Key clinical point: Over 22 years of follow-up found no association between the use of hormone therapy (HT) and the risk for disability accrual in women with multiple sclerosis (MS) treated with a disease-modifying therapy (DMT) when used for <5 years.

Major finding: Overall, current HT use vs. no use was not associated with a significantly higher risk for disability accrual; however, the risk of reaching 6-month confirmed and sustained Expanded Disability Status Scale 4 increased from 0.6 (95% CI 0.3-1.2) after <1 year of use to 1.4 (95% CI 0.9-2.2) after >5 years of HT use vs. no use.

Study details: The data come from a nationwide, population-based cohort study of 3,325 women with relapsing-remitting MS treated with DMT.

Disclosures: This study received no external funding. TI Kopp revealed his role as an adviser for Novartis and received Biogen's sponsorship for congress participation. M Magyari declared serving as an advisor and receiving honoraria for lecturing and research support for congress participation from various sources. Ø Lidegaard had no conflicts of interest.

Source: Kopp TI et al. Hormone therapy and disease activity in Danish women with multiple sclerosis: A population-based cohort study. Eur J Neurol. 2022 (Feb 23). Doi: 10.1111/ene.15299

Key clinical point: Over 22 years of follow-up found no association between the use of hormone therapy (HT) and the risk for disability accrual in women with multiple sclerosis (MS) treated with a disease-modifying therapy (DMT) when used for <5 years.

Major finding: Overall, current HT use vs. no use was not associated with a significantly higher risk for disability accrual; however, the risk of reaching 6-month confirmed and sustained Expanded Disability Status Scale 4 increased from 0.6 (95% CI 0.3-1.2) after <1 year of use to 1.4 (95% CI 0.9-2.2) after >5 years of HT use vs. no use.

Study details: The data come from a nationwide, population-based cohort study of 3,325 women with relapsing-remitting MS treated with DMT.

Disclosures: This study received no external funding. TI Kopp revealed his role as an adviser for Novartis and received Biogen's sponsorship for congress participation. M Magyari declared serving as an advisor and receiving honoraria for lecturing and research support for congress participation from various sources. Ø Lidegaard had no conflicts of interest.

Source: Kopp TI et al. Hormone therapy and disease activity in Danish women with multiple sclerosis: A population-based cohort study. Eur J Neurol. 2022 (Feb 23). Doi: 10.1111/ene.15299

Key clinical point: Over 22 years of follow-up found no association between the use of hormone therapy (HT) and the risk for disability accrual in women with multiple sclerosis (MS) treated with a disease-modifying therapy (DMT) when used for <5 years.

Major finding: Overall, current HT use vs. no use was not associated with a significantly higher risk for disability accrual; however, the risk of reaching 6-month confirmed and sustained Expanded Disability Status Scale 4 increased from 0.6 (95% CI 0.3-1.2) after <1 year of use to 1.4 (95% CI 0.9-2.2) after >5 years of HT use vs. no use.

Study details: The data come from a nationwide, population-based cohort study of 3,325 women with relapsing-remitting MS treated with DMT.

Disclosures: This study received no external funding. TI Kopp revealed his role as an adviser for Novartis and received Biogen's sponsorship for congress participation. M Magyari declared serving as an advisor and receiving honoraria for lecturing and research support for congress participation from various sources. Ø Lidegaard had no conflicts of interest.

Source: Kopp TI et al. Hormone therapy and disease activity in Danish women with multiple sclerosis: A population-based cohort study. Eur J Neurol. 2022 (Feb 23). Doi: 10.1111/ene.15299

The Diagnosis: Odontogenic Cutaneous Sinus Tract

In our patient, panoramic radiography showed a radiolucency in the periapex of the mandibular first molar (Figure 1). Ultrasonography depicted a hypoechoic band that originated from the cutaneous lesion and extended through the subcutaneous tissue to the defective alveolar bone, suggesting odontogenic inflammation (Figure 2).¹ The infected pulp was removed, and the purulent nodules then disappeared.

