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Baricitinib demonstrates consistent long-term safety profile in RA
Key clinical point: Baricitinib maintained a stable safety profile with no new safety signals even with long-term exposure of up to 9.3 years in patients with active rheumatoid arthritis (RA).
Major finding: Incidence rates (IRs) per 100 patient-years at risk for serious infections (incidence ratio [IR], 2.6; 95% CI, 2.33-2.86), herpes zoster (IR, 3.0; 95% CI, 2.70-3.28), major adverse cardiovascular events (IR, 0.5; 95% CI, 0.40-0.64), and malignancies excluding nonmelanoma skin cancer (IR, 0.9; 95% CI, 0.77-1.09) remained stable from previous report.
Study details: This was an integrated analysis of 9 randomized clinical trials and 1 long-term extension trial including 3,770 patients with RA who received any dose of baricitinib.
Disclosures: Eli Lilly and Company funded this research. W Deberdt, M Issa, JR Terres, and N Bello reported being employees and stockholders of Eli Lilly and Company. The other authors reported receiving grant/research assistance and consultancy/speakers’ fees from various companies including Eli Lilly.
Source: Taylor PC et al. Ann Rheum Dis. 2021 Oct 27. doi: 10.1136/annrheumdis-2021-221276.
Key clinical point: Baricitinib maintained a stable safety profile with no new safety signals even with long-term exposure of up to 9.3 years in patients with active rheumatoid arthritis (RA).
Major finding: Incidence rates (IRs) per 100 patient-years at risk for serious infections (incidence ratio [IR], 2.6; 95% CI, 2.33-2.86), herpes zoster (IR, 3.0; 95% CI, 2.70-3.28), major adverse cardiovascular events (IR, 0.5; 95% CI, 0.40-0.64), and malignancies excluding nonmelanoma skin cancer (IR, 0.9; 95% CI, 0.77-1.09) remained stable from previous report.
Study details: This was an integrated analysis of 9 randomized clinical trials and 1 long-term extension trial including 3,770 patients with RA who received any dose of baricitinib.
Disclosures: Eli Lilly and Company funded this research. W Deberdt, M Issa, JR Terres, and N Bello reported being employees and stockholders of Eli Lilly and Company. The other authors reported receiving grant/research assistance and consultancy/speakers’ fees from various companies including Eli Lilly.
Source: Taylor PC et al. Ann Rheum Dis. 2021 Oct 27. doi: 10.1136/annrheumdis-2021-221276.
Key clinical point: Baricitinib maintained a stable safety profile with no new safety signals even with long-term exposure of up to 9.3 years in patients with active rheumatoid arthritis (RA).
Major finding: Incidence rates (IRs) per 100 patient-years at risk for serious infections (incidence ratio [IR], 2.6; 95% CI, 2.33-2.86), herpes zoster (IR, 3.0; 95% CI, 2.70-3.28), major adverse cardiovascular events (IR, 0.5; 95% CI, 0.40-0.64), and malignancies excluding nonmelanoma skin cancer (IR, 0.9; 95% CI, 0.77-1.09) remained stable from previous report.
Study details: This was an integrated analysis of 9 randomized clinical trials and 1 long-term extension trial including 3,770 patients with RA who received any dose of baricitinib.
Disclosures: Eli Lilly and Company funded this research. W Deberdt, M Issa, JR Terres, and N Bello reported being employees and stockholders of Eli Lilly and Company. The other authors reported receiving grant/research assistance and consultancy/speakers’ fees from various companies including Eli Lilly.
Source: Taylor PC et al. Ann Rheum Dis. 2021 Oct 27. doi: 10.1136/annrheumdis-2021-221276.
RA: bDMARD monotherapy may accelerate radiographic progression of preexisting distal hand osteoarthritis
Key clinical point: Biological disease-modifying antirheumatic drug (bDMARD) monotherapy may increase the risk for progression of preexisting distal interphalangeal (DIP) osteoarthritis in patients with rheumatoid arthritis (RA), primarily by promoting osteophyte growth.
