Key clinical point: Nemolizumab was safe and more effective than placebo in reducing the severity of atopic dermatitis (AD) or pruritus.

Major finding: Nemolizumab vs placebo significantly reduced the pruritus visual analogue scale score (weighted mean difference [WMD] −18.86; P < .001) and Eczema Area and Severity Index score (WMD −11.76; P = .009). Adverse events were mostly mild and similar in both the groups (P = .593).

Study details: This was a meta-analysis of 14 cohorts of participants from six randomized controlled studies that included 569 and 240 patients with AD or pruritus who received nemolizumab and placebo, respectively.

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

Source: Liang J et al. Safety and efficacy of nemolizumab for atopic dermatitis with pruritus: a systematic review and meta-regression analysis of randomized controlled trials. Front Immunol. 2022;13:825312 (Apr 26). Doi: 10.3389/fimmu.2022.825312

Key clinical point: Nemolizumab was safe and more effective than placebo in reducing the severity of atopic dermatitis (AD) or pruritus.

Major finding: Nemolizumab vs placebo significantly reduced the pruritus visual analogue scale score (weighted mean difference [WMD] −18.86; P < .001) and Eczema Area and Severity Index score (WMD −11.76; P = .009). Adverse events were mostly mild and similar in both the groups (P = .593).

Study details: This was a meta-analysis of 14 cohorts of participants from six randomized controlled studies that included 569 and 240 patients with AD or pruritus who received nemolizumab and placebo, respectively.

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

Source: Liang J et al. Safety and efficacy of nemolizumab for atopic dermatitis with pruritus: a systematic review and meta-regression analysis of randomized controlled trials. Front Immunol. 2022;13:825312 (Apr 26). Doi: 10.3389/fimmu.2022.825312

Key clinical point: Nemolizumab was safe and more effective than placebo in reducing the severity of atopic dermatitis (AD) or pruritus.

Major finding: Nemolizumab vs placebo significantly reduced the pruritus visual analogue scale score (weighted mean difference [WMD] −18.86; P < .001) and Eczema Area and Severity Index score (WMD −11.76; P = .009). Adverse events were mostly mild and similar in both the groups (P = .593).

Study details: This was a meta-analysis of 14 cohorts of participants from six randomized controlled studies that included 569 and 240 patients with AD or pruritus who received nemolizumab and placebo, respectively.

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

Source: Liang J et al. Safety and efficacy of nemolizumab for atopic dermatitis with pruritus: a systematic review and meta-regression analysis of randomized controlled trials. Front Immunol. 2022;13:825312 (Apr 26). Doi: 10.3389/fimmu.2022.825312

Key clinical point: Children with atopic dermatitis (AD) may have a higher sensitivity to contact allergens, such as fragrances and metals, than children without AD.

Major finding: Overall, 36.9% vs 26.4% of children with vs without AD presented with at least one positive patch test. Children with v. without AD showed a higher prevalence of ≥1 positive patch test for allergens, such as nickel sulfate, cobalt chloride, methylisothiazolinone, fragrance mix-2, potassium dichromate, fragrance mix-1, methylchloroisothiazolinone/methylisothiazolinone, and neomycin sulfate, with the prevalence difference being highest for fragrance mix-1 (5.8% vs 0.9%; P = .004293).

Study details: This retrospective study included 432 children aged 0-14 years with eczematous dermatitis who underwent patch testing, of which 23.8% of children were diagnosed with AD.

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

Source: Bonamonte D et al. Contact allergy in children with and without atopic dermatitis: An Italian multicentre study. Contact Dermatitis. 2022 (Apr 21). Doi: 10.1111/cod.14130

Key clinical point: Children with atopic dermatitis (AD) may have a higher sensitivity to contact allergens, such as fragrances and metals, than children without AD.

Major finding: Overall, 36.9% vs 26.4% of children with vs without AD presented with at least one positive patch test. Children with v. without AD showed a higher prevalence of ≥1 positive patch test for allergens, such as nickel sulfate, cobalt chloride, methylisothiazolinone, fragrance mix-2, potassium dichromate, fragrance mix-1, methylchloroisothiazolinone/methylisothiazolinone, and neomycin sulfate, with the prevalence difference being highest for fragrance mix-1 (5.8% vs 0.9%; P = .004293).

