Clinical Edge Journal Scan

Key clinical point: Parsaclisib provided rapid and durable responses and a manageable safety profile in patients with relapsed or refractory follicular lymphoma (FL).

Major finding: Among patients receiving parsaclisib daily, 77.7% (95% CI 68.4%-85.3%) achieved an objective response and 19.4% (95% CI 12.3%-28.4%) achieved a complete response. The median duration of response was 14.7 months (95% CI 10.4-not estimable) and the median time to response was 8.1 weeks. Most treatment-emergent adverse events were low-grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-203 study included 126 adult Bruton tyrosine kinase inhibitor-naive patients with relapsed or refractory FL previously treated with ≥2 systemic therapies who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly (n = 23) or 2.5 mg parsaclisib once daily (n = 103).

Disclosures: This study was sponsored by Incyte Corporation, USA. Some authors declared serving as consultants or speakers for or receiving honoraria, research funding, or reimbursements for travel, accommodations, or expenses from Incyte and other sources. Four authors declared being employees and stockowners of Incyte.

Source: Trněný M et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): A phase 2 study. EClinicalMedicine. 2023;63:102130 (Aug 18). doi: 10.1016/j.eclinm.2023.102130

Key clinical point: Parsaclisib provided rapid and durable responses and a manageable safety profile in patients with relapsed or refractory follicular lymphoma (FL).

Major finding: Among patients receiving parsaclisib daily, 77.7% (95% CI 68.4%-85.3%) achieved an objective response and 19.4% (95% CI 12.3%-28.4%) achieved a complete response. The median duration of response was 14.7 months (95% CI 10.4-not estimable) and the median time to response was 8.1 weeks. Most treatment-emergent adverse events were low-grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-203 study included 126 adult Bruton tyrosine kinase inhibitor-naive patients with relapsed or refractory FL previously treated with ≥2 systemic therapies who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly (n = 23) or 2.5 mg parsaclisib once daily (n = 103).

Disclosures: This study was sponsored by Incyte Corporation, USA. Some authors declared serving as consultants or speakers for or receiving honoraria, research funding, or reimbursements for travel, accommodations, or expenses from Incyte and other sources. Four authors declared being employees and stockowners of Incyte.

Source: Trněný M et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): A phase 2 study. EClinicalMedicine. 2023;63:102130 (Aug 18). doi: 10.1016/j.eclinm.2023.102130

Key clinical point: Parsaclisib provided rapid and durable responses and a manageable safety profile in patients with relapsed or refractory follicular lymphoma (FL).

Major finding: Among patients receiving parsaclisib daily, 77.7% (95% CI 68.4%-85.3%) achieved an objective response and 19.4% (95% CI 12.3%-28.4%) achieved a complete response. The median duration of response was 14.7 months (95% CI 10.4-not estimable) and the median time to response was 8.1 weeks. Most treatment-emergent adverse events were low-grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-203 study included 126 adult Bruton tyrosine kinase inhibitor-naive patients with relapsed or refractory FL previously treated with ≥2 systemic therapies who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly (n = 23) or 2.5 mg parsaclisib once daily (n = 103).

Disclosures: This study was sponsored by Incyte Corporation, USA. Some authors declared serving as consultants or speakers for or receiving honoraria, research funding, or reimbursements for travel, accommodations, or expenses from Incyte and other sources. Four authors declared being employees and stockowners of Incyte.

Source: Trněný M et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): A phase 2 study. EClinicalMedicine. 2023;63:102130 (Aug 18). doi: 10.1016/j.eclinm.2023.102130

Key clinical point: Compared with the conventional third line or higher lines of chemotherapy, tisagenlecleucel led to a 41% reduction in the risk for death in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients receiving tisagenlecleucel vs conventional treatments had significantly longer median overall survival (11.7 vs 5.4 months; adjusted hazard ratio 0.59; P = .0035).

Study details: This study analyzed the published summary data of patients with relapsed or refractory DLBCL treated with tisagenlecleucel in the JULIET study (n = 111) and the real-world individual patient data of those treated with conventional therapies in the first and second Samsung Medical Center-Lymphoma Cohort studies (n = 53).

Disclosures: This study was supported by grants from the Ministry of Food and Drug Safety, South Korea. S Park and JY Shin declared receiving grants from various sources.

