Incremental benefits with filgotinib 200 mg+methotraxate in RA patients with poor prognostic factors

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Key clinical point: The combination of filgotinib 200 mg and methotrexate showed an incremental benefit vs. methotrexate monotherapy in methotrexate-naive patients with rheumatoid arthritis (RA) and poor prognostic factors (PPF) with no new safety signals.

Major finding: Among patients with 4 PPFs, methotrexate + 200 mg filgotinib vs. methotrexate monotherapy was associated with higher rates of American College of Rheumatology (ACR) core criteria 20 (85.5% vs. 74.7%), ACR50 (70.3% vs. 48.2%), and ACR70 (54.1% vs. 28.3%) responses at week 24 and weeks 12 and 52 (nominal P < .05 for all).

Study details: This was a post hoc analysis of the phase 3 FINCH 3 study involving 1,249 methotrexate-naive adult patients with moderate-to-severe active RA with multiple PPFs. Patients were randomly assigned to once-weekly methotrexate with once-daily oral filgotinib (200 mg or 100 mg), 200 mg filgotinib monotherapy, or oral methotrexate monotherapy for up to 52 weeks.

Disclosures: The study was funded by Gilead Sciences, Inc. The authors, including the lead author, reported receiving grants, speaker’s fees, and consultancy fees from various sources. Three authors reported being employees and shareholders of Gilead Sciences, Inc.

Source: Aletaha D et al. RMD Open. 2021 Aug 12. doi: 10.1136/rmdopen-2021-001621.

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Key clinical point: The combination of filgotinib 200 mg and methotrexate showed an incremental benefit vs. methotrexate monotherapy in methotrexate-naive patients with rheumatoid arthritis (RA) and poor prognostic factors (PPF) with no new safety signals.

Major finding: Among patients with 4 PPFs, methotrexate + 200 mg filgotinib vs. methotrexate monotherapy was associated with higher rates of American College of Rheumatology (ACR) core criteria 20 (85.5% vs. 74.7%), ACR50 (70.3% vs. 48.2%), and ACR70 (54.1% vs. 28.3%) responses at week 24 and weeks 12 and 52 (nominal P < .05 for all).

Study details: This was a post hoc analysis of the phase 3 FINCH 3 study involving 1,249 methotrexate-naive adult patients with moderate-to-severe active RA with multiple PPFs. Patients were randomly assigned to once-weekly methotrexate with once-daily oral filgotinib (200 mg or 100 mg), 200 mg filgotinib monotherapy, or oral methotrexate monotherapy for up to 52 weeks.

Disclosures: The study was funded by Gilead Sciences, Inc. The authors, including the lead author, reported receiving grants, speaker’s fees, and consultancy fees from various sources. Three authors reported being employees and shareholders of Gilead Sciences, Inc.

Source: Aletaha D et al. RMD Open. 2021 Aug 12. doi: 10.1136/rmdopen-2021-001621.

Key clinical point: The combination of filgotinib 200 mg and methotrexate showed an incremental benefit vs. methotrexate monotherapy in methotrexate-naive patients with rheumatoid arthritis (RA) and poor prognostic factors (PPF) with no new safety signals.

Major finding: Among patients with 4 PPFs, methotrexate + 200 mg filgotinib vs. methotrexate monotherapy was associated with higher rates of American College of Rheumatology (ACR) core criteria 20 (85.5% vs. 74.7%), ACR50 (70.3% vs. 48.2%), and ACR70 (54.1% vs. 28.3%) responses at week 24 and weeks 12 and 52 (nominal P < .05 for all).

Study details: This was a post hoc analysis of the phase 3 FINCH 3 study involving 1,249 methotrexate-naive adult patients with moderate-to-severe active RA with multiple PPFs. Patients were randomly assigned to once-weekly methotrexate with once-daily oral filgotinib (200 mg or 100 mg), 200 mg filgotinib monotherapy, or oral methotrexate monotherapy for up to 52 weeks.

Disclosures: The study was funded by Gilead Sciences, Inc. The authors, including the lead author, reported receiving grants, speaker’s fees, and consultancy fees from various sources. Three authors reported being employees and shareholders of Gilead Sciences, Inc.

