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Expanded living donor liver transplant criteria improves HCC outcomes
Key clinical point: Overall survival and recurrence were not significantly different for patients with HCC when selection protocols expanded the criteria for tumor size and number and included alpha-fetoprotein levels.
Major finding: The 5-year overall survival in the UCSF and UCSF+ groups was 72% and 69%, respectively, (P = 0.7); the recurrence risk was 13% and 36%, respectively (P = 0.1). In addition, the 5-year overall survival rate was 85% among low-risk MVI patients.
Study details: The data come from a retrospective review of 244 adults with preoperative HCC who underwent living donor liver transplantation for HCC, including 159 who met the University of California San Francisco (UCSF) transplant criteria (single tumor ≤ 6.5 cm, up to 3 tumors ≤ 4.5 cm, total tumor diameter ≤ 8 cm), 58 patients whose largest tumor was 10 cm or less (described as UCSF+), and 27 who had macrovascular invasion.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Bhatti ABH et al. J Cancer Res Clin Oncol. 2021 June 12. doi: 10.1007/s00432-021-03665-9.
Key clinical point: Overall survival and recurrence were not significantly different for patients with HCC when selection protocols expanded the criteria for tumor size and number and included alpha-fetoprotein levels.
Major finding: The 5-year overall survival in the UCSF and UCSF+ groups was 72% and 69%, respectively, (P = 0.7); the recurrence risk was 13% and 36%, respectively (P = 0.1). In addition, the 5-year overall survival rate was 85% among low-risk MVI patients.
Study details: The data come from a retrospective review of 244 adults with preoperative HCC who underwent living donor liver transplantation for HCC, including 159 who met the University of California San Francisco (UCSF) transplant criteria (single tumor ≤ 6.5 cm, up to 3 tumors ≤ 4.5 cm, total tumor diameter ≤ 8 cm), 58 patients whose largest tumor was 10 cm or less (described as UCSF+), and 27 who had macrovascular invasion.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Bhatti ABH et al. J Cancer Res Clin Oncol. 2021 June 12. doi: 10.1007/s00432-021-03665-9.
Key clinical point: Overall survival and recurrence were not significantly different for patients with HCC when selection protocols expanded the criteria for tumor size and number and included alpha-fetoprotein levels.
Major finding: The 5-year overall survival in the UCSF and UCSF+ groups was 72% and 69%, respectively, (P = 0.7); the recurrence risk was 13% and 36%, respectively (P = 0.1). In addition, the 5-year overall survival rate was 85% among low-risk MVI patients.
Study details: The data come from a retrospective review of 244 adults with preoperative HCC who underwent living donor liver transplantation for HCC, including 159 who met the University of California San Francisco (UCSF) transplant criteria (single tumor ≤ 6.5 cm, up to 3 tumors ≤ 4.5 cm, total tumor diameter ≤ 8 cm), 58 patients whose largest tumor was 10 cm or less (described as UCSF+), and 27 who had macrovascular invasion.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Bhatti ABH et al. J Cancer Res Clin Oncol. 2021 June 12. doi: 10.1007/s00432-021-03665-9.
Immune-related genes show promise as HCC survival predictors
Key clinical point: A prognostic model based on immune-related genes showed promise as a predictor of overall survival in hepatocellular carcinoma patients; 7 genes were better prognosticators than the tumor/node/metastasis (TNM) staging system.
Major finding: Clinical outcomes in HCC patients were associated with 100 immune-related differentially-expressed genes (DEGs). The researchers identified 7 prognostic immune-related genes (IRGs) after combining data types from multiple databases: Fatty Acid Binding Protein 6 (FABP6), Microtubule-Associated Protein Tau (MAPT), Baculoviral IAP Repeat Containing 5 (BIRC5), Plexin-A1 (PLXNA1), Secreted Phosphoprotein 1 (SPP1), Stanniocalcin 2 (STC2) and Chondroitin Sulfate Proteoglycan 5 (CSPG5).
Study details: The data come from 424 adults with hepatocellular carcinoma; the researchers integrated RNA sequencing profiles from the patients with immune-related genes to calculate immune-related differentially-expressed genes.
Disclosures: The study was supported in part by Guangzhou University of Chinese Medicine, Guangzhou University of Chinese Medicine National University Student Innovation and Entrepreneurship Training Project, and the First Affiliated Hospital of Guangzhou University of Chinese Medicine Innovation and Student Training Team Incubation Project. The researchers had no financial conflicts to disclose.
Source: Yan Q et al. BioData Min. 2021 May 7. doi: 0.1186/s13040-021-00261-y.
Key clinical point: A prognostic model based on immune-related genes showed promise as a predictor of overall survival in hepatocellular carcinoma patients; 7 genes were better prognosticators than the tumor/node/metastasis (TNM) staging system.