Study details: This retrospective study included 432 children aged 0-14 years with eczematous dermatitis who underwent patch testing, of which 23.8% of children were diagnosed with AD.

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

Source: Bonamonte D et al. Contact allergy in children with and without atopic dermatitis: An Italian multicentre study. Contact Dermatitis. 2022 (Apr 21). Doi: 10.1111/cod.14130

Key clinical point: Children with atopic dermatitis (AD) may have a higher sensitivity to contact allergens, such as fragrances and metals, than children without AD.

Major finding: Overall, 36.9% vs 26.4% of children with vs without AD presented with at least one positive patch test. Children with v. without AD showed a higher prevalence of ≥1 positive patch test for allergens, such as nickel sulfate, cobalt chloride, methylisothiazolinone, fragrance mix-2, potassium dichromate, fragrance mix-1, methylchloroisothiazolinone/methylisothiazolinone, and neomycin sulfate, with the prevalence difference being highest for fragrance mix-1 (5.8% vs 0.9%; P = .004293).

Study details: This retrospective study included 432 children aged 0-14 years with eczematous dermatitis who underwent patch testing, of which 23.8% of children were diagnosed with AD.

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

Source: Bonamonte D et al. Contact allergy in children with and without atopic dermatitis: An Italian multicentre study. Contact Dermatitis. 2022 (Apr 21). Doi: 10.1111/cod.14130

Key clinical point: Dupilumab showed an acceptable safety profile and sustained efficacy through 4 years in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At 4 years, the exposure-adjusted incidence rate of treatment emergent adverse events (TEAE) was 256.86 events/100 patient-years, with most events being mild to moderate in severity. At least one serious and severe TEAE was experienced by 10.4% and 9.8% of patients in two dose categories. At week 204, the mean Eczema Area and Severity Index (EASI) score improved by 91.07%, with patients switching from 300 mg dupilumab weekly to every-2-weeks dosing while maintaining EASI scores up to 48 weeks post-transition.

Study details: Findings are from an interim analysis of the ongoing phase 3, LIBERTY AD open-label extension study including 2677 adults with moderate-to-severe AD who received 300 mg dupilumab  weekly or every 2 weeks in previous phase 1-3 AD trials.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Seven authors declared being employees or shareholders of Regeneron Pharmaceuticals or Sanofi, and other authors reported ties with various sources.

Source: Beck LA et al. Dupilumab provides acceptable safety and sustained efficacy for up to 4 years in an open-label study of adults with moderate-to-severe atopic dermatitis. Am J Clin Dermatol. 2022 (May 3). Doi: 10.1007/s40257-022-00685-0

Key clinical point: Dupilumab showed an acceptable safety profile and sustained efficacy through 4 years in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At 4 years, the exposure-adjusted incidence rate of treatment emergent adverse events (TEAE) was 256.86 events/100 patient-years, with most events being mild to moderate in severity. At least one serious and severe TEAE was experienced by 10.4% and 9.8% of patients in two dose categories. At week 204, the mean Eczema Area and Severity Index (EASI) score improved by 91.07%, with patients switching from 300 mg dupilumab weekly to every-2-weeks dosing while maintaining EASI scores up to 48 weeks post-transition.

Study details: Findings are from an interim analysis of the ongoing phase 3, LIBERTY AD open-label extension study including 2677 adults with moderate-to-severe AD who received 300 mg dupilumab  weekly or every 2 weeks in previous phase 1-3 AD trials.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Seven authors declared being employees or shareholders of Regeneron Pharmaceuticals or Sanofi, and other authors reported ties with various sources.

Source: Beck LA et al. Dupilumab provides acceptable safety and sustained efficacy for up to 4 years in an open-label study of adults with moderate-to-severe atopic dermatitis. Am J Clin Dermatol. 2022 (May 3). Doi: 10.1007/s40257-022-00685-0

Key clinical point: Dupilumab showed an acceptable safety profile and sustained efficacy through 4 years in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At 4 years, the exposure-adjusted incidence rate of treatment emergent adverse events (TEAE) was 256.86 events/100 patient-years, with most events being mild to moderate in severity. At least one serious and severe TEAE was experienced by 10.4% and 9.8% of patients in two dose categories. At week 204, the mean Eczema Area and Severity Index (EASI) score improved by 91.07%, with patients switching from 300 mg dupilumab weekly to every-2-weeks dosing while maintaining EASI scores up to 48 weeks post-transition.

