting, and/or grants from various sources.

Source: Redeker I et al. Ann Rheum Dis. 2021 Jul 28. doi: 10.1136/annrheumdis-2021-220651.

Key clinical point: In patients with rheumatoid arthritis (RA), treatment with targeted synthetic and biologic disease-modifying antirheumatic drugs (tsDMARDs/bDMARDs) vs conventional synthetic DMARDs (csDMARDs) was associated with a significantly higher risk for herpes zoster (HZ).

Major finding: Compared with csDMARDs, Janus kinase inhibitors (adjusted hazard ratio [aHR], 3.66; P less than .0001), monoclonal anti-tumor necrosis factor antibodies (aHR, 1.63; P = .0042), and B-cell targeted treatment (aHR, 1.57; P = .0355) were associated with a significantly higher risk for HZ.

Study details: The data come from an analysis of 13,991 patients with RA from the German RABBIT register, which included patients who initiated tsDMARD/bDMARD or csDMARD treatment after at least 1 prior DMARD.

Disclosures: RABBIT is supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Hexal, Lilly, MSD, Viatris, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. A Strangfeld, A Zink, GR Burmester, and J Braun declared receiving speaker fees, honoraria, consulting, and/or grants from various sources.

Source: Redeker I et al. Ann Rheum Dis. 2021 Jul 28. doi: 10.1136/annrheumdis-2021-220651.

Key clinical point: In patients with rheumatoid arthritis (RA), treatment with targeted synthetic and biologic disease-modifying antirheumatic drugs (tsDMARDs/bDMARDs) vs conventional synthetic DMARDs (csDMARDs) was associated with a significantly higher risk for herpes zoster (HZ).

Major finding: Compared with csDMARDs, Janus kinase inhibitors (adjusted hazard ratio [aHR], 3.66; P less than .0001), monoclonal anti-tumor necrosis factor antibodies (aHR, 1.63; P = .0042), and B-cell targeted treatment (aHR, 1.57; P = .0355) were associated with a significantly higher risk for HZ.

Study details: The data come from an analysis of 13,991 patients with RA from the German RABBIT register, which included patients who initiated tsDMARD/bDMARD or csDMARD treatment after at least 1 prior DMARD.

Disclosures: RABBIT is supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Hexal, Lilly, MSD, Viatris, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, and UCB. A Strangfeld, A Zink, GR Burmester, and J Braun declared receiving speaker fees, honoraria, consulting, and/or grants from various sources.

Source: Redeker I et al. Ann Rheum Dis. 2021 Jul 28. doi: 10.1136/annrheumdis-2021-220651.