Major finding: Clinical outcomes in HCC patients were associated with 100 immune-related differentially-expressed genes (DEGs). The researchers identified 7 prognostic immune-related genes (IRGs) after combining data types from multiple databases: Fatty Acid Binding Protein 6 (FABP6), Microtubule-Associated Protein Tau (MAPT), Baculoviral IAP Repeat Containing 5 (BIRC5), Plexin-A1 (PLXNA1), Secreted Phosphoprotein 1 (SPP1), Stanniocalcin 2 (STC2) and Chondroitin Sulfate Proteoglycan 5 (CSPG5).
Study details: The data come from 424 adults with hepatocellular carcinoma; the researchers integrated RNA sequencing profiles from the patients with immune-related genes to calculate immune-related differentially-expressed genes.
Disclosures: The study was supported in part by Guangzhou University of Chinese Medicine, Guangzhou University of Chinese Medicine National University Student Innovation and Entrepreneurship Training Project, and the First Affiliated Hospital of Guangzhou University of Chinese Medicine Innovation and Student Training Team Incubation Project. The researchers had no financial conflicts to disclose.
Source: Yan Q et al. BioData Min. 2021 May 7. doi: 0.1186/s13040-021-00261-y.
Key clinical point: A prognostic model based on immune-related genes showed promise as a predictor of overall survival in hepatocellular carcinoma patients; 7 genes were better prognosticators than the tumor/node/metastasis (TNM) staging system.
Major finding: Clinical outcomes in HCC patients were associated with 100 immune-related differentially-expressed genes (DEGs). The researchers identified 7 prognostic immune-related genes (IRGs) after combining data types from multiple databases: Fatty Acid Binding Protein 6 (FABP6), Microtubule-Associated Protein Tau (MAPT), Baculoviral IAP Repeat Containing 5 (BIRC5), Plexin-A1 (PLXNA1), Secreted Phosphoprotein 1 (SPP1), Stanniocalcin 2 (STC2) and Chondroitin Sulfate Proteoglycan 5 (CSPG5).
Study details: The data come from 424 adults with hepatocellular carcinoma; the researchers integrated RNA sequencing profiles from the patients with immune-related genes to calculate immune-related differentially-expressed genes.
Disclosures: The study was supported in part by Guangzhou University of Chinese Medicine, Guangzhou University of Chinese Medicine National University Student Innovation and Entrepreneurship Training Project, and the First Affiliated Hospital of Guangzhou University of Chinese Medicine Innovation and Student Training Team Incubation Project. The researchers had no financial conflicts to disclose.
Source: Yan Q et al. BioData Min. 2021 May 7. doi: 0.1186/s13040-021-00261-y.
Clinical Edge Journal Scan Commentary: HCC July 2021
Treatment of hepatocellular carcinoma (HCC) benefits from a multidisciplinary approach. This month we will review some articles that address both localized and systemic therapies.
The first paper is a retrospective review of patients who underwent living donor liver transplantation (LDLT). Bhatti et al reviewed the outcomes of 244 patients with HCC who underwent LDLT at one center. All patients had AFP <1000 at time of LDLT. Out of those, 159 had tumors within UCSF criteria (single tumor ≤ 6.5 cm, up to 3 tumors ≤ 4.5 cm, total tumor diameter ≤ 8 cm), while 58 patients had tumors that were outside UCSF but <10cm, and 27 patients who were outside UCSF with macrovascular invasion (UCSF+). All patients within UCSF criteria were offered upfront LDLT. Patients outside UCSF criteria (UCSF+) were also considered for upfront LDLT, however patients with AFP >1000 ng/ml and UCSF + tumors were considered for downstaging. The authors reported that survival at 5 years was similar in the UCSF and UCSF+ groups (72% vs 69%, P = 0.7), while the rate of HCC recurrence was 13% vs 36% (P = 0.1). They concluded that carefully selected patients with HCC outside UCSF may benefit from LDLT.
Chemoembolization is a common treatment used for patients with localized HCC. Postembolization syndrome (abdominal pain, nausea, vomiting, fever and/or infection) is a frequent complication that adversely affects the patient’s quality of life. Lu et al report the results of a retrospective study of the use of dexamethasone in patients undergoing transarterial chemoembolization (TACE). The course of 255 HCC patients who underwent TACE were reviewed. The patients were divided into 2 nonrandomized groups to receive TACE using lipiodol + chemotherapeutic emulsion group (133 patients) or TACE using lipiodol + dexamethasone 10 mg + chemotherapeutic emulsion group (122 patients). Incidence of postembolization syndrome was reduced in the dexamethasone group: abdominal pain, 55.6% vs 36.1% (P = .002); fever, 37.6% vs 13.1% (P < .05); nausea, 60.9% vs 41.0% (P = .001); vomiting, 48.1% vs 21.3% (P < .05). Incidence of infection was 1.5% vs 2.5% (P = .583). The authors concluded that the incidence of postembolization syndrome could be reduced by adding dexamethasone to TACE.