Source: Aletaha D et al. RMD Open. 2021 Aug 12. doi: 10.1136/rmdopen-2021-001621.

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Fasting C-peptide levels tied to EPI in patients with T2DM

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Key clinical point: Fasting C-peptide (FCP) was positively associated with fecal elastase (FE)-1 levels with an independent predictive value for exocrine pancreatic insufficiency (EPI) in patients with type 2 diabetes mellitus (T2DM).

Major finding: Overall, the prevalence of EPI (FE-1 < 200 mg/g) was 18.8%. FE-1 levels were positively associated with FCP levels (correlation coefficient 0.451; P < .001). FCP level was an independent factor (odds ratio 0.204; P = .024) with a good predictive value (area under the receiver operating curve 0.793; sensitivity 0.710; specificity 0.812; P < .001) for EPI.

Study details: Findings are from a cross-sectional analysis of 85 adult inpatients with T2DM without known exocrine pancreatic disorders or digestive system diseases.

Disclosures: This study was supported by the National Natural Science Foundation of China, the Key Research & Development Program of Jiangsu Province, and the Joint Key Project funded by the Southeast University and Nanjing Medical University. The authors declared no conflict of interests.

 

Source: Lv Y et al. Clin Chim Acta. 2021 Sep 14. doi: 10.1016/j.cca.2021.09.008.

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Key clinical point: Fasting C-peptide (FCP) was positively associated with fecal elastase (FE)-1 levels with an independent predictive value for exocrine pancreatic insufficiency (EPI) in patients with type 2 diabetes mellitus (T2DM).

Major finding: Overall, the prevalence of EPI (FE-1 < 200 mg/g) was 18.8%. FE-1 levels were positively associated with FCP levels (correlation coefficient 0.451; P < .001). FCP level was an independent factor (odds ratio 0.204; P = .024) with a good predictive value (area under the receiver operating curve 0.793; sensitivity 0.710; specificity 0.812; P < .001) for EPI.

Study details: Findings are from a cross-sectional analysis of 85 adult inpatients with T2DM without known exocrine pancreatic disorders or digestive system diseases.

Disclosures: This study was supported by the National Natural Science Foundation of China, the Key Research & Development Program of Jiangsu Province, and the Joint Key Project funded by the Southeast University and Nanjing Medical University. The authors declared no conflict of interests.

 

Source: Lv Y et al. Clin Chim Acta. 2021 Sep 14. doi: 10.1016/j.cca.2021.09.008.

Key clinical point: Fasting C-peptide (FCP) was positively associated with fecal elastase (FE)-1 levels with an independent predictive value for exocrine pancreatic insufficiency (EPI) in patients with type 2 diabetes mellitus (T2DM).

Major finding: Overall, the prevalence of EPI (FE-1 < 200 mg/g) was 18.8%. FE-1 levels were positively associated with FCP levels (correlation coefficient 0.451; P < .001). FCP level was an independent factor (odds ratio 0.204; P = .024) with a good predictive value (area under the receiver operating curve 0.793; sensitivity 0.710; specificity 0.812; P < .001) for EPI.

Study details: Findings are from a cross-sectional analysis of 85 adult inpatients with T2DM without known exocrine pancreatic disorders or digestive system diseases.

Disclosures: This study was supported by the National Natural Science Foundation of China, the Key Research & Development Program of Jiangsu Province, and the Joint Key Project funded by the Southeast University and Nanjing Medical University. The authors declared no conflict of interests.

 

Source: Lv Y et al. Clin Chim Acta. 2021 Sep 14. doi: 10.1016/j.cca.2021.09.008.

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Higher prevalence of EPI in patients with pancreatic enzyme abnormalities with or without functional dyspepsia

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Key clinical point: The prevalence of exocrine pancreatic insufficiency (EPI) was higher in patients with functional dyspepsia (FD) with pancreatic enzyme abnormalities (PEA) compared to asymptomatic patients (AP) with PEA and was associated with physical function but not with the state of anxiety.

