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Late detection and worse outcomes in invasive lobular vs ductal carcinomas of the breast
Key clinical point: Invasive lobular carcinomas (ILC) are often detected at more advanced stages and have worse survival outcomes than invasive ductal carcinomas (IDC).
Major finding: ILCs vs IDC were more frequently diagnosed at later stages (stage III and IV; 20.7% vs 10.4%), with more lymph node involvement (N2 and 3; 9.9% vs 5.5%), and at larger sizes (T3 and 4; 14.7% vs 4.0%; all P < .001). Among patients with estrogen receptor-positive and human epidermal growth factor receptor 2-negative breast cancer (BC), ILC vs IDC were associated with worse overall survival (hazard ratio [HR] 1.32; P < .001) and disease-free survival (HR 1.18; P = .03).
Study details: Findings are from a retrospective cohort study, the Great Lakes Breast Cancer Consortium, including 33,662 patients with BC, of which 10.7% of patients had ILC and 89.3% of patients had IDC.
Disclosures: This work was supported by the Breast Cancer Research Foundation and other sources. The authors declared no conflicts of interest.
Source: Oesterreich S et al. Clinicopathological features and outcomes comparing patients with invasive ductal and lobular breast cancer. J Natl Cancer Inst. 2022 (Oct 14). Doi: 10.1093/jnci/djac157
Key clinical point: Invasive lobular carcinomas (ILC) are often detected at more advanced stages and have worse survival outcomes than invasive ductal carcinomas (IDC).
Major finding: ILCs vs IDC were more frequently diagnosed at later stages (stage III and IV; 20.7% vs 10.4%), with more lymph node involvement (N2 and 3; 9.9% vs 5.5%), and at larger sizes (T3 and 4; 14.7% vs 4.0%; all P < .001). Among patients with estrogen receptor-positive and human epidermal growth factor receptor 2-negative breast cancer (BC), ILC vs IDC were associated with worse overall survival (hazard ratio [HR] 1.32; P < .001) and disease-free survival (HR 1.18; P = .03).
Study details: Findings are from a retrospective cohort study, the Great Lakes Breast Cancer Consortium, including 33,662 patients with BC, of which 10.7% of patients had ILC and 89.3% of patients had IDC.
Disclosures: This work was supported by the Breast Cancer Research Foundation and other sources. The authors declared no conflicts of interest.
Source: Oesterreich S et al. Clinicopathological features and outcomes comparing patients with invasive ductal and lobular breast cancer. J Natl Cancer Inst. 2022 (Oct 14). Doi: 10.1093/jnci/djac157
Key clinical point: Invasive lobular carcinomas (ILC) are often detected at more advanced stages and have worse survival outcomes than invasive ductal carcinomas (IDC).
Major finding: ILCs vs IDC were more frequently diagnosed at later stages (stage III and IV; 20.7% vs 10.4%), with more lymph node involvement (N2 and 3; 9.9% vs 5.5%), and at larger sizes (T3 and 4; 14.7% vs 4.0%; all P < .001). Among patients with estrogen receptor-positive and human epidermal growth factor receptor 2-negative breast cancer (BC), ILC vs IDC were associated with worse overall survival (hazard ratio [HR] 1.32; P < .001) and disease-free survival (HR 1.18; P = .03).
Study details: Findings are from a retrospective cohort study, the Great Lakes Breast Cancer Consortium, including 33,662 patients with BC, of which 10.7% of patients had ILC and 89.3% of patients had IDC.
Disclosures: This work was supported by the Breast Cancer Research Foundation and other sources. The authors declared no conflicts of interest.
Source: Oesterreich S et al. Clinicopathological features and outcomes comparing patients with invasive ductal and lobular breast cancer. J Natl Cancer Inst. 2022 (Oct 14). Doi: 10.1093/jnci/djac157
gBRCA1/2pv-associated HER2− early BC: Adjuvant olaparib improves OS in the long run
Key clinical point: The prespecified second interim analysis of the OlympiA trial revealed a significant improvement in overall survival (OS) with adjuvant olaparib vs placebo in patients with pathogenic variants in BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative (HER2−), early breast cancer (BC).
Major finding: After a median follow-up of 3.5 years, OS improved significantly (hazard ratio 0.68; P = .009) and improvement in 4-year invasive disease-free survival was maintained (82.7% vs 75.4%) in the olaparib vs placebo group. No new safety signals were identified.
Study details: Findings are from the double-blind, phase 3, OlympiA study including 1836 patients with gBRCA1/2pv-associated high-risk, HER2−, early BC who were randomly assigned to receive olaparib or placebo in the adjuvant setting.
Disclosures: This work was supported by the US National Institutes of Health. Some authors declared receiving research funding, honoraria, consulting fees, compensation, accommodations and travel expenses, and royalties from and having other ties with several sources.
Source: Geyer CE Jr et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer. Ann Oncol. 2022 (Oct 10). Doi: 10.1016/j.annonc.2022.09.159
Key clinical point: The prespecified second interim analysis of the OlympiA trial revealed a significant improvement in overall survival (OS) with adjuvant olaparib vs placebo in patients with pathogenic variants in BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative (HER2−), early breast cancer (BC).