Major finding: Compared with conventional synthetic DMARD (csDMARD) monotherapy, bDMARD monotherapy was associated with an increased risk for radiographic progression of existing DIP osteoarthritis (adjusted hazard ratio [aHR], 1.34; 95% CI, 1.07-1.69), with osteophyte progression (aHR, 1.74; 95% CI, 1.11-2.74) being the most elevated osteoarthritis feature with bDMARD vs. csDMARD use.
Study details: This study included 2,234 adult patients with RA from a longitudinal Swiss registry of rheumatic diseases, who had at least 2 hand radiographs and were grouped into cohorts with (n=1,340) or without (n=894) DIP osteoarthritis at baseline.
Disclosures: This study was sponsored by pharmaceutical companies like AbbVie, Amgen, and Gilead. All the authors declared no conflict of interests.
Source: Lechtenboehmer CA et al. Arthritis Res Ther. 2021 Oct 26. doi: 10.1186/s13075-021-02654-0.
Key clinical point: Biological disease-modifying antirheumatic drug (bDMARD) monotherapy may increase the risk for progression of preexisting distal interphalangeal (DIP) osteoarthritis in patients with rheumatoid arthritis (RA), primarily by promoting osteophyte growth.
Major finding: Compared with conventional synthetic DMARD (csDMARD) monotherapy, bDMARD monotherapy was associated with an increased risk for radiographic progression of existing DIP osteoarthritis (adjusted hazard ratio [aHR], 1.34; 95% CI, 1.07-1.69), with osteophyte progression (aHR, 1.74; 95% CI, 1.11-2.74) being the most elevated osteoarthritis feature with bDMARD vs. csDMARD use.
Study details: This study included 2,234 adult patients with RA from a longitudinal Swiss registry of rheumatic diseases, who had at least 2 hand radiographs and were grouped into cohorts with (n=1,340) or without (n=894) DIP osteoarthritis at baseline.
Disclosures: This study was sponsored by pharmaceutical companies like AbbVie, Amgen, and Gilead. All the authors declared no conflict of interests.
Source: Lechtenboehmer CA et al. Arthritis Res Ther. 2021 Oct 26. doi: 10.1186/s13075-021-02654-0.
Key clinical point: Biological disease-modifying antirheumatic drug (bDMARD) monotherapy may increase the risk for progression of preexisting distal interphalangeal (DIP) osteoarthritis in patients with rheumatoid arthritis (RA), primarily by promoting osteophyte growth.
Major finding: Compared with conventional synthetic DMARD (csDMARD) monotherapy, bDMARD monotherapy was associated with an increased risk for radiographic progression of existing DIP osteoarthritis (adjusted hazard ratio [aHR], 1.34; 95% CI, 1.07-1.69), with osteophyte progression (aHR, 1.74; 95% CI, 1.11-2.74) being the most elevated osteoarthritis feature with bDMARD vs. csDMARD use.
Study details: This study included 2,234 adult patients with RA from a longitudinal Swiss registry of rheumatic diseases, who had at least 2 hand radiographs and were grouped into cohorts with (n=1,340) or without (n=894) DIP osteoarthritis at baseline.
Disclosures: This study was sponsored by pharmaceutical companies like AbbVie, Amgen, and Gilead. All the authors declared no conflict of interests.
Source: Lechtenboehmer CA et al. Arthritis Res Ther. 2021 Oct 26. doi: 10.1186/s13075-021-02654-0.
No risk of increased flare after 2 doses of COVID-19 vaccination in RA
Key clinical point: Patients with rheumatoid arthritis (RA) did not show an increased risk for arthritis flare after completing 2 doses of mRNA (BNT162b2) or inactivated virus (CoronaVac) COVID-19 vaccination.
Major finding: There was no association between receiving 2 doses of mRNA vaccine (adjusted incidence rate ratio [aIRR], 0.86; 95% CI, 0.73-1.01) or inactivated virus vaccine (aIRR, 0.87; 95% CI, 0.74-1.02) and experiencing arthritis flares. The per-patient prescription and distribution of rheumatic drug prescriptions were similar for vaccinated and nonvaccinated patients (P > .1).