Source: Park S et al. Comparison of tisagenlecleucel with conventional treatments for relapsed/refractory diffuse large B-cell lymphomas: A retrospective external comparator study. Blood Cancer J. 2023;13:123 (Aug 18). doi: 10.1038/s41408-023-00889-5

Key clinical point: Compared with the conventional third line or higher lines of chemotherapy, tisagenlecleucel led to a 41% reduction in the risk for death in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients receiving tisagenlecleucel vs conventional treatments had significantly longer median overall survival (11.7 vs 5.4 months; adjusted hazard ratio 0.59; P = .0035).

Study details: This study analyzed the published summary data of patients with relapsed or refractory DLBCL treated with tisagenlecleucel in the JULIET study (n = 111) and the real-world individual patient data of those treated with conventional therapies in the first and second Samsung Medical Center-Lymphoma Cohort studies (n = 53).

Disclosures: This study was supported by grants from the Ministry of Food and Drug Safety, South Korea. S Park and JY Shin declared receiving grants from various sources.

Source: Park S et al. Comparison of tisagenlecleucel with conventional treatments for relapsed/refractory diffuse large B-cell lymphomas: A retrospective external comparator study. Blood Cancer J. 2023;13:123 (Aug 18). doi: 10.1038/s41408-023-00889-5

Key clinical point: Compared with the conventional third line or higher lines of chemotherapy, tisagenlecleucel led to a 41% reduction in the risk for death in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: Patients receiving tisagenlecleucel vs conventional treatments had significantly longer median overall survival (11.7 vs 5.4 months; adjusted hazard ratio 0.59; P = .0035).

Study details: This study analyzed the published summary data of patients with relapsed or refractory DLBCL treated with tisagenlecleucel in the JULIET study (n = 111) and the real-world individual patient data of those treated with conventional therapies in the first and second Samsung Medical Center-Lymphoma Cohort studies (n = 53).

Disclosures: This study was supported by grants from the Ministry of Food and Drug Safety, South Korea. S Park and JY Shin declared receiving grants from various sources.

Source: Park S et al. Comparison of tisagenlecleucel with conventional treatments for relapsed/refractory diffuse large B-cell lymphomas: A retrospective external comparator study. Blood Cancer J. 2023;13:123 (Aug 18). doi: 10.1038/s41408-023-00889-5

Key clinical point: The baseline CAR-HEMATOTOX (HT) score enables the early identification of patients at high risk for prolonged neutropenia, severe infections, and poor survival outcomes following brexucabtagene autoleucel (brexu-cel) infusion for relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Patients with high (score 2-7) vs low (score 0-1) HT scores had significantly longer median duration of severe neutropenia (P < .0001), higher rates of severe infections (P = .001), and lower overall response rates (P = .003). The HT score represented an independent predictor of poor progression-free (adjusted hazard ratio [aHR] 3.7; P < .001) and overall (aHR 5.6; P = .002) survival.

Study details: This multicenter observational study included 103 patients with relapsed or refractory MCL receiving brexu-cel, of whom 47 patients had high and 56 patients had low HT scores.

Disclosures: This study was supported by the Gilead Research Scholar Program and other sources. Some authors declared serving as consultants or advisory board members for or receiving research funding, speakers’ honoraria, personal fees, or travel support from Gilead Sciences and other sources.

Source: Rejeski K et al. The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL. Am J Hematol. 2023 (Aug 16). doi: 10.1002/ajh.27056

Key clinical point: The baseline CAR-HEMATOTOX (HT) score enables the early identification of patients at high risk for prolonged neutropenia, severe infections, and poor survival outcomes following brexucabtagene autoleucel (brexu-cel) infusion for relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Patients with high (score 2-7) vs low (score 0-1) HT scores had significantly longer median duration of severe neutropenia (P < .0001), higher rates of severe infections (P = .001), and lower overall response rates (P = .003). The HT score represented an independent predictor of poor progression-free (adjusted hazard ratio [aHR] 3.7; P < .001) and overall (aHR 5.6; P = .002) survival.

Study details: This multicenter observational study included 103 patients with relapsed or refractory MCL receiving brexu-cel, of whom 47 patients had high and 56 patients had low HT scores.

Disclosures: This study was supported by the Gilead Research Scholar Program and other sources. Some authors declared serving as consultants or advisory board members for or receiving research funding, speakers’ honoraria, personal fees, or travel support from Gilead Sciences and other sources.

Source: Rejeski K et al. The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL. Am J Hematol. 2023 (Aug 16). doi: 10.1002/ajh.27056

Key clinical point: The baseline CAR-HEMATOTOX (HT) score enables the early identification of patients at high risk for prolonged neutropenia, severe infections, and poor survival outcomes following brexucabtagene autoleucel (brexu-cel) infusion for relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Patients with high (score 2-7) vs low (score 0-1) HT scores had significantly longer median duration of severe neutropenia (P < .0001), higher rates of severe infections (P = .001), and lower overall response rates (P = .003). The HT score represented an independent predictor of poor progression-free (adjusted hazard ratio [aHR] 3.7; P < .001) and overall (aHR 5.6; P = .002) survival.

