Clinical Edge Journal Scan

Key clinical point: Patients with psoriatic arthritis (PsA) have higher adiposity and lower lean mass than healthy controls. Treatment with ustekinumab for 6-months decreased total lean mass slightly with no significant change in body composition.

Major finding: Patients with PsA had significantly lower total (P = .013) and appendicular (P = .010) lean mass and a significantly higher total fat mass and body fat percentage (both, P less than .001) compared with matched controls. After 6 months of ustekinumab treatment, total lean mass decreased significantly (P = .046) with no significant changes in body mass index.

Study details: This was a cross-sectional analysis of patients with established PsA (n=30) and matched non-PsA healthy controls (n=60). Patients with PsA who subsequently initiated ustekinumab were enrolled in a 6-month open-label follow-up study.

Disclosures: This study received an unrestricted grant from Janssen France. The authors declared no conflicts of interest.

Source: Paccou J et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24623.

Key clinical point: Patients with psoriatic arthritis (PsA) have higher adiposity and lower lean mass than healthy controls. Treatment with ustekinumab for 6-months decreased total lean mass slightly with no significant change in body composition.

Major finding: Patients with PsA had significantly lower total (P = .013) and appendicular (P = .010) lean mass and a significantly higher total fat mass and body fat percentage (both, P less than .001) compared with matched controls. After 6 months of ustekinumab treatment, total lean mass decreased significantly (P = .046) with no significant changes in body mass index.

Study details: This was a cross-sectional analysis of patients with established PsA (n=30) and matched non-PsA healthy controls (n=60). Patients with PsA who subsequently initiated ustekinumab were enrolled in a 6-month open-label follow-up study.

Disclosures: This study received an unrestricted grant from Janssen France. The authors declared no conflicts of interest.

Source: Paccou J et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24623.

Key clinical point: Patients with psoriatic arthritis (PsA) have higher adiposity and lower lean mass than healthy controls. Treatment with ustekinumab for 6-months decreased total lean mass slightly with no significant change in body composition.

Major finding: Patients with PsA had significantly lower total (P = .013) and appendicular (P = .010) lean mass and a significantly higher total fat mass and body fat percentage (both, P less than .001) compared with matched controls. After 6 months of ustekinumab treatment, total lean mass decreased significantly (P = .046) with no significant changes in body mass index.

Study details: This was a cross-sectional analysis of patients with established PsA (n=30) and matched non-PsA healthy controls (n=60). Patients with PsA who subsequently initiated ustekinumab were enrolled in a 6-month open-label follow-up study.

Disclosures: This study received an unrestricted grant from Janssen France. The authors declared no conflicts of interest.

Source: Paccou J et al. Arthritis Care Res (Hoboken). 2021 May 10. doi: 10.1002/acr.24623.

Key clinical point: Interleukin 17A inhibitor, secukinumab provides a comprehensive biologic treatment profile for management of concomitant features of psoriasis and psoriatic arthritis (PsA).

Major finding: At 52 weeks, the proportion of patients who achieved 20% or more improvement in the American College of Rheumatology response criteria was not significantly different between secukinumab and adalimumab (76.4% vs. 68.3%; P = .1752) groups. Psoriasis Area and Severity Index 90 response was higher with secukinumab vs. adalimumab (68.6% vs. 41.7%; P less than .0001).

Study details: Findings are from a prespecified analysis of 853 patients with active PsA having concomitant moderate-to-severe plaque psoriasis from phase 3b EXCEED study. Patients were randomly allocated to either subcutaneous secukinumab 300 mg (n=426) or adalimumab 40 mg (n=427).

Disclosures: EXCEED trial was funded by Novartis Pharma AG, Basel, Switzerland. The authors including the lead author reported receiving research/educational grants, consulting/speaker fees, and/or honoraria from various sources including Novartis. Three of the authors reported being employees and shareholders of Novartis.

Source: Gottlieb AB et al. Br J Dermatol. 2021 Apr 29. doi: 10.1111/bjd.20413.

Key clinical point: Interleukin 17A inhibitor, secukinumab provides a comprehensive biologic treatment profile for management of concomitant features of psoriasis and psoriatic arthritis (PsA).

Major finding: At 52 weeks, the proportion of patients who achieved 20% or more improvement in the American College of Rheumatology response criteria was not significantly different between secukinumab and adalimumab (76.4% vs. 68.3%; P = .1752) groups. Psoriasis Area and Severity Index 90 response was higher with secukinumab vs. adalimumab (68.6% vs. 41.7%; P less than .0001).

Study details: Findings are from a prespecified analysis of 853 patients with active PsA having concomitant moderate-to-severe plaque psoriasis from phase 3b EXCEED study. Patients were randomly allocated to either subcutaneous secukinumab 300 mg (n=426) or adalimumab 40 mg (n=427).

Disclosures: EXCEED trial was funded by Novartis Pharma AG, Basel, Switzerland. The authors including the lead author reported receiving research/educational grants, consulting/speaker fees, and/or honoraria from various sources including Novartis. Three of the authors reported being employees and shareholders of Novartis.