Study details: Findings are from a retrospective cohort study including 5,493 patients with RA, of which 653 patients received mRNA vaccine, 671 patients received inactivated virus vaccine, and the remaining were nonvaccinated.
Disclosures: This study was funded by the Food and Health Bureau (FHB), Hong Kong. The authors declared receiving research grants, consultancy fees, postdoctoral fellowship, speaker fees, and/ or honorarium from various sources including FHB.
Source: Li X et al. Ann Rheum Dis. 2021 Oct 22. doi: 10.1136/annrheumdis-2021-221571.
Key clinical point: Patients with rheumatoid arthritis (RA) did not show an increased risk for arthritis flare after completing 2 doses of mRNA (BNT162b2) or inactivated virus (CoronaVac) COVID-19 vaccination.
Major finding: There was no association between receiving 2 doses of mRNA vaccine (adjusted incidence rate ratio [aIRR], 0.86; 95% CI, 0.73-1.01) or inactivated virus vaccine (aIRR, 0.87; 95% CI, 0.74-1.02) and experiencing arthritis flares. The per-patient prescription and distribution of rheumatic drug prescriptions were similar for vaccinated and nonvaccinated patients (P > .1).
Study details: Findings are from a retrospective cohort study including 5,493 patients with RA, of which 653 patients received mRNA vaccine, 671 patients received inactivated virus vaccine, and the remaining were nonvaccinated.
Disclosures: This study was funded by the Food and Health Bureau (FHB), Hong Kong. The authors declared receiving research grants, consultancy fees, postdoctoral fellowship, speaker fees, and/ or honorarium from various sources including FHB.
Source: Li X et al. Ann Rheum Dis. 2021 Oct 22. doi: 10.1136/annrheumdis-2021-221571.
Key clinical point: Patients with rheumatoid arthritis (RA) did not show an increased risk for arthritis flare after completing 2 doses of mRNA (BNT162b2) or inactivated virus (CoronaVac) COVID-19 vaccination.
Major finding: There was no association between receiving 2 doses of mRNA vaccine (adjusted incidence rate ratio [aIRR], 0.86; 95% CI, 0.73-1.01) or inactivated virus vaccine (aIRR, 0.87; 95% CI, 0.74-1.02) and experiencing arthritis flares. The per-patient prescription and distribution of rheumatic drug prescriptions were similar for vaccinated and nonvaccinated patients (P > .1).
Study details: Findings are from a retrospective cohort study including 5,493 patients with RA, of which 653 patients received mRNA vaccine, 671 patients received inactivated virus vaccine, and the remaining were nonvaccinated.
Disclosures: This study was funded by the Food and Health Bureau (FHB), Hong Kong. The authors declared receiving research grants, consultancy fees, postdoctoral fellowship, speaker fees, and/ or honorarium from various sources including FHB.
Source: Li X et al. Ann Rheum Dis. 2021 Oct 22. doi: 10.1136/annrheumdis-2021-221571.
ANKRD36: A novel biomarker of CML disease progression
Key clinical point: Mutations in a novel gene ANKRD36 were associated with disease progression in chronic myeloid leukemia (CML) and may help identify patients at risk of disease progression.
Major finding: Mutations in the ANKRD36 gene (c.1183_1184 delGC and c.1187_1188 dupTT) were exclusively found in all patients with CML in blast crisis (CML-BC) and accelerated phase (CML-AP) but not in those with chronic-phase CML (CML-CP) and healthy controls.
Study details: This study included 141 patients with either CML-CP (n = 123), CML-AP (n = 6), or CML-BC (n = 12) and 10 age- and gender-matched healthy controls.
Disclosures: This study was funded by the National Plan for Science, Technology and Innovation, King Abdul-Aziz City for Science and Technology, Kingdom of Saudi Arabia. The authors declared no conflict of interests.
Source: Iqbal Z et al. Biology. 2021;10(11):1182 (Nov 15). Doi: 10.3390/biology10111182.
Key clinical point: Mutations in a novel gene ANKRD36 were associated with disease progression in chronic myeloid leukemia (CML) and may help identify patients at risk of disease progression.