Hepatic arterial infusion (HAI) chemotherapy has been used in the treatment of several types of liver-dominant tumors. Abdelmaksoud et al report on their experience using HAI to treat HCC with portal vein thrombosis and compensated cirrhosis. In this case-controlled study, 20 patients were treated with HAIC (50 mg doxorubicin and 50 mg cisplatin infused into the hepatic artery), 42 patients received best supportive care, and 29 patients were treated with sorafenib. The authors report that patients who received HAI had the longest survival compared with the best supportive care and sorafenib groups (29.2 ± 21.8, 4.55 ± 11.41, and 11.52 ± 8.72 months respectively, P = 0.007), concluding that HAI is an effective option for selected patients with HCC and portal vein thrombosis.
Finally, Hiraoka et al reported a retrospective study of 171 adults with unresectable HCC who received systemic therapy with atezolizumab with bevacizumab. In this report, only 75 patients received this as their first-line systemic therapy. After 6 weeks of treatment, the overall response rate was 10.6% (9.7% for previously treated and 12.2% for previously untreated), and the disease control rate was 79.6%. In 111 patients, the albumin-bilirubin score that assesses liver function was significantly worse at 3 weeks after starting treatment (−2.525 ± 0.419 vs −2.323 ± 0.445, P < .001), but then recovered at 6-weeks, confirming the efficacy and safety of this treatment regimen.
Treatment of hepatocellular carcinoma (HCC) benefits from a multidisciplinary approach. This month we will review some articles that address both localized and systemic therapies.
The first paper is a retrospective review of patients who underwent living donor liver transplantation (LDLT). Bhatti et al reviewed the outcomes of 244 patients with HCC who underwent LDLT at one center. All patients had AFP <1000 at time of LDLT. Out of those, 159 had tumors within UCSF criteria (single tumor ≤ 6.5 cm, up to 3 tumors ≤ 4.5 cm, total tumor diameter ≤ 8 cm), while 58 patients had tumors that were outside UCSF but <10cm, and 27 patients who were outside UCSF with macrovascular invasion (UCSF+). All patients within UCSF criteria were offered upfront LDLT. Patients outside UCSF criteria (UCSF+) were also considered for upfront LDLT, however patients with AFP >1000 ng/ml and UCSF + tumors were considered for downstaging. The authors reported that survival at 5 years was similar in the UCSF and UCSF+ groups (72% vs 69%, P = 0.7), while the rate of HCC recurrence was 13% vs 36% (P = 0.1). They concluded that carefully selected patients with HCC outside UCSF may benefit from LDLT.
Chemoembolization is a common treatment used for patients with localized HCC. Postembolization syndrome (abdominal pain, nausea, vomiting, fever and/or infection) is a frequent complication that adversely affects the patient’s quality of life. Lu et al report the results of a retrospective study of the use of dexamethasone in patients undergoing transarterial chemoembolization (TACE). The course of 255 HCC patients who underwent TACE were reviewed. The patients were divided into 2 nonrandomized groups to receive TACE using lipiodol + chemotherapeutic emulsion group (133 patients) or TACE using lipiodol + dexamethasone 10 mg + chemotherapeutic emulsion group (122 patients). Incidence of postembolization syndrome was reduced in the dexamethasone group: abdominal pain, 55.6% vs 36.1% (P = .002); fever, 37.6% vs 13.1% (P < .05); nausea, 60.9% vs 41.0% (P = .001); vomiting, 48.1% vs 21.3% (P < .05). Incidence of infection was 1.5% vs 2.5% (P = .583). The authors concluded that the incidence of postembolization syndrome could be reduced by adding dexamethasone to TACE.
Hepatic arterial infusion (HAI) chemotherapy has been used in the treatment of several types of liver-dominant tumors. Abdelmaksoud et al report on their experience using HAI to treat HCC with portal vein thrombosis and compensated cirrhosis. In this case-controlled study, 20 patients were treated with HAIC (50 mg doxorubicin and 50 mg cisplatin infused into the hepatic artery), 42 patients received best supportive care, and 29 patients were treated with sorafenib. The authors report that patients who received HAI had the longest survival compared with the best supportive care and sorafenib groups (29.2 ± 21.8, 4.55 ± 11.41, and 11.52 ± 8.72 months respectively, P = 0.007), concluding that HAI is an effective option for selected patients with HCC and portal vein thrombosis.