Major finding: After a median follow-up of 3.5 years, OS improved significantly (hazard ratio 0.68; P = .009) and improvement in 4-year invasive disease-free survival was maintained (82.7% vs 75.4%) in the olaparib vs placebo group. No new safety signals were identified.
Study details: Findings are from the double-blind, phase 3, OlympiA study including 1836 patients with gBRCA1/2pv-associated high-risk, HER2−, early BC who were randomly assigned to receive olaparib or placebo in the adjuvant setting.
Disclosures: This work was supported by the US National Institutes of Health. Some authors declared receiving research funding, honoraria, consulting fees, compensation, accommodations and travel expenses, and royalties from and having other ties with several sources.
Source: Geyer CE Jr et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer. Ann Oncol. 2022 (Oct 10). Doi: 10.1016/j.annonc.2022.09.159
Key clinical point: The prespecified second interim analysis of the OlympiA trial revealed a significant improvement in overall survival (OS) with adjuvant olaparib vs placebo in patients with pathogenic variants in BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative (HER2−), early breast cancer (BC).
Major finding: After a median follow-up of 3.5 years, OS improved significantly (hazard ratio 0.68; P = .009) and improvement in 4-year invasive disease-free survival was maintained (82.7% vs 75.4%) in the olaparib vs placebo group. No new safety signals were identified.
Study details: Findings are from the double-blind, phase 3, OlympiA study including 1836 patients with gBRCA1/2pv-associated high-risk, HER2−, early BC who were randomly assigned to receive olaparib or placebo in the adjuvant setting.
Disclosures: This work was supported by the US National Institutes of Health. Some authors declared receiving research funding, honoraria, consulting fees, compensation, accommodations and travel expenses, and royalties from and having other ties with several sources.
Source: Geyer CE Jr et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer. Ann Oncol. 2022 (Oct 10). Doi: 10.1016/j.annonc.2022.09.159
Radiotherapy increases risk for thoracic angiosarcoma in breast cancer survivors
Key clinical point: Patients who had survived breast cancer (BC) were more likely to develop soft tissue sarcoma if they received radiotherapy.
Major finding: A very small fraction of BC survivors (~0.1%) developed thoracic soft tissue sarcoma, with radiotherapy being the strongest risk factor in the Kaiser Permanente (KP) cohort (relative risk [RR] 8.1; P = .0052) and the Surveillance, Epidemiology, and End Results (SEER) 13 registries cohort (RR 3.0; P < .0001).
Study details: This retrospective study of data sourced from two cohorts, the KP cohort (n = 15,940) and the SEER 13 registries cohort (n = 457,300) and included patients who had BC surgery and survived ≥1 year after BC diagnosis.
Disclosures: This study was supported by the US National Cancer Institute and National Institutes of Health. The authors declared no conflicts of interest.
Source: Veiga LHS et al. Treatment-related thoracic soft tissue sarcomas in US breast cancer survivors: A retrospective cohort study. Lancet Oncol. 2022;23(11):1451-1464 (Oct 11). Doi: 10.1016/S1470-2045(22)00561-7
Key clinical point: Patients who had survived breast cancer (BC) were more likely to develop soft tissue sarcoma if they received radiotherapy.
Major finding: A very small fraction of BC survivors (~0.1%) developed thoracic soft tissue sarcoma, with radiotherapy being the strongest risk factor in the Kaiser Permanente (KP) cohort (relative risk [RR] 8.1; P = .0052) and the Surveillance, Epidemiology, and End Results (SEER) 13 registries cohort (RR 3.0; P < .0001).
Study details: This retrospective study of data sourced from two cohorts, the KP cohort (n = 15,940) and the SEER 13 registries cohort (n = 457,300) and included patients who had BC surgery and survived ≥1 year after BC diagnosis.
Disclosures: This study was supported by the US National Cancer Institute and National Institutes of Health. The authors declared no conflicts of interest.
Source: Veiga LHS et al. Treatment-related thoracic soft tissue sarcomas in US breast cancer survivors: A retrospective cohort study. Lancet Oncol. 2022;23(11):1451-1464 (Oct 11). Doi: 10.1016/S1470-2045(22)00561-7
Key clinical point: Patients who had survived breast cancer (BC) were more likely to develop soft tissue sarcoma if they received radiotherapy.
Major finding: A very small fraction of BC survivors (~0.1%) developed thoracic soft tissue sarcoma, with radiotherapy being the strongest risk factor in the Kaiser Permanente (KP) cohort (relative risk [RR] 8.1; P = .0052) and the Surveillance, Epidemiology, and End Results (SEER) 13 registries cohort (RR 3.0; P < .0001).
Study details: This retrospective study of data sourced from two cohorts, the KP cohort (n = 15,940) and the SEER 13 registries cohort (n = 457,300) and included patients who had BC surgery and survived ≥1 year after BC diagnosis.
Disclosures: This study was supported by the US National Cancer Institute and National Institutes of Health. The authors declared no conflicts of interest.