Source: Gottlieb AB et al. Br J Dermatol. 2021 Apr 29. doi: 10.1111/bjd.20413.

Key clinical point: Interleukin 17A inhibitor, secukinumab provides a comprehensive biologic treatment profile for management of concomitant features of psoriasis and psoriatic arthritis (PsA).

Major finding: At 52 weeks, the proportion of patients who achieved 20% or more improvement in the American College of Rheumatology response criteria was not significantly different between secukinumab and adalimumab (76.4% vs. 68.3%; P = .1752) groups. Psoriasis Area and Severity Index 90 response was higher with secukinumab vs. adalimumab (68.6% vs. 41.7%; P less than .0001).

Study details: Findings are from a prespecified analysis of 853 patients with active PsA having concomitant moderate-to-severe plaque psoriasis from phase 3b EXCEED study. Patients were randomly allocated to either subcutaneous secukinumab 300 mg (n=426) or adalimumab 40 mg (n=427).

Disclosures: EXCEED trial was funded by Novartis Pharma AG, Basel, Switzerland. The authors including the lead author reported receiving research/educational grants, consulting/speaker fees, and/or honoraria from various sources including Novartis. Three of the authors reported being employees and shareholders of Novartis.

Source: Gottlieb AB et al. Br J Dermatol. 2021 Apr 29. doi: 10.1111/bjd.20413.

Key clinical point: Guselkumab 100 mg every 4 weeks (Q4W) and every 8 weeks (Q8W) was well tolerated in patients with psoriatic arthritis (PsA) without any new safety concerns through 1 year of DISCOVER trials.

Major finding: At 24 weeks, combined guselkumab- and placebo-treated patients showed a similar incidence of serious adverse events (SAEs; 4.4 and 7.1/100 patient-years [PY]), adverse events (AEs) leading to discontinuation of study agent (3.8 and 4.1/100 PY), infections (49.5 and 49.9/100 PY), and serious infections (1.2 and 1.7/100 PY), respectively. At 52 weeks, the time-adjusted incidence of SAEs and AEs remained stable with both guselkumab regimens.

Study details: This was a pooled analysis of phase 3 trials DISCOVER-1, and DISCOVER-2 including 1,120 patients with active PsA who had inadequate responses to standard therapies. Patients were randomly allocated to receive subcutaneous guselkumab 100 mg at week 0, then Q4W; guselkumab 100 mg at weeks 0, 4, then Q8W; or placebo at Q4W.

Disclosures: This study was funded by Janssen Research & Development, LLC.  The authors reported receiving research support, speaker bureau support, consultant fees, honoraria, and being an employee of and/or holding stocks/stock options in various sources including Janssen and Johnson & Johnson.

Source:  Rahman P et al. J Rheumatol. 2021 May 1. doi: 10.3899/jrheum.201532.

Key clinical point: Guselkumab 100 mg every 4 weeks (Q4W) and every 8 weeks (Q8W) was well tolerated in patients with psoriatic arthritis (PsA) without any new safety concerns through 1 year of DISCOVER trials.

Major finding: At 24 weeks, combined guselkumab- and placebo-treated patients showed a similar incidence of serious adverse events (SAEs; 4.4 and 7.1/100 patient-years [PY]), adverse events (AEs) leading to discontinuation of study agent (3.8 and 4.1/100 PY), infections (49.5 and 49.9/100 PY), and serious infections (1.2 and 1.7/100 PY), respectively. At 52 weeks, the time-adjusted incidence of SAEs and AEs remained stable with both guselkumab regimens.

Study details: This was a pooled analysis of phase 3 trials DISCOVER-1, and DISCOVER-2 including 1,120 patients with active PsA who had inadequate responses to standard therapies. Patients were randomly allocated to receive subcutaneous guselkumab 100 mg at week 0, then Q4W; guselkumab 100 mg at weeks 0, 4, then Q8W; or placebo at Q4W.

Disclosures: This study was funded by Janssen Research & Development, LLC.  The authors reported receiving research support, speaker bureau support, consultant fees, honoraria, and being an employee of and/or holding stocks/stock options in various sources including Janssen and Johnson & Johnson.

Source:  Rahman P et al. J Rheumatol. 2021 May 1. doi: 10.3899/jrheum.201532.

Key clinical point: Guselkumab 100 mg every 4 weeks (Q4W) and every 8 weeks (Q8W) was well tolerated in patients with psoriatic arthritis (PsA) without any new safety concerns through 1 year of DISCOVER trials.

Major finding: At 24 weeks, combined guselkumab- and placebo-treated patients showed a similar incidence of serious adverse events (SAEs; 4.4 and 7.1/100 patient-years [PY]), adverse events (AEs) leading to discontinuation of study agent (3.8 and 4.1/100 PY), infections (49.5 and 49.9/100 PY), and serious infections (1.2 and 1.7/100 PY), respectively. At 52 weeks, the time-adjusted incidence of SAEs and AEs remained stable with both guselkumab regimens.

Study details: This was a pooled analysis of phase 3 trials DISCOVER-1, and DISCOVER-2 including 1,120 patients with active PsA who had inadequate responses to standard therapies. Patients were randomly allocated to receive subcutaneous guselkumab 100 mg at week 0, then Q4W; guselkumab 100 mg at weeks 0, 4, then Q8W; or placebo at Q4W.