Major finding: Mutations in the ANKRD36 gene (c.1183_1184 delGC and c.1187_1188 dupTT) were exclusively found in all patients with CML in blast crisis (CML-BC) and accelerated phase (CML-AP) but not in those with chronic-phase CML (CML-CP) and healthy controls.
Study details: This study included 141 patients with either CML-CP (n = 123), CML-AP (n = 6), or CML-BC (n = 12) and 10 age- and gender-matched healthy controls.
Disclosures: This study was funded by the National Plan for Science, Technology and Innovation, King Abdul-Aziz City for Science and Technology, Kingdom of Saudi Arabia. The authors declared no conflict of interests.
Source: Iqbal Z et al. Biology. 2021;10(11):1182 (Nov 15). Doi: 10.3390/biology10111182.
Key clinical point: Mutations in a novel gene ANKRD36 were associated with disease progression in chronic myeloid leukemia (CML) and may help identify patients at risk of disease progression.
Major finding: Mutations in the ANKRD36 gene (c.1183_1184 delGC and c.1187_1188 dupTT) were exclusively found in all patients with CML in blast crisis (CML-BC) and accelerated phase (CML-AP) but not in those with chronic-phase CML (CML-CP) and healthy controls.
Study details: This study included 141 patients with either CML-CP (n = 123), CML-AP (n = 6), or CML-BC (n = 12) and 10 age- and gender-matched healthy controls.
Disclosures: This study was funded by the National Plan for Science, Technology and Innovation, King Abdul-Aziz City for Science and Technology, Kingdom of Saudi Arabia. The authors declared no conflict of interests.
Source: Iqbal Z et al. Biology. 2021;10(11):1182 (Nov 15). Doi: 10.3390/biology10111182.
Factors affecting HRQoL in children with CML-CP on TKI therapy
Key clinical point: Female sex, tyrosine kinase inhibitor (TKI) therapy-related symptoms, older age at diagnosis, younger age at the time of the study, and low maternal education were associated with worse health-related quality of life (HRQoL) in children with chronic-phase chronic myeloid leukemia (CML-CP) receiving TKI therapy.
Major finding: Worse HRQoL was observed in children with symptoms (P < .001), children with mothers having low educational qualifications (P = .005), children at a younger age at the time of the study (P = .008), children with older age at the time of diagnosis (P = .007), and female children (P = .038).
Study details: Findings are from a cross-sectional study of 240 respondents including children with CML-CP (age < 18 years at diagnosis) receiving TKI therapy and whose parents responded to a cross-sectional questionnaire.
Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflict of interests.
Source: Zheng F et al. J Cancer Res Clin Oncol. 2021(Oct 29). Doi: 10.1007/s00432-021-03832-y.
Key clinical point: Female sex, tyrosine kinase inhibitor (TKI) therapy-related symptoms, older age at diagnosis, younger age at the time of the study, and low maternal education were associated with worse health-related quality of life (HRQoL) in children with chronic-phase chronic myeloid leukemia (CML-CP) receiving TKI therapy.
Major finding: Worse HRQoL was observed in children with symptoms (P < .001), children with mothers having low educational qualifications (P = .005), children at a younger age at the time of the study (P = .008), children with older age at the time of diagnosis (P = .007), and female children (P = .038).
Study details: Findings are from a cross-sectional study of 240 respondents including children with CML-CP (age < 18 years at diagnosis) receiving TKI therapy and whose parents responded to a cross-sectional questionnaire.
Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflict of interests.
Source: Zheng F et al. J Cancer Res Clin Oncol. 2021(Oct 29). Doi: 10.1007/s00432-021-03832-y.
Key clinical point: Female sex, tyrosine kinase inhibitor (TKI) therapy-related symptoms, older age at diagnosis, younger age at the time of the study, and low maternal education were associated with worse health-related quality of life (HRQoL) in children with chronic-phase chronic myeloid leukemia (CML-CP) receiving TKI therapy.
