First-line bevacizumab better than cetuximab/panitumumab in right-sided RAS WT mCRC

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Key clinical point: First-line bevacizumab (BEV) is more effective than cetuximab or panitumumab (CET/PAN) against right-sided RAS wild-type (WT) metastatic colorectal cancer (mCRC), but comparably effective against left-sided RAS WT mCRC.

Major finding: Patients who received BEV vs CET/PAN had a significantly longer overall survival (hazard ratio [HR] 0.52; 95% CI 0.28-0.96) in the right-sided group, but similar overall survival in the left-sided group (HR 0.78; 95% CI 0.58-1.07).

Study details: This real-world multicenter retrospective study propensity score-matched patients with right-sided (n = 110) and left-sided (n = 450) RAS WT mCRC who received first-line treatment with BEV or CET/PAN plus fluoropyrimidine-based doublet chemotherapy (oxaliplatin or irinotecan).

Disclosures: The study received no specific funding. Some authors declared receiving grants, personal fees, honoraria for lecture and advisory roles, or research funding from various sources.

Source: Ito T et al. Primary tumor location as a predictor of survival in patients with RAS wild-type colorectal cancer who receive molecularly targeted drugs as first-line therapy: A multicenter real-world observational study by the Japanese Society for Cancer of the Colon and Rectum. Int J Clin Oncol. 2022 (Jul 21). Doi: 10.1007/s10147-022-02208-7

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Key clinical point: First-line bevacizumab (BEV) is more effective than cetuximab or panitumumab (CET/PAN) against right-sided RAS wild-type (WT) metastatic colorectal cancer (mCRC), but comparably effective against left-sided RAS WT mCRC.

Major finding: Patients who received BEV vs CET/PAN had a significantly longer overall survival (hazard ratio [HR] 0.52; 95% CI 0.28-0.96) in the right-sided group, but similar overall survival in the left-sided group (HR 0.78; 95% CI 0.58-1.07).

Study details: This real-world multicenter retrospective study propensity score-matched patients with right-sided (n = 110) and left-sided (n = 450) RAS WT mCRC who received first-line treatment with BEV or CET/PAN plus fluoropyrimidine-based doublet chemotherapy (oxaliplatin or irinotecan).

Disclosures: The study received no specific funding. Some authors declared receiving grants, personal fees, honoraria for lecture and advisory roles, or research funding from various sources.

Source: Ito T et al. Primary tumor location as a predictor of survival in patients with RAS wild-type colorectal cancer who receive molecularly targeted drugs as first-line therapy: A multicenter real-world observational study by the Japanese Society for Cancer of the Colon and Rectum. Int J Clin Oncol. 2022 (Jul 21). Doi: 10.1007/s10147-022-02208-7

Key clinical point: First-line bevacizumab (BEV) is more effective than cetuximab or panitumumab (CET/PAN) against right-sided RAS wild-type (WT) metastatic colorectal cancer (mCRC), but comparably effective against left-sided RAS WT mCRC.

Major finding: Patients who received BEV vs CET/PAN had a significantly longer overall survival (hazard ratio [HR] 0.52; 95% CI 0.28-0.96) in the right-sided group, but similar overall survival in the left-sided group (HR 0.78; 95% CI 0.58-1.07).

Study details: This real-world multicenter retrospective study propensity score-matched patients with right-sided (n = 110) and left-sided (n = 450) RAS WT mCRC who received first-line treatment with BEV or CET/PAN plus fluoropyrimidine-based doublet chemotherapy (oxaliplatin or irinotecan).

Disclosures: The study received no specific funding. Some authors declared receiving grants, personal fees, honoraria for lecture and advisory roles, or research funding from various sources.

Source: Ito T et al. Primary tumor location as a predictor of survival in patients with RAS wild-type colorectal cancer who receive molecularly targeted drugs as first-line therapy: A multicenter real-world observational study by the Japanese Society for Cancer of the Colon and Rectum. Int J Clin Oncol. 2022 (Jul 21). Doi: 10.1007/s10147-022-02208-7

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No increase in second cancer development after additive chemotherapy for colon cancer

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Key clinical point: Postoperative additive chemotherapy does not increase the rate of second cancer development in patients with Union for International Cancer Control (UICC)-stage III/IV colon cancer.

Major finding: The 5-year cumulative rates for the development of a subsequent second cancer were not significantly different in patients who received vs did not receive additive chemotherapy (8.8% vs 9.0%; hazard ratio [HR] 0.944; P  =  .685), with the findings being similar even after adjusting for further risk factors (adjusted HR 1.066; P  =  .673).