Disclosures: This study was funded by Janssen Research & Development, LLC.  The authors reported receiving research support, speaker bureau support, consultant fees, honoraria, and being an employee of and/or holding stocks/stock options in various sources including Janssen and Johnson & Johnson.

Source:  Rahman P et al. J Rheumatol. 2021 May 1. doi: 10.3899/jrheum.201532.

Key clinical point: Fecal microbiota transplantation (FMT) was safe but appeared inferior to sham in reducing disease activity in patients with active peripheral psoriatic arthritis (PsA) concomitantly treated with methotrexate.

Major finding: At 6 months, the treatment failure rate was significantly higher in FMT vs. sham group (60% vs. 19%; P = .018). Improvement in Health Assessment Questionnaire Disability Index favored sham vs. FMT by 0.23 points (P = .031) while the proportion of American College of Rheumatology 20 respondents was similar (between-group difference, 0.93; 95% confidence interval, 0.45-1.94). No serious adverse events or deaths were observed.

Study details: The findings are from a 26-week, double-blind, superiority trial of 31 participants with active peripheral PsA despite ongoing treatment with methotrexate who were randomly allocated to either gastroscopic-guided FMT (n=15) or sham transplantation (n=16) into the duodenum.

Disclosures: This study was supported by the Danish Rheumatism Association, Danish Psoriasis Research Foundation, Novartis Healthcare, and others. V Andersen and R Christensen declared receiving personal fees and grants/honoraria from Merck, Janssen, and other sources.

Source: Kragsnaes MS et al. Ann Rheum Dis. 2021 Apr 29. doi: 10.1136/annrheumdis-2020-219511.

Key clinical point: Fecal microbiota transplantation (FMT) was safe but appeared inferior to sham in reducing disease activity in patients with active peripheral psoriatic arthritis (PsA) concomitantly treated with methotrexate.

Major finding: At 6 months, the treatment failure rate was significantly higher in FMT vs. sham group (60% vs. 19%; P = .018). Improvement in Health Assessment Questionnaire Disability Index favored sham vs. FMT by 0.23 points (P = .031) while the proportion of American College of Rheumatology 20 respondents was similar (between-group difference, 0.93; 95% confidence interval, 0.45-1.94). No serious adverse events or deaths were observed.

Study details: The findings are from a 26-week, double-blind, superiority trial of 31 participants with active peripheral PsA despite ongoing treatment with methotrexate who were randomly allocated to either gastroscopic-guided FMT (n=15) or sham transplantation (n=16) into the duodenum.

Disclosures: This study was supported by the Danish Rheumatism Association, Danish Psoriasis Research Foundation, Novartis Healthcare, and others. V Andersen and R Christensen declared receiving personal fees and grants/honoraria from Merck, Janssen, and other sources.

Source: Kragsnaes MS et al. Ann Rheum Dis. 2021 Apr 29. doi: 10.1136/annrheumdis-2020-219511.

Key clinical point: Fecal microbiota transplantation (FMT) was safe but appeared inferior to sham in reducing disease activity in patients with active peripheral psoriatic arthritis (PsA) concomitantly treated with methotrexate.

Major finding: At 6 months, the treatment failure rate was significantly higher in FMT vs. sham group (60% vs. 19%; P = .018). Improvement in Health Assessment Questionnaire Disability Index favored sham vs. FMT by 0.23 points (P = .031) while the proportion of American College of Rheumatology 20 respondents was similar (between-group difference, 0.93; 95% confidence interval, 0.45-1.94). No serious adverse events or deaths were observed.

Study details: The findings are from a 26-week, double-blind, superiority trial of 31 participants with active peripheral PsA despite ongoing treatment with methotrexate who were randomly allocated to either gastroscopic-guided FMT (n=15) or sham transplantation (n=16) into the duodenum.

Disclosures: This study was supported by the Danish Rheumatism Association, Danish Psoriasis Research Foundation, Novartis Healthcare, and others. V Andersen and R Christensen declared receiving personal fees and grants/honoraria from Merck, Janssen, and other sources.

Source: Kragsnaes MS et al. Ann Rheum Dis. 2021 Apr 29. doi: 10.1136/annrheumdis-2020-219511.

Several important studies on psoriatic arthritis (PsA) were published in the month of May 2021. Although, 50% of patients with PsA are women, many of them being in the child-beaing age, few studies have investigated pregnancy outcomes in women with psoriatic disease. Xie et al, report the results of their systematic review and meta-analysis of observational studies evaluating the impact of psoriasis and PsA on pregnancy outcomes. They retrieved 16 articles that met their study criteria. They demonstrate that pregnant women with psoriatic disease have significantly higher risk of adverse maternal outcomes (caesarean delivery, preterm birth, (pre)eclampsia, gestational diabetes, or gestational hypertension) compared with general population. However, no increased risk of fetal complications was observed. The authors recommend close monitoring of the mothers’ clinical status before and during pregnancy.