Finally, Hiraoka et al reported a retrospective study of 171 adults with unresectable HCC who received systemic therapy with atezolizumab with bevacizumab. In this report, only 75 patients received this as their first-line systemic therapy. After 6 weeks of treatment, the overall response rate was 10.6% (9.7% for previously treated and 12.2% for previously untreated), and the disease control rate was 79.6%. In 111 patients, the albumin-bilirubin score that assesses liver function was significantly worse at 3 weeks after starting treatment (−2.525 ± 0.419 vs −2.323 ± 0.445, P < .001), but then recovered at 6-weeks, confirming the efficacy and safety of this treatment regimen.
Treatment of hepatocellular carcinoma (HCC) benefits from a multidisciplinary approach. This month we will review some articles that address both localized and systemic therapies.
The first paper is a retrospective review of patients who underwent living donor liver transplantation (LDLT). Bhatti et al reviewed the outcomes of 244 patients with HCC who underwent LDLT at one center. All patients had AFP <1000 at time of LDLT. Out of those, 159 had tumors within UCSF criteria (single tumor ≤ 6.5 cm, up to 3 tumors ≤ 4.5 cm, total tumor diameter ≤ 8 cm), while 58 patients had tumors that were outside UCSF but <10cm, and 27 patients who were outside UCSF with macrovascular invasion (UCSF+). All patients within UCSF criteria were offered upfront LDLT. Patients outside UCSF criteria (UCSF+) were also considered for upfront LDLT, however patients with AFP >1000 ng/ml and UCSF + tumors were considered for downstaging. The authors reported that survival at 5 years was similar in the UCSF and UCSF+ groups (72% vs 69%, P = 0.7), while the rate of HCC recurrence was 13% vs 36% (P = 0.1). They concluded that carefully selected patients with HCC outside UCSF may benefit from LDLT.
Chemoembolization is a common treatment used for patients with localized HCC. Postembolization syndrome (abdominal pain, nausea, vomiting, fever and/or infection) is a frequent complication that adversely affects the patient’s quality of life. Lu et al report the results of a retrospective study of the use of dexamethasone in patients undergoing transarterial chemoembolization (TACE). The course of 255 HCC patients who underwent TACE were reviewed. The patients were divided into 2 nonrandomized groups to receive TACE using lipiodol + chemotherapeutic emulsion group (133 patients) or TACE using lipiodol + dexamethasone 10 mg + chemotherapeutic emulsion group (122 patients). Incidence of postembolization syndrome was reduced in the dexamethasone group: abdominal pain, 55.6% vs 36.1% (P = .002); fever, 37.6% vs 13.1% (P < .05); nausea, 60.9% vs 41.0% (P = .001); vomiting, 48.1% vs 21.3% (P < .05). Incidence of infection was 1.5% vs 2.5% (P = .583). The authors concluded that the incidence of postembolization syndrome could be reduced by adding dexamethasone to TACE.
Hepatic arterial infusion (HAI) chemotherapy has been used in the treatment of several types of liver-dominant tumors. Abdelmaksoud et al report on their experience using HAI to treat HCC with portal vein thrombosis and compensated cirrhosis. In this case-controlled study, 20 patients were treated with HAIC (50 mg doxorubicin and 50 mg cisplatin infused into the hepatic artery), 42 patients received best supportive care, and 29 patients were treated with sorafenib. The authors report that patients who received HAI had the longest survival compared with the best supportive care and sorafenib groups (29.2 ± 21.8, 4.55 ± 11.41, and 11.52 ± 8.72 months respectively, P = 0.007), concluding that HAI is an effective option for selected patients with HCC and portal vein thrombosis.
Finally, Hiraoka et al reported a retrospective study of 171 adults with unresectable HCC who received systemic therapy with atezolizumab with bevacizumab. In this report, only 75 patients received this as their first-line systemic therapy. After 6 weeks of treatment, the overall response rate was 10.6% (9.7% for previously treated and 12.2% for previously untreated), and the disease control rate was 79.6%. In 111 patients, the albumin-bilirubin score that assesses liver function was significantly worse at 3 weeks after starting treatment (−2.525 ± 0.419 vs −2.323 ± 0.445, P < .001), but then recovered at 6-weeks, confirming the efficacy and safety of this treatment regimen.
Predictive factors for development of axial involvement in PsA
Key clinical point: Axial involvement in psoriatic arthritis (axPsA) is a unique phenotype with characteristics lying between axial spondyloarthritis and pure peripheral PsA. Male gender, elevated C-reactive protein (CRP), and absence of psoriasis were associated with axPsA.
Major finding: Axial involvement was observed in 35.5% of patients with PsA, and they were thus classified as axPsA. Being male (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.09-2.61), having elevated CRP (OR, 2.87; 95% CI, 1.80-4.60), and absence of psoriasis (OR, 0.33; 95% CI, 0.15-0.72) were independently associated with axPsA.