Study details: This retrospective study included 2856 patients with UICC-stage III/IV colon cancer, of which 1520 patients received additive chemotherapy after R0 resection of the primary tumor and metastatic lesions.

Disclosures: The study received no funding. The authors declared no conflicts of interest.

Source: Teufel A et al. Second cancer after additive chemotherapy in patients with colon cancer. Clin Colorectal Cancer. 2022 (Jul 15). Doi: 10.1016/j.clcc.2022.07.002

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Key clinical point: Postoperative additive chemotherapy does not increase the rate of second cancer development in patients with Union for International Cancer Control (UICC)-stage III/IV colon cancer.

Major finding: The 5-year cumulative rates for the development of a subsequent second cancer were not significantly different in patients who received vs did not receive additive chemotherapy (8.8% vs 9.0%; hazard ratio [HR] 0.944; P  =  .685), with the findings being similar even after adjusting for further risk factors (adjusted HR 1.066; P  =  .673).

Study details: This retrospective study included 2856 patients with UICC-stage III/IV colon cancer, of which 1520 patients received additive chemotherapy after R0 resection of the primary tumor and metastatic lesions.

Disclosures: The study received no funding. The authors declared no conflicts of interest.

Source: Teufel A et al. Second cancer after additive chemotherapy in patients with colon cancer. Clin Colorectal Cancer. 2022 (Jul 15). Doi: 10.1016/j.clcc.2022.07.002

Key clinical point: Postoperative additive chemotherapy does not increase the rate of second cancer development in patients with Union for International Cancer Control (UICC)-stage III/IV colon cancer.

Major finding: The 5-year cumulative rates for the development of a subsequent second cancer were not significantly different in patients who received vs did not receive additive chemotherapy (8.8% vs 9.0%; hazard ratio [HR] 0.944; P  =  .685), with the findings being similar even after adjusting for further risk factors (adjusted HR 1.066; P  =  .673).

Study details: This retrospective study included 2856 patients with UICC-stage III/IV colon cancer, of which 1520 patients received additive chemotherapy after R0 resection of the primary tumor and metastatic lesions.

Disclosures: The study received no funding. The authors declared no conflicts of interest.

Source: Teufel A et al. Second cancer after additive chemotherapy in patients with colon cancer. Clin Colorectal Cancer. 2022 (Jul 15). Doi: 10.1016/j.clcc.2022.07.002

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Locally advanced rectal cancer: mFOLFOXIRI chemotherapy reduces the need for radiotherapy

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Key clinical point: Neoadjuvant treatment with folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan (mFOLFOXIRI) plus selective radiotherapy offers better disease-free survival (DFS) than neoadjuvant chemoradiotherapy (CRT; fluorouracil plus radiotherapy) in patients with locally advanced rectal cancer (LARC).

Major finding: Patients receiving mFOLFOXIRI without routine radiotherapy vs CRT had a significantly higher 3-year DFS rate (87.6% vs 75.8%; hazard ratio 0.46; P  =  .037).

Study details: This phase 2 study, FORTUNE, studied propensity score-matched patients with LARC who received neoadjuvant mFOLFOXIRI without routine radiotherapy (n = 73) with those who received neoadjuvant CRT in the phase 3 FOWARC study (n = 73).

Disclosures: This study was sponsored by the National Key Research and Development Program of China and Science and Technology Program of Guangzhou. The authors declared no conflicts of interest.

Source: Zhang J et al. Neoadjuvant mfolfoxiri with selective radiotherapy in locally advanced rectal cancer: Long-term outcomes of phase II study and propensity-score matched comparison with chemoradiotherapy. Dis Colon Rectum. 2022 (Jul 12). Doi: 10.1097/DCR.0000000000002424

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Key clinical point: Neoadjuvant treatment with folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan (mFOLFOXIRI) plus selective radiotherapy offers better disease-free survival (DFS) than neoadjuvant chemoradiotherapy (CRT; fluorouracil plus radiotherapy) in patients with locally advanced rectal cancer (LARC).

Major finding: Patients receiving mFOLFOXIRI without routine radiotherapy vs CRT had a significantly higher 3-year DFS rate (87.6% vs 75.8%; hazard ratio 0.46; P  =  .037).

Study details: This phase 2 study, FORTUNE, studied propensity score-matched patients with LARC who received neoadjuvant mFOLFOXIRI without routine radiotherapy (n = 73) with those who received neoadjuvant CRT in the phase 3 FOWARC study (n = 73).