Major finding: Worse HRQoL was observed in children with symptoms (P < .001), children with mothers having low educational qualifications (P = .005), children at a younger age at the time of the study (P = .008), children with older age at the time of diagnosis (P = .007), and female children (P = .038).
Study details: Findings are from a cross-sectional study of 240 respondents including children with CML-CP (age < 18 years at diagnosis) receiving TKI therapy and whose parents responded to a cross-sectional questionnaire.
Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflict of interests.
Source: Zheng F et al. J Cancer Res Clin Oncol. 2021(Oct 29). Doi: 10.1007/s00432-021-03832-y.
Better clinical outcomes with adjuvant IFN therapy vs. adjuvant vaccine in TKI-treated patients with CML-CP
Key clinical point: Adjuvant therapy with interferon-a+sargramostim (IFN) vs. K562/granulocyte macrophage-colony stimulating factor (GM-CSF) vaccine led to better molecular responses with sustained treatment-free remission (TFR) in tyrosine kinase inhibitor (TKI)-treated patients with chronic-phase chronic myeloid leukemia (CML-CP).
Major finding: Patients receiving IFN vs. K562/GM-CSF vaccine had a higher rate of undetectable minimal residual disease at 1 year (47.4%; 95% CI 16.7%-66.7% vs. 25%; 95% CI 0.5%-43.5%). TFR was maintained by 36.6% vs. 0.0% of patients receiving IFN vs. K562/GM-CSF vaccine. Treatment discontinuation because of side effects was higher in IFN-treated patients.
Study details: Findings are from a phase 2 trial including 34 adult patients with CML-CP receiving stable dosing of frontline TKI therapy for ≥1 year with a complete cytogenic response who were randomly assigned to IFN or K562/GM-CSF vaccine.
Disclosures: This study was supported by grants from US National Institute of Health. The authors declared no conflict of interests.
Source: Webster JA et al. Leuk Res. 2021;111:106737 (Nov 2). Doi: 10.1016/j.leukres.2021.106737.
Key clinical point: Adjuvant therapy with interferon-a+sargramostim (IFN) vs. K562/granulocyte macrophage-colony stimulating factor (GM-CSF) vaccine led to better molecular responses with sustained treatment-free remission (TFR) in tyrosine kinase inhibitor (TKI)-treated patients with chronic-phase chronic myeloid leukemia (CML-CP).
Major finding: Patients receiving IFN vs. K562/GM-CSF vaccine had a higher rate of undetectable minimal residual disease at 1 year (47.4%; 95% CI 16.7%-66.7% vs. 25%; 95% CI 0.5%-43.5%). TFR was maintained by 36.6% vs. 0.0% of patients receiving IFN vs. K562/GM-CSF vaccine. Treatment discontinuation because of side effects was higher in IFN-treated patients.
Study details: Findings are from a phase 2 trial including 34 adult patients with CML-CP receiving stable dosing of frontline TKI therapy for ≥1 year with a complete cytogenic response who were randomly assigned to IFN or K562/GM-CSF vaccine.
Disclosures: This study was supported by grants from US National Institute of Health. The authors declared no conflict of interests.
Source: Webster JA et al. Leuk Res. 2021;111:106737 (Nov 2). Doi: 10.1016/j.leukres.2021.106737.
Key clinical point: Adjuvant therapy with interferon-a+sargramostim (IFN) vs. K562/granulocyte macrophage-colony stimulating factor (GM-CSF) vaccine led to better molecular responses with sustained treatment-free remission (TFR) in tyrosine kinase inhibitor (TKI)-treated patients with chronic-phase chronic myeloid leukemia (CML-CP).
Major finding: Patients receiving IFN vs. K562/GM-CSF vaccine had a higher rate of undetectable minimal residual disease at 1 year (47.4%; 95% CI 16.7%-66.7% vs. 25%; 95% CI 0.5%-43.5%). TFR was maintained by 36.6% vs. 0.0% of patients receiving IFN vs. K562/GM-CSF vaccine. Treatment discontinuation because of side effects was higher in IFN-treated patients.