Study details: This multicenter observational study included 103 patients with relapsed or refractory MCL receiving brexu-cel, of whom 47 patients had high and 56 patients had low HT scores.

Disclosures: This study was supported by the Gilead Research Scholar Program and other sources. Some authors declared serving as consultants or advisory board members for or receiving research funding, speakers’ honoraria, personal fees, or travel support from Gilead Sciences and other sources.

Source: Rejeski K et al. The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL. Am J Hematol. 2023 (Aug 16). doi: 10.1002/ajh.27056

Key clinical point: Loncastuximab tesirine (Lonca) shows long-term efficacy and a manageable safety profile in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: At a median follow-up of 7.8 months, 48.3% of patients achieved an overall response, with a complete response being achieved by 24.8% of patients, 44% and 31% of whom remained event-free for ≥ 1 year and ≥ 2 years, respectively. The median overall and progression-free survival durations were 9.5 and 4.9 months, respectively. No new safety concerns were detected.

Study details: This long-term follow-up analysis of the phase 2 LOTIS-2 study included 145 heavily pretreated adult patients with relapsed or refractory DLBCL who received Lonca once every 3 weeks (0.15 mg/kg for 2 cycles; 0.075 mg/kg for subsequent cycles).

Disclosures: This study was funded by ADC Therapeutics SA. Some authors declared serving as consultants, advisors, or speakers for or receiving research funding or honoraria from various sources, including ADC Therapeutics. Four authors declared being employees of and holding equity and stock options in ADC Therapeutics.

Source: Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase 2 LOTIS-2 study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283459

Key clinical point: Loncastuximab tesirine (Lonca) shows long-term efficacy and a manageable safety profile in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: At a median follow-up of 7.8 months, 48.3% of patients achieved an overall response, with a complete response being achieved by 24.8% of patients, 44% and 31% of whom remained event-free for ≥ 1 year and ≥ 2 years, respectively. The median overall and progression-free survival durations were 9.5 and 4.9 months, respectively. No new safety concerns were detected.

Study details: This long-term follow-up analysis of the phase 2 LOTIS-2 study included 145 heavily pretreated adult patients with relapsed or refractory DLBCL who received Lonca once every 3 weeks (0.15 mg/kg for 2 cycles; 0.075 mg/kg for subsequent cycles).

Disclosures: This study was funded by ADC Therapeutics SA. Some authors declared serving as consultants, advisors, or speakers for or receiving research funding or honoraria from various sources, including ADC Therapeutics. Four authors declared being employees of and holding equity and stock options in ADC Therapeutics.

Source: Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase 2 LOTIS-2 study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283459

Key clinical point: Loncastuximab tesirine (Lonca) shows long-term efficacy and a manageable safety profile in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Major finding: At a median follow-up of 7.8 months, 48.3% of patients achieved an overall response, with a complete response being achieved by 24.8% of patients, 44% and 31% of whom remained event-free for ≥ 1 year and ≥ 2 years, respectively. The median overall and progression-free survival durations were 9.5 and 4.9 months, respectively. No new safety concerns were detected.

Study details: This long-term follow-up analysis of the phase 2 LOTIS-2 study included 145 heavily pretreated adult patients with relapsed or refractory DLBCL who received Lonca once every 3 weeks (0.15 mg/kg for 2 cycles; 0.075 mg/kg for subsequent cycles).

Disclosures: This study was funded by ADC Therapeutics SA. Some authors declared serving as consultants, advisors, or speakers for or receiving research funding or honoraria from various sources, including ADC Therapeutics. Four authors declared being employees of and holding equity and stock options in ADC Therapeutics.

Source: Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase 2 LOTIS-2 study. Haematologica. 2023 (Aug 31). doi: 10.3324/haematol.2023.283459

Key clinical point: Parsaclisib led to clinically meaningful improvements and a manageable safety profile in Bruton tyrosine kinase inhibitor (BTKi)-naive patients with relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Among BTKi-naive patients who received parsaclisib once daily, 70.1% (95% CI 58.6%-80.0%) and 15.6% (95% CI 8.3%-25.6%) of patients achieved an objective response and a complete response, respectively, with the median duration of response being 12.1 (95% CI 9.0-not evaluable) months. Most treatment-emergent adverse events were low grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-205 study included adult patients with relapsed or refractory MCL previously treated with 1-3 systemic therapies, with (n = 53) or without (n = 108) prior BTKi treatment, who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly or 2.5 mg parsaclisib once daily.