Study details: Findings are from an interim analysis of the ongoing phase 3, LIBERTY AD open-label extension study including 2677 adults with moderate-to-severe AD who received 300 mg dupilumab  weekly or every 2 weeks in previous phase 1-3 AD trials.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Seven authors declared being employees or shareholders of Regeneron Pharmaceuticals or Sanofi, and other authors reported ties with various sources.

Source: Beck LA et al. Dupilumab provides acceptable safety and sustained efficacy for up to 4 years in an open-label study of adults with moderate-to-severe atopic dermatitis. Am J Clin Dermatol. 2022 (May 3). Doi: 10.1007/s40257-022-00685-0

Key clinical point: Baricitinib plus topical corticosteroids (TCS) improved the signs and symptoms of atopic dermatitis (AD) through 1 year along with a consistent safety profile in patients with moderate-to-severe AD and an inadequate response, intolerance, or contraindication to cyclosporine A (CyA).

Major finding: At week 16, ≥75% improvement in the Eczema Area and Severity Index was achieved by a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS (32% vs 17%; P = .031), with improvements maintained through week 52. Treatment emergent adverse events were more frequent with baricitinib, but were mostly mild or moderate in severity.

Study details: Findings are from the phase 3 BREEZE-AD4 study including 463 patients with moderate-to-severe AD and an inadequate response, contraindication, or intolerance to CyA who were randomly assigned to receive placebo+TCS or 1, 2, or 4 mg baricitinib+TCS for 52 weeks.

Disclosures: Eli Lilly and Company developed baricitinib. Six authors declared being employees and shareholders of Eli Lilly, and other authors reported ties with various sources, including Eli Lilly.

Source: Bieber T et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance, or contraindication to cyclosporine: Results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). Br J Dermatol. 2022 (Apr 28). Doi: 10.1111/bjd.21630

Key clinical point: Baricitinib plus topical corticosteroids (TCS) improved the signs and symptoms of atopic dermatitis (AD) through 1 year along with a consistent safety profile in patients with moderate-to-severe AD and an inadequate response, intolerance, or contraindication to cyclosporine A (CyA).

Major finding: At week 16, ≥75% improvement in the Eczema Area and Severity Index was achieved by a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS (32% vs 17%; P = .031), with improvements maintained through week 52. Treatment emergent adverse events were more frequent with baricitinib, but were mostly mild or moderate in severity.

Study details: Findings are from the phase 3 BREEZE-AD4 study including 463 patients with moderate-to-severe AD and an inadequate response, contraindication, or intolerance to CyA who were randomly assigned to receive placebo+TCS or 1, 2, or 4 mg baricitinib+TCS for 52 weeks.

Disclosures: Eli Lilly and Company developed baricitinib. Six authors declared being employees and shareholders of Eli Lilly, and other authors reported ties with various sources, including Eli Lilly.

Source: Bieber T et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance, or contraindication to cyclosporine: Results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). Br J Dermatol. 2022 (Apr 28). Doi: 10.1111/bjd.21630

Key clinical point: Baricitinib plus topical corticosteroids (TCS) improved the signs and symptoms of atopic dermatitis (AD) through 1 year along with a consistent safety profile in patients with moderate-to-severe AD and an inadequate response, intolerance, or contraindication to cyclosporine A (CyA).

Major finding: At week 16, ≥75% improvement in the Eczema Area and Severity Index was achieved by a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS (32% vs 17%; P = .031), with improvements maintained through week 52. Treatment emergent adverse events were more frequent with baricitinib, but were mostly mild or moderate in severity.

Study details: Findings are from the phase 3 BREEZE-AD4 study including 463 patients with moderate-to-severe AD and an inadequate response, contraindication, or intolerance to CyA who were randomly assigned to receive placebo+TCS or 1, 2, or 4 mg baricitinib+TCS for 52 weeks.