Study details: Findings are from a phase 2 trial including 34 adult patients with CML-CP receiving stable dosing of frontline TKI therapy for ≥1 year with a complete cytogenic response who were randomly assigned to IFN or K562/GM-CSF vaccine.
Disclosures: This study was supported by grants from US National Institute of Health. The authors declared no conflict of interests.
Source: Webster JA et al. Leuk Res. 2021;111:106737 (Nov 2). Doi: 10.1016/j.leukres.2021.106737.
Statins enhance molecular response rates in imatinib-treated patients with CML-CP
Key clinical point: Statin use alongside imatinib therapy significantly improved deep molecular response (DMR) and major molecular response (MMR) in patients with chronic-phase chronic myeloid leukemia (CML-CP).
Major finding: Imatinib-treated patients receiving statins had higher rates of DMR (55.8% vs. 41.0%; P = .0016) and MMR (56.8% vs. 47.0%; P = .0048) at 5 years than those not receiving statins. Concomitant statin use was independently associated with DMR (hazard ratio [HR] 1.785; P = .001) and MMR (HR 1.541; P = .043).
Study details: Findings are from a retrospective analysis of 408 patients with CML-CP receiving imatinib therapy with (n = 88) or without (n = 320) statins.
Disclosures: This study was supported by a National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflict of interests.
Source: Jang HJ et al. Cancers. 2021;13(21):5543 (Nov 4). Doi: 10.3390/cancers13215543.
Key clinical point: Statin use alongside imatinib therapy significantly improved deep molecular response (DMR) and major molecular response (MMR) in patients with chronic-phase chronic myeloid leukemia (CML-CP).
Major finding: Imatinib-treated patients receiving statins had higher rates of DMR (55.8% vs. 41.0%; P = .0016) and MMR (56.8% vs. 47.0%; P = .0048) at 5 years than those not receiving statins. Concomitant statin use was independently associated with DMR (hazard ratio [HR] 1.785; P = .001) and MMR (HR 1.541; P = .043).
Study details: Findings are from a retrospective analysis of 408 patients with CML-CP receiving imatinib therapy with (n = 88) or without (n = 320) statins.
Disclosures: This study was supported by a National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflict of interests.
Source: Jang HJ et al. Cancers. 2021;13(21):5543 (Nov 4). Doi: 10.3390/cancers13215543.
Key clinical point: Statin use alongside imatinib therapy significantly improved deep molecular response (DMR) and major molecular response (MMR) in patients with chronic-phase chronic myeloid leukemia (CML-CP).
Major finding: Imatinib-treated patients receiving statins had higher rates of DMR (55.8% vs. 41.0%; P = .0016) and MMR (56.8% vs. 47.0%; P = .0048) at 5 years than those not receiving statins. Concomitant statin use was independently associated with DMR (hazard ratio [HR] 1.785; P = .001) and MMR (HR 1.541; P = .043).
Study details: Findings are from a retrospective analysis of 408 patients with CML-CP receiving imatinib therapy with (n = 88) or without (n = 320) statins.
Disclosures: This study was supported by a National Research Foundation of Korea grant funded by the Korean government. The authors declared no conflict of interests.
Source: Jang HJ et al. Cancers. 2021;13(21):5543 (Nov 4). Doi: 10.3390/cancers13215543.
Identification of mutations by ultra-deep sequencing may help predict nilotinib response in CML-CP patients
Key clinical point: Ultra-deep sequencing identified genetic mutations of the BCR/ABL1 tyrosine kinase domain in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukemia (CML-CP) receiving nilotinib that could have prognostic implications in predicting molecular response (MR) duration.
Major finding: V299 L mutation associated with dasatinib resistance and nilotinib sensitivity was observed in 98% of patients. Of all the detected mutations, only V371A mutation vs. no mutation was associated with shorter sustained major MR for 2 years (75% vs. 100%; P = .039) and sustained MR 4.5 for 15 months (25.0% vs. 94.1%; P = .002).
Study details: Findings are from a prospective analysis of 50 patients with newly diagnosed Ph+ CML-CP undergoing first-line nilotinib therapy.
Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors declared no conflict of interests.