Source: Veiga LHS et al. Treatment-related thoracic soft tissue sarcomas in US breast cancer survivors: A retrospective cohort study. Lancet Oncol. 2022;23(11):1451-1464 (Oct 11). Doi: 10.1016/S1470-2045(22)00561-7
Exceptional responders to neoadjuvant systemic therapy may omit breast cancer surgery
Key clinical point: Breast cancer (BC) surgery may be eliminated in patients with early-stage triple-negative BC (TNBC) or human epidermal growth factor receptor 2-positive (HER2+) BC who have achieved pathological complete response (pCR) after neoadjuvant systemic therapy (NST).
Major finding: After a median follow-up of 26.4 months, there were no incidences of ipsilateral breast tumor recurrence in the 31 patients who had achieved a pCR on percutaneous image-guided vacuum-assisted core biopsy (VACB) after NST.
Study details: Findings are from a multicenter, single-arm, phase 2 study including 50 patients with invasive HER2+ BC or TNBC who received percutaneous image-guided VACB after NST.
Disclosures: This study was funded by the US National Cancer Institute. Some authors declared serving in leadership roles or receiving consulting fees, honorarium, royalties, or research funding from several sources.
Source: Kuerer HM et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: A multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 (Oct 25). Doi: 10.1016/S1470-2045(22)00613-1
Key clinical point: Breast cancer (BC) surgery may be eliminated in patients with early-stage triple-negative BC (TNBC) or human epidermal growth factor receptor 2-positive (HER2+) BC who have achieved pathological complete response (pCR) after neoadjuvant systemic therapy (NST).
Major finding: After a median follow-up of 26.4 months, there were no incidences of ipsilateral breast tumor recurrence in the 31 patients who had achieved a pCR on percutaneous image-guided vacuum-assisted core biopsy (VACB) after NST.
Study details: Findings are from a multicenter, single-arm, phase 2 study including 50 patients with invasive HER2+ BC or TNBC who received percutaneous image-guided VACB after NST.
Disclosures: This study was funded by the US National Cancer Institute. Some authors declared serving in leadership roles or receiving consulting fees, honorarium, royalties, or research funding from several sources.
Source: Kuerer HM et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: A multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 (Oct 25). Doi: 10.1016/S1470-2045(22)00613-1
Key clinical point: Breast cancer (BC) surgery may be eliminated in patients with early-stage triple-negative BC (TNBC) or human epidermal growth factor receptor 2-positive (HER2+) BC who have achieved pathological complete response (pCR) after neoadjuvant systemic therapy (NST).
Major finding: After a median follow-up of 26.4 months, there were no incidences of ipsilateral breast tumor recurrence in the 31 patients who had achieved a pCR on percutaneous image-guided vacuum-assisted core biopsy (VACB) after NST.
Study details: Findings are from a multicenter, single-arm, phase 2 study including 50 patients with invasive HER2+ BC or TNBC who received percutaneous image-guided VACB after NST.
Disclosures: This study was funded by the US National Cancer Institute. Some authors declared serving in leadership roles or receiving consulting fees, honorarium, royalties, or research funding from several sources.
Source: Kuerer HM et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: A multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 (Oct 25). Doi: 10.1016/S1470-2045(22)00613-1
Proactive TCS fails to reduce relapse rate in moderate-to-severe atopic dermatitis
Key clinical point: Although proactive (PA) topical corticosteroid (TCS) therapy did not show lower relapse rates in pediatric patients with moderate-to-severe atopic dermatitis (AD) in remission, it was more effective against itch and as safe as rank-down (RD) TCS therapy.
Major finding: There was no significant decrease in the relapse rate (8.33% vs 20.0%; P = .0859) in the PA vs RD treatment group; however, at week 4, the mean itching score increased significantly in the RD group (2.5 to 3.6; P = .0438) but not in the PA group (P = .1877). The safety profile was similar in both groups.
Study details: Findings are from an open-label, active-controlled, parallel-group study including 49 pediatric patients with moderate-to-severe AD who had achieved remission with a very strong TCS therapy and were randomly assigned to receive PA or RD TCS therapy.
Disclosures: This study was funded by Torii Pharmaceutical Co., Ltd. The authors declared receiving payments, honoraria, funds, research grants, or fees from several sources, including Torii Pharmaceutical.
Source: Kamiya K et al. Proactive versus rank-down topical corticosteroid therapy for maintenance of remission in pediatric atopic dermatitis: A randomized, open-label, active-controlled, parallel-group study (Anticipate study). J Clin Med. 2022;11(21):6477 (Oct 31). Doi: 10.3390/jcm11216477
Key clinical point: Although proactive (PA) topical corticosteroid (TCS) therapy did not show lower relapse rates in pediatric patients with moderate-to-severe atopic dermatitis (AD) in remission, it was more effective against itch and as safe as rank-down (RD) TCS therapy.
Major finding: There was no significant decrease in the relapse rate (8.33% vs 20.0%; P = .0859) in the PA vs RD treatment group; however, at week 4, the mean itching score increased significantly in the RD group (2.5 to 3.6; P = .0438) but not in the PA group (P = .1877). The safety profile was similar in both groups.