The dental etiology of odontogenic cutaneous sinus tracts can be confirmed by panoramic radiography and ultrasonography. The odontogenic sinus path can be clearly observed via radiography by injecting or inserting a radiopaque substance into the sinus tract.² Effective treatment of the diseased tooth is removal of the infected pulp, performance of a root canal to eliminate infection, closure and filling of the root canal, and repair of the crown. Once the source of infection is eliminated, the sinus typically subsides within 2 weeks. When residual skin retreats or scars are present, cosmetic surgery can be performed to improve the appearance.^3,4

Odontogenic cutaneous sinus tracts usually are caused by a route of drainage from a chronic apical abscess. They follow a path of least resistance through the alveolar bone and periosteum, spreading into the surrounding soft tissues. With the formation of abscesses, sinus tracts will erupt intraorally or cutaneously, depending on the relationship of the posterior tooth apices to the mandibular attachments of the mylohyoid and buccinator muscles and the maxillary attachment of the buccinator.^2,5 Clinically, cutaneous lesions present as nodules, cysts, or dimples that have attached to deep tissues through the sinus tract. Half of patients may have no dental symptoms and often are misdiagnosed with nonodontogenic lesions. Subsequent improper treatments, such as repeated use of antibiotics, multiple biopsies, surgical excision, and chemotherapy, often are repeated and ineffective.⁶ The most common cause of chronic cutaneous sinus tracts in the face and neck is a chronically draining dental infection.^2,5 A thorough history is necessary when odontogenic cutaneous sinuses are suspected. Toothache before the development of the sinus tract is an important diagnostic clue.

Pyogenic granuloma, syringocystadenoma papilliferum, osteomyelitis, infected epidermoid cyst, actinomycoses, and salivary gland fistula also should be considered in the differential diagnosis.^7-10 Pyogenic granuloma (also known as lobular capillary hemangioma) is a benign overgrowth of capillaries showing a vascular phenotype that usually occurs as a response to different stimulating factors such as local stimuli, trauma, or hormonal factors. Clinically, pyogenic granuloma presents as a red, solitary, painless nodule on the face or distal extremities.^11,12 Syringocystadenoma papilliferum is a benign adnexal proliferation with apocrine differentiation that usually presents as a hairless papillomatous plaque or nodule measuring 1 to 4 cm in diameter and often is first noted at birth or during early childhood.⁷ Osteomyelitis is progressive inflammation of the periosteum and bone marrow that rapidly breaks through the periosteum and spreads to surrounding areas. The mandible is the most susceptible bone for facial osteomyelitis.⁸ Epidermoid cysts are formed by the proliferation of epidermal cells within a circumscribed dermal space. Infection of the cysts is characterized by redness, swelling, heat, and pain. As the infection progresses, suppurative inflammation develops, leading to local liquefaction and abscesses.⁹

This case was initially misdiagnosed as infectious skin lesions by outside clinicians. Multiple surgical treatments and long-term antibiotic therapy were attempted before the correct diagnosis was made. The clinical diagnosis of odontogenic cutaneous sinus tracts is challenging due to the variety of affected sites and clinical signs. Ultrasonography should be performed as early as possible to identify the disease and avoid unnecessary surgery. For appropriate dental therapy, close liaison with the stomatology department is warranted.

The Diagnosis: Odontogenic Cutaneous Sinus Tract

In our patient, panoramic radiography showed a radiolucency in the periapex of the mandibular first molar (Figure 1). Ultrasonography depicted a hypoechoic band that originated from the cutaneous lesion and extended through the subcutaneous tissue to the defective alveolar bone, suggesting odontogenic inflammation (Figure 2).¹ The infected pulp was removed, and the purulent nodules then disappeared.