Major finding: The prevalence of EPI was higher in patients with FD-PEA vs. AP-PEA (N-benzoyl-L-tyrosyl-p-aminobenzoic acid test scores, 61.67% ± 5.55% vs. 95.38% ± 2.36%; P = .01). Physical component scale was significantly lower in FD-PEA vs. AP-PEA group (44.60 ± 2.40 vs. 53.56 ± 1.31; P = .002). No difference was observed in State-Trait Anxiety Inventory (STAI)-state (P = .089) and STAI-trait (P = .483) scores between groups.

Study details: This study included 49 patients with PEA with (n=20) or without (n=29) symptoms of FD.

Disclosures: This study was funded by the Ministry of Education, Culture, and Science and the Ministry of Health, Japan. The authors declared no conflict of interests.

Source: Agawa S et al. J Clin Biochem Nutr. 2021 Sep 3. doi: 10.3164/jcbn.21-67.

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Key clinical point: The prevalence of exocrine pancreatic insufficiency (EPI) was higher in patients with functional dyspepsia (FD) with pancreatic enzyme abnormalities (PEA) compared to asymptomatic patients (AP) with PEA and was associated with physical function but not with the state of anxiety.

Major finding: The prevalence of EPI was higher in patients with FD-PEA vs. AP-PEA (N-benzoyl-L-tyrosyl-p-aminobenzoic acid test scores, 61.67% ± 5.55% vs. 95.38% ± 2.36%; P = .01). Physical component scale was significantly lower in FD-PEA vs. AP-PEA group (44.60 ± 2.40 vs. 53.56 ± 1.31; P = .002). No difference was observed in State-Trait Anxiety Inventory (STAI)-state (P = .089) and STAI-trait (P = .483) scores between groups.

Study details: This study included 49 patients with PEA with (n=20) or without (n=29) symptoms of FD.

Disclosures: This study was funded by the Ministry of Education, Culture, and Science and the Ministry of Health, Japan. The authors declared no conflict of interests.

Source: Agawa S et al. J Clin Biochem Nutr. 2021 Sep 3. doi: 10.3164/jcbn.21-67.

Key clinical point: The prevalence of exocrine pancreatic insufficiency (EPI) was higher in patients with functional dyspepsia (FD) with pancreatic enzyme abnormalities (PEA) compared to asymptomatic patients (AP) with PEA and was associated with physical function but not with the state of anxiety.

Major finding: The prevalence of EPI was higher in patients with FD-PEA vs. AP-PEA (N-benzoyl-L-tyrosyl-p-aminobenzoic acid test scores, 61.67% ± 5.55% vs. 95.38% ± 2.36%; P = .01). Physical component scale was significantly lower in FD-PEA vs. AP-PEA group (44.60 ± 2.40 vs. 53.56 ± 1.31; P = .002). No difference was observed in State-Trait Anxiety Inventory (STAI)-state (P = .089) and STAI-trait (P = .483) scores between groups.

Study details: This study included 49 patients with PEA with (n=20) or without (n=29) symptoms of FD.

Disclosures: This study was funded by the Ministry of Education, Culture, and Science and the Ministry of Health, Japan. The authors declared no conflict of interests.

Source: Agawa S et al. J Clin Biochem Nutr. 2021 Sep 3. doi: 10.3164/jcbn.21-67.

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EPI in diabetes is associated with autonomic dysfunction

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Key clinical point: Patients with diabetes and exocrine pancreatic insufficiency (EPI) had reduced autonomic function compared with those with diabetes without EPI.

Major finding: Overall, the prevalence of EPI (fecal elastase [FE] < 200 mg/g) was 20%. Patients with or without EPI had reduced baroreflex sensitivity (all P < .05) and heart rate variability (P < .05), but not increased frequency of orthostatic hypotension (P = .92).

Study details: This study included 59 patients with type 1 or type 2 diabetes. Patients with diabetes were stratified into EPI (n=8) and control (n=13) groups based on FE levels.

Disclosures: This study was funded by Haukeland University Hospital. The authors declared no conflict of interests.