Study details: Findings are from an open-label, active-controlled, parallel-group study including 49 pediatric patients with moderate-to-severe AD who had achieved remission with a very strong TCS therapy and were randomly assigned to receive PA or RD TCS therapy.
Disclosures: This study was funded by Torii Pharmaceutical Co., Ltd. The authors declared receiving payments, honoraria, funds, research grants, or fees from several sources, including Torii Pharmaceutical.
Source: Kamiya K et al. Proactive versus rank-down topical corticosteroid therapy for maintenance of remission in pediatric atopic dermatitis: A randomized, open-label, active-controlled, parallel-group study (Anticipate study). J Clin Med. 2022;11(21):6477 (Oct 31). Doi: 10.3390/jcm11216477
Key clinical point: Although proactive (PA) topical corticosteroid (TCS) therapy did not show lower relapse rates in pediatric patients with moderate-to-severe atopic dermatitis (AD) in remission, it was more effective against itch and as safe as rank-down (RD) TCS therapy.
Major finding: There was no significant decrease in the relapse rate (8.33% vs 20.0%; P = .0859) in the PA vs RD treatment group; however, at week 4, the mean itching score increased significantly in the RD group (2.5 to 3.6; P = .0438) but not in the PA group (P = .1877). The safety profile was similar in both groups.
Study details: Findings are from an open-label, active-controlled, parallel-group study including 49 pediatric patients with moderate-to-severe AD who had achieved remission with a very strong TCS therapy and were randomly assigned to receive PA or RD TCS therapy.
Disclosures: This study was funded by Torii Pharmaceutical Co., Ltd. The authors declared receiving payments, honoraria, funds, research grants, or fees from several sources, including Torii Pharmaceutical.
Source: Kamiya K et al. Proactive versus rank-down topical corticosteroid therapy for maintenance of remission in pediatric atopic dermatitis: A randomized, open-label, active-controlled, parallel-group study (Anticipate study). J Clin Med. 2022;11(21):6477 (Oct 31). Doi: 10.3390/jcm11216477
Early application of a standardized skin care product does not prevent atopic dermatitis in predisposed infants
Key clinical point: Regular application of a standardized skin care regimen during the first year of life did not prevent the development of atopic dermatitis (AD) in predisposed infants.
Major finding: In the first year of life, the overall cumulative incidence rate of AD was similar with regular standardized skin care and no predetermined skin care/skin care preferred by parents (odds ratio 1.0; P = .999).
Study details: Findings are from a prospective trial (ADAPI) including 150 infants who were at an enhanced risk of developing AD and were randomly assigned to receive a regular standardized skin care regimen or skin care as preferred by parents.
Disclosures: The study was sponsored by HiPP GmbH & Co Vertrieb KG, Germany. Two authors declared being employees of HiPP GmbH & Co Vertrieb KG. The other authors declared no conflicts of interest.
Source: Kottner J et al for the ADAPI Study Group. Effectiveness of a standardized skin care regimen to prevent atopic dermatitis in infants at risk for atopy: A randomized, pragmatic, parallel-group study. J Eur Acad Dermatol Venereol. 2022 (Oct 29). Doi: 10.1111/jdv.18698
Key clinical point: Regular application of a standardized skin care regimen during the first year of life did not prevent the development of atopic dermatitis (AD) in predisposed infants.
Major finding: In the first year of life, the overall cumulative incidence rate of AD was similar with regular standardized skin care and no predetermined skin care/skin care preferred by parents (odds ratio 1.0; P = .999).
Study details: Findings are from a prospective trial (ADAPI) including 150 infants who were at an enhanced risk of developing AD and were randomly assigned to receive a regular standardized skin care regimen or skin care as preferred by parents.
Disclosures: The study was sponsored by HiPP GmbH & Co Vertrieb KG, Germany. Two authors declared being employees of HiPP GmbH & Co Vertrieb KG. The other authors declared no conflicts of interest.
Source: Kottner J et al for the ADAPI Study Group. Effectiveness of a standardized skin care regimen to prevent atopic dermatitis in infants at risk for atopy: A randomized, pragmatic, parallel-group study. J Eur Acad Dermatol Venereol. 2022 (Oct 29). Doi: 10.1111/jdv.18698
Key clinical point: Regular application of a standardized skin care regimen during the first year of life did not prevent the development of atopic dermatitis (AD) in predisposed infants.
Major finding: In the first year of life, the overall cumulative incidence rate of AD was similar with regular standardized skin care and no predetermined skin care/skin care preferred by parents (odds ratio 1.0; P = .999).
Study details: Findings are from a prospective trial (ADAPI) including 150 infants who were at an enhanced risk of developing AD and were randomly assigned to receive a regular standardized skin care regimen or skin care as preferred by parents.
Disclosures: The study was sponsored by HiPP GmbH & Co Vertrieb KG, Germany. Two authors declared being employees of HiPP GmbH & Co Vertrieb KG. The other authors declared no conflicts of interest.