Study details: The data come from an observational, cross-sectional ASAS-perSpA study of 3,684 patients with axial spondyloarthritis or PsA.
Disclosures: The ASAS-PerSpA study was funded by Pfizer, Lilly, AbbVie, Novartis, UCB, Janssen, and Merck. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources including AbbVie. Three authors reported no conflicts of interest.
Source: Benavent D et al. Semin Arthritis Rheum. 2021 May 5. doi: 10.1016/j.semarthrit.2021.04.018.
Key clinical point: Axial involvement in psoriatic arthritis (axPsA) is a unique phenotype with characteristics lying between axial spondyloarthritis and pure peripheral PsA. Male gender, elevated C-reactive protein (CRP), and absence of psoriasis were associated with axPsA.
Major finding: Axial involvement was observed in 35.5% of patients with PsA, and they were thus classified as axPsA. Being male (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.09-2.61), having elevated CRP (OR, 2.87; 95% CI, 1.80-4.60), and absence of psoriasis (OR, 0.33; 95% CI, 0.15-0.72) were independently associated with axPsA.
Study details: The data come from an observational, cross-sectional ASAS-perSpA study of 3,684 patients with axial spondyloarthritis or PsA.
Disclosures: The ASAS-PerSpA study was funded by Pfizer, Lilly, AbbVie, Novartis, UCB, Janssen, and Merck. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources including AbbVie. Three authors reported no conflicts of interest.
Source: Benavent D et al. Semin Arthritis Rheum. 2021 May 5. doi: 10.1016/j.semarthrit.2021.04.018.
Key clinical point: Axial involvement in psoriatic arthritis (axPsA) is a unique phenotype with characteristics lying between axial spondyloarthritis and pure peripheral PsA. Male gender, elevated C-reactive protein (CRP), and absence of psoriasis were associated with axPsA.
Major finding: Axial involvement was observed in 35.5% of patients with PsA, and they were thus classified as axPsA. Being male (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.09-2.61), having elevated CRP (OR, 2.87; 95% CI, 1.80-4.60), and absence of psoriasis (OR, 0.33; 95% CI, 0.15-0.72) were independently associated with axPsA.
Study details: The data come from an observational, cross-sectional ASAS-perSpA study of 3,684 patients with axial spondyloarthritis or PsA.
Disclosures: The ASAS-PerSpA study was funded by Pfizer, Lilly, AbbVie, Novartis, UCB, Janssen, and Merck. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources including AbbVie. Three authors reported no conflicts of interest.
Source: Benavent D et al. Semin Arthritis Rheum. 2021 May 5. doi: 10.1016/j.semarthrit.2021.04.018.
Metabolic syndrome is more prevalent in PsA than in psoriasis and RA
Key clinical point: The prevalence of metabolic syndrome (MetS) was significantly higher in patients with psoriatic arthritis (PsA) than those with psoriasis or rheumatoid arthritis (RA).
Major finding: Patients with PsA were 1.61 (95% confidence interval [CI], 1.49-1.74) and 1.66 (95% CI, 1.54-1.79) times more likely to have MetS than patients with psoriasis and RA, respectively.
Study details: Findings are from a systematic review and meta-analysis of 24, 89, and 53 studies on PsA, psoriasis, and RA, respectively.
Disclosures: The study reported no source of funding and conflicts of interest.
Source: Loganathan A et al. Int J Rheum Dis. 2021 Jun 2. doi: 10.1111/1 756-185X.14147.
Key clinical point: The prevalence of metabolic syndrome (MetS) was significantly higher in patients with psoriatic arthritis (PsA) than those with psoriasis or rheumatoid arthritis (RA).
Major finding: Patients with PsA were 1.61 (95% confidence interval [CI], 1.49-1.74) and 1.66 (95% CI, 1.54-1.79) times more likely to have MetS than patients with psoriasis and RA, respectively.
Study details: Findings are from a systematic review and meta-analysis of 24, 89, and 53 studies on PsA, psoriasis, and RA, respectively.
Disclosures: The study reported no source of funding and conflicts of interest.
Source: Loganathan A et al. Int J Rheum Dis. 2021 Jun 2. doi: 10.1111/1 756-185X.14147.
Key clinical point: The prevalence of metabolic syndrome (MetS) was significantly higher in patients with psoriatic arthritis (PsA) than those with psoriasis or rheumatoid arthritis (RA).
Major finding: Patients with PsA were 1.61 (95% confidence interval [CI], 1.49-1.74) and 1.66 (95% CI, 1.54-1.79) times more likely to have MetS than patients with psoriasis and RA, respectively.
Study details: Findings are from a systematic review and meta-analysis of 24, 89, and 53 studies on PsA, psoriasis, and RA, respectively.
Disclosures: The study reported no source of funding and conflicts of interest.