Source: Park H et al. Leuk Res. 2021;111:106728 (Oct 15).Doi: 10.1016/j.leukres.2021.106728.
Key clinical point: Ultra-deep sequencing identified genetic mutations of the BCR/ABL1 tyrosine kinase domain in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukemia (CML-CP) receiving nilotinib that could have prognostic implications in predicting molecular response (MR) duration.
Major finding: V299 L mutation associated with dasatinib resistance and nilotinib sensitivity was observed in 98% of patients. Of all the detected mutations, only V371A mutation vs. no mutation was associated with shorter sustained major MR for 2 years (75% vs. 100%; P = .039) and sustained MR 4.5 for 15 months (25.0% vs. 94.1%; P = .002).
Study details: Findings are from a prospective analysis of 50 patients with newly diagnosed Ph+ CML-CP undergoing first-line nilotinib therapy.
Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors declared no conflict of interests.
Source: Park H et al. Leuk Res. 2021;111:106728 (Oct 15).Doi: 10.1016/j.leukres.2021.106728.
Key clinical point: Ultra-deep sequencing identified genetic mutations of the BCR/ABL1 tyrosine kinase domain in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukemia (CML-CP) receiving nilotinib that could have prognostic implications in predicting molecular response (MR) duration.
Major finding: V299 L mutation associated with dasatinib resistance and nilotinib sensitivity was observed in 98% of patients. Of all the detected mutations, only V371A mutation vs. no mutation was associated with shorter sustained major MR for 2 years (75% vs. 100%; P = .039) and sustained MR 4.5 for 15 months (25.0% vs. 94.1%; P = .002).
Study details: Findings are from a prospective analysis of 50 patients with newly diagnosed Ph+ CML-CP undergoing first-line nilotinib therapy.
Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors declared no conflict of interests.
Source: Park H et al. Leuk Res. 2021;111:106728 (Oct 15).Doi: 10.1016/j.leukres.2021.106728.
Routine monitoring of imatinib plasma levels may help decide clinical course in CML
Key clinical point: Monitoring routine plasma levels of imatinib may help optimize treatment dosage, thereby enabling treatment individualization and improving clinical outcomes in patients with chronic myeloid leukemia (CML).
Major finding: Only 39.3% patients showed minimum imatinib plasma concentrations measured at steady state (Cssmin) within therapeutic range (750-1500 ng/mL). Optimal molecular response was achieved by 100% vs. 50% of patients with Cssmin ≥750 ng/mL vs. <750 ng/mL (P = .0004). The rate of toxicity was higher in patients with Cssmin >1500 ng/mL vs. ≤1500 ng/mL (36.4% vs. 5.9%; P = .039).
Study details: This cross-sectional study included 28 patients with CML treated with imatinib for >1 month.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Del Rosario García B et al. J Oncol Pharm Pract. 2021 (Oct 18). Doi: 10.1177/10781552211052535.
Key clinical point: Monitoring routine plasma levels of imatinib may help optimize treatment dosage, thereby enabling treatment individualization and improving clinical outcomes in patients with chronic myeloid leukemia (CML).
Major finding: Only 39.3% patients showed minimum imatinib plasma concentrations measured at steady state (Cssmin) within therapeutic range (750-1500 ng/mL). Optimal molecular response was achieved by 100% vs. 50% of patients with Cssmin ≥750 ng/mL vs. <750 ng/mL (P = .0004). The rate of toxicity was higher in patients with Cssmin >1500 ng/mL vs. ≤1500 ng/mL (36.4% vs. 5.9%; P = .039).
Study details: This cross-sectional study included 28 patients with CML treated with imatinib for >1 month.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Del Rosario García B et al. J Oncol Pharm Pract. 2021 (Oct 18). Doi: 10.1177/10781552211052535.
Key clinical point: Monitoring routine plasma levels of imatinib may help optimize treatment dosage, thereby enabling treatment individualization and improving clinical outcomes in patients with chronic myeloid leukemia (CML).