Source: Sangnes DA et al. Scand J Gastroenterol. 2021 Sep 7. doi: 10.1080/00365521.2021.1957496.

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Key clinical point: Patients with diabetes and exocrine pancreatic insufficiency (EPI) had reduced autonomic function compared with those with diabetes without EPI.

Major finding: Overall, the prevalence of EPI (fecal elastase [FE] < 200 mg/g) was 20%. Patients with or without EPI had reduced baroreflex sensitivity (all P < .05) and heart rate variability (P < .05), but not increased frequency of orthostatic hypotension (P = .92).

Study details: This study included 59 patients with type 1 or type 2 diabetes. Patients with diabetes were stratified into EPI (n=8) and control (n=13) groups based on FE levels.

Disclosures: This study was funded by Haukeland University Hospital. The authors declared no conflict of interests.

Source: Sangnes DA et al. Scand J Gastroenterol. 2021 Sep 7. doi: 10.1080/00365521.2021.1957496.

Key clinical point: Patients with diabetes and exocrine pancreatic insufficiency (EPI) had reduced autonomic function compared with those with diabetes without EPI.

Major finding: Overall, the prevalence of EPI (fecal elastase [FE] < 200 mg/g) was 20%. Patients with or without EPI had reduced baroreflex sensitivity (all P < .05) and heart rate variability (P < .05), but not increased frequency of orthostatic hypotension (P = .92).

Study details: This study included 59 patients with type 1 or type 2 diabetes. Patients with diabetes were stratified into EPI (n=8) and control (n=13) groups based on FE levels.

Disclosures: This study was funded by Haukeland University Hospital. The authors declared no conflict of interests.

Source: Sangnes DA et al. Scand J Gastroenterol. 2021 Sep 7. doi: 10.1080/00365521.2021.1957496.

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EPI-related fat malabsorption correlates with autonomic dysfunction in T2DM

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Key clinical point: High prevalence of exocrine pancreatic insufficiency (EPI)-related fat malabsorption was observed in Asian Indian patients with type 2 diabetes mellitus (T2DM), which was significantly associated with autonomic dysfunction.

Major finding: EPI-related fat malabsorption (72 hours fecal fat > 18 g) was present in 44.9% and 6.1% of patients with and without T2DM, respectively (P < .05). Among patients with T2DM, those with or without EPI-related fat malabsorption had significantly higher proportion of parasympathetic nervous system (PNS) dysfunction (86.7% vs. 61.5%), sympathetic nervous system (SNS) dysfunction (92.4% vs. 72.3%), and PNS+SNS dysfunction (83.1 vs. 66.0%; all P < .05).

Study details: Findings are from a cross-sectional analysis of 118 patients with T2DM and 82 normoglycemic individuals.

Disclosures: This study was supported by the FLUID research grant of CMC, Vellore, India. The authors declared no conflict of interests.

Source: Anoop S et al. Diab Metab Syndr Clin Res Rev. 2021 Sep 4. doi: 10.1016/j.dsx.2021.102273.

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Key clinical point: High prevalence of exocrine pancreatic insufficiency (EPI)-related fat malabsorption was observed in Asian Indian patients with type 2 diabetes mellitus (T2DM), which was significantly associated with autonomic dysfunction.

Major finding: EPI-related fat malabsorption (72 hours fecal fat > 18 g) was present in 44.9% and 6.1% of patients with and without T2DM, respectively (P < .05). Among patients with T2DM, those with or without EPI-related fat malabsorption had significantly higher proportion of parasympathetic nervous system (PNS) dysfunction (86.7% vs. 61.5%), sympathetic nervous system (SNS) dysfunction (92.4% vs. 72.3%), and PNS+SNS dysfunction (83.1 vs. 66.0%; all P < .05).

Study details: Findings are from a cross-sectional analysis of 118 patients with T2DM and 82 normoglycemic individuals.

Disclosures: This study was supported by the FLUID research grant of CMC, Vellore, India. The authors declared no conflict of interests.

Source: Anoop S et al. Diab Metab Syndr Clin Res Rev. 2021 Sep 4. doi: 10.1016/j.dsx.2021.102273.