The dental etiology of odontogenic cutaneous sinus tracts can be confirmed by panoramic radiography and ultrasonography. The odontogenic sinus path can be clearly observed via radiography by injecting or inserting a radiopaque substance into the sinus tract.² Effective treatment of the diseased tooth is removal of the infected pulp, performance of a root canal to eliminate infection, closure and filling of the root canal, and repair of the crown. Once the source of infection is eliminated, the sinus typically subsides within 2 weeks. When residual skin retreats or scars are present, cosmetic surgery can be performed to improve the appearance.^3,4

Odontogenic cutaneous sinus tracts usually are caused by a route of drainage from a chronic apical abscess. They follow a path of least resistance through the alveolar bone and periosteum, spreading into the surrounding soft tissues. With the formation of abscesses, sinus tracts will erupt intraorally or cutaneously, depending on the relationship of the posterior tooth apices to the mandibular attachments of the mylohyoid and buccinator muscles and the maxillary attachment of the buccinator.^2,5 Clinically, cutaneous lesions present as nodules, cysts, or dimples that have attached to deep tissues through the sinus tract. Half of patients may have no dental symptoms and often are misdiagnosed with nonodontogenic lesions. Subsequent improper treatments, such as repeated use of antibiotics, multiple biopsies, surgical excision, and chemotherapy, often are repeated and ineffective.⁶ The most common cause of chronic cutaneous sinus tracts in the face and neck is a chronically draining dental infection.^2,5 A thorough history is necessary when odontogenic cutaneous sinuses are suspected. Toothache before the development of the sinus tract is an important diagnostic clue.

Pyogenic granuloma, syringocystadenoma papilliferum, osteomyelitis, infected epidermoid cyst, actinomycoses, and salivary gland fistula also should be considered in the differential diagnosis.^7-10 Pyogenic granuloma (also known as lobular capillary hemangioma) is a benign overgrowth of capillaries showing a vascular phenotype that usually occurs as a response to different stimulating factors such as local stimuli, trauma, or hormonal factors. Clinically, pyogenic granuloma presents as a red, solitary, painless nodule on the face or distal extremities.^11,12 Syringocystadenoma papilliferum is a benign adnexal proliferation with apocrine differentiation that usually presents as a hairless papillomatous plaque or nodule measuring 1 to 4 cm in diameter and often is first noted at birth or during early childhood.⁷ Osteomyelitis is progressive inflammation of the periosteum and bone marrow that rapidly breaks through the periosteum and spreads to surrounding areas. The mandible is the most susceptible bone for facial osteomyelitis.⁸ Epidermoid cysts are formed by the proliferation of epidermal cells within a circumscribed dermal space. Infection of the cysts is characterized by redness, swelling, heat, and pain. As the infection progresses, suppurative inflammation develops, leading to local liquefaction and abscesses.⁹

This case was initially misdiagnosed as infectious skin lesions by outside clinicians. Multiple surgical treatments and long-term antibiotic therapy were attempted before the correct diagnosis was made. The clinical diagnosis of odontogenic cutaneous sinus tracts is challenging due to the variety of affected sites and clinical signs. Ultrasonography should be performed as early as possible to identify the disease and avoid unnecessary surgery. For appropriate dental therapy, close liaison with the stomatology department is warranted.

The Diagnosis: Odontogenic Cutaneous Sinus Tract

In our patient, panoramic radiography showed a radiolucency in the periapex of the mandibular first molar (Figure 1). Ultrasonography depicted a hypoechoic band that originated from the cutaneous lesion and extended through the subcutaneous tissue to the defective alveolar bone, suggesting odontogenic inflammation (Figure 2).¹ The infected pulp was removed, and the purulent nodules then disappeared.