Major finding: Only 39.3% patients showed minimum imatinib plasma concentrations measured at steady state (Cssmin) within therapeutic range (750-1500 ng/mL). Optimal molecular response was achieved by 100% vs. 50% of patients with Cssmin ≥750 ng/mL vs. <750 ng/mL (P = .0004). The rate of toxicity was higher in patients with Cssmin >1500 ng/mL vs. ≤1500 ng/mL (36.4% vs. 5.9%; P = .039).
Study details: This cross-sectional study included 28 patients with CML treated with imatinib for >1 month.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Del Rosario García B et al. J Oncol Pharm Pract. 2021 (Oct 18). Doi: 10.1177/10781552211052535.
Suboptimal adherence to oral anticancer medication in CML patients
Key clinical point: Suboptimal adherence to oral anticancer (OAC) agents was observed among patients with chronic myeloid leukemia (CML), highlighting the need for implementation of personalized counseling to address the risk for nonadherence and enhance treatment outcomes.
Major finding: Almost 17.9% of participants reported nonadherence, i.e., missing at least 1 dose of CML medication in the previous week. Patients who missed at least 1 vs. 0 doses in the last 7 days reported that medication was somewhat to very hard to take (50.0% vs. 18.6%; P = .008) or they missed doses because of side effects (50.0% vs. 11.4%; P = .001) or busy schedule (37.5% vs. 2.9%; P = .004).
Study details: This study included 86 adult patients with CML with a prescription of OAC agents (imatinib, nilotinib, dasatinib, bosutinib, or ponatinib) for at least 30 days.
Disclosures: This study was funded by grants from the National Cancer Institute and partly by the Institute of General Medical Sciences of the National Institutes of Health. The authors declared no conflict of interests.
Source: Davis TC et al. Int J Environ Res Public Health. 2021;18(21):11045 (Oct 21). Doi: 10.3390/ijerph182111045.
Key clinical point: Suboptimal adherence to oral anticancer (OAC) agents was observed among patients with chronic myeloid leukemia (CML), highlighting the need for implementation of personalized counseling to address the risk for nonadherence and enhance treatment outcomes.
Major finding: Almost 17.9% of participants reported nonadherence, i.e., missing at least 1 dose of CML medication in the previous week. Patients who missed at least 1 vs. 0 doses in the last 7 days reported that medication was somewhat to very hard to take (50.0% vs. 18.6%; P = .008) or they missed doses because of side effects (50.0% vs. 11.4%; P = .001) or busy schedule (37.5% vs. 2.9%; P = .004).
Study details: This study included 86 adult patients with CML with a prescription of OAC agents (imatinib, nilotinib, dasatinib, bosutinib, or ponatinib) for at least 30 days.
Disclosures: This study was funded by grants from the National Cancer Institute and partly by the Institute of General Medical Sciences of the National Institutes of Health. The authors declared no conflict of interests.
Source: Davis TC et al. Int J Environ Res Public Health. 2021;18(21):11045 (Oct 21). Doi: 10.3390/ijerph182111045.
Key clinical point: Suboptimal adherence to oral anticancer (OAC) agents was observed among patients with chronic myeloid leukemia (CML), highlighting the need for implementation of personalized counseling to address the risk for nonadherence and enhance treatment outcomes.
Major finding: Almost 17.9% of participants reported nonadherence, i.e., missing at least 1 dose of CML medication in the previous week. Patients who missed at least 1 vs. 0 doses in the last 7 days reported that medication was somewhat to very hard to take (50.0% vs. 18.6%; P = .008) or they missed doses because of side effects (50.0% vs. 11.4%; P = .001) or busy schedule (37.5% vs. 2.9%; P = .004).
Study details: This study included 86 adult patients with CML with a prescription of OAC agents (imatinib, nilotinib, dasatinib, bosutinib, or ponatinib) for at least 30 days.
Disclosures: This study was funded by grants from the National Cancer Institute and partly by the Institute of General Medical Sciences of the National Institutes of Health. The authors declared no conflict of interests.
Source: Davis TC et al. Int J Environ Res Public Health. 2021;18(21):11045 (Oct 21). Doi: 10.3390/ijerph182111045.