Despite availability of multiple targeted therapies, only about 60% of patients achieve a meaningful response to therapy in randomized trials and only a quarter of patients achieve a state of minimal disease activity. The assessment of musculoskeletal inflammation is heavily dependent on assessment of tender and swollen joints. However, whether tender or swollen joints, especially tender joints, truly reflect joint inflammation is a matter of debate. Felbo et al investigated the association between clinical joint tenderness and intra- and periarticular inflammation as assessed by ultrasound and magnetic resonance imaging (MRI) in patients with active PsA. They found that tender joints poorly reflect intra- and periarticular inflammation assessed by imaging. The association between swollen joints and ultrasound and MRI assessed inflammation was stronger but still only low-to-moderate. The agreement between joint tenderness and imaging assessed inflammation was even weaker in patients with high overall pain scores, high disability scores, or nonerosive disease. Therefore, it is recommended that imaging be used to supplement clinical examination in patients with PsA and high overall pain, disability, and/or nonerosive disease.

With regard to PsA treatment, Rahman et al reported the pooled safety results through one year of two phase 3 trials with guselkumab in PsA. This drug inhibits IL-23, has proven efficacy in PsA and psoriasis, and was recently approved for the treatment of PsA. No active tuberculosis, opportunistic infections, or inflammatory bowel disease, and low rates of malignancy and major adverse cardiovascular events, were observed in guselkumab-treated patients. In another study, using data from 2 large US claims databases, MarketScan and Optum’s De-identified Clinformatics® Data Mart, Jin et al demonstrated that other biologics and apremilast were associated with 1.4- to 3-times higher risk of hospitalized serious infections in patients with psoriatic disease when compared with ustekinumab. Ustekinumab is a biologic agent that inhibits IL-12 and IL-23 and is approved for the treatment of psoriasis, PsA, and ulcerative colitis. The two studies speak to the safety of targeting IL-23 with biologics in psoriatic disease.

Finally, an exploratory, proof-of-concept study explored whether fecal microbiota transplantation (FMT) improves the signs and symptoms of PsA. Kragsnaes et al conducted a double-blind, parallel-group, placebo-controlled, superiority trial, randomly allocating adults with active PsA despite ongoing treatment with methotrexate to one gastroscopic-guided FMT (15 patients) or sham transplantation (16 patients) into the duodenum. Surprisingly, treatment failure occurred more frequently in the FMT group than in the sham group (9 [60%] vs 3 [19%]; risk ratio, 3.20; 95% CI 1.06 to 9.62; P = 0.018). Improvement in HAQ-DI favoured sham treatment. There was no difference in the proportion of ACR20 responders between groups. No serious adverse events were observed. This study highlights that such studies are feasible but indicates that such interventions may not provide significant benefit. Further investigations including careful selection of donors, patients and concomitant therapy is required.

Several important studies on psoriatic arthritis (PsA) were published in the month of May 2021. Although, 50% of patients with PsA are women, many of them being in the child-beaing age, few studies have investigated pregnancy outcomes in women with psoriatic disease. Xie et al, report the results of their systematic review and meta-analysis of observational studies evaluating the impact of psoriasis and PsA on pregnancy outcomes. They retrieved 16 articles that met their study criteria. They demonstrate that pregnant women with psoriatic disease have significantly higher risk of adverse maternal outcomes (caesarean delivery, preterm birth, (pre)eclampsia, gestational diabetes, or gestational hypertension) compared with general population. However, no increased risk of fetal complications was observed. The authors recommend close monitoring of the mothers’ clinical status before and during pregnancy.

Despite availability of multiple targeted therapies, only about 60% of patients achieve a meaningful response to therapy in randomized trials and only a quarter of patients achieve a state of minimal disease activity. The assessment of musculoskeletal inflammation is heavily dependent on assessment of tender and swollen joints. However, whether tender or swollen joints, especially tender joints, truly reflect joint inflammation is a matter of debate. Felbo et al investigated the association between clinical joint tenderness and intra- and periarticular inflammation as assessed by ultrasound and magnetic resonance imaging (MRI) in patients with active PsA. They found that tender joints poorly reflect intra- and periarticular inflammation assessed by imaging. The association between swollen joints and ultrasound and MRI assessed inflammation was stronger but still only low-to-moderate. The agreement between joint tenderness and imaging assessed inflammation was even weaker in patients with high overall pain scores, high disability scores, or nonerosive disease. Therefore, it is recommended that imaging be used to supplement clinical examination in patients with PsA and high overall pain, disability, and/or nonerosive disease.

With regard to PsA treatment, Rahman et al reported the pooled safety results through one year of two phase 3 trials with guselkumab in PsA. This drug inhibits IL-23, has proven efficacy in PsA and psoriasis, and was recently approved for the treatment of PsA. No active tuberculosis, opportunistic infections, or inflammatory bowel disease, and low rates of malignancy and major adverse cardiovascular events, were observed in guselkumab-treated patients. In another study, using data from 2 large US claims databases, MarketScan and Optum’s De-identified Clinformatics® Data Mart, Jin et al demonstrated that other biologics and apremilast were associated with 1.4- to 3-times higher risk of hospitalized serious infections in patients with psoriatic disease when compared with ustekinumab. Ustekinumab is a biologic agent that inhibits IL-12 and IL-23 and is approved for the treatment of psoriasis, PsA, and ulcerative colitis. The two studies speak to the safety of targeting IL-23 with biologics in psoriatic disease.