Disclosures: This study was funded by Incyte Corporation. Some authors declared serving as consultants, advisors, or board members for or receiving research funding, honoraria, or travel and accommodation expenses from Incyte and others. Four authors declared being employees of and owning stocks in Incyte.

Source: Zinzani PL et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): A phase 2 study. EClinicalMedicine. 2023;62:102131 (Aug 10). doi: 10.1016/j.eclinm.2023.102131

Key clinical point: Parsaclisib led to clinically meaningful improvements and a manageable safety profile in Bruton tyrosine kinase inhibitor (BTKi)-naive patients with relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Among BTKi-naive patients who received parsaclisib once daily, 70.1% (95% CI 58.6%-80.0%) and 15.6% (95% CI 8.3%-25.6%) of patients achieved an objective response and a complete response, respectively, with the median duration of response being 12.1 (95% CI 9.0-not evaluable) months. Most treatment-emergent adverse events were low grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-205 study included adult patients with relapsed or refractory MCL previously treated with 1-3 systemic therapies, with (n = 53) or without (n = 108) prior BTKi treatment, who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly or 2.5 mg parsaclisib once daily.

Disclosures: This study was funded by Incyte Corporation. Some authors declared serving as consultants, advisors, or board members for or receiving research funding, honoraria, or travel and accommodation expenses from Incyte and others. Four authors declared being employees of and owning stocks in Incyte.

Source: Zinzani PL et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): A phase 2 study. EClinicalMedicine. 2023;62:102131 (Aug 10). doi: 10.1016/j.eclinm.2023.102131

Key clinical point: Parsaclisib led to clinically meaningful improvements and a manageable safety profile in Bruton tyrosine kinase inhibitor (BTKi)-naive patients with relapsed or refractory mantle cell lymphoma (MCL).

Major finding: Among BTKi-naive patients who received parsaclisib once daily, 70.1% (95% CI 58.6%-80.0%) and 15.6% (95% CI 8.3%-25.6%) of patients achieved an objective response and a complete response, respectively, with the median duration of response being 12.1 (95% CI 9.0-not evaluable) months. Most treatment-emergent adverse events were low grade and manageable by dose interruptions or reductions.

Study details: This phase 2 CITADEL-205 study included adult patients with relapsed or refractory MCL previously treated with 1-3 systemic therapies, with (n = 53) or without (n = 108) prior BTKi treatment, who received 20 mg parsaclisib once daily for 8 weeks followed by either 20 mg parsaclisib once weekly or 2.5 mg parsaclisib once daily.

Disclosures: This study was funded by Incyte Corporation. Some authors declared serving as consultants, advisors, or board members for or receiving research funding, honoraria, or travel and accommodation expenses from Incyte and others. Four authors declared being employees of and owning stocks in Incyte.

Source: Zinzani PL et al. Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): A phase 2 study. EClinicalMedicine. 2023;62:102131 (Aug 10). doi: 10.1016/j.eclinm.2023.102131

Key clinical point: Uveitis is far more prevalent in patients with axial spondylarthritis (axSpA) than in those with psoriatic arthritis (PsA). A family history of SpA, axial disease at diagnosis, and disease duration were important factors associated with the occurrence of uveitis in PsA.

Major finding: Uveitis was more frequent in patients with axSpA vs PsA (11.7% vs 2.7%), with a median uveitis recurrence rate of 0.205 episodes per year and 0.285 episodes per year for axSpA and PsA, respectively. Family history of SpA (odds ratio [OR] 6.35; P = .023), axial disease at diagnosis (OR 5.61; P = .038), and disease duration (OR 1.12; P = .004) were associated with the occurrence of uveitis in PsA.

Study details: Findings are from a retrospective study including 264 patients with axSpA and 369 patients with PsA.

Disclosures: This study did not receive any specific funding except open access funding by HEAL-Link Greece. The authors declared no conflicts of interest.

Source: Kougkas N et al. Higher frequency but similar recurrence rate of uveitis episodes in axial spondylarthritis compared to psoriatic arthritis. A multicentre retrospective study. Rheumatol Int. 2023;43:2081-2088 (Aug 23). doi: 10.1007/s00296-023-05424-0

Key clinical point: Uveitis is far more prevalent in patients with axial spondylarthritis (axSpA) than in those with psoriatic arthritis (PsA). A family history of SpA, axial disease at diagnosis, and disease duration were important factors associated with the occurrence of uveitis in PsA.