The dental etiology of odontogenic cutaneous sinus tracts can be confirmed by panoramic radiography and ultrasonography. The odontogenic sinus path can be clearly observed via radiography by injecting or inserting a radiopaque substance into the sinus tract.² Effective treatment of the diseased tooth is removal of the infected pulp, performance of a root canal to eliminate infection, closure and filling of the root canal, and repair of the crown. Once the source of infection is eliminated, the sinus typically subsides within 2 weeks. When residual skin retreats or scars are present, cosmetic surgery can be performed to improve the appearance.^3,4

Odontogenic cutaneous sinus tracts usually are caused by a route of drainage from a chronic apical abscess. They follow a path of least resistance through the alveolar bone and periosteum, spreading into the surrounding soft tissues. With the formation of abscesses, sinus tracts will erupt intraorally or cutaneously, depending on the relationship of the posterior tooth apices to the mandibular attachments of the mylohyoid and buccinator muscles and the maxillary attachment of the buccinator.^2,5 Clinically, cutaneous lesions present as nodules, cysts, or dimples that have attached to deep tissues through the sinus tract. Half of patients may have no dental symptoms and often are misdiagnosed with nonodontogenic lesions. Subsequent improper treatments, such as repeated use of antibiotics, multiple biopsies, surgical excision, and chemotherapy, often are repeated and ineffective.⁶ The most common cause of chronic cutaneous sinus tracts in the face and neck is a chronically draining dental infection.^2,5 A thorough history is necessary when odontogenic cutaneous sinuses are suspected. Toothache before the development of the sinus tract is an important diagnostic clue.

Pyogenic granuloma, syringocystadenoma papilliferum, osteomyelitis, infected epidermoid cyst, actinomycoses, and salivary gland fistula also should be considered in the differential diagnosis.^7-10 Pyogenic granuloma (also known as lobular capillary hemangioma) is a benign overgrowth of capillaries showing a vascular phenotype that usually occurs as a response to different stimulating factors such as local stimuli, trauma, or hormonal factors. Clinically, pyogenic granuloma presents as a red, solitary, painless nodule on the face or distal extremities.^11,12 Syringocystadenoma papilliferum is a benign adnexal proliferation with apocrine differentiation that usually presents as a hairless papillomatous plaque or nodule measuring 1 to 4 cm in diameter and often is first noted at birth or during early childhood.⁷ Osteomyelitis is progressive inflammation of the periosteum and bone marrow that rapidly breaks through the periosteum and spreads to surrounding areas. The mandible is the most susceptible bone for facial osteomyelitis.⁸ Epidermoid cysts are formed by the proliferation of epidermal cells within a circumscribed dermal space. Infection of the cysts is characterized by redness, swelling, heat, and pain. As the infection progresses, suppurative inflammation develops, leading to local liquefaction and abscesses.⁹

This case was initially misdiagnosed as infectious skin lesions by outside clinicians. Multiple surgical treatments and long-term antibiotic therapy were attempted before the correct diagnosis was made. The clinical diagnosis of odontogenic cutaneous sinus tracts is challenging due to the variety of affected sites and clinical signs. Ultrasonography should be performed as early as possible to identify the disease and avoid unnecessary surgery. For appropriate dental therapy, close liaison with the stomatology department is warranted.

Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).

Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.

Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.

Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.

Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148

Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).

Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.

Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.

Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.

Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148

Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).

Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.

Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.

Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.

Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148

Key clinical point: Plasma levels of S100A12 and apolipoprotein A1 (Apo-A1) could serve as effective biomarkers for the early detection and screening of relapsing-remitting multiple sclerosis (RRMS) in patients with early disease and those at high risk.

Major finding: The mean plasma S100A12 level was significantly lower in patients with new untreated RRMS (36.781 pg/mL) and their first-degree family members (15.979 pg/mL) vs. healthy control (HC) participants (42.586 pg/mL; P ≤ .05). Mean plasma Apo-A1 levels were significantly lower in the first-degree family members of patients with RRMS vs. HC participants (111.78 pg/mL vs. 205.88 pg/mL; P ≤ .05).

Study details: The study involved 35 patients with new untreated RRMS, 26 first-degree relatives of patients with RRMS, and 24 participants who formed the HC group.

Disclosure: No source of funding was declared. The authors reported no conflicts of interest.

Source: Samangooei M et al. Evaluation of S100A12 and Apo-A1 plasma level potency in untreated new relapsing–remitting multiple sclerosis patients and their family members. Sci Rep. 2022;12:2160 (Feb 9). Doi: 10.1038/s41598-022-06322-4

Key clinical point: Plasma levels of S100A12 and apolipoprotein A1 (Apo-A1) could serve as effective biomarkers for the early detection and screening of relapsing-remitting multiple sclerosis (RRMS) in patients with early disease and those at high risk.