Finally, an exploratory, proof-of-concept study explored whether fecal microbiota transplantation (FMT) improves the signs and symptoms of PsA. Kragsnaes et al conducted a double-blind, parallel-group, placebo-controlled, superiority trial, randomly allocating adults with active PsA despite ongoing treatment with methotrexate to one gastroscopic-guided FMT (15 patients) or sham transplantation (16 patients) into the duodenum. Surprisingly, treatment failure occurred more frequently in the FMT group than in the sham group (9 [60%] vs 3 [19%]; risk ratio, 3.20; 95% CI 1.06 to 9.62; P = 0.018). Improvement in HAQ-DI favoured sham treatment. There was no difference in the proportion of ACR20 responders between groups. No serious adverse events were observed. This study highlights that such studies are feasible but indicates that such interventions may not provide significant benefit. Further investigations including careful selection of donors, patients and concomitant therapy is required.

Several important studies on psoriatic arthritis (PsA) were published in the month of May 2021. Although, 50% of patients with PsA are women, many of them being in the child-beaing age, few studies have investigated pregnancy outcomes in women with psoriatic disease. Xie et al, report the results of their systematic review and meta-analysis of observational studies evaluating the impact of psoriasis and PsA on pregnancy outcomes. They retrieved 16 articles that met their study criteria. They demonstrate that pregnant women with psoriatic disease have significantly higher risk of adverse maternal outcomes (caesarean delivery, preterm birth, (pre)eclampsia, gestational diabetes, or gestational hypertension) compared with general population. However, no increased risk of fetal complications was observed. The authors recommend close monitoring of the mothers’ clinical status before and during pregnancy.

Despite availability of multiple targeted therapies, only about 60% of patients achieve a meaningful response to therapy in randomized trials and only a quarter of patients achieve a state of minimal disease activity. The assessment of musculoskeletal inflammation is heavily dependent on assessment of tender and swollen joints. However, whether tender or swollen joints, especially tender joints, truly reflect joint inflammation is a matter of debate. Felbo et al investigated the association between clinical joint tenderness and intra- and periarticular inflammation as assessed by ultrasound and magnetic resonance imaging (MRI) in patients with active PsA. They found that tender joints poorly reflect intra- and periarticular inflammation assessed by imaging. The association between swollen joints and ultrasound and MRI assessed inflammation was stronger but still only low-to-moderate. The agreement between joint tenderness and imaging assessed inflammation was even weaker in patients with high overall pain scores, high disability scores, or nonerosive disease. Therefore, it is recommended that imaging be used to supplement clinical examination in patients with PsA and high overall pain, disability, and/or nonerosive disease.

With regard to PsA treatment, Rahman et al reported the pooled safety results through one year of two phase 3 trials with guselkumab in PsA. This drug inhibits IL-23, has proven efficacy in PsA and psoriasis, and was recently approved for the treatment of PsA. No active tuberculosis, opportunistic infections, or inflammatory bowel disease, and low rates of malignancy and major adverse cardiovascular events, were observed in guselkumab-treated patients. In another study, using data from 2 large US claims databases, MarketScan and Optum’s De-identified Clinformatics® Data Mart, Jin et al demonstrated that other biologics and apremilast were associated with 1.4- to 3-times higher risk of hospitalized serious infections in patients with psoriatic disease when compared with ustekinumab. Ustekinumab is a biologic agent that inhibits IL-12 and IL-23 and is approved for the treatment of psoriasis, PsA, and ulcerative colitis. The two studies speak to the safety of targeting IL-23 with biologics in psoriatic disease.

Finally, an exploratory, proof-of-concept study explored whether fecal microbiota transplantation (FMT) improves the signs and symptoms of PsA. Kragsnaes et al conducted a double-blind, parallel-group, placebo-controlled, superiority trial, randomly allocating adults with active PsA despite ongoing treatment with methotrexate to one gastroscopic-guided FMT (15 patients) or sham transplantation (16 patients) into the duodenum. Surprisingly, treatment failure occurred more frequently in the FMT group than in the sham group (9 [60%] vs 3 [19%]; risk ratio, 3.20; 95% CI 1.06 to 9.62; P = 0.018). Improvement in HAQ-DI favoured sham treatment. There was no difference in the proportion of ACR20 responders between groups. No serious adverse events were observed. This study highlights that such studies are feasible but indicates that such interventions may not provide significant benefit. Further investigations including careful selection of donors, patients and concomitant therapy is required.

Key clinical point: Higher sugar-sweetened beverages (SSB) consumption after a breast cancer diagnosis was associated with greater breast cancer-specific and all-cause mortality.

Major finding: Compared with no consumption, the risk for breast cancer-specific and all-cause mortality increased with increasing consumption of SSB (P_trend= .001 and .0001, respectively). The consumption of artificially sweetened beverages was not associated with higher breast cancer-specific or all-cause mortality.