Disclosures: This study was sponsored by the National Key Research and Development Program of China and Science and Technology Program of Guangzhou. The authors declared no conflicts of interest.

Source: Zhang J et al. Neoadjuvant mfolfoxiri with selective radiotherapy in locally advanced rectal cancer: Long-term outcomes of phase II study and propensity-score matched comparison with chemoradiotherapy. Dis Colon Rectum. 2022 (Jul 12). Doi: 10.1097/DCR.0000000000002424

Key clinical point: Neoadjuvant treatment with folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan (mFOLFOXIRI) plus selective radiotherapy offers better disease-free survival (DFS) than neoadjuvant chemoradiotherapy (CRT; fluorouracil plus radiotherapy) in patients with locally advanced rectal cancer (LARC).

Major finding: Patients receiving mFOLFOXIRI without routine radiotherapy vs CRT had a significantly higher 3-year DFS rate (87.6% vs 75.8%; hazard ratio 0.46; P  =  .037).

Study details: This phase 2 study, FORTUNE, studied propensity score-matched patients with LARC who received neoadjuvant mFOLFOXIRI without routine radiotherapy (n = 73) with those who received neoadjuvant CRT in the phase 3 FOWARC study (n = 73).

Disclosures: This study was sponsored by the National Key Research and Development Program of China and Science and Technology Program of Guangzhou. The authors declared no conflicts of interest.

Source: Zhang J et al. Neoadjuvant mfolfoxiri with selective radiotherapy in locally advanced rectal cancer: Long-term outcomes of phase II study and propensity-score matched comparison with chemoradiotherapy. Dis Colon Rectum. 2022 (Jul 12). Doi: 10.1097/DCR.0000000000002424

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High-dose vitamin C prolongs the PFS of patients with RAS mutation

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Key clinical point: Adding high-dose vitamin C to first-line chemotherapy does not significantly improve progression-free survival (PFS) in patients with metastatic colorectal cancer (mCRC) but may benefit patients with RAS mutation.

Major finding: Patients who received high-dose vitamin C plus FOLFOX ± bevacizumab and those who received FOLFOX ± bevacizumab had a similar median PFS (8.6 and 8.3 months, respectively; hazard ratio [HR] 0.86; P  =  .1); however, those with RAS mutation treated with high-dose vitamin C plus FOLFOX ± bevacizumab vs FOLFOX ± bevacizumab had a significantly longer PFS (9.2 vs 7.8 months; HR 0.67; P  =  .01).

Study details: Findings are from a multicenter, phase 3 study that included 442 chemotherapy-naive patients with mCRC who were randomly assigned to receive FOLFOX ± bevacizumab or high-dose vitamin C plus FOLFOX ± bevacizumab.

Disclosures: This study was sponsored by the Sun Yat-sen University Clinical Research 5010 Program, China, among others. The authors declared no conflicts of interest.

Source: Wang F et al. A randomized, open-label, multicenter, phase 3 study of high-dose vitamin C plus FOLFOX +/- bevacizumab versus FOLFOX +/- bevacizumab in unresectable untreated metastatic colorectal cancer. Clin Cancer Res. 2022 (Aug 5). Doi: 10.1158/1078-0432.CCR-22-0655

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Key clinical point: Adding high-dose vitamin C to first-line chemotherapy does not significantly improve progression-free survival (PFS) in patients with metastatic colorectal cancer (mCRC) but may benefit patients with RAS mutation.

Major finding: Patients who received high-dose vitamin C plus FOLFOX ± bevacizumab and those who received FOLFOX ± bevacizumab had a similar median PFS (8.6 and 8.3 months, respectively; hazard ratio [HR] 0.86; P  =  .1); however, those with RAS mutation treated with high-dose vitamin C plus FOLFOX ± bevacizumab vs FOLFOX ± bevacizumab had a significantly longer PFS (9.2 vs 7.8 months; HR 0.67; P  =  .01).

Study details: Findings are from a multicenter, phase 3 study that included 442 chemotherapy-naive patients with mCRC who were randomly assigned to receive FOLFOX ± bevacizumab or high-dose vitamin C plus FOLFOX ± bevacizumab.

Disclosures: This study was sponsored by the Sun Yat-sen University Clinical Research 5010 Program, China, among others. The authors declared no conflicts of interest.

Source: Wang F et al. A randomized, open-label, multicenter, phase 3 study of high-dose vitamin C plus FOLFOX +/- bevacizumab versus FOLFOX +/- bevacizumab in unresectable untreated metastatic colorectal cancer. Clin Cancer Res. 2022 (Aug 5). Doi: 10.1158/1078-0432.CCR-22-0655

Key clinical point: Adding high-dose vitamin C to first-line chemotherapy does not significantly improve progression-free survival (PFS) in patients with metastatic colorectal cancer (mCRC) but may benefit patients with RAS mutation.