Key clinical point: High prevalence of exocrine pancreatic insufficiency (EPI)-related fat malabsorption was observed in Asian Indian patients with type 2 diabetes mellitus (T2DM), which was significantly associated with autonomic dysfunction.

Major finding: EPI-related fat malabsorption (72 hours fecal fat > 18 g) was present in 44.9% and 6.1% of patients with and without T2DM, respectively (P < .05). Among patients with T2DM, those with or without EPI-related fat malabsorption had significantly higher proportion of parasympathetic nervous system (PNS) dysfunction (86.7% vs. 61.5%), sympathetic nervous system (SNS) dysfunction (92.4% vs. 72.3%), and PNS+SNS dysfunction (83.1 vs. 66.0%; all P < .05).

Study details: Findings are from a cross-sectional analysis of 118 patients with T2DM and 82 normoglycemic individuals.

Disclosures: This study was supported by the FLUID research grant of CMC, Vellore, India. The authors declared no conflict of interests.

Source: Anoop S et al. Diab Metab Syndr Clin Res Rev. 2021 Sep 4. doi: 10.1016/j.dsx.2021.102273.

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No impact of insulin resistance on FE-1 levels or rate of EPI in obese patients

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Key clinical point: Blood specimens from patients with chronic pancreatitis (CP) yielded a panel of 6 metabolites that showed differential expression with the presence or absence of exocrine pancreatic insufficiency (EPI;

Key clinical point: Presence of insulin resistance did not change the fecal elastase-1 (FE-1) levels or the rate of exocrine pancreatic insufficiency (EPI) in patients with obesity.

Major finding: Mean FE-1 levels (430.27 ± 207.63 vs. 508.64 ± 188.77; P = .119) and the rate of EPI (FE-1 < 200 mg/g; 25.7% vs. 10.0%; P = .104) were not significantly different in patients with or without insulin resistance.

Study details: Findings are from a retrospective analysis of 65 patients with obesity (body mass index, >30 kg/m2) with (n=35) or without (n=30) insulin resistance.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Uysal BB et al. Med Sci. 2021 Aug 23. doi: 10.5455/medscience.2021.05.164.

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Key clinical point: Blood specimens from patients with chronic pancreatitis (CP) yielded a panel of 6 metabolites that showed differential expression with the presence or absence of exocrine pancreatic insufficiency (EPI;

Key clinical point: Presence of insulin resistance did not change the fecal elastase-1 (FE-1) levels or the rate of exocrine pancreatic insufficiency (EPI) in patients with obesity.

Major finding: Mean FE-1 levels (430.27 ± 207.63 vs. 508.64 ± 188.77; P = .119) and the rate of EPI (FE-1 < 200 mg/g; 25.7% vs. 10.0%; P = .104) were not significantly different in patients with or without insulin resistance.

Study details: Findings are from a retrospective analysis of 65 patients with obesity (body mass index, >30 kg/m2) with (n=35) or without (n=30) insulin resistance.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Uysal BB et al. Med Sci. 2021 Aug 23. doi: 10.5455/medscience.2021.05.164.

Key clinical point: Blood specimens from patients with chronic pancreatitis (CP) yielded a panel of 6 metabolites that showed differential expression with the presence or absence of exocrine pancreatic insufficiency (EPI;

Key clinical point: Presence of insulin resistance did not change the fecal elastase-1 (FE-1) levels or the rate of exocrine pancreatic insufficiency (EPI) in patients with obesity.

Major finding: Mean FE-1 levels (430.27 ± 207.63 vs. 508.64 ± 188.77; P = .119) and the rate of EPI (FE-1 < 200 mg/g; 25.7% vs. 10.0%; P = .104) were not significantly different in patients with or without insulin resistance.

Study details: Findings are from a retrospective analysis of 65 patients with obesity (body mass index, >30 kg/m2) with (n=35) or without (n=30) insulin resistance.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Uysal BB et al. Med Sci. 2021 Aug 23. doi: 10.5455/medscience.2021.05.164.