Source: Kottner J et al for the ADAPI Study Group. Effectiveness of a standardized skin care regimen to prevent atopic dermatitis in infants at risk for atopy: A randomized, pragmatic, parallel-group study. J Eur Acad Dermatol Venereol. 2022 (Oct 29). Doi: 10.1111/jdv.18698
First classification criteria proposed for chronic osteomyelitis
PHILADELPHIA – An international group of researchers has proposed the first classification criteria for chronic nonbacterial osteomyelitis (CNO) and a severe form of it, chronic recurrent multifocal osteomyelitis (CRMO).
CNO/CRMO most frequently affect children and adolescents and can significantly affect quality of life.
Yongdong (Dan) Zhao, MD, PhD, a pediatric rheumatologist at Seattle Children’s Hospital, Seattle, Washington, and Seza Ozen, MD, MSc, medical faculty head at Hacettepe University in Ankara, Turkey – members of the expert panel for criteria development – explained the proposed criteria, developed over 6 years, at the American College of Rheumatology 2022 Annual Meeting.
They gave examples of the point system that will help researchers correctly classify CNO/CRMO if the criteria are approved by ACR and the European Alliance of Associations for Rheumatology (EULAR).
Melissa S. Oliver, MD, a pediatric rheumatologist at Riley Children’s Hospital and Indiana University, Indianapolis, told this news organization: “This proposal is important because CNO/CRMO has primarily been a diagnosis of exclusion. There are no specific tests or biomarkers for this disease. It can mimic malignancy and infectious osteomyelitis in its presentation, and these must be ruled out thoroughly first.”
However, she noted, this can be challenging and can delay diagnosis and treatment.
The classification criteria are novel, she said, because an international collaborative group used a consensus process involving physicians managing CNO and patients or caregivers of children with CNO.
Findings for and against CNO
Dr. Ozen summarized some examples of findings for and against a CNO/CRMO classification.
Statistically significant findings in favor of CNO/CRMO, she said, include intermittent bone pain; bone pain in upper torso; swelling of upper torso; presence of symmetric lesions; and presence of adaptive immune cell and/or fibrosis in biopsy.
Conversely, findings against CNO/CRMO include fever; signs of infection by labs; signs of cancer by biopsy; specific abnormal x-ray/CT scan; specific abnormal MRI; or pain resolved with antibiotics alone.
Dr. Zhao described a point system with a threshold of 55 points for classification of CNO/CRMO.
He gave actual examples from the registry to demonstrate high and low probability of CNO/CRMO.
Pro-CNO example
The first was a boy, aged 7 years 10 months, who had a year and a half of pain in his back and legs, but no fever. Pain was constant, waxing and waning. He had a personal and family history of psoriasis and was tender to palpation at multiple sites. Labs were normal and bone biopsy and vitamin C tests were not done; imaging findings showed multiple bones were affected. There was no antibiotic treatment.
That patient was scored 81, much higher than the threshold of 55, and would be classified as having CNO.
Non-CNO example
Conversely, the following example of a patient would score 47 – under the threshold – and would not be classified as having CNO.
That patient was an 11-year-old boy who had 2 months of pain in his right thigh with no fever. The pain was constantly waxing and waning. He was tender to palpation at only his right thigh without swelling. Labs were normal. He had no coexisting conditions. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were not measured, and no vitamin C test was performed. Imaging showed one right femur lesion on a PET-CT scan. There was no antibiotic treatment, and a bone biopsy culture showed malignancy but no inflammation or fibrosis.
Dr. Zhao said the mimickers most likely to be misclassified are vitamin C deficiency; hypophosphatasia; benign bone tumor, such as osteogenic osteoma; and a malignancy with normal labs and multifocal pattern of bone lesions.
The classification criteria will be “extremely helpful to diagnose patients with CNO/CRMO earlier,” said Dr. Oliver, who helped develop the criteria.
“The goal is that the proposed classification criteria will be used by all physicians to diagnose suspected CNO patients earlier and refer to a rheumatologist earlier so that appropriate therapies will not be delayed.”
The group will seek ACR and EULAR endorsement, and if granted, work toward widespread implementation. The criteria will allow researchers to have a more homogeneous study population for future clinical trials, Dr. Zhao said.
Dr. Zhao, Dr. Ozen, and Dr. Oliver declared no relevant financial relationships. Dr. Oliver helped develop the proposed guidelines.
A version of this article first appeared on Medscape.com.
PHILADELPHIA – An international group of researchers has proposed the first classification criteria for chronic nonbacterial osteomyelitis (CNO) and a severe form of it, chronic recurrent multifocal osteomyelitis (CRMO).
CNO/CRMO most frequently affect children and adolescents and can significantly affect quality of life.
Yongdong (Dan) Zhao, MD, PhD, a pediatric rheumatologist at Seattle Children’s Hospital, Seattle, Washington, and Seza Ozen, MD, MSc, medical faculty head at Hacettepe University in Ankara, Turkey – members of the expert panel for criteria development – explained the proposed criteria, developed over 6 years, at the American College of Rheumatology 2022 Annual Meeting.
They gave examples of the point system that will help researchers correctly classify CNO/CRMO if the criteria are approved by ACR and the European Alliance of Associations for Rheumatology (EULAR).