Disclosures: Eli Lilly and Company developed baricitinib. Six authors declared being employees and shareholders of Eli Lilly, and other authors reported ties with various sources, including Eli Lilly.

Source: Bieber T et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance, or contraindication to cyclosporine: Results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). Br J Dermatol. 2022 (Apr 28). Doi: 10.1111/bjd.21630

Key clinical point: A substantial proportion of patients with moderate-to-severe atopic dermatitis (AD) achieved a higher threshold efficacy response (90% to <100% improvement in the Eczema Area and Severity Index [EASI-90 to <EASI-100] and EASI-100) with abrocitinib, which subsequently improved their quality of life (QoL).

Major finding: At week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib vs. placebo achieved EASI-90 to <EASI-100 (29.3% and 15.9% vs 5.9%) and EASI-100 (10.7% and 6.0% vs 0%), of which 48.9% and 48.1% vs 33.3% of patients with EASI-90 to <EASI-100 and 67.6% and 63.2% vs 0% of patients with EASI-100 showed QoL benefits.

Study details: Findings are from a post hoc analysis of one phase 2b and two phase 3 (JADE Mono-1 and JADE Mono-2) studies including 942 patients with moderate-to-severe AD and an inadequate response to topical medications who received once-daily 200 mg abrocitinib, 100 mg abrocitinib, or placebo.

Disclosures: This study was sponsored by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer, and other authors reported ties with several sources, including Pfizer.

Source: Stander S et al. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 (Apr 24). Doi: 10.1111/jdv.18170

Key clinical point: A substantial proportion of patients with moderate-to-severe atopic dermatitis (AD) achieved a higher threshold efficacy response (90% to <100% improvement in the Eczema Area and Severity Index [EASI-90 to <EASI-100] and EASI-100) with abrocitinib, which subsequently improved their quality of life (QoL).

Major finding: At week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib vs. placebo achieved EASI-90 to <EASI-100 (29.3% and 15.9% vs 5.9%) and EASI-100 (10.7% and 6.0% vs 0%), of which 48.9% and 48.1% vs 33.3% of patients with EASI-90 to <EASI-100 and 67.6% and 63.2% vs 0% of patients with EASI-100 showed QoL benefits.

Study details: Findings are from a post hoc analysis of one phase 2b and two phase 3 (JADE Mono-1 and JADE Mono-2) studies including 942 patients with moderate-to-severe AD and an inadequate response to topical medications who received once-daily 200 mg abrocitinib, 100 mg abrocitinib, or placebo.

Disclosures: This study was sponsored by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer, and other authors reported ties with several sources, including Pfizer.

Source: Stander S et al. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 (Apr 24). Doi: 10.1111/jdv.18170

Key clinical point: A substantial proportion of patients with moderate-to-severe atopic dermatitis (AD) achieved a higher threshold efficacy response (90% to <100% improvement in the Eczema Area and Severity Index [EASI-90 to <EASI-100] and EASI-100) with abrocitinib, which subsequently improved their quality of life (QoL).

Major finding: At week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib vs. placebo achieved EASI-90 to <EASI-100 (29.3% and 15.9% vs 5.9%) and EASI-100 (10.7% and 6.0% vs 0%), of which 48.9% and 48.1% vs 33.3% of patients with EASI-90 to <EASI-100 and 67.6% and 63.2% vs 0% of patients with EASI-100 showed QoL benefits.

Study details: Findings are from a post hoc analysis of one phase 2b and two phase 3 (JADE Mono-1 and JADE Mono-2) studies including 942 patients with moderate-to-severe AD and an inadequate response to topical medications who received once-daily 200 mg abrocitinib, 100 mg abrocitinib, or placebo.

Disclosures: This study was sponsored by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer, and other authors reported ties with several sources, including Pfizer.

Source: Stander S et al. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 (Apr 24). Doi: 10.1111/jdv.18170

Key clinical point: Abrocitinib can be considered a treatment option for patients with moderate-to-severe atopic dermatitis (AD) regardless of prior response to dupilumab.