Major finding: The mean plasma S100A12 level was significantly lower in patients with new untreated RRMS (36.781 pg/mL) and their first-degree family members (15.979 pg/mL) vs. healthy control (HC) participants (42.586 pg/mL; P ≤ .05). Mean plasma Apo-A1 levels were significantly lower in the first-degree family members of patients with RRMS vs. HC participants (111.78 pg/mL vs. 205.88 pg/mL; P ≤ .05).

Study details: The study involved 35 patients with new untreated RRMS, 26 first-degree relatives of patients with RRMS, and 24 participants who formed the HC group.

Disclosure: No source of funding was declared. The authors reported no conflicts of interest.

Source: Samangooei M et al. Evaluation of S100A12 and Apo-A1 plasma level potency in untreated new relapsing–remitting multiple sclerosis patients and their family members. Sci Rep. 2022;12:2160 (Feb 9). Doi: 10.1038/s41598-022-06322-4

Key clinical point: Plasma levels of S100A12 and apolipoprotein A1 (Apo-A1) could serve as effective biomarkers for the early detection and screening of relapsing-remitting multiple sclerosis (RRMS) in patients with early disease and those at high risk.

Major finding: The mean plasma S100A12 level was significantly lower in patients with new untreated RRMS (36.781 pg/mL) and their first-degree family members (15.979 pg/mL) vs. healthy control (HC) participants (42.586 pg/mL; P ≤ .05). Mean plasma Apo-A1 levels were significantly lower in the first-degree family members of patients with RRMS vs. HC participants (111.78 pg/mL vs. 205.88 pg/mL; P ≤ .05).

Study details: The study involved 35 patients with new untreated RRMS, 26 first-degree relatives of patients with RRMS, and 24 participants who formed the HC group.

Disclosure: No source of funding was declared. The authors reported no conflicts of interest.

Source: Samangooei M et al. Evaluation of S100A12 and Apo-A1 plasma level potency in untreated new relapsing–remitting multiple sclerosis patients and their family members. Sci Rep. 2022;12:2160 (Feb 9). Doi: 10.1038/s41598-022-06322-4

Key clinical point: Bacillus Calmette-Guérin (BCG) vaccination had no effect on the incidence of relapsing-remitting multiple sclerosis (RRMS), but was positively associated with the incidence of MS diagnosed later in life.

Major finding: BCG vaccination was not associated with the incidence of RRMS during the entire follow-up period (adjusted hazard ratio [aHR] 1.01; 95% CI 0.85-1.20), but was positively associated with the incidence of MS diagnosed later in life (aHR 1.22; 95% CI 1.09-1.36).

Study details: Findings are from an analysis of 400,563 individuals from the Quebec Birth Cohort for Immunity and Health (QBCIH) who were followed up from 1983 to 2014.

Disclosures: The establishment of QBCIH was supported by the Canada Foundation for Innovation; Québec Ministry of Education, Leisure, and Sports; Canadian Institutes of Health Research; Fonds de recherche du Québec-Santé, and the Multiple Sclerosis Society of Canada. The authors declared no conflicts of interest.

Source: Corsenac P et al. Bacillus Calmette–Guerin vaccination and multiple sclerosis: A population-based birth cohort study in Quebec, Canada. Eur J Neurol. 2022 (Feb 15). Doi: 10.1111/ene.15290

Key clinical point: Bacillus Calmette-Guérin (BCG) vaccination had no effect on the incidence of relapsing-remitting multiple sclerosis (RRMS), but was positively associated with the incidence of MS diagnosed later in life.

Major finding: BCG vaccination was not associated with the incidence of RRMS during the entire follow-up period (adjusted hazard ratio [aHR] 1.01; 95% CI 0.85-1.20), but was positively associated with the incidence of MS diagnosed later in life (aHR 1.22; 95% CI 1.09-1.36).