Study details: A prospective cohort of 8,863 women with stages I-III breast cancer who completed a validated food frequency questionnaire every 4 years.

Disclosure: This study was supported by the National Institutes of Health, the American Institute for Cancer Research, and the Breast Cancer Research Foundation. Dr. Holmes received grants, personal fees, and nonfinancial support from various sources outside this work. The remaining authors made no disclosures.

Source: Farvid MS et al. Cancer. 2021 May 4. doi: 10.1002/cncr.33461.

Key clinical point: Higher sugar-sweetened beverages (SSB) consumption after a breast cancer diagnosis was associated with greater breast cancer-specific and all-cause mortality.

Major finding: Compared with no consumption, the risk for breast cancer-specific and all-cause mortality increased with increasing consumption of SSB (P_trend= .001 and .0001, respectively). The consumption of artificially sweetened beverages was not associated with higher breast cancer-specific or all-cause mortality.

Study details: A prospective cohort of 8,863 women with stages I-III breast cancer who completed a validated food frequency questionnaire every 4 years.

Disclosure: This study was supported by the National Institutes of Health, the American Institute for Cancer Research, and the Breast Cancer Research Foundation. Dr. Holmes received grants, personal fees, and nonfinancial support from various sources outside this work. The remaining authors made no disclosures.

Source: Farvid MS et al. Cancer. 2021 May 4. doi: 10.1002/cncr.33461.

Key clinical point: Higher sugar-sweetened beverages (SSB) consumption after a breast cancer diagnosis was associated with greater breast cancer-specific and all-cause mortality.

Major finding: Compared with no consumption, the risk for breast cancer-specific and all-cause mortality increased with increasing consumption of SSB (P_trend= .001 and .0001, respectively). The consumption of artificially sweetened beverages was not associated with higher breast cancer-specific or all-cause mortality.

Study details: A prospective cohort of 8,863 women with stages I-III breast cancer who completed a validated food frequency questionnaire every 4 years.

Disclosure: This study was supported by the National Institutes of Health, the American Institute for Cancer Research, and the Breast Cancer Research Foundation. Dr. Holmes received grants, personal fees, and nonfinancial support from various sources outside this work. The remaining authors made no disclosures.

Source: Farvid MS et al. Cancer. 2021 May 4. doi: 10.1002/cncr.33461.

Key clinical point: In older women with stage I hormone receptor (HR)-positive breast cancer, radiation without endocrine therapy does not increase the risk for second breast cancer events (SBCE).

Major finding: Compared with endocrine therapy plus radiotherapy, radiotherapy alone was not associated with a higher risk for SBCE (P = .137), whereas no therapy (standardized hazard ratio [SHR], 3.7; P less than .001) or endocrine therapy (SHR, 2.2; P = .008) alone was associated with higher risk for SBCE.

Study details: A retrospective study of 13,321 women aged 66 years and older with stage I HR-positive breast cancer who underwent breast-conserving surgery between 2007 and 2012.

Disclosures: The study received funding from the Department of Radiation Oncology, NYU School of Medicine. Dr. Deb received personal fees from the NYU School of Medicine. The other authors did not disclose any conflicts of interest.

Source: Gerber NK et al. Int J Radiat Oncol Biol Phys. 2021 May 8. doi: 10.1016/j.ijrobp.2021.04.030.

Key clinical point: In older women with stage I hormone receptor (HR)-positive breast cancer, radiation without endocrine therapy does not increase the risk for second breast cancer events (SBCE).

Major finding: Compared with endocrine therapy plus radiotherapy, radiotherapy alone was not associated with a higher risk for SBCE (P = .137), whereas no therapy (standardized hazard ratio [SHR], 3.7; P less than .001) or endocrine therapy (SHR, 2.2; P = .008) alone was associated with higher risk for SBCE.

Study details: A retrospective study of 13,321 women aged 66 years and older with stage I HR-positive breast cancer who underwent breast-conserving surgery between 2007 and 2012.

Disclosures: The study received funding from the Department of Radiation Oncology, NYU School of Medicine. Dr. Deb received personal fees from the NYU School of Medicine. The other authors did not disclose any conflicts of interest.

Source: Gerber NK et al. Int J Radiat Oncol Biol Phys. 2021 May 8. doi: 10.1016/j.ijrobp.2021.04.030.

Key clinical point: In older women with stage I hormone receptor (HR)-positive breast cancer, radiation without endocrine therapy does not increase the risk for second breast cancer events (SBCE).

Major finding: Compared with endocrine therapy plus radiotherapy, radiotherapy alone was not associated with a higher risk for SBCE (P = .137), whereas no therapy (standardized hazard ratio [SHR], 3.7; P less than .001) or endocrine therapy (SHR, 2.2; P = .008) alone was associated with higher risk for SBCE.

Study details: A retrospective study of 13,321 women aged 66 years and older with stage I HR-positive breast cancer who underwent breast-conserving surgery between 2007 and 2012.

Disclosures: The study received funding from the Department of Radiation Oncology, NYU School of Medicine. Dr. Deb received personal fees from the NYU School of Medicine. The other authors did not disclose any conflicts of interest.