Major finding: At 12 weeks, ≥75% improvement in the Eczema Area and Severity Index was achieved by 80.0% (95% CI 62.5%-97.5%) and 67.7% (95% CI 51.3%-84.2%) of prior dupilumab nonresponders and 93.5% (95% CI 86.3%-100.0%) and 90.2% (95% CI 84.1%-96.3%) of prior dupilumab responders who received 200 mg and 100 mg abrocitinib, respectively. The most common treatment emergent adverse events were nasopharyngitis, nausea, acne, and headache.

Study details: This phase 3 study, JADE EXTEND,  included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg abrocitinib once-daily after receiving dupilumab for 14 weeks in JADE COMPARE.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current or former employees or shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Shi VY et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. 2022 (Apr 16). Doi: 10.1016/j.jaad.2022.04.009

Key clinical point: Abrocitinib can be considered a treatment option for patients with moderate-to-severe atopic dermatitis (AD) regardless of prior response to dupilumab.

Major finding: At 12 weeks, ≥75% improvement in the Eczema Area and Severity Index was achieved by 80.0% (95% CI 62.5%-97.5%) and 67.7% (95% CI 51.3%-84.2%) of prior dupilumab nonresponders and 93.5% (95% CI 86.3%-100.0%) and 90.2% (95% CI 84.1%-96.3%) of prior dupilumab responders who received 200 mg and 100 mg abrocitinib, respectively. The most common treatment emergent adverse events were nasopharyngitis, nausea, acne, and headache.

Study details: This phase 3 study, JADE EXTEND,  included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg abrocitinib once-daily after receiving dupilumab for 14 weeks in JADE COMPARE.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current or former employees or shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Shi VY et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. 2022 (Apr 16). Doi: 10.1016/j.jaad.2022.04.009

Key clinical point: Abrocitinib can be considered a treatment option for patients with moderate-to-severe atopic dermatitis (AD) regardless of prior response to dupilumab.

Major finding: At 12 weeks, ≥75% improvement in the Eczema Area and Severity Index was achieved by 80.0% (95% CI 62.5%-97.5%) and 67.7% (95% CI 51.3%-84.2%) of prior dupilumab nonresponders and 93.5% (95% CI 86.3%-100.0%) and 90.2% (95% CI 84.1%-96.3%) of prior dupilumab responders who received 200 mg and 100 mg abrocitinib, respectively. The most common treatment emergent adverse events were nasopharyngitis, nausea, acne, and headache.

Study details: This phase 3 study, JADE EXTEND,  included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg abrocitinib once-daily after receiving dupilumab for 14 weeks in JADE COMPARE.

Disclosures: This study was funded by Pfizer Inc. Five authors declared being current or former employees or shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.

Source: Shi VY et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. 2022 (Apr 16). Doi: 10.1016/j.jaad.2022.04.009

Key clinical point: Female sex and progressive forms of multiple sclerosis (MS) are the prognostic factors for worsening lower urinary tract symptoms in patients with MS, with neurogenic lower urinary tract dysfunction being a contributor to disease progression.

Major finding: A higher bowel/bladder functional system (FS) score, indicating worsening symptoms and functions, was significantly associated with female vs male sex (P = .001) and progressive vs relapsing-remitting MS type (P ≤ .001), with each point increase in the bowel/bladder FS score during follow-up visit at 1 year being associated with an increased risk of worsening disability over the subsequent year (area under curve 0.63).

Study details: This prospective study evaluated 802 patients with clinically isolated syndrome or MS.

Disclosures: This research was funded by the National Multiple Sclerosis Society, US National Institutes of Health, and Valhalla Foundation. Some authors declared receiving consulting and advisory board fees, research support, or personal compensation or serving on boards of trustees or on advisory boards for various sources.

Source: Kaplan TB et al. Challenges to longitudinal characterization of lower urinary tract dysfunction in multiple sclerosis. Mult Scler Relat Disord. 2022;62:103793 (Apr 10). Doi: 10.1016/j.msard.2022.103793

Key clinical point: Female sex and progressive forms of multiple sclerosis (MS) are the prognostic factors for worsening lower urinary tract symptoms in patients with MS, with neurogenic lower urinary tract dysfunction being a contributor to disease progression.