Major finding: Uveitis was more frequent in patients with axSpA vs PsA (11.7% vs 2.7%), with a median uveitis recurrence rate of 0.205 episodes per year and 0.285 episodes per year for axSpA and PsA, respectively. Family history of SpA (odds ratio [OR] 6.35; P = .023), axial disease at diagnosis (OR 5.61; P = .038), and disease duration (OR 1.12; P = .004) were associated with the occurrence of uveitis in PsA.

Study details: Findings are from a retrospective study including 264 patients with axSpA and 369 patients with PsA.

Disclosures: This study did not receive any specific funding except open access funding by HEAL-Link Greece. The authors declared no conflicts of interest.

Source: Kougkas N et al. Higher frequency but similar recurrence rate of uveitis episodes in axial spondylarthritis compared to psoriatic arthritis. A multicentre retrospective study. Rheumatol Int. 2023;43:2081-2088 (Aug 23). doi: 10.1007/s00296-023-05424-0

Key clinical point: Uveitis is far more prevalent in patients with axial spondylarthritis (axSpA) than in those with psoriatic arthritis (PsA). A family history of SpA, axial disease at diagnosis, and disease duration were important factors associated with the occurrence of uveitis in PsA.

Major finding: Uveitis was more frequent in patients with axSpA vs PsA (11.7% vs 2.7%), with a median uveitis recurrence rate of 0.205 episodes per year and 0.285 episodes per year for axSpA and PsA, respectively. Family history of SpA (odds ratio [OR] 6.35; P = .023), axial disease at diagnosis (OR 5.61; P = .038), and disease duration (OR 1.12; P = .004) were associated with the occurrence of uveitis in PsA.

Study details: Findings are from a retrospective study including 264 patients with axSpA and 369 patients with PsA.

Disclosures: This study did not receive any specific funding except open access funding by HEAL-Link Greece. The authors declared no conflicts of interest.

Source: Kougkas N et al. Higher frequency but similar recurrence rate of uveitis episodes in axial spondylarthritis compared to psoriatic arthritis. A multicentre retrospective study. Rheumatol Int. 2023;43:2081-2088 (Aug 23). doi: 10.1007/s00296-023-05424-0

Key clinical point: Compared with placebo, tofacitinib demonstrated greater improvement in enthesitis in patients with psoriatic arthritis (PsA), irrespective of enthesitis location and severity.

Major finding: Tofacitinib vs placebo led to greater changes in the Leeds Enthesitis Index (LEI) and Spondyloarthritis Research Consortium of Canada Enthesitis Index scores up to month 3, irrespective of baseline enthesitis locations and severities, with all improvements with tofacitinib being maintained and continued through month 6. Among patients with baseline LEI >0 whose enthesitis had resolved at month 1, relapse at month 3 was experienced by 26.3% and 15.6% vs 30.8% of patients treated with 5 mg tofacitinib and 10 mg tofacitinib vs placebo, respectively.

Study details: This post hoc analysis of pooled data from 2 phase 3 studies (OPAL Broaden and OPAL Beyond) and included 710 patients with PsA who received tofacitinib for 6 months or placebo for 3 months.

Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer Inc. Five authors declared receiving grants, research support, or consulting fees from or having ties with various sources, including Pfizer.

Source: Mease PJ et al. Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: Analysis of pooled data from two phase 3 studies. Arthritis Res Ther. 2023;25:153 (Aug 22). doi: 10.1186/s13075-023-03108-5

Key clinical point: Compared with placebo, tofacitinib demonstrated greater improvement in enthesitis in patients with psoriatic arthritis (PsA), irrespective of enthesitis location and severity.

Major finding: Tofacitinib vs placebo led to greater changes in the Leeds Enthesitis Index (LEI) and Spondyloarthritis Research Consortium of Canada Enthesitis Index scores up to month 3, irrespective of baseline enthesitis locations and severities, with all improvements with tofacitinib being maintained and continued through month 6. Among patients with baseline LEI >0 whose enthesitis had resolved at month 1, relapse at month 3 was experienced by 26.3% and 15.6% vs 30.8% of patients treated with 5 mg tofacitinib and 10 mg tofacitinib vs placebo, respectively.

Study details: This post hoc analysis of pooled data from 2 phase 3 studies (OPAL Broaden and OPAL Beyond) and included 710 patients with PsA who received tofacitinib for 6 months or placebo for 3 months.

Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer Inc. Five authors declared receiving grants, research support, or consulting fees from or having ties with various sources, including Pfizer.

Source: Mease PJ et al. Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: Analysis of pooled data from two phase 3 studies. Arthritis Res Ther. 2023;25:153 (Aug 22). doi: 10.1186/s13075-023-03108-5

Key clinical point: Compared with placebo, tofacitinib demonstrated greater improvement in enthesitis in patients with psoriatic arthritis (PsA), irrespective of enthesitis location and severity.

Major finding: Tofacitinib vs placebo led to greater changes in the Leeds Enthesitis Index (LEI) and Spondyloarthritis Research Consortium of Canada Enthesitis Index scores up to month 3, irrespective of baseline enthesitis locations and severities, with all improvements with tofacitinib being maintained and continued through month 6. Among patients with baseline LEI >0 whose enthesitis had resolved at month 1, relapse at month 3 was experienced by 26.3% and 15.6% vs 30.8% of patients treated with 5 mg tofacitinib and 10 mg tofacitinib vs placebo, respectively.

Study details: This post hoc analysis of pooled data from 2 phase 3 studies (OPAL Broaden and OPAL Beyond) and included 710 patients with PsA who received tofacitinib for 6 months or placebo for 3 months.

Disclosures: This study was sponsored by Pfizer Inc. Three authors declared being employees and shareholders of Pfizer Inc. Five authors declared receiving grants, research support, or consulting fees from or having ties with various sources, including Pfizer.

Source: Mease PJ et al. Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: Analysis of pooled data from two phase 3 studies. Arthritis Res Ther. 2023;25:153 (Aug 22). doi: 10.1186/s13075-023-03108-5

Key clinical point: Patients with active psoriatic arthritis (PsA) who initiated secukinumab treatment had stable improvements in synovitis and sustained clinical improvements in enthesitis up to week 52.

Major finding: At week 12, secukinumab vs placebo led to significant improvements in power Doppler ultrasound (PDUS)-assessed synovitis (Global EULAR-OMERACT Synovitis Score: −9 vs −6; one-sided P = .004) and PDUS-assessed enthesitis (Spondyloarthritis Research Consortium of Canada enthesitis index score: −2.2 vs −1.6; one-sided P = .03), with the improvements being sustained up to week 52.

Study details: This 52-week, phase 3 ULTIMATE study included 166 patients with active PsA, who were naive to biologics and intolerant to conventional synthetic disease-modifying anti-rheumatic drugs and were randomly assigned to receive secukinumab or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Three authors declared being employees or stockholders of Novartis. Several authors declared ties with various sources, including Novartis. Three authors declared no conflicts of interest.

Source: D’Agostino MA et al. Effects of secukinumab on synovitis and enthesitis in patients with psoriatic arthritis: 52-week clinical and ultrasound results from the randomised, double-blind ULTIMATE trial with open label extension. Semin Arthritis Rheum. 2023;63:152259 (Aug 19). doi: 10.1016/j.semarthrit.2023.152259

Key clinical point: Patients with active psoriatic arthritis (PsA) who initiated secukinumab treatment had stable improvements in synovitis and sustained clinical improvements in enthesitis up to week 52.

Major finding: At week 12, secukinumab vs placebo led to significant improvements in power Doppler ultrasound (PDUS)-assessed synovitis (Global EULAR-OMERACT Synovitis Score: −9 vs −6; one-sided P = .004) and PDUS-assessed enthesitis (Spondyloarthritis Research Consortium of Canada enthesitis index score: −2.2 vs −1.6; one-sided P = .03), with the improvements being sustained up to week 52.

Study details: This 52-week, phase 3 ULTIMATE study included 166 patients with active PsA, who were naive to biologics and intolerant to conventional synthetic disease-modifying anti-rheumatic drugs and were randomly assigned to receive secukinumab or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Three authors declared being employees or stockholders of Novartis. Several authors declared ties with various sources, including Novartis. Three authors declared no conflicts of interest.

Source: D’Agostino MA et al. Effects of secukinumab on synovitis and enthesitis in patients with psoriatic arthritis: 52-week clinical and ultrasound results from the randomised, double-blind ULTIMATE trial with open label extension. Semin Arthritis Rheum. 2023;63:152259 (Aug 19). doi: 10.1016/j.semarthrit.2023.152259

Key clinical point: Patients with active psoriatic arthritis (PsA) who initiated secukinumab treatment had stable improvements in synovitis and sustained clinical improvements in enthesitis up to week 52.