Melissa S. Oliver, MD, a pediatric rheumatologist at Riley Children’s Hospital and Indiana University, Indianapolis, told this news organization: “This proposal is important because CNO/CRMO has primarily been a diagnosis of exclusion. There are no specific tests or biomarkers for this disease. It can mimic malignancy and infectious osteomyelitis in its presentation, and these must be ruled out thoroughly first.”
However, she noted, this can be challenging and can delay diagnosis and treatment.
The classification criteria are novel, she said, because an international collaborative group used a consensus process involving physicians managing CNO and patients or caregivers of children with CNO.
Findings for and against CNO
Dr. Ozen summarized some examples of findings for and against a CNO/CRMO classification.
Statistically significant findings in favor of CNO/CRMO, she said, include intermittent bone pain; bone pain in upper torso; swelling of upper torso; presence of symmetric lesions; and presence of adaptive immune cell and/or fibrosis in biopsy.
Conversely, findings against CNO/CRMO include fever; signs of infection by labs; signs of cancer by biopsy; specific abnormal x-ray/CT scan; specific abnormal MRI; or pain resolved with antibiotics alone.
Dr. Zhao described a point system with a threshold of 55 points for classification of CNO/CRMO.
He gave actual examples from the registry to demonstrate high and low probability of CNO/CRMO.
Pro-CNO example
The first was a boy, aged 7 years 10 months, who had a year and a half of pain in his back and legs, but no fever. Pain was constant, waxing and waning. He had a personal and family history of psoriasis and was tender to palpation at multiple sites. Labs were normal and bone biopsy and vitamin C tests were not done; imaging findings showed multiple bones were affected. There was no antibiotic treatment.
That patient was scored 81, much higher than the threshold of 55, and would be classified as having CNO.
Non-CNO example
Conversely, the following example of a patient would score 47 – under the threshold – and would not be classified as having CNO.
That patient was an 11-year-old boy who had 2 months of pain in his right thigh with no fever. The pain was constantly waxing and waning. He was tender to palpation at only his right thigh without swelling. Labs were normal. He had no coexisting conditions. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were not measured, and no vitamin C test was performed. Imaging showed one right femur lesion on a PET-CT scan. There was no antibiotic treatment, and a bone biopsy culture showed malignancy but no inflammation or fibrosis.
Dr. Zhao said the mimickers most likely to be misclassified are vitamin C deficiency; hypophosphatasia; benign bone tumor, such as osteogenic osteoma; and a malignancy with normal labs and multifocal pattern of bone lesions.
The classification criteria will be “extremely helpful to diagnose patients with CNO/CRMO earlier,” said Dr. Oliver, who helped develop the criteria.
“The goal is that the proposed classification criteria will be used by all physicians to diagnose suspected CNO patients earlier and refer to a rheumatologist earlier so that appropriate therapies will not be delayed.”
The group will seek ACR and EULAR endorsement, and if granted, work toward widespread implementation. The criteria will allow researchers to have a more homogeneous study population for future clinical trials, Dr. Zhao said.
Dr. Zhao, Dr. Ozen, and Dr. Oliver declared no relevant financial relationships. Dr. Oliver helped develop the proposed guidelines.
A version of this article first appeared on Medscape.com.
PHILADELPHIA – An international group of researchers has proposed the first classification criteria for chronic nonbacterial osteomyelitis (CNO) and a severe form of it, chronic recurrent multifocal osteomyelitis (CRMO).
CNO/CRMO most frequently affect children and adolescents and can significantly affect quality of life.
Yongdong (Dan) Zhao, MD, PhD, a pediatric rheumatologist at Seattle Children’s Hospital, Seattle, Washington, and Seza Ozen, MD, MSc, medical faculty head at Hacettepe University in Ankara, Turkey – members of the expert panel for criteria development – explained the proposed criteria, developed over 6 years, at the American College of Rheumatology 2022 Annual Meeting.
They gave examples of the point system that will help researchers correctly classify CNO/CRMO if the criteria are approved by ACR and the European Alliance of Associations for Rheumatology (EULAR).
Melissa S. Oliver, MD, a pediatric rheumatologist at Riley Children’s Hospital and Indiana University, Indianapolis, told this news organization: “This proposal is important because CNO/CRMO has primarily been a diagnosis of exclusion. There are no specific tests or biomarkers for this disease. It can mimic malignancy and infectious osteomyelitis in its presentation, and these must be ruled out thoroughly first.”
However, she noted, this can be challenging and can delay diagnosis and treatment.
The classification criteria are novel, she said, because an international collaborative group used a consensus process involving physicians managing CNO and patients or caregivers of children with CNO.
Findings for and against CNO
Dr. Ozen summarized some examples of findings for and against a CNO/CRMO classification.
Statistically significant findings in favor of CNO/CRMO, she said, include intermittent bone pain; bone pain in upper torso; swelling of upper torso; presence of symmetric lesions; and presence of adaptive immune cell and/or fibrosis in biopsy.
Conversely, findings against CNO/CRMO include fever; signs of infection by labs; signs of cancer by biopsy; specific abnormal x-ray/CT scan; specific abnormal MRI; or pain resolved with antibiotics alone.
Dr. Zhao described a point system with a threshold of 55 points for classification of CNO/CRMO.