Study details: Findings are from an analysis of 400,563 individuals from the Quebec Birth Cohort for Immunity and Health (QBCIH) who were followed up from 1983 to 2014.

Disclosures: The establishment of QBCIH was supported by the Canada Foundation for Innovation; Québec Ministry of Education, Leisure, and Sports; Canadian Institutes of Health Research; Fonds de recherche du Québec-Santé, and the Multiple Sclerosis Society of Canada. The authors declared no conflicts of interest.

Source: Corsenac P et al. Bacillus Calmette–Guerin vaccination and multiple sclerosis: A population-based birth cohort study in Quebec, Canada. Eur J Neurol. 2022 (Feb 15). Doi: 10.1111/ene.15290

Key clinical point: Bacillus Calmette-Guérin (BCG) vaccination had no effect on the incidence of relapsing-remitting multiple sclerosis (RRMS), but was positively associated with the incidence of MS diagnosed later in life.

Major finding: BCG vaccination was not associated with the incidence of RRMS during the entire follow-up period (adjusted hazard ratio [aHR] 1.01; 95% CI 0.85-1.20), but was positively associated with the incidence of MS diagnosed later in life (aHR 1.22; 95% CI 1.09-1.36).

Study details: Findings are from an analysis of 400,563 individuals from the Quebec Birth Cohort for Immunity and Health (QBCIH) who were followed up from 1983 to 2014.

Disclosures: The establishment of QBCIH was supported by the Canada Foundation for Innovation; Québec Ministry of Education, Leisure, and Sports; Canadian Institutes of Health Research; Fonds de recherche du Québec-Santé, and the Multiple Sclerosis Society of Canada. The authors declared no conflicts of interest.

Source: Corsenac P et al. Bacillus Calmette–Guerin vaccination and multiple sclerosis: A population-based birth cohort study in Quebec, Canada. Eur J Neurol. 2022 (Feb 15). Doi: 10.1111/ene.15290

Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).

Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of −0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.

Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.

Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.

Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6

Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).

Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of −0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.

Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.

Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.

Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6

Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).

Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of −0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.

Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.

Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.

Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6

Key clinical point: A delay in initiation of adjuvant hormone therapy (AHT) beyond 150 days was significantly associated with poor survival in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (ERBB2)-negative breast cancer (BC) not receiving chemotherapy.

Major finding: Time to AHT (TTH) >150 days vs. ≤150 days was associated with an increased risk for death in the overall population (hazard ratio 1.31; P < .001).

Study details: Findings are from a population-based retrospective study including 144,103 patients with HR-positive/ERBB2-negative early BC who received AHT without chemotherapy, of which 6.4% of patients experienced a delay in AHT initiation (TTH >150 days) and 93.6% initiated AHT on time (TTH ≤150 days).

Disclosures: This study was supported by the Natural Science Foundation of Fujian Province and the Fujian Provincial Health Technology Project. The authors declared no conflicts of interest.

Source: Fu F et al. Association of adjuvant hormone therapy timing with overall survival among patients with hormone receptor–positive human epidermal growth factor receptor-2–negative early breast cancer without chemotherapy. JAMA Netw Open. 2022;5(2):e2145934 (Feb 15). Doi: 10.1001/jamanetworkopen.2021.45934

Key clinical point: A delay in initiation of adjuvant hormone therapy (AHT) beyond 150 days was significantly associated with poor survival in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (ERBB2)-negative breast cancer (BC) not receiving chemotherapy.

Major finding: Time to AHT (TTH) >150 days vs. ≤150 days was associated with an increased risk for death in the overall population (hazard ratio 1.31; P < .001).

Study details: Findings are from a population-based retrospective study including 144,103 patients with HR-positive/ERBB2-negative early BC who received AHT without chemotherapy, of which 6.4% of patients experienced a delay in AHT initiation (TTH >150 days) and 93.6% initiated AHT on time (TTH ≤150 days).