Source: Gerber NK et al. Int J Radiat Oncol Biol Phys. 2021 May 8. doi: 10.1016/j.ijrobp.2021.04.030.

Key clinical point: In patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, BRCA germline-mutated breast cancer, poly (ADP-ribose) polymerase (PARP) inhibitors improve progression-free survival (PFS), overall survival (OS), and tumor response rate.

Major findings: A PARP-containing regimen showed a small advantage in OS (hazard ratio, 0.87; 95% confidence interval, 0.76-1.00) vs. non-PARP regimen. PARP inhibitors improved PFS (hazard ratio, 0.63; P less than .00001) and tumor response rate (66.9% vs. 48.9%). The rate of grade 3 or higher adverse events was not significantly different in the PARP-containing vs. non-PARP regimen.

Study details: A meta-analysis of 5 randomized controlled trials comparing PARP-containing and non-PARP regimens in patients with locally advanced or metastatic breast cancer.

Disclosures: The funding source for this meta-analysis was not identified. Some of the authors received honoraria, research funding, compensation, financial support, consulting fees, and/or grants outside this work. Dr. Redfern is the Principal Investigator on the Brightness trial and served on the advisory board of AstraZeneca and Pfizer.

Source: Taylor AM. Cochrane Database Syst Rev. 2021 Apr 22. doi: 10.1002/14651858.CD011395.pub2.

Key clinical point: In patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, BRCA germline-mutated breast cancer, poly (ADP-ribose) polymerase (PARP) inhibitors improve progression-free survival (PFS), overall survival (OS), and tumor response rate.

Major findings: A PARP-containing regimen showed a small advantage in OS (hazard ratio, 0.87; 95% confidence interval, 0.76-1.00) vs. non-PARP regimen. PARP inhibitors improved PFS (hazard ratio, 0.63; P less than .00001) and tumor response rate (66.9% vs. 48.9%). The rate of grade 3 or higher adverse events was not significantly different in the PARP-containing vs. non-PARP regimen.

Study details: A meta-analysis of 5 randomized controlled trials comparing PARP-containing and non-PARP regimens in patients with locally advanced or metastatic breast cancer.

Disclosures: The funding source for this meta-analysis was not identified. Some of the authors received honoraria, research funding, compensation, financial support, consulting fees, and/or grants outside this work. Dr. Redfern is the Principal Investigator on the Brightness trial and served on the advisory board of AstraZeneca and Pfizer.

Source: Taylor AM. Cochrane Database Syst Rev. 2021 Apr 22. doi: 10.1002/14651858.CD011395.pub2.

Key clinical point: In patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, BRCA germline-mutated breast cancer, poly (ADP-ribose) polymerase (PARP) inhibitors improve progression-free survival (PFS), overall survival (OS), and tumor response rate.

Major findings: A PARP-containing regimen showed a small advantage in OS (hazard ratio, 0.87; 95% confidence interval, 0.76-1.00) vs. non-PARP regimen. PARP inhibitors improved PFS (hazard ratio, 0.63; P less than .00001) and tumor response rate (66.9% vs. 48.9%). The rate of grade 3 or higher adverse events was not significantly different in the PARP-containing vs. non-PARP regimen.

Study details: A meta-analysis of 5 randomized controlled trials comparing PARP-containing and non-PARP regimens in patients with locally advanced or metastatic breast cancer.

Disclosures: The funding source for this meta-analysis was not identified. Some of the authors received honoraria, research funding, compensation, financial support, consulting fees, and/or grants outside this work. Dr. Redfern is the Principal Investigator on the Brightness trial and served on the advisory board of AstraZeneca and Pfizer.

Source: Taylor AM. Cochrane Database Syst Rev. 2021 Apr 22. doi: 10.1002/14651858.CD011395.pub2.

Key clinical point: Fertility concerns affect adjuvant endocrine therapy (ET) decisions in one-third of young breast cancer survivors.

Major finding: Within 2 years after diagnosis, fertility concerns affected ET decisions in 33.12% of women. Parity at diagnosis showed a significant association with fertility concerns. The women who reported that fertility concerns affected their ET decisions showed a higher rate of noninitiation/nonpersistence with ET vs. those without fertility concerns (40% vs. 20%; P less than .0001).

Study details: An analysis of 643 hormone receptor-positive women (mean age, 36 years) who completed a survey from the Young Women’s Breast Cancer Study.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Dr. Rosenberg received a grant from the Agency for Healthcare Research and Quality. Dr. Sella was supported by the Pinchas Borenstein Talpiot Medical Leadership Program at Sheba Medical Center and the American Physicians Fellowship for Medicine in Israel. The authors reported receiving honorarium/research funding/consultancy fees/personal fees outside this study work. Dr. Peppercorn reported employment by/stocks in GlaxoSmithKline.

Source: Sella T. Cancer. 2021 Apr 22. doi: 10.1002/cncr.33596.

Key clinical point: Fertility concerns affect adjuvant endocrine therapy (ET) decisions in one-third of young breast cancer survivors.