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A 6-metabolite panel may help EPI diagnosis in chronic pancreatitis

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Key clinical point: Blood specimens from patients with chronic pancreatitis (CP) yielded a panel of 6 metabolites that showed differential expression with the presence or absence of exocrine pancreatic insufficiency (EPI; fecal elastase < 200 mg/g). Findings highlight the usefulness of metabolic studies to identify novel biomarkers for EPI diagnosis in CP.

Major finding: A 6-metabolite panel including arginine-proline-threonine tripeptide, 1 phosphatidylcholine, pentasine, and 3 phosphatidylserines was effective in discriminating between the presence and absence of EPI in patients with CP (area under the receiver operator characteristic curve, 0.79; 95% CI 0.62-0.92).

Study details: This metabolic study included 53 patients with CP with (60.4%) or without (39.6%) EPI.

Disclosures: This study was funded by grants from the Junta de Andalucia and the Instituto de Salud Carlos III. The authors declared no conflict of interests.

Source: Díaz C et al. Medicina. 2021 Aug 26. doi: 10.3390/medicina57090876.

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Key clinical point: Blood specimens from patients with chronic pancreatitis (CP) yielded a panel of 6 metabolites that showed differential expression with the presence or absence of exocrine pancreatic insufficiency (EPI; fecal elastase < 200 mg/g). Findings highlight the usefulness of metabolic studies to identify novel biomarkers for EPI diagnosis in CP.

Major finding: A 6-metabolite panel including arginine-proline-threonine tripeptide, 1 phosphatidylcholine, pentasine, and 3 phosphatidylserines was effective in discriminating between the presence and absence of EPI in patients with CP (area under the receiver operator characteristic curve, 0.79; 95% CI 0.62-0.92).

Study details: This metabolic study included 53 patients with CP with (60.4%) or without (39.6%) EPI.

Disclosures: This study was funded by grants from the Junta de Andalucia and the Instituto de Salud Carlos III. The authors declared no conflict of interests.

Source: Díaz C et al. Medicina. 2021 Aug 26. doi: 10.3390/medicina57090876.

Key clinical point: Blood specimens from patients with chronic pancreatitis (CP) yielded a panel of 6 metabolites that showed differential expression with the presence or absence of exocrine pancreatic insufficiency (EPI; fecal elastase < 200 mg/g). Findings highlight the usefulness of metabolic studies to identify novel biomarkers for EPI diagnosis in CP.

Major finding: A 6-metabolite panel including arginine-proline-threonine tripeptide, 1 phosphatidylcholine, pentasine, and 3 phosphatidylserines was effective in discriminating between the presence and absence of EPI in patients with CP (area under the receiver operator characteristic curve, 0.79; 95% CI 0.62-0.92).

Study details: This metabolic study included 53 patients with CP with (60.4%) or without (39.6%) EPI.

Disclosures: This study was funded by grants from the Junta de Andalucia and the Instituto de Salud Carlos III. The authors declared no conflict of interests.

Source: Díaz C et al. Medicina. 2021 Aug 26. doi: 10.3390/medicina57090876.

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Patients with CML may continue TKI treatment during COVID-19 pandemic

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Key clinical point: Prevalence of positive anti-SARS-CoV-2 antibodies was similar in chronic myeloid leukemia (CML) population and general populations in Italy and was not associated with the type of tyrosine kinase inhibitor (TKI) therapy or treatment-free remission (TFR) status, thereby reassuring the safe continuation of TKI treatment in patients with CML during the COVID-19 pandemic.

Major finding: The prevalence of SARS-CoV-2 infection was comparable in CML (1.95%; 95% CI 1.09-3.46) and general (2.5%) populations in Italy. Positive anti-SARS-CoV-2 serological test was not associated with the type of TKI treatment (P = .19) or TFR status (P = .40).

Study details: Findings are from a cross-sectional study including 564 adult patients with CML tested for anti-SARS-CoV-2 immunoglobulin (Ig)M and/or IgG antibodies.

Disclosures: This study was supported by Fondazione Cariverona (ENACT Project). The authors declared no conflict of interests.

 

Source: Bonifacio M et al. Cancer Med. 2021 Aug 31. doi: 10.1002/cam4.4179.