Disclosures: This study was supported by the Natural Science Foundation of Fujian Province and the Fujian Provincial Health Technology Project. The authors declared no conflicts of interest.

Source: Fu F et al. Association of adjuvant hormone therapy timing with overall survival among patients with hormone receptor–positive human epidermal growth factor receptor-2–negative early breast cancer without chemotherapy. JAMA Netw Open. 2022;5(2):e2145934 (Feb 15). Doi: 10.1001/jamanetworkopen.2021.45934

Key clinical point: A delay in initiation of adjuvant hormone therapy (AHT) beyond 150 days was significantly associated with poor survival in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (ERBB2)-negative breast cancer (BC) not receiving chemotherapy.

Major finding: Time to AHT (TTH) >150 days vs. ≤150 days was associated with an increased risk for death in the overall population (hazard ratio 1.31; P < .001).

Study details: Findings are from a population-based retrospective study including 144,103 patients with HR-positive/ERBB2-negative early BC who received AHT without chemotherapy, of which 6.4% of patients experienced a delay in AHT initiation (TTH >150 days) and 93.6% initiated AHT on time (TTH ≤150 days).

Disclosures: This study was supported by the Natural Science Foundation of Fujian Province and the Fujian Provincial Health Technology Project. The authors declared no conflicts of interest.

Source: Fu F et al. Association of adjuvant hormone therapy timing with overall survival among patients with hormone receptor–positive human epidermal growth factor receptor-2–negative early breast cancer without chemotherapy. JAMA Netw Open. 2022;5(2):e2145934 (Feb 15). Doi: 10.1001/jamanetworkopen.2021.45934

Key clinical point: Pretreatment levels of testosterone and follicle-stimulating hormone (FSH) independently predicted pathological complete response (pCR) in premenopausal and postmenopausal women with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The likelihood of achieving pCR was higher in premenopausal women with lower vs. higher testosterone levels (odds ratio [OR] 0.996; P = .026) and in postmenopausal women with higher vs. lower FSH levels (OR 1.045; P = .005).

Study details: This was a retrospective study of 196 premenopausal and 137 postmenopausal women with invasive BC who received NAC.

Disclosures: This study was funded by National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Lan A et al. Pre-treatment circulating reproductive hormones levels predict pathological and survival outcomes in breast cancer submitted to neoadjuvant chemotherapy. Int J Clin Oncol. 2022 (Mar 3). Doi: 10.1007/s10147-022-02141-9

Key clinical point: Pretreatment levels of testosterone and follicle-stimulating hormone (FSH) independently predicted pathological complete response (pCR) in premenopausal and postmenopausal women with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The likelihood of achieving pCR was higher in premenopausal women with lower vs. higher testosterone levels (odds ratio [OR] 0.996; P = .026) and in postmenopausal women with higher vs. lower FSH levels (OR 1.045; P = .005).

Study details: This was a retrospective study of 196 premenopausal and 137 postmenopausal women with invasive BC who received NAC.

Disclosures: This study was funded by National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Lan A et al. Pre-treatment circulating reproductive hormones levels predict pathological and survival outcomes in breast cancer submitted to neoadjuvant chemotherapy. Int J Clin Oncol. 2022 (Mar 3). Doi: 10.1007/s10147-022-02141-9

Key clinical point: Pretreatment levels of testosterone and follicle-stimulating hormone (FSH) independently predicted pathological complete response (pCR) in premenopausal and postmenopausal women with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The likelihood of achieving pCR was higher in premenopausal women with lower vs. higher testosterone levels (odds ratio [OR] 0.996; P = .026) and in postmenopausal women with higher vs. lower FSH levels (OR 1.045; P = .005).

Study details: This was a retrospective study of 196 premenopausal and 137 postmenopausal women with invasive BC who received NAC.