Major finding: At week 12, secukinumab vs placebo led to significant improvements in power Doppler ultrasound (PDUS)-assessed synovitis (Global EULAR-OMERACT Synovitis Score: −9 vs −6; one-sided P = .004) and PDUS-assessed enthesitis (Spondyloarthritis Research Consortium of Canada enthesitis index score: −2.2 vs −1.6; one-sided P = .03), with the improvements being sustained up to week 52.

Study details: This 52-week, phase 3 ULTIMATE study included 166 patients with active PsA, who were naive to biologics and intolerant to conventional synthetic disease-modifying anti-rheumatic drugs and were randomly assigned to receive secukinumab or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. Three authors declared being employees or stockholders of Novartis. Several authors declared ties with various sources, including Novartis. Three authors declared no conflicts of interest.

Source: D’Agostino MA et al. Effects of secukinumab on synovitis and enthesitis in patients with psoriatic arthritis: 52-week clinical and ultrasound results from the randomised, double-blind ULTIMATE trial with open label extension. Semin Arthritis Rheum. 2023;63:152259 (Aug 19). doi: 10.1016/j.semarthrit.2023.152259

Key clinical point: Secukinumab demonstrated sustained efficacy, high retention rates, and a consistent safety profile in patients with active psoriatic arthritis (PsA) who were followed for ≥ 2 years.

Major finding: The treatment retention rate with secukinumab was 78.2% in PsA. The mean swollen joint counts (enrolment vs 2 years: 4.5 vs 3.6) and tender joint counts (enrolment vs 2 years: 12.8 vs 9.2) remained stable over 2 years of treatment. Serious adverse events occurred in 13.6% of patients, but no deaths related to treatment-emergent adverse events were reported.

Study details: Findings are from an interim analysis of the ongoing SERENA study including patients with active PsA (n = 81) or radiographic axial spondyloarthritis (n = 108) who had received secukinumab for ≥16 weeks prior to enrolment.

Disclosures: This study was supported by Novartis Pharma AG. Two authors declared being employees of Novartis Pharmaceuticals U.K. Ltd. Three authors declared ties with various sources, including Novartis.

Source: Gaffney K et al. Real-world evidence for secukinumab in UK patients with psoriatic arthritis or radiographic axial spondyloarthritis: Interim 2-year analysis from SERENA. Rheumatol Adv Pract. 2023;7(3):rkad055 (Aug 21). doi: 10.1093/rap/rkad055

Key clinical point: Secukinumab demonstrated sustained efficacy, high retention rates, and a consistent safety profile in patients with active psoriatic arthritis (PsA) who were followed for ≥ 2 years.

Major finding: The treatment retention rate with secukinumab was 78.2% in PsA. The mean swollen joint counts (enrolment vs 2 years: 4.5 vs 3.6) and tender joint counts (enrolment vs 2 years: 12.8 vs 9.2) remained stable over 2 years of treatment. Serious adverse events occurred in 13.6% of patients, but no deaths related to treatment-emergent adverse events were reported.

Study details: Findings are from an interim analysis of the ongoing SERENA study including patients with active PsA (n = 81) or radiographic axial spondyloarthritis (n = 108) who had received secukinumab for ≥16 weeks prior to enrolment.

Disclosures: This study was supported by Novartis Pharma AG. Two authors declared being employees of Novartis Pharmaceuticals U.K. Ltd. Three authors declared ties with various sources, including Novartis.

Source: Gaffney K et al. Real-world evidence for secukinumab in UK patients with psoriatic arthritis or radiographic axial spondyloarthritis: Interim 2-year analysis from SERENA. Rheumatol Adv Pract. 2023;7(3):rkad055 (Aug 21). doi: 10.1093/rap/rkad055

Key clinical point: Secukinumab demonstrated sustained efficacy, high retention rates, and a consistent safety profile in patients with active psoriatic arthritis (PsA) who were followed for ≥ 2 years.

Major finding: The treatment retention rate with secukinumab was 78.2% in PsA. The mean swollen joint counts (enrolment vs 2 years: 4.5 vs 3.6) and tender joint counts (enrolment vs 2 years: 12.8 vs 9.2) remained stable over 2 years of treatment. Serious adverse events occurred in 13.6% of patients, but no deaths related to treatment-emergent adverse events were reported.

Study details: Findings are from an interim analysis of the ongoing SERENA study including patients with active PsA (n = 81) or radiographic axial spondyloarthritis (n = 108) who had received secukinumab for ≥16 weeks prior to enrolment.