Major finding: Patients who received high-dose vitamin C plus FOLFOX ± bevacizumab and those who received FOLFOX ± bevacizumab had a similar median PFS (8.6 and 8.3 months, respectively; hazard ratio [HR] 0.86; P  =  .1); however, those with RAS mutation treated with high-dose vitamin C plus FOLFOX ± bevacizumab vs FOLFOX ± bevacizumab had a significantly longer PFS (9.2 vs 7.8 months; HR 0.67; P  =  .01).

Study details: Findings are from a multicenter, phase 3 study that included 442 chemotherapy-naive patients with mCRC who were randomly assigned to receive FOLFOX ± bevacizumab or high-dose vitamin C plus FOLFOX ± bevacizumab.

Disclosures: This study was sponsored by the Sun Yat-sen University Clinical Research 5010 Program, China, among others. The authors declared no conflicts of interest.

Source: Wang F et al. A randomized, open-label, multicenter, phase 3 study of high-dose vitamin C plus FOLFOX +/- bevacizumab versus FOLFOX +/- bevacizumab in unresectable untreated metastatic colorectal cancer. Clin Cancer Res. 2022 (Aug 5). Doi: 10.1158/1078-0432.CCR-22-0655

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Fatigue impairs general health outcomes in PsA

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Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) reported fatigue, and the degree of fatigue had a significant impact on their disease severity and physical functionality.

Major finding: The majority of patients with PsA (78.3%) reported fatigue. Patients with higher fatigue scores reported more severe disease, greater pain levels, and higher tender/swollen joint count (all P < .001). Higher fatigue scores were associated with worse physical functioning and higher overall work impairment (both P < .001).

Study details: Findings are from an analysis of an independent, cross-sectional, multinational, real-world survey, Adelphi Real World Spondyloarthritis (SpA) IV Disease Specific Programme, including 831 patients with PsA.

Disclosures: The Adelphi SpA IV Disease Specific Programme was funded by Janssen. Three authors declared being employees of Janssen and shareholders of Janssen/Johnson & Johnson. Four authors declared being employees of Adelphi Real World. Other authors declared receiving grants of serving as consultants for several sources, including Janssen.

Source: Gossec L et al. Impact of fatigue on health-related quality of life and work productivity in psoriatic arthritis: Findings from a real-world survey. J Rheumatol. 2022 (Jul 15). Doi: 10.3899/jrheum.211288

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Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) reported fatigue, and the degree of fatigue had a significant impact on their disease severity and physical functionality.

Major finding: The majority of patients with PsA (78.3%) reported fatigue. Patients with higher fatigue scores reported more severe disease, greater pain levels, and higher tender/swollen joint count (all P < .001). Higher fatigue scores were associated with worse physical functioning and higher overall work impairment (both P < .001).

Study details: Findings are from an analysis of an independent, cross-sectional, multinational, real-world survey, Adelphi Real World Spondyloarthritis (SpA) IV Disease Specific Programme, including 831 patients with PsA.

Disclosures: The Adelphi SpA IV Disease Specific Programme was funded by Janssen. Three authors declared being employees of Janssen and shareholders of Janssen/Johnson & Johnson. Four authors declared being employees of Adelphi Real World. Other authors declared receiving grants of serving as consultants for several sources, including Janssen.

Source: Gossec L et al. Impact of fatigue on health-related quality of life and work productivity in psoriatic arthritis: Findings from a real-world survey. J Rheumatol. 2022 (Jul 15). Doi: 10.3899/jrheum.211288

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) reported fatigue, and the degree of fatigue had a significant impact on their disease severity and physical functionality.

Major finding: The majority of patients with PsA (78.3%) reported fatigue. Patients with higher fatigue scores reported more severe disease, greater pain levels, and higher tender/swollen joint count (all P < .001). Higher fatigue scores were associated with worse physical functioning and higher overall work impairment (both P < .001).

Study details: Findings are from an analysis of an independent, cross-sectional, multinational, real-world survey, Adelphi Real World Spondyloarthritis (SpA) IV Disease Specific Programme, including 831 patients with PsA.

Disclosures: The Adelphi SpA IV Disease Specific Programme was funded by Janssen. Three authors declared being employees of Janssen and shareholders of Janssen/Johnson & Johnson. Four authors declared being employees of Adelphi Real World. Other authors declared receiving grants of serving as consultants for several sources, including Janssen.