He gave actual examples from the registry to demonstrate high and low probability of CNO/CRMO.
Pro-CNO example
The first was a boy, aged 7 years 10 months, who had a year and a half of pain in his back and legs, but no fever. Pain was constant, waxing and waning. He had a personal and family history of psoriasis and was tender to palpation at multiple sites. Labs were normal and bone biopsy and vitamin C tests were not done; imaging findings showed multiple bones were affected. There was no antibiotic treatment.
That patient was scored 81, much higher than the threshold of 55, and would be classified as having CNO.
Non-CNO example
Conversely, the following example of a patient would score 47 – under the threshold – and would not be classified as having CNO.
That patient was an 11-year-old boy who had 2 months of pain in his right thigh with no fever. The pain was constantly waxing and waning. He was tender to palpation at only his right thigh without swelling. Labs were normal. He had no coexisting conditions. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were not measured, and no vitamin C test was performed. Imaging showed one right femur lesion on a PET-CT scan. There was no antibiotic treatment, and a bone biopsy culture showed malignancy but no inflammation or fibrosis.
Dr. Zhao said the mimickers most likely to be misclassified are vitamin C deficiency; hypophosphatasia; benign bone tumor, such as osteogenic osteoma; and a malignancy with normal labs and multifocal pattern of bone lesions.
The classification criteria will be “extremely helpful to diagnose patients with CNO/CRMO earlier,” said Dr. Oliver, who helped develop the criteria.
“The goal is that the proposed classification criteria will be used by all physicians to diagnose suspected CNO patients earlier and refer to a rheumatologist earlier so that appropriate therapies will not be delayed.”
The group will seek ACR and EULAR endorsement, and if granted, work toward widespread implementation. The criteria will allow researchers to have a more homogeneous study population for future clinical trials, Dr. Zhao said.
Dr. Zhao, Dr. Ozen, and Dr. Oliver declared no relevant financial relationships. Dr. Oliver helped develop the proposed guidelines.
A version of this article first appeared on Medscape.com.
AT ACR 2022
Topical POLG nanoemulsion improves dryness and itchiness in atopic dermatitis
Key clinical point: Daily continuous use of 10% phytosteryl/octyldodecyl lauroyl glutamate (POLG) nanoemulsion improved several dry skin symptoms and itchiness in patients with atopic dermatitis (AD).
Major finding: Significant improvement was observed with POLG nanoemulsion in itchiness as early as at 3 weeks (P < .05) and dryness at 6 weeks (P < .01). By 6 weeks, scaliness and smoothness of the skin were also significantly improved (P < .01).
Study details: Findings are from a clinical study including patients with AD who received 10% POLG nanoemulsion for 6 weeks.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Takada M et al. A nano-emulsion containing ceramide-like lipo-amino acid cholesteryl derivatives improves skin symptoms in patients with atopic dermatitis by ameliorating the water-holding function. Int J Mol Sci. 2022;23(21):13362 (Nov 1). Doi: 10.3390/ijms232113362
Key clinical point: Daily continuous use of 10% phytosteryl/octyldodecyl lauroyl glutamate (POLG) nanoemulsion improved several dry skin symptoms and itchiness in patients with atopic dermatitis (AD).
Major finding: Significant improvement was observed with POLG nanoemulsion in itchiness as early as at 3 weeks (P < .05) and dryness at 6 weeks (P < .01). By 6 weeks, scaliness and smoothness of the skin were also significantly improved (P < .01).
Study details: Findings are from a clinical study including patients with AD who received 10% POLG nanoemulsion for 6 weeks.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Takada M et al. A nano-emulsion containing ceramide-like lipo-amino acid cholesteryl derivatives improves skin symptoms in patients with atopic dermatitis by ameliorating the water-holding function. Int J Mol Sci. 2022;23(21):13362 (Nov 1). Doi: 10.3390/ijms232113362
Key clinical point: Daily continuous use of 10% phytosteryl/octyldodecyl lauroyl glutamate (POLG) nanoemulsion improved several dry skin symptoms and itchiness in patients with atopic dermatitis (AD).
Major finding: Significant improvement was observed with POLG nanoemulsion in itchiness as early as at 3 weeks (P < .05) and dryness at 6 weeks (P < .01). By 6 weeks, scaliness and smoothness of the skin were also significantly improved (P < .01).
Study details: Findings are from a clinical study including patients with AD who received 10% POLG nanoemulsion for 6 weeks.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Takada M et al. A nano-emulsion containing ceramide-like lipo-amino acid cholesteryl derivatives improves skin symptoms in patients with atopic dermatitis by ameliorating the water-holding function. Int J Mol Sci. 2022;23(21):13362 (Nov 1). Doi: 10.3390/ijms232113362
Emollient use in the first year of life does not protect against atopic dermatitis in the long term
Key clinical point: Daily application of emollients during the first year of life did not prevent the development of atopic dermatitis (AD) in the long term.
Major finding: A similar proportion of children in the emollient and standard skincare groups were clinically diagnosed with AD between 12 and 60 months (31% and 28%, respectively; adjusted relative risk 1.10; 95% CI 0.93-1.30).