Disclosures: This study was supported by Novartis Pharma AG. Two authors declared being employees of Novartis Pharmaceuticals U.K. Ltd. Three authors declared ties with various sources, including Novartis.

Source: Gaffney K et al. Real-world evidence for secukinumab in UK patients with psoriatic arthritis or radiographic axial spondyloarthritis: Interim 2-year analysis from SERENA. Rheumatol Adv Pract. 2023;7(3):rkad055 (Aug 21). doi: 10.1093/rap/rkad055

Key clinical point: In a real-world population of patients with treatment-resistant, long-standing active psoriatic arthritis (PsA), nearly 80% persisted with guselkumab treatment for 6 months and showed improvements in peripheral joint and skin symptoms of PsA.

Major finding: Overall, 78.9% of patients who initiated guselkumab had persistent use at the 6-month follow-up. The mean scores for clinical Disease Activity in PsA (mean change [Δ] −5.4), overall joint+skin activity (Δ −19.0), patient-reported pain (Δ −9.1), and percentage of skin with psoriasis (Δ −5.1%) improved significantly in patients receiving guselkumab for 6 months (all P < .001).

Study details: This study evaluated 114 patients with active PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated guselkumab.

Disclosures: This study was sponsored by CorEvitas, LLC, and the analysis was funded by Janssen Scientific Affairs, LLC. Six authors declared employment with CorEvitas, LLC, or Janssen Scientific Affairs, LLC, or owned stock or stock options in Johnson & Johnson or others. Several authors declared ties with various sources, including Janssen and CorEvitas.

Source: Mease PJ et al. Six-month persistence and multi-domain effectiveness of guselkumab in adults with psoriatic arthritis: Real-world data from the CorEvitas psoriatic arthritis/spondyloarthritis registry. Rheumatol Ther. 2023 (Aug 19). doi: 10.1007/s40744-023-00582-w

Key clinical point: In a real-world population of patients with treatment-resistant, long-standing active psoriatic arthritis (PsA), nearly 80% persisted with guselkumab treatment for 6 months and showed improvements in peripheral joint and skin symptoms of PsA.

Major finding: Overall, 78.9% of patients who initiated guselkumab had persistent use at the 6-month follow-up. The mean scores for clinical Disease Activity in PsA (mean change [Δ] −5.4), overall joint+skin activity (Δ −19.0), patient-reported pain (Δ −9.1), and percentage of skin with psoriasis (Δ −5.1%) improved significantly in patients receiving guselkumab for 6 months (all P < .001).

Study details: This study evaluated 114 patients with active PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated guselkumab.

Disclosures: This study was sponsored by CorEvitas, LLC, and the analysis was funded by Janssen Scientific Affairs, LLC. Six authors declared employment with CorEvitas, LLC, or Janssen Scientific Affairs, LLC, or owned stock or stock options in Johnson & Johnson or others. Several authors declared ties with various sources, including Janssen and CorEvitas.

Source: Mease PJ et al. Six-month persistence and multi-domain effectiveness of guselkumab in adults with psoriatic arthritis: Real-world data from the CorEvitas psoriatic arthritis/spondyloarthritis registry. Rheumatol Ther. 2023 (Aug 19). doi: 10.1007/s40744-023-00582-w

Key clinical point: In a real-world population of patients with treatment-resistant, long-standing active psoriatic arthritis (PsA), nearly 80% persisted with guselkumab treatment for 6 months and showed improvements in peripheral joint and skin symptoms of PsA.

Major finding: Overall, 78.9% of patients who initiated guselkumab had persistent use at the 6-month follow-up. The mean scores for clinical Disease Activity in PsA (mean change [Δ] −5.4), overall joint+skin activity (Δ −19.0), patient-reported pain (Δ −9.1), and percentage of skin with psoriasis (Δ −5.1%) improved significantly in patients receiving guselkumab for 6 months (all P < .001).

Study details: This study evaluated 114 patients with active PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated guselkumab.

Disclosures: This study was sponsored by CorEvitas, LLC, and the analysis was funded by Janssen Scientific Affairs, LLC. Six authors declared employment with CorEvitas, LLC, or Janssen Scientific Affairs, LLC, or owned stock or stock options in Johnson & Johnson or others. Several authors declared ties with various sources, including Janssen and CorEvitas.

Source: Mease PJ et al. Six-month persistence and multi-domain effectiveness of guselkumab in adults with psoriatic arthritis: Real-world data from the CorEvitas psoriatic arthritis/spondyloarthritis registry. Rheumatol Ther. 2023 (Aug 19). doi: 10.1007/s40744-023-00582-w