Source: Loganathan A et al. Int J Rheum Dis. 2021 Jun 2. doi: 10.1111/1 756-185X.14147.
Women with PsA more likely to discontinue b/ts DMARDs
Key clinical point: Women with psoriatic arthritis (PsA) were at greater risk of discontinuing biologic or targeted synthetic disease‐modifying antirheumatic drugs (b/ts DMARDs) because of both lack of efficacy and adverse events. Moreover, the first-line treatment was associated with a lower risk for treatment discontinuation.
Major finding: Women (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.15-1.62) and patients receiving the second and further lines of treatment (HR, 1.69; 95% CI, 1.41-2.03) were at greater risk of discontinuing treatment because of lack of efficacy. The risk for discontinuation because of adverse events was higher in women (HR, 1.92; 95% CI, 1.44-2.56) and older patients (HR, 1.01; 95% CI, 1.00-1.03).
Study details: Findings are from a real-world multicenter prospective study of 4,752 patients with rheumatic disease from the BIODASER registry who were initiated on b/ts DMARDs, of which 1,250 patients had PsA.
Disclosures: BIOBADASER is supported by the Spanish Agency of Medicines and Medical Devices, Biogen, Bristol Myers Squibb, Celltrion Healthcare, Lilly, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, and Samsung Bioepis. The authors declared no conflicts of interest.
Source: Prior-Español A et al. Sci Rep. 2021 May 27. doi: 10.1038/s41598-021-90442-w.
Key clinical point: Women with psoriatic arthritis (PsA) were at greater risk of discontinuing biologic or targeted synthetic disease‐modifying antirheumatic drugs (b/ts DMARDs) because of both lack of efficacy and adverse events. Moreover, the first-line treatment was associated with a lower risk for treatment discontinuation.
Major finding: Women (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.15-1.62) and patients receiving the second and further lines of treatment (HR, 1.69; 95% CI, 1.41-2.03) were at greater risk of discontinuing treatment because of lack of efficacy. The risk for discontinuation because of adverse events was higher in women (HR, 1.92; 95% CI, 1.44-2.56) and older patients (HR, 1.01; 95% CI, 1.00-1.03).
Study details: Findings are from a real-world multicenter prospective study of 4,752 patients with rheumatic disease from the BIODASER registry who were initiated on b/ts DMARDs, of which 1,250 patients had PsA.
Disclosures: BIOBADASER is supported by the Spanish Agency of Medicines and Medical Devices, Biogen, Bristol Myers Squibb, Celltrion Healthcare, Lilly, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, and Samsung Bioepis. The authors declared no conflicts of interest.
Source: Prior-Español A et al. Sci Rep. 2021 May 27. doi: 10.1038/s41598-021-90442-w.
Key clinical point: Women with psoriatic arthritis (PsA) were at greater risk of discontinuing biologic or targeted synthetic disease‐modifying antirheumatic drugs (b/ts DMARDs) because of both lack of efficacy and adverse events. Moreover, the first-line treatment was associated with a lower risk for treatment discontinuation.
Major finding: Women (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.15-1.62) and patients receiving the second and further lines of treatment (HR, 1.69; 95% CI, 1.41-2.03) were at greater risk of discontinuing treatment because of lack of efficacy. The risk for discontinuation because of adverse events was higher in women (HR, 1.92; 95% CI, 1.44-2.56) and older patients (HR, 1.01; 95% CI, 1.00-1.03).
Study details: Findings are from a real-world multicenter prospective study of 4,752 patients with rheumatic disease from the BIODASER registry who were initiated on b/ts DMARDs, of which 1,250 patients had PsA.
Disclosures: BIOBADASER is supported by the Spanish Agency of Medicines and Medical Devices, Biogen, Bristol Myers Squibb, Celltrion Healthcare, Lilly, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, and Samsung Bioepis. The authors declared no conflicts of interest.
Source: Prior-Español A et al. Sci Rep. 2021 May 27. doi: 10.1038/s41598-021-90442-w.
PsA: Tildrakizumab shows promise in phase 2b trial
Key clinical point: Treatment with tildrakizumab was more effective than placebo and was well tolerated through 52 weeks of treatment in patients with active psoriatic arthritis (PsA).
Major finding: At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs. placebo (71.4%-79.5% vs. 50.6%; all P less than or equal to .0125). Treatment-emergent adverse events (TEAEs) and serious TEAEs occurred in 64.5% and 3.3%, respectively, and were comparable among treatment arms.
Study details: Findings are from a 52-week phase 2b study of 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W.
Disclosures: This study was funded by Sun Pharma Global FZE, and the analyses were funded by Sun Pharmaceutical Industries, Princeton, NJ, USA. Some of the authors reported receiving research grants, honoraria, consulting fees, and/or speaker fees from various sources. AM Mendelsohn and SJ Rozzo reported being an employee of Sun Pharmaceutical Industries, Inc. and/or holding shares in Johnson and Johnson.