Major finding: A higher bowel/bladder functional system (FS) score, indicating worsening symptoms and functions, was significantly associated with female vs male sex (P = .001) and progressive vs relapsing-remitting MS type (P ≤ .001), with each point increase in the bowel/bladder FS score during follow-up visit at 1 year being associated with an increased risk of worsening disability over the subsequent year (area under curve 0.63).

Study details: This prospective study evaluated 802 patients with clinically isolated syndrome or MS.

Disclosures: This research was funded by the National Multiple Sclerosis Society, US National Institutes of Health, and Valhalla Foundation. Some authors declared receiving consulting and advisory board fees, research support, or personal compensation or serving on boards of trustees or on advisory boards for various sources.

Source: Kaplan TB et al. Challenges to longitudinal characterization of lower urinary tract dysfunction in multiple sclerosis. Mult Scler Relat Disord. 2022;62:103793 (Apr 10). Doi: 10.1016/j.msard.2022.103793

Key clinical point: Female sex and progressive forms of multiple sclerosis (MS) are the prognostic factors for worsening lower urinary tract symptoms in patients with MS, with neurogenic lower urinary tract dysfunction being a contributor to disease progression.

Major finding: A higher bowel/bladder functional system (FS) score, indicating worsening symptoms and functions, was significantly associated with female vs male sex (P = .001) and progressive vs relapsing-remitting MS type (P ≤ .001), with each point increase in the bowel/bladder FS score during follow-up visit at 1 year being associated with an increased risk of worsening disability over the subsequent year (area under curve 0.63).

Study details: This prospective study evaluated 802 patients with clinically isolated syndrome or MS.

Disclosures: This research was funded by the National Multiple Sclerosis Society, US National Institutes of Health, and Valhalla Foundation. Some authors declared receiving consulting and advisory board fees, research support, or personal compensation or serving on boards of trustees or on advisory boards for various sources.

Source: Kaplan TB et al. Challenges to longitudinal characterization of lower urinary tract dysfunction in multiple sclerosis. Mult Scler Relat Disord. 2022;62:103793 (Apr 10). Doi: 10.1016/j.msard.2022.103793

Key clinical point: Decreased SARS-CoV-2 antibody level is the major contributor to breakthrough SARS-CoV-2 infection in vaccinated patients with multiple sclerosis (MS) on various disease modifying therapies (DMT), with the third dose significantly reducing the risk for infection.

Major finding: After the second vaccine dose, the only significant factor associated with the risk for breakthrough infection was low antibody level (hazard ratio [HR] 0.51; P < .001), with the third dose reducing the risk for infection by 56% (HR 0.44; P = .025) during the Omicron wave.

Study details: Findings are from a prospective study of 1705 patients with MS on various DMT who received 2 doses of BNT162b2 (BioNTech-Pfizer) (n = 1391) or mRNA-1273 (Moderna) (n = 314) SARS-CoV-2 vaccine, with most receiving the third dose.

Disclosures: This study was funded by Fondazione Italiana Sclerosi Multipla. Some authors declared receiving grants, travel compensation, speaker honoraria, or advisory board/lecture and consulting fees from various sources.

Source: Sormani MP et al. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy. EBioMedicine. 2022;80:104042 (May 4). Doi: 10.1016/j.ebiom.2022.104042

Key clinical point: Decreased SARS-CoV-2 antibody level is the major contributor to breakthrough SARS-CoV-2 infection in vaccinated patients with multiple sclerosis (MS) on various disease modifying therapies (DMT), with the third dose significantly reducing the risk for infection.

Major finding: After the second vaccine dose, the only significant factor associated with the risk for breakthrough infection was low antibody level (hazard ratio [HR] 0.51; P < .001), with the third dose reducing the risk for infection by 56% (HR 0.44; P = .025) during the Omicron wave.

Study details: Findings are from a prospective study of 1705 patients with MS on various DMT who received 2 doses of BNT162b2 (BioNTech-Pfizer) (n = 1391) or mRNA-1273 (Moderna) (n = 314) SARS-CoV-2 vaccine, with most receiving the third dose.