Source: Gossec L et al. Impact of fatigue on health-related quality of life and work productivity in psoriatic arthritis: Findings from a real-world survey. J Rheumatol. 2022 (Jul 15). Doi: 10.3899/jrheum.211288

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Elevated IL-23 levels associated with psychiatric disorders in PsA

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Key clinical point: In patients with psoriatic arthritis (PsA), serum interleukin-23 (IL-23) levels were elevated and significantly correlated with disease activity (DA), depression, and anxiety.

Major finding: Serum IL-23 levels were higher in patients with PsA vs healthy volunteers without PsA (225.19 vs 118.12 pg/mL; P < .0001), and a significantly higher proportion of patients vs volunteers reported anxiety (45% vs 20%) and depression (35% vs 15%; both P < .0001). Serum IL-23 levels were positively correlated with Disease Activity Index for Psoriatic Arthritis (correlation coefficient [r] 0.959), Hospital Anxiety and Depression Scale (HADS) anxiety (r 0.932), and HADS depression (r 0.934; all P  =  .0001) scores.

Study details: Findings are from an observational case-control study including 80 patients with PsA and 80 matched healthy volunteers.

Disclosures: This study was funded by The Science, Technology & Innovation Funding Authority, Egypt, in cooperation with The Egyptian Knowledge Bank. The authors declared no conflicts of interest.

Source: Tabra SA et al. Serum interleukin-23 levels: Relation to depression, anxiety, and disease activity in psoriatic arthritis patients. Clin Rheumatol. 2022 (Jul 21). Doi: 10.1007/s10067-022-06300-1

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Key clinical point: In patients with psoriatic arthritis (PsA), serum interleukin-23 (IL-23) levels were elevated and significantly correlated with disease activity (DA), depression, and anxiety.

Major finding: Serum IL-23 levels were higher in patients with PsA vs healthy volunteers without PsA (225.19 vs 118.12 pg/mL; P < .0001), and a significantly higher proportion of patients vs volunteers reported anxiety (45% vs 20%) and depression (35% vs 15%; both P < .0001). Serum IL-23 levels were positively correlated with Disease Activity Index for Psoriatic Arthritis (correlation coefficient [r] 0.959), Hospital Anxiety and Depression Scale (HADS) anxiety (r 0.932), and HADS depression (r 0.934; all P  =  .0001) scores.

Study details: Findings are from an observational case-control study including 80 patients with PsA and 80 matched healthy volunteers.

Disclosures: This study was funded by The Science, Technology & Innovation Funding Authority, Egypt, in cooperation with The Egyptian Knowledge Bank. The authors declared no conflicts of interest.

Source: Tabra SA et al. Serum interleukin-23 levels: Relation to depression, anxiety, and disease activity in psoriatic arthritis patients. Clin Rheumatol. 2022 (Jul 21). Doi: 10.1007/s10067-022-06300-1

Key clinical point: In patients with psoriatic arthritis (PsA), serum interleukin-23 (IL-23) levels were elevated and significantly correlated with disease activity (DA), depression, and anxiety.

Major finding: Serum IL-23 levels were higher in patients with PsA vs healthy volunteers without PsA (225.19 vs 118.12 pg/mL; P < .0001), and a significantly higher proportion of patients vs volunteers reported anxiety (45% vs 20%) and depression (35% vs 15%; both P < .0001). Serum IL-23 levels were positively correlated with Disease Activity Index for Psoriatic Arthritis (correlation coefficient [r] 0.959), Hospital Anxiety and Depression Scale (HADS) anxiety (r 0.932), and HADS depression (r 0.934; all P  =  .0001) scores.

Study details: Findings are from an observational case-control study including 80 patients with PsA and 80 matched healthy volunteers.

Disclosures: This study was funded by The Science, Technology & Innovation Funding Authority, Egypt, in cooperation with The Egyptian Knowledge Bank. The authors declared no conflicts of interest.

Source: Tabra SA et al. Serum interleukin-23 levels: Relation to depression, anxiety, and disease activity in psoriatic arthritis patients. Clin Rheumatol. 2022 (Jul 21). Doi: 10.1007/s10067-022-06300-1

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PsA remission depends on patient perception and is multidimensional

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Key clinical point: Patients with psoriatic arthritis (PsA) were more likely to report remission if they perceived an acceptable disease state, psoriasis remission, and a lower impact of PsA on global quality of life.