Source: Mease PJ et al. Ann Rheum Dis. 2021 May 13. doi: 10.1136/annrheumdis-2020-219014.
Key clinical point: Treatment with tildrakizumab was more effective than placebo and was well tolerated through 52 weeks of treatment in patients with active psoriatic arthritis (PsA).
Major finding: At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs. placebo (71.4%-79.5% vs. 50.6%; all P less than or equal to .0125). Treatment-emergent adverse events (TEAEs) and serious TEAEs occurred in 64.5% and 3.3%, respectively, and were comparable among treatment arms.
Study details: Findings are from a 52-week phase 2b study of 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W.
Disclosures: This study was funded by Sun Pharma Global FZE, and the analyses were funded by Sun Pharmaceutical Industries, Princeton, NJ, USA. Some of the authors reported receiving research grants, honoraria, consulting fees, and/or speaker fees from various sources. AM Mendelsohn and SJ Rozzo reported being an employee of Sun Pharmaceutical Industries, Inc. and/or holding shares in Johnson and Johnson.
Source: Mease PJ et al. Ann Rheum Dis. 2021 May 13. doi: 10.1136/annrheumdis-2020-219014.
Key clinical point: Treatment with tildrakizumab was more effective than placebo and was well tolerated through 52 weeks of treatment in patients with active psoriatic arthritis (PsA).
Major finding: At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs. placebo (71.4%-79.5% vs. 50.6%; all P less than or equal to .0125). Treatment-emergent adverse events (TEAEs) and serious TEAEs occurred in 64.5% and 3.3%, respectively, and were comparable among treatment arms.
Study details: Findings are from a 52-week phase 2b study of 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W.
Disclosures: This study was funded by Sun Pharma Global FZE, and the analyses were funded by Sun Pharmaceutical Industries, Princeton, NJ, USA. Some of the authors reported receiving research grants, honoraria, consulting fees, and/or speaker fees from various sources. AM Mendelsohn and SJ Rozzo reported being an employee of Sun Pharmaceutical Industries, Inc. and/or holding shares in Johnson and Johnson.
Source: Mease PJ et al. Ann Rheum Dis. 2021 May 13. doi: 10.1136/annrheumdis-2020-219014.
Targeted metabolomic profiling predicts CV risk in psoriasis and PsA
Key clinical point: A range of novel metabolite markers associated with the risk for cardiovascular (CV) events when combined in a model matched with age and sex showed improved performance in predicting CV diseases in patients with psoriasis and psoriatic disease (PsA).
Major finding: Alanine, tyrosine, degree of unsaturation of fatty acids, and high-density lipoprotein particles were associated with decreased CV risk, whereas glycoprotein acetyls, apolipoprotein B, and cholesterol remnants were associated with increased CV risk (all P less than .05). The addition of 13 metabolites in the expanded model improved CV risk prediction beyond the base model with only age and sex (area under the receiver operator characteristic curve, 79.9 vs. 72.6; P = .02).
Study details: This was a prospective study of 977 patients with psoriasis and PsA.
Disclosures: The study was supported by a grant from the National Psoriasis Foundation and Arthritis Society. Some of the authors including the lead author declared receiving grants, personal fees, and/or advisory roles for various sources.
Source: Colaco K et al. Ann Rheum Dis. 2021 May 28. doi: 10.1136/annrheumdis-2021-220168.
Key clinical point: A range of novel metabolite markers associated with the risk for cardiovascular (CV) events when combined in a model matched with age and sex showed improved performance in predicting CV diseases in patients with psoriasis and psoriatic disease (PsA).
Major finding: Alanine, tyrosine, degree of unsaturation of fatty acids, and high-density lipoprotein particles were associated with decreased CV risk, whereas glycoprotein acetyls, apolipoprotein B, and cholesterol remnants were associated with increased CV risk (all P less than .05). The addition of 13 metabolites in the expanded model improved CV risk prediction beyond the base model with only age and sex (area under the receiver operator characteristic curve, 79.9 vs. 72.6; P = .02).
Study details: This was a prospective study of 977 patients with psoriasis and PsA.
Disclosures: The study was supported by a grant from the National Psoriasis Foundation and Arthritis Society. Some of the authors including the lead author declared receiving grants, personal fees, and/or advisory roles for various sources.
Source: Colaco K et al. Ann Rheum Dis. 2021 May 28. doi: 10.1136/annrheumdis-2021-220168.
Key clinical point: A range of novel metabolite markers associated with the risk for cardiovascular (CV) events when combined in a model matched with age and sex showed improved performance in predicting CV diseases in patients with psoriasis and psoriatic disease (PsA).