Disclosures: This study was funded by Fondazione Italiana Sclerosi Multipla. Some authors declared receiving grants, travel compensation, speaker honoraria, or advisory board/lecture and consulting fees from various sources.

Source: Sormani MP et al. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy. EBioMedicine. 2022;80:104042 (May 4). Doi: 10.1016/j.ebiom.2022.104042

Key clinical point: Decreased SARS-CoV-2 antibody level is the major contributor to breakthrough SARS-CoV-2 infection in vaccinated patients with multiple sclerosis (MS) on various disease modifying therapies (DMT), with the third dose significantly reducing the risk for infection.

Major finding: After the second vaccine dose, the only significant factor associated with the risk for breakthrough infection was low antibody level (hazard ratio [HR] 0.51; P < .001), with the third dose reducing the risk for infection by 56% (HR 0.44; P = .025) during the Omicron wave.

Study details: Findings are from a prospective study of 1705 patients with MS on various DMT who received 2 doses of BNT162b2 (BioNTech-Pfizer) (n = 1391) or mRNA-1273 (Moderna) (n = 314) SARS-CoV-2 vaccine, with most receiving the third dose.

Disclosures: This study was funded by Fondazione Italiana Sclerosi Multipla. Some authors declared receiving grants, travel compensation, speaker honoraria, or advisory board/lecture and consulting fees from various sources.

Source: Sormani MP et al. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy. EBioMedicine. 2022;80:104042 (May 4). Doi: 10.1016/j.ebiom.2022.104042

Key clinical point: In ocrelizumab-treated patients with multiple sclerosis (MS), a third SARS-CoV-2 vaccine boosted the T-cell response, but had no additive effect on the maximal T-cell response.

Major finding: SARS-CoV-2-specific T-cell response in patients treated with ocrelizumab was comparable to those not treated with disease modifying therapy (DMT) and healthy controls (HC) after the second SARS-CoV-2 vaccination; however, the third SARS-CoV-2 vaccination had no additive effect on T-cell response, but it did induce a booster response (P < .05).

Study details: This was a prospective longitudinal study including patients with MS treated with ocrelizumab (n = 24), fingolimod (n = 12), or no DMT (n = 10) and HC (n = 12) who received three SARS-CoV-2 vaccine doses (BNT162b2 [BioNTech-Pfizer] or CX-024414 [Moderna]).

Disclosures: This study was funded by The Netherlands Organisation for Health Research and Development. Some authors reported receiving consulting fees and research support from various sources.

Source: Cabeza VP et al. Longitudinal T-cell responses after a third SARS-CoV-2 vaccination in patients with multiple sclerosis on ocrelizumab or fingolimod. Neurol Neuroimmunol Neuroinflamm. 2022;9(4):e1178 (May 6). Doi: 10.1212/NXI.0000000000001178

Key clinical point: In ocrelizumab-treated patients with multiple sclerosis (MS), a third SARS-CoV-2 vaccine boosted the T-cell response, but had no additive effect on the maximal T-cell response.

Major finding: SARS-CoV-2-specific T-cell response in patients treated with ocrelizumab was comparable to those not treated with disease modifying therapy (DMT) and healthy controls (HC) after the second SARS-CoV-2 vaccination; however, the third SARS-CoV-2 vaccination had no additive effect on T-cell response, but it did induce a booster response (P < .05).

Study details: This was a prospective longitudinal study including patients with MS treated with ocrelizumab (n = 24), fingolimod (n = 12), or no DMT (n = 10) and HC (n = 12) who received three SARS-CoV-2 vaccine doses (BNT162b2 [BioNTech-Pfizer] or CX-024414 [Moderna]).

Disclosures: This study was funded by The Netherlands Organisation for Health Research and Development. Some authors reported receiving consulting fees and research support from various sources.

Source: Cabeza VP et al. Longitudinal T-cell responses after a third SARS-CoV-2 vaccination in patients with multiple sclerosis on ocrelizumab or fingolimod. Neurol Neuroimmunol Neuroinflamm. 2022;9(4):e1178 (May 6). Doi: 10.1212/NXI.0000000000001178

Key clinical point: In ocrelizumab-treated patients with multiple sclerosis (MS), a third SARS-CoV-2 vaccine boosted the T-cell response, but had no additive effect on the maximal T-cell response.