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Key clinical point: Prevalence of positive anti-SARS-CoV-2 antibodies was similar in chronic myeloid leukemia (CML) population and general populations in Italy and was not associated with the type of tyrosine kinase inhibitor (TKI) therapy or treatment-free remission (TFR) status, thereby reassuring the safe continuation of TKI treatment in patients with CML during the COVID-19 pandemic.

Major finding: The prevalence of SARS-CoV-2 infection was comparable in CML (1.95%; 95% CI 1.09-3.46) and general (2.5%) populations in Italy. Positive anti-SARS-CoV-2 serological test was not associated with the type of TKI treatment (P = .19) or TFR status (P = .40).

Study details: Findings are from a cross-sectional study including 564 adult patients with CML tested for anti-SARS-CoV-2 immunoglobulin (Ig)M and/or IgG antibodies.

Disclosures: This study was supported by Fondazione Cariverona (ENACT Project). The authors declared no conflict of interests.

 

Source: Bonifacio M et al. Cancer Med. 2021 Aug 31. doi: 10.1002/cam4.4179.

Key clinical point: Prevalence of positive anti-SARS-CoV-2 antibodies was similar in chronic myeloid leukemia (CML) population and general populations in Italy and was not associated with the type of tyrosine kinase inhibitor (TKI) therapy or treatment-free remission (TFR) status, thereby reassuring the safe continuation of TKI treatment in patients with CML during the COVID-19 pandemic.

Major finding: The prevalence of SARS-CoV-2 infection was comparable in CML (1.95%; 95% CI 1.09-3.46) and general (2.5%) populations in Italy. Positive anti-SARS-CoV-2 serological test was not associated with the type of TKI treatment (P = .19) or TFR status (P = .40).

Study details: Findings are from a cross-sectional study including 564 adult patients with CML tested for anti-SARS-CoV-2 immunoglobulin (Ig)M and/or IgG antibodies.

Disclosures: This study was supported by Fondazione Cariverona (ENACT Project). The authors declared no conflict of interests.

 

Source: Bonifacio M et al. Cancer Med. 2021 Aug 31. doi: 10.1002/cam4.4179.

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CML-CP: Imatinib discontinuation feasible in children with sustained DMR for at least 2 years

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Key clinical point: Imatinib discontinuation was feasible without affecting clinical outcomes in pediatric patients with chronic-phase chronic myeloid leukemia (CML-CP) treated with frontline imatinib with a sustained deep molecular response (DMR) for at least 2 years with imatinib.

Major finding: The molecular-free remission rate at 6, 12, and 36 months was 61%, 56%, and 56%, respectively. Of the 7 children who had a molecular relapse, 6 regained molecular response (MR) 4 and 1 patient achieved major MR after restarting imatinib. No deaths or disease progression were reported.

Study details: Findings are from a retrospective analysis of 18 children with CML-CP from the International Registry of Childhood CML who were treated with frontline imatinib and had sustained MR4 for at least 2 years before imatinib discontinuation to attempt treatment-free remission.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Millot F et al. Cancers. 2021 Aug 15. doi: 10.3390/cancers13164102.

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Key clinical point: Imatinib discontinuation was feasible without affecting clinical outcomes in pediatric patients with chronic-phase chronic myeloid leukemia (CML-CP) treated with frontline imatinib with a sustained deep molecular response (DMR) for at least 2 years with imatinib.

Major finding: The molecular-free remission rate at 6, 12, and 36 months was 61%, 56%, and 56%, respectively. Of the 7 children who had a molecular relapse, 6 regained molecular response (MR) 4 and 1 patient achieved major MR after restarting imatinib. No deaths or disease progression were reported.

Study details: Findings are from a retrospective analysis of 18 children with CML-CP from the International Registry of Childhood CML who were treated with frontline imatinib and had sustained MR4 for at least 2 years before imatinib discontinuation to attempt treatment-free remission.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Millot F et al. Cancers. 2021 Aug 15. doi: 10.3390/cancers13164102.