Disclosures: This study was funded by National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Lan A et al. Pre-treatment circulating reproductive hormones levels predict pathological and survival outcomes in breast cancer submitted to neoadjuvant chemotherapy. Int J Clin Oncol. 2022 (Mar 3). Doi: 10.1007/s10147-022-02141-9

Key clinical point: An anthracycline-containing chemotherapy (AC-T) regimen was not associated with a survival benefit compared with 6 cycles of docetaxel/cyclophosphamide (TC6) in an overall cohort of patients with human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer (BC); however, patients with lobular tumor and ≥3 affected lymph nodes may benefit.

Major finding: Although disease-free survival (DFS) was similar between AC-T and TC6 treatment arms in the overall cohort (P = .57), the subgroup of patients with lobular tumor and ≥3 affected lymph nodes showed improved DFS with AC-T vs. TC6 (hazard ratio 3.521; P = .003). The frequency of grade 3/4 adverse events was significantly higher in AC-T vs. TC6 treatment arm (P < .001).

Study details: Findings are from the pooled analysis of two phase 3 studies, SUCCESS-C and PlanB, including 5,924 patients with high-risk HER2-negative invasive early BC who were randomly assigned to receive TC6 or AC-T.

Disclosures: The study did not receive any funding. Some authors declared receiving financial and nonfinancial support from several sources.

Source: Gregorio AD et al. The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer—a pooled analysis of the randomised clinical trials PlanB and SUCCESS C. Br J Cancer. 2022 (Feb 22). Doi: 10.1038/s41416-021-01690-6

Key clinical point: An anthracycline-containing chemotherapy (AC-T) regimen was not associated with a survival benefit compared with 6 cycles of docetaxel/cyclophosphamide (TC6) in an overall cohort of patients with human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer (BC); however, patients with lobular tumor and ≥3 affected lymph nodes may benefit.

Major finding: Although disease-free survival (DFS) was similar between AC-T and TC6 treatment arms in the overall cohort (P = .57), the subgroup of patients with lobular tumor and ≥3 affected lymph nodes showed improved DFS with AC-T vs. TC6 (hazard ratio 3.521; P = .003). The frequency of grade 3/4 adverse events was significantly higher in AC-T vs. TC6 treatment arm (P < .001).

Study details: Findings are from the pooled analysis of two phase 3 studies, SUCCESS-C and PlanB, including 5,924 patients with high-risk HER2-negative invasive early BC who were randomly assigned to receive TC6 or AC-T.

Disclosures: The study did not receive any funding. Some authors declared receiving financial and nonfinancial support from several sources.

Source: Gregorio AD et al. The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer—a pooled analysis of the randomised clinical trials PlanB and SUCCESS C. Br J Cancer. 2022 (Feb 22). Doi: 10.1038/s41416-021-01690-6

Key clinical point: An anthracycline-containing chemotherapy (AC-T) regimen was not associated with a survival benefit compared with 6 cycles of docetaxel/cyclophosphamide (TC6) in an overall cohort of patients with human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer (BC); however, patients with lobular tumor and ≥3 affected lymph nodes may benefit.

Major finding: Although disease-free survival (DFS) was similar between AC-T and TC6 treatment arms in the overall cohort (P = .57), the subgroup of patients with lobular tumor and ≥3 affected lymph nodes showed improved DFS with AC-T vs. TC6 (hazard ratio 3.521; P = .003). The frequency of grade 3/4 adverse events was significantly higher in AC-T vs. TC6 treatment arm (P < .001).

Study details: Findings are from the pooled analysis of two phase 3 studies, SUCCESS-C and PlanB, including 5,924 patients with high-risk HER2-negative invasive early BC who were randomly assigned to receive TC6 or AC-T.

Disclosures: The study did not receive any funding. Some authors declared receiving financial and nonfinancial support from several sources.

Source: Gregorio AD et al. The impact of anthracyclines in intermediate and high-risk HER2-negative early breast cancer—a pooled analysis of the randomised clinical trials PlanB and SUCCESS C. Br J Cancer. 2022 (Feb 22). Doi: 10.1038/s41416-021-01690-6

Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).

Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.

Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.

Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.

Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1

Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).

Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.

Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.

Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.

Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1

Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).

Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.

Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.

Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.

Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1