Major finding: SARS-CoV-2-specific T-cell response in patients treated with ocrelizumab was comparable to those not treated with disease modifying therapy (DMT) and healthy controls (HC) after the second SARS-CoV-2 vaccination; however, the third SARS-CoV-2 vaccination had no additive effect on T-cell response, but it did induce a booster response (P < .05).

Study details: This was a prospective longitudinal study including patients with MS treated with ocrelizumab (n = 24), fingolimod (n = 12), or no DMT (n = 10) and HC (n = 12) who received three SARS-CoV-2 vaccine doses (BNT162b2 [BioNTech-Pfizer] or CX-024414 [Moderna]).

Disclosures: This study was funded by The Netherlands Organisation for Health Research and Development. Some authors reported receiving consulting fees and research support from various sources.

Source: Cabeza VP et al. Longitudinal T-cell responses after a third SARS-CoV-2 vaccination in patients with multiple sclerosis on ocrelizumab or fingolimod. Neurol Neuroimmunol Neuroinflamm. 2022;9(4):e1178 (May 6). Doi: 10.1212/NXI.0000000000001178

Key clinical point: Continuous siponimod treatment for up to >5 years showed sustained efficacy and a consistent safety profile in patients with secondary progressive multiple sclerosis (SPMS).

Major finding:  The risk for 6-month confirmed disability progression (CDP) was 22% lower (P = .0026) and confirmed worsening in cognitive processing speed was 23% lower (P = .0047) in patients who received continuous siponimod vs those who switched from placebo to siponimod. Siponimod had a manageable and consistent safety profile.

Study details: Findings are from the phase 3 EXPAND study including the extension phase that included 1220 of 1651 patients with SPMS from the core phase. In the extension phase, patients who had received placebo in the core phase switched to siponimod, whereas those who had received siponimod continued the same treatment.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. Five authors reported being employees of Novartis. Some authors reported receiving consulting or speakers’ fees or personal compensation or serving as a steering committee member or on an advisory board for various sources.

Source: Cree BAC et al. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 (Apr 5). Doi: 10.1177/13524585221083194

Key clinical point: Continuous siponimod treatment for up to >5 years showed sustained efficacy and a consistent safety profile in patients with secondary progressive multiple sclerosis (SPMS).

Major finding:  The risk for 6-month confirmed disability progression (CDP) was 22% lower (P = .0026) and confirmed worsening in cognitive processing speed was 23% lower (P = .0047) in patients who received continuous siponimod vs those who switched from placebo to siponimod. Siponimod had a manageable and consistent safety profile.

Study details: Findings are from the phase 3 EXPAND study including the extension phase that included 1220 of 1651 patients with SPMS from the core phase. In the extension phase, patients who had received placebo in the core phase switched to siponimod, whereas those who had received siponimod continued the same treatment.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. Five authors reported being employees of Novartis. Some authors reported receiving consulting or speakers’ fees or personal compensation or serving as a steering committee member or on an advisory board for various sources.

Source: Cree BAC et al. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 (Apr 5). Doi: 10.1177/13524585221083194

Key clinical point: Continuous siponimod treatment for up to >5 years showed sustained efficacy and a consistent safety profile in patients with secondary progressive multiple sclerosis (SPMS).

Major finding:  The risk for 6-month confirmed disability progression (CDP) was 22% lower (P = .0026) and confirmed worsening in cognitive processing speed was 23% lower (P = .0047) in patients who received continuous siponimod vs those who switched from placebo to siponimod. Siponimod had a manageable and consistent safety profile.

Study details: Findings are from the phase 3 EXPAND study including the extension phase that included 1220 of 1651 patients with SPMS from the core phase. In the extension phase, patients who had received placebo in the core phase switched to siponimod, whereas those who had received siponimod continued the same treatment.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. Five authors reported being employees of Novartis. Some authors reported receiving consulting or speakers’ fees or personal compensation or serving as a steering committee member or on an advisory board for various sources.

Source: Cree BAC et al. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 (Apr 5). Doi: 10.1177/13524585221083194