Major finding: Alanine, tyrosine, degree of unsaturation of fatty acids, and high-density lipoprotein particles were associated with decreased CV risk, whereas glycoprotein acetyls, apolipoprotein B, and cholesterol remnants were associated with increased CV risk (all P less than .05). The addition of 13 metabolites in the expanded model improved CV risk prediction beyond the base model with only age and sex (area under the receiver operator characteristic curve, 79.9 vs. 72.6; P = .02).
Study details: This was a prospective study of 977 patients with psoriasis and PsA.
Disclosures: The study was supported by a grant from the National Psoriasis Foundation and Arthritis Society. Some of the authors including the lead author declared receiving grants, personal fees, and/or advisory roles for various sources.
Source: Colaco K et al. Ann Rheum Dis. 2021 May 28. doi: 10.1136/annrheumdis-2021-220168.
ABP 501 safe and effective for PsA and plaque-type psoriasis
Key clinical point: ABP 501, an adalimumab biosimilar, was safe and effective for the treatment of plaque-type psoriasis and psoriatic arthritis (PsA) irrespective of whether patients were originator-naive or switched from the reference adalimumab.
Major finding: In originator-naive patients, mean Psoriasis Area and Severity Index (PASI) significantly improved from baseline to week 24 (P less than .0001). Among patients who underwent nonmedical switch from adalimumab to ABP 501, PASI (0.45 vs. 0.45) and 28-joints Disease Activity Score erythrocyte sedimentation rate (2.35 vs. 2.31) were not significantly different at 16 weeks before to 24 weeks after the switch. The incidence of adverse events was similar in ABP 501 vs. adalimumab groups (67.2% vs. 63.6%).
Study details: Data come from a retrospective, real-life study of 94 patients with psoriasis and PsA who received ABP 501, of which 46 patients underwent a nonmedical switch from the adalimumab reference product to ABP 501.
Disclosures: The study did not receive any funding. A Giunta reported serving as a consultant, board member, and/or speaker for various sources. No other disclosures were reported.
Source: Giunta A et al. Curr Med Res Opin. 2021 May 20. doi: 10.1080/03007995.2021.1923467.
Key clinical point: ABP 501, an adalimumab biosimilar, was safe and effective for the treatment of plaque-type psoriasis and psoriatic arthritis (PsA) irrespective of whether patients were originator-naive or switched from the reference adalimumab.
Major finding: In originator-naive patients, mean Psoriasis Area and Severity Index (PASI) significantly improved from baseline to week 24 (P less than .0001). Among patients who underwent nonmedical switch from adalimumab to ABP 501, PASI (0.45 vs. 0.45) and 28-joints Disease Activity Score erythrocyte sedimentation rate (2.35 vs. 2.31) were not significantly different at 16 weeks before to 24 weeks after the switch. The incidence of adverse events was similar in ABP 501 vs. adalimumab groups (67.2% vs. 63.6%).
Study details: Data come from a retrospective, real-life study of 94 patients with psoriasis and PsA who received ABP 501, of which 46 patients underwent a nonmedical switch from the adalimumab reference product to ABP 501.
Disclosures: The study did not receive any funding. A Giunta reported serving as a consultant, board member, and/or speaker for various sources. No other disclosures were reported.
Source: Giunta A et al. Curr Med Res Opin. 2021 May 20. doi: 10.1080/03007995.2021.1923467.
Key clinical point: ABP 501, an adalimumab biosimilar, was safe and effective for the treatment of plaque-type psoriasis and psoriatic arthritis (PsA) irrespective of whether patients were originator-naive or switched from the reference adalimumab.
Major finding: In originator-naive patients, mean Psoriasis Area and Severity Index (PASI) significantly improved from baseline to week 24 (P less than .0001). Among patients who underwent nonmedical switch from adalimumab to ABP 501, PASI (0.45 vs. 0.45) and 28-joints Disease Activity Score erythrocyte sedimentation rate (2.35 vs. 2.31) were not significantly different at 16 weeks before to 24 weeks after the switch. The incidence of adverse events was similar in ABP 501 vs. adalimumab groups (67.2% vs. 63.6%).
Study details: Data come from a retrospective, real-life study of 94 patients with psoriasis and PsA who received ABP 501, of which 46 patients underwent a nonmedical switch from the adalimumab reference product to ABP 501.
Disclosures: The study did not receive any funding. A Giunta reported serving as a consultant, board member, and/or speaker for various sources. No other disclosures were reported.
Source: Giunta A et al. Curr Med Res Opin. 2021 May 20. doi: 10.1080/03007995.2021.1923467.
Guselkumab induces robust reduction in acute-phase proteins and effector cytokines in PsA
Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).
Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.
Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.
Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.
Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.
Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).
Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.
Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.
Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.
Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.
Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).
Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.
Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.
Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.
Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.