Major finding: Within 2 years after diagnosis, fertility concerns affected ET decisions in 33.12% of women. Parity at diagnosis showed a significant association with fertility concerns. The women who reported that fertility concerns affected their ET decisions showed a higher rate of noninitiation/nonpersistence with ET vs. those without fertility concerns (40% vs. 20%; P less than .0001).

Study details: An analysis of 643 hormone receptor-positive women (mean age, 36 years) who completed a survey from the Young Women’s Breast Cancer Study.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Dr. Rosenberg received a grant from the Agency for Healthcare Research and Quality. Dr. Sella was supported by the Pinchas Borenstein Talpiot Medical Leadership Program at Sheba Medical Center and the American Physicians Fellowship for Medicine in Israel. The authors reported receiving honorarium/research funding/consultancy fees/personal fees outside this study work. Dr. Peppercorn reported employment by/stocks in GlaxoSmithKline.

Source: Sella T. Cancer. 2021 Apr 22. doi: 10.1002/cncr.33596.

Key clinical point: Fertility concerns affect adjuvant endocrine therapy (ET) decisions in one-third of young breast cancer survivors.

Major finding: Within 2 years after diagnosis, fertility concerns affected ET decisions in 33.12% of women. Parity at diagnosis showed a significant association with fertility concerns. The women who reported that fertility concerns affected their ET decisions showed a higher rate of noninitiation/nonpersistence with ET vs. those without fertility concerns (40% vs. 20%; P less than .0001).

Study details: An analysis of 643 hormone receptor-positive women (mean age, 36 years) who completed a survey from the Young Women’s Breast Cancer Study.

Disclosures: This study was funded by Susan G. Komen and the Breast Cancer Research Foundation. Dr. Rosenberg received a grant from the Agency for Healthcare Research and Quality. Dr. Sella was supported by the Pinchas Borenstein Talpiot Medical Leadership Program at Sheba Medical Center and the American Physicians Fellowship for Medicine in Israel. The authors reported receiving honorarium/research funding/consultancy fees/personal fees outside this study work. Dr. Peppercorn reported employment by/stocks in GlaxoSmithKline.

Source: Sella T. Cancer. 2021 Apr 22. doi: 10.1002/cncr.33596.

Key clinical point: The risk for breast cancer-specific mortality (BCSM) remains high beyond 5 years. The BCSM rate is significantly higher in hormone receptor (HR)-positive vs. HR-negative women.

Major finding: The overall BCSM rate was 14.9%. Of all BCSM, 54.2% of deaths occurred after 5 years and were significantly higher in HR-positive vs. HR-negative patients (P less than .001). Among patients with HR-positive and HR-negative breast cancer, independent risk factors for BCSM conditional on having survived 5 years were tumor size, nodal status, age, and year of diagnosis. Among patients with HR-positive status, tumor grade, marital status, and race were also independently associated with the risk for BCSM.

Study details: An observational study of 202,080 women with breast cancer with known HR status diagnosed between 1990 and 2005.

Disclosures: The study did not receive any funding. Some authors received research funding and/or advisory/consulting fees from various sources.

Source: Leone JP. Breast Cancer Res Treat. 2021 Apr 24. doi: 10.1007/s10549-021-06233-4.

Key clinical point: The risk for breast cancer-specific mortality (BCSM) remains high beyond 5 years. The BCSM rate is significantly higher in hormone receptor (HR)-positive vs. HR-negative women.

Major finding: The overall BCSM rate was 14.9%. Of all BCSM, 54.2% of deaths occurred after 5 years and were significantly higher in HR-positive vs. HR-negative patients (P less than .001). Among patients with HR-positive and HR-negative breast cancer, independent risk factors for BCSM conditional on having survived 5 years were tumor size, nodal status, age, and year of diagnosis. Among patients with HR-positive status, tumor grade, marital status, and race were also independently associated with the risk for BCSM.

Study details: An observational study of 202,080 women with breast cancer with known HR status diagnosed between 1990 and 2005.

Disclosures: The study did not receive any funding. Some authors received research funding and/or advisory/consulting fees from various sources.

Source: Leone JP. Breast Cancer Res Treat. 2021 Apr 24. doi: 10.1007/s10549-021-06233-4.

Key clinical point: The risk for breast cancer-specific mortality (BCSM) remains high beyond 5 years. The BCSM rate is significantly higher in hormone receptor (HR)-positive vs. HR-negative women.

Major finding: The overall BCSM rate was 14.9%. Of all BCSM, 54.2% of deaths occurred after 5 years and were significantly higher in HR-positive vs. HR-negative patients (P less than .001). Among patients with HR-positive and HR-negative breast cancer, independent risk factors for BCSM conditional on having survived 5 years were tumor size, nodal status, age, and year of diagnosis. Among patients with HR-positive status, tumor grade, marital status, and race were also independently associated with the risk for BCSM.

Study details: An observational study of 202,080 women with breast cancer with known HR status diagnosed between 1990 and 2005.

Disclosures: The study did not receive any funding. Some authors received research funding and/or advisory/consulting fees from various sources.

Source: Leone JP. Breast Cancer Res Treat. 2021 Apr 24. doi: 10.1007/s10549-021-06233-4.