Major finding: Patient-reported PsA remission was associated with the achievement of 9-question Psoriatic Arthritis Impact of Disease score of ≤4 (odds ratio [OR] 4.58; P < .05), perception of psoriasis remission (OR 4.51; P < .05), and global quality of life score (OR 0.55; P < .001).

Study details: Findings are from a cross-sectional survey by the National Psoriasis Foundation including 834 patients with psoriasis or PsA.

Disclosures: This study did not receive any funding. Several authors declared serving as research or principal investigators, advisors, or consultants for several sources.

Source: Gondo G et al. Demographic and clinical factors associated with patient-reported remission in psoriatic arthritis. Dermatol Ther (Heidelb). 2022;12(8):1885-1895 (Jul 21). Doi: 10.1007/s13555-022-00770-6

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Key clinical point: Patients with psoriatic arthritis (PsA) were more likely to report remission if they perceived an acceptable disease state, psoriasis remission, and a lower impact of PsA on global quality of life.

Major finding: Patient-reported PsA remission was associated with the achievement of 9-question Psoriatic Arthritis Impact of Disease score of ≤4 (odds ratio [OR] 4.58; P < .05), perception of psoriasis remission (OR 4.51; P < .05), and global quality of life score (OR 0.55; P < .001).

Study details: Findings are from a cross-sectional survey by the National Psoriasis Foundation including 834 patients with psoriasis or PsA.

Disclosures: This study did not receive any funding. Several authors declared serving as research or principal investigators, advisors, or consultants for several sources.

Source: Gondo G et al. Demographic and clinical factors associated with patient-reported remission in psoriatic arthritis. Dermatol Ther (Heidelb). 2022;12(8):1885-1895 (Jul 21). Doi: 10.1007/s13555-022-00770-6

Key clinical point: Patients with psoriatic arthritis (PsA) were more likely to report remission if they perceived an acceptable disease state, psoriasis remission, and a lower impact of PsA on global quality of life.

Major finding: Patient-reported PsA remission was associated with the achievement of 9-question Psoriatic Arthritis Impact of Disease score of ≤4 (odds ratio [OR] 4.58; P < .05), perception of psoriasis remission (OR 4.51; P < .05), and global quality of life score (OR 0.55; P < .001).

Study details: Findings are from a cross-sectional survey by the National Psoriasis Foundation including 834 patients with psoriasis or PsA.

Disclosures: This study did not receive any funding. Several authors declared serving as research or principal investigators, advisors, or consultants for several sources.

Source: Gondo G et al. Demographic and clinical factors associated with patient-reported remission in psoriatic arthritis. Dermatol Ther (Heidelb). 2022;12(8):1885-1895 (Jul 21). Doi: 10.1007/s13555-022-00770-6

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Long-term safety and efficacy of risankizumab in PsA

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Key clinical point: In patients with psoriatic arthritis (PsA), risankizumab demonstrated long-term (76 weeks) effectiveness in reducing joint symptoms with a favorable safety profile.

Major finding: At week 16, the American College of Rheumatology 20 criteria response rate was significantly higher with 150 mg risankizumab at weeks 0, 4, 8, 12, and 16 (arm 1) or 150 mg risankizumab at weeks 0, 4, and 16 (arm 2) vs placebo (59.5% [pooled arms 1 and 2] vs 35.7%; P  =  .007), which further improved (75.2%) at week 52. Both risankizumab and placebo had a similar safety profile.

Study details: Findings are from a phase 2 study including 185 patients with active PsA and inadequate response or intolerance to standard therapies who were randomly assigned to receive risankizumab or placebo, of which 145 patients entered the 52-week open-label extension study and received 150 mg risankizumab for 36 weeks.

Disclosures: This study was funded by AbbVie and Boehringer Ingelheim. Some authors declared being current or former employees of Boehringer Ingelheim or AbbVie or owning stocks in AbbVie. The other authors reported ties with several sources, including AbbVie and Boehringer Ingelheim.

Source: Mease PJ et al. Long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis: Results from a 76-week phase 2 randomized trial. Rheumatol Ther. 2022 (Aug 5). Doi: 10.1007/s40744-022-00474-5

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Key clinical point: In patients with psoriatic arthritis (PsA), risankizumab demonstrated long-term (76 weeks) effectiveness in reducing joint symptoms with a favorable safety profile.

Major finding: At week 16, the American College of Rheumatology 20 criteria response rate was significantly higher with 150 mg risankizumab at weeks 0, 4, 8, 12, and 16 (arm 1) or 150 mg risankizumab at weeks 0, 4, and 16 (arm 2) vs placebo (59.5% [pooled arms 1 and 2] vs 35.7%; P  =  .007), which further improved (75.2%) at week 52. Both risankizumab and placebo had a similar safety profile.