Key clinical point: Imatinib discontinuation was feasible without affecting clinical outcomes in pediatric patients with chronic-phase chronic myeloid leukemia (CML-CP) treated with frontline imatinib with a sustained deep molecular response (DMR) for at least 2 years with imatinib.

Major finding: The molecular-free remission rate at 6, 12, and 36 months was 61%, 56%, and 56%, respectively. Of the 7 children who had a molecular relapse, 6 regained molecular response (MR) 4 and 1 patient achieved major MR after restarting imatinib. No deaths or disease progression were reported.

Study details: Findings are from a retrospective analysis of 18 children with CML-CP from the International Registry of Childhood CML who were treated with frontline imatinib and had sustained MR4 for at least 2 years before imatinib discontinuation to attempt treatment-free remission.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Millot F et al. Cancers. 2021 Aug 15. doi: 10.3390/cancers13164102.

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Restarting TKI deteriorates functional outcomes in CML-CP patients in TFR

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Key clinical point: Improvements in patient-reported functional outcomes in patients with chronic-phase chronic myeloid leukemia (CML-CP) in treatment-free remission (TFR) deteriorated after restarting tyrosine kinase inhibitor (TKI).

Major finding: Among patients in TFR at 12 months, 92.0% had at least a 3-point improvement in social function, 71.4% in social isolation, 9.8% in sexual satisfaction, and 3.6% in physical function. No patients had at least a 3-point improvement in cognitive function or interest in sexual activity. All functional changes worsened after restarting TKI.

Study details: Findings are from the prospective LAST study including 172 adult patients with CML-CP attempting TFR after at least 3 years of treatment with a first- or second-generation TKI and at least 2 years in molecular response 4.

Disclosures: This study was supported by the National Cancer Institute at the National Institute of Health. The lead author reported research support from the American Society of Hematology. Some investigators reported ties with various pharmaceutical companies.

 

Source: Schoenbeck KL et al. J Natl Cancer Inst. 2021 Sep 7. doi: 10.1093/jnci/djab184.

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Key clinical point: Improvements in patient-reported functional outcomes in patients with chronic-phase chronic myeloid leukemia (CML-CP) in treatment-free remission (TFR) deteriorated after restarting tyrosine kinase inhibitor (TKI).

Major finding: Among patients in TFR at 12 months, 92.0% had at least a 3-point improvement in social function, 71.4% in social isolation, 9.8% in sexual satisfaction, and 3.6% in physical function. No patients had at least a 3-point improvement in cognitive function or interest in sexual activity. All functional changes worsened after restarting TKI.

Study details: Findings are from the prospective LAST study including 172 adult patients with CML-CP attempting TFR after at least 3 years of treatment with a first- or second-generation TKI and at least 2 years in molecular response 4.

Disclosures: This study was supported by the National Cancer Institute at the National Institute of Health. The lead author reported research support from the American Society of Hematology. Some investigators reported ties with various pharmaceutical companies.

 

Source: Schoenbeck KL et al. J Natl Cancer Inst. 2021 Sep 7. doi: 10.1093/jnci/djab184.

Key clinical point: Improvements in patient-reported functional outcomes in patients with chronic-phase chronic myeloid leukemia (CML-CP) in treatment-free remission (TFR) deteriorated after restarting tyrosine kinase inhibitor (TKI).

Major finding: Among patients in TFR at 12 months, 92.0% had at least a 3-point improvement in social function, 71.4% in social isolation, 9.8% in sexual satisfaction, and 3.6% in physical function. No patients had at least a 3-point improvement in cognitive function or interest in sexual activity. All functional changes worsened after restarting TKI.

Study details: Findings are from the prospective LAST study including 172 adult patients with CML-CP attempting TFR after at least 3 years of treatment with a first- or second-generation TKI and at least 2 years in molecular response 4.

Disclosures: This study was supported by the National Cancer Institute at the National Institute of Health. The lead author reported research support from the American Society of Hematology. Some investigators reported ties with various pharmaceutical companies.

 

Source: Schoenbeck KL et al. J Natl Cancer Inst. 2021 Sep 7. doi: 10.1093/jnci/djab184.

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