Study details: Findings are from the multicenter, parallel, Barrier Enhancement for Eczema Prevention trial including 1394 infants at high risk of developing AD who were randomly assigned to receive emollient for the first year plus standard skincare or only standard skincare.
Disclosures: This study was funded by the UK National Institute for Health and Care Research Health Technology Assessment. Some authors declared receiving personal fees, grants, or research funding from or serving as an investigator or director for several sources.
Source: Bradshaw LE et al. Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial. Allergy. 2022 (Oct 19). Doi: 10.1111/all.15555
Key clinical point: Daily application of emollients during the first year of life did not prevent the development of atopic dermatitis (AD) in the long term.
Major finding: A similar proportion of children in the emollient and standard skincare groups were clinically diagnosed with AD between 12 and 60 months (31% and 28%, respectively; adjusted relative risk 1.10; 95% CI 0.93-1.30).
Study details: Findings are from the multicenter, parallel, Barrier Enhancement for Eczema Prevention trial including 1394 infants at high risk of developing AD who were randomly assigned to receive emollient for the first year plus standard skincare or only standard skincare.
Disclosures: This study was funded by the UK National Institute for Health and Care Research Health Technology Assessment. Some authors declared receiving personal fees, grants, or research funding from or serving as an investigator or director for several sources.
Source: Bradshaw LE et al. Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial. Allergy. 2022 (Oct 19). Doi: 10.1111/all.15555
Key clinical point: Daily application of emollients during the first year of life did not prevent the development of atopic dermatitis (AD) in the long term.
Major finding: A similar proportion of children in the emollient and standard skincare groups were clinically diagnosed with AD between 12 and 60 months (31% and 28%, respectively; adjusted relative risk 1.10; 95% CI 0.93-1.30).
Study details: Findings are from the multicenter, parallel, Barrier Enhancement for Eczema Prevention trial including 1394 infants at high risk of developing AD who were randomly assigned to receive emollient for the first year plus standard skincare or only standard skincare.
Disclosures: This study was funded by the UK National Institute for Health and Care Research Health Technology Assessment. Some authors declared receiving personal fees, grants, or research funding from or serving as an investigator or director for several sources.
Source: Bradshaw LE et al. Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial. Allergy. 2022 (Oct 19). Doi: 10.1111/all.15555
Topical prebiotics and postbiotics effective and well tolerated in mild-to-moderate atopic dermatitis
Key clinical point: A topical formulation containing a mixture of prebiotics and postbiotics was effective and well tolerated in patients with mild-to-moderate atopic dermatitis (AD).
Major finding: After 15 weeks, the SCORing AD index (−59.2%; P < .001) and the PRURISCORE (−64.1%; P < .001) reduced significantly, with 68.0% of patients reporting the tolerability of the drug as “very good” or “excellent.”
Study details: Findings are from a study including 396 patients with mild or moderate AD who received a topical formulation containing a mixture of prebiotics and postbiotics.
Disclosures: This work was supported by the Istituto Ganassini di Ricerche Biochimiche, Italy. The authors declared no conflicts of interest.
Source: Gelmetti C et al. Topical prebiotics/postbiotics and PRURISCORE validation in atopic dermatitis. International study of 396 patients. J Dermatolog Treat. 2022 (Oct 17). Doi: 10.1080/09546634.2022.2131703
Key clinical point: A topical formulation containing a mixture of prebiotics and postbiotics was effective and well tolerated in patients with mild-to-moderate atopic dermatitis (AD).
Major finding: After 15 weeks, the SCORing AD index (−59.2%; P < .001) and the PRURISCORE (−64.1%; P < .001) reduced significantly, with 68.0% of patients reporting the tolerability of the drug as “very good” or “excellent.”
Study details: Findings are from a study including 396 patients with mild or moderate AD who received a topical formulation containing a mixture of prebiotics and postbiotics.
Disclosures: This work was supported by the Istituto Ganassini di Ricerche Biochimiche, Italy. The authors declared no conflicts of interest.
Source: Gelmetti C et al. Topical prebiotics/postbiotics and PRURISCORE validation in atopic dermatitis. International study of 396 patients. J Dermatolog Treat. 2022 (Oct 17). Doi: 10.1080/09546634.2022.2131703
Key clinical point: A topical formulation containing a mixture of prebiotics and postbiotics was effective and well tolerated in patients with mild-to-moderate atopic dermatitis (AD).
Major finding: After 15 weeks, the SCORing AD index (−59.2%; P < .001) and the PRURISCORE (−64.1%; P < .001) reduced significantly, with 68.0% of patients reporting the tolerability of the drug as “very good” or “excellent.”
Study details: Findings are from a study including 396 patients with mild or moderate AD who received a topical formulation containing a mixture of prebiotics and postbiotics.
Disclosures: This work was supported by the Istituto Ganassini di Ricerche Biochimiche, Italy. The authors declared no conflicts of interest.
Source: Gelmetti C et al. Topical prebiotics/postbiotics and PRURISCORE validation in atopic dermatitis. International study of 396 patients. J Dermatolog Treat. 2022 (Oct 17). Doi: 10.1080/09546634.2022.2131703