Study details: Findings are from a phase 2 study including 185 patients with active PsA and inadequate response or intolerance to standard therapies who were randomly assigned to receive risankizumab or placebo, of which 145 patients entered the 52-week open-label extension study and received 150 mg risankizumab for 36 weeks.

Disclosures: This study was funded by AbbVie and Boehringer Ingelheim. Some authors declared being current or former employees of Boehringer Ingelheim or AbbVie or owning stocks in AbbVie. The other authors reported ties with several sources, including AbbVie and Boehringer Ingelheim.

Source: Mease PJ et al. Long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis: Results from a 76-week phase 2 randomized trial. Rheumatol Ther. 2022 (Aug 5). Doi: 10.1007/s40744-022-00474-5

Key clinical point: In patients with psoriatic arthritis (PsA), risankizumab demonstrated long-term (76 weeks) effectiveness in reducing joint symptoms with a favorable safety profile.

Major finding: At week 16, the American College of Rheumatology 20 criteria response rate was significantly higher with 150 mg risankizumab at weeks 0, 4, 8, 12, and 16 (arm 1) or 150 mg risankizumab at weeks 0, 4, and 16 (arm 2) vs placebo (59.5% [pooled arms 1 and 2] vs 35.7%; P  =  .007), which further improved (75.2%) at week 52. Both risankizumab and placebo had a similar safety profile.

Study details: Findings are from a phase 2 study including 185 patients with active PsA and inadequate response or intolerance to standard therapies who were randomly assigned to receive risankizumab or placebo, of which 145 patients entered the 52-week open-label extension study and received 150 mg risankizumab for 36 weeks.

Disclosures: This study was funded by AbbVie and Boehringer Ingelheim. Some authors declared being current or former employees of Boehringer Ingelheim or AbbVie or owning stocks in AbbVie. The other authors reported ties with several sources, including AbbVie and Boehringer Ingelheim.

Source: Mease PJ et al. Long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis: Results from a 76-week phase 2 randomized trial. Rheumatol Ther. 2022 (Aug 5). Doi: 10.1007/s40744-022-00474-5

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Robust and consistent improvement in HRQoL with guselkumab

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Key clinical point: A dose of 100 mg guselkumab every 4/8 weeks (Q4W/Q8W) improved health-related quality of life (HRQoL) through 52 weeks in patients with psoriatic arthritis (PsA).

Major finding: A significantly higher proportion of patients receiving guselkumab Q4W/Q8W vs placebo reported minimally important differences in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index (56.0%/56.0% vs 43.4%; P < .006) and Visual Analog Scale (EQ-VAS) score (62.8%/63.5% vs 44.4%; P < .0001) at week 24, with >60% of patients reporting improvements at week 52.

Study details: Findings are from an analysis of the phase 3 DISCOVER 2 trial including 738 biologic-naive patients with active PsA and an inadequate response to standard treatments who were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was supported by Janssen, a subsidiary of Johnson and Johnson. Eight authors declared being employees of one of the subsidiaries of or owning stocks in Johnson and Johnson. The other authors reported ties with several sources.

Source: Curtis JR et al. The effect of guselkumab on general health state in biologic-naïve patients with active psoriatic arthritis through week 52 of the phase 3, randomized, placebo-controlled DISCOVER-2 trial. Adv Ther. 2022 (Aug 10). Doi: 10.1007/s12325-022-02269-0

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Key clinical point: A dose of 100 mg guselkumab every 4/8 weeks (Q4W/Q8W) improved health-related quality of life (HRQoL) through 52 weeks in patients with psoriatic arthritis (PsA).

Major finding: A significantly higher proportion of patients receiving guselkumab Q4W/Q8W vs placebo reported minimally important differences in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index (56.0%/56.0% vs 43.4%; P < .006) and Visual Analog Scale (EQ-VAS) score (62.8%/63.5% vs 44.4%; P < .0001) at week 24, with >60% of patients reporting improvements at week 52.

Study details: Findings are from an analysis of the phase 3 DISCOVER 2 trial including 738 biologic-naive patients with active PsA and an inadequate response to standard treatments who were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was supported by Janssen, a subsidiary of Johnson and Johnson. Eight authors declared being employees of one of the subsidiaries of or owning stocks in Johnson and Johnson. The other authors reported ties with several sources.

