Key clinical point: Lactobacillus rhamnosus, with or without other probiotics, reduced the incidence risk for atopic dermatitis (AD) in children when administered to mothers and infants in the perinatal period.

Major finding: The risk of developing AD was significantly reduced at 2 years (risk ratio [RR] 0.60; P < .00001) and 6-7 years (RR  0.62; P < .00001) with L. rhamnosus or L. rhamnosus + other probiotic strains.

Study details: Findings are from a meta-analysis of 11 randomized controlled trials that reported the incidence of AD after oral administration of L. rhamnosus or L. rhamnasos + other probiotics during pregnancy and post-pregnancy in mothers and infants.

Disclosures: J Voigt received partial funding. The authors declared serving as an evidence assessment expert or an executive for Lil Mixins, a manufacturer of probiotic supplements.

Source: Voigt J and Lele M. Lactobacillus rhamnosus used in the perinatal period for the prevention of atopic dermatitis in infants: A systematic review and meta-analysis of randomized trials. Am J Clin Dermatol. 2022;23:801–811 (Sep 26). Doi: 10.1007/s40257-022-00723-x

Key clinical point: Lactobacillus rhamnosus, with or without other probiotics, reduced the incidence risk for atopic dermatitis (AD) in children when administered to mothers and infants in the perinatal period.

Major finding: The risk of developing AD was significantly reduced at 2 years (risk ratio [RR] 0.60; P < .00001) and 6-7 years (RR  0.62; P < .00001) with L. rhamnosus or L. rhamnosus + other probiotic strains.

Study details: Findings are from a meta-analysis of 11 randomized controlled trials that reported the incidence of AD after oral administration of L. rhamnosus or L. rhamnasos + other probiotics during pregnancy and post-pregnancy in mothers and infants.

Disclosures: J Voigt received partial funding. The authors declared serving as an evidence assessment expert or an executive for Lil Mixins, a manufacturer of probiotic supplements.

Source: Voigt J and Lele M. Lactobacillus rhamnosus used in the perinatal period for the prevention of atopic dermatitis in infants: A systematic review and meta-analysis of randomized trials. Am J Clin Dermatol. 2022;23:801–811 (Sep 26). Doi: 10.1007/s40257-022-00723-x

Key clinical point: Lactobacillus rhamnosus, with or without other probiotics, reduced the incidence risk for atopic dermatitis (AD) in children when administered to mothers and infants in the perinatal period.

Major finding: The risk of developing AD was significantly reduced at 2 years (risk ratio [RR] 0.60; P < .00001) and 6-7 years (RR  0.62; P < .00001) with L. rhamnosus or L. rhamnosus + other probiotic strains.

Study details: Findings are from a meta-analysis of 11 randomized controlled trials that reported the incidence of AD after oral administration of L. rhamnosus or L. rhamnasos + other probiotics during pregnancy and post-pregnancy in mothers and infants.

Disclosures: J Voigt received partial funding. The authors declared serving as an evidence assessment expert or an executive for Lil Mixins, a manufacturer of probiotic supplements.

Source: Voigt J and Lele M. Lactobacillus rhamnosus used in the perinatal period for the prevention of atopic dermatitis in infants: A systematic review and meta-analysis of randomized trials. Am J Clin Dermatol. 2022;23:801–811 (Sep 26). Doi: 10.1007/s40257-022-00723-x

Key clinical point: Patients with atopic dermatitis (AD) who received adjunctive allergen immunotherapy (AIT) reported improvements in disease severity and quality of life despite an increase in the rate of adverse events (AE).

Major finding: AIT vs no AIT improved disease severity (risk ratio [RR] 1.53; 95% CI 1.31-1.78) and the Dermatology Life Quality Index by at least 4 points (RR 1.44; 95% CI 1.03-2.01). The rates of local (RR 