Source: Curtis JR et al. The effect of guselkumab on general health state in biologic-naïve patients with active psoriatic arthritis through week 52 of the phase 3, randomized, placebo-controlled DISCOVER-2 trial. Adv Ther. 2022 (Aug 10). Doi: 10.1007/s12325-022-02269-0

Key clinical point: A dose of 100 mg guselkumab every 4/8 weeks (Q4W/Q8W) improved health-related quality of life (HRQoL) through 52 weeks in patients with psoriatic arthritis (PsA).

Major finding: A significantly higher proportion of patients receiving guselkumab Q4W/Q8W vs placebo reported minimally important differences in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index (56.0%/56.0% vs 43.4%; P < .006) and Visual Analog Scale (EQ-VAS) score (62.8%/63.5% vs 44.4%; P < .0001) at week 24, with >60% of patients reporting improvements at week 52.

Study details: Findings are from an analysis of the phase 3 DISCOVER 2 trial including 738 biologic-naive patients with active PsA and an inadequate response to standard treatments who were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was supported by Janssen, a subsidiary of Johnson and Johnson. Eight authors declared being employees of one of the subsidiaries of or owning stocks in Johnson and Johnson. The other authors reported ties with several sources.

Source: Curtis JR et al. The effect of guselkumab on general health state in biologic-naïve patients with active psoriatic arthritis through week 52 of the phase 3, randomized, placebo-controlled DISCOVER-2 trial. Adv Ther. 2022 (Aug 10). Doi: 10.1007/s12325-022-02269-0

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Clinically meaningful improvement in PRO with risankizumab vs placebo in PsA

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Key clinical point: Patients with psoriatic arthritis (PsA) who received risankizumab vs placebo were more likely to achieve clinically meaningful improvements in patient-reported outcomes (PRO).

Major finding: At week 24, patients receiving risankizumab vs placebo were significantly more likely to report minimal clinically important differences (MCID) in Patient’s Global Assessment of Disease Activity (PtGA) in both KEEPsAKE-1 (odds ratio [OR] 2.0; P < .001) and KEEPsAKE-2 (OR 1.9; P < .01) studies, with further improvement until week 52. Risankizumab significantly improved other PRO like pain, fatigue, quality of life, and physical functioning (P < .05).

Study details: The data come from an analysis of 2 phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, including adults with PsA and inadequate response or intolerance to disease-modifying antirheumatic drugs or biologics who were randomly assigned to receive risankizumab or placebo for 24 weeks and only risankizumab during weeks 24-52.

Disclosures: This study was funded by AbbVie. Three authors declared being employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: Results from KEEPsAKE 1 and 2. J Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18475

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Key clinical point: Patients with psoriatic arthritis (PsA) who received risankizumab vs placebo were more likely to achieve clinically meaningful improvements in patient-reported outcomes (PRO).

Major finding: At week 24, patients receiving risankizumab vs placebo were significantly more likely to report minimal clinically important differences (MCID) in Patient’s Global Assessment of Disease Activity (PtGA) in both KEEPsAKE-1 (odds ratio [OR] 2.0; P < .001) and KEEPsAKE-2 (OR 1.9; P < .01) studies, with further improvement until week 52. Risankizumab significantly improved other PRO like pain, fatigue, quality of life, and physical functioning (P < .05).

Study details: The data come from an analysis of 2 phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, including adults with PsA and inadequate response or intolerance to disease-modifying antirheumatic drugs or biologics who were randomly assigned to receive risankizumab or placebo for 24 weeks and only risankizumab during weeks 24-52.

Disclosures: This study was funded by AbbVie. Three authors declared being employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: Results from KEEPsAKE 1 and 2. J Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18475

Key clinical point: Patients with psoriatic arthritis (PsA) who received risankizumab vs placebo were more likely to achieve clinically meaningful improvements in patient-reported outcomes (PRO).

Major finding: At week 24, patients receiving risankizumab vs placebo were significantly more likely to report minimal clinically important differences (MCID) in Patient’s Global Assessment of Disease Activity (PtGA) in both KEEPsAKE-1 (odds ratio [OR] 2.0; P < .001) and KEEPsAKE-2 (OR 1.9; P < .01) studies, with further improvement until week 52. Risankizumab significantly improved other PRO like pain, fatigue, quality of life, and physical functioning (P < .05).

Study details: The data come from an analysis of 2 phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, including adults with PsA and inadequate response or intolerance to disease-modifying antirheumatic drugs or biologics who were randomly assigned to receive risankizumab or placebo for 24 weeks and only risankizumab during weeks 24-52.

Disclosures: This study was funded by AbbVie. Three authors declared being employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: Results from KEEPsAKE 1 and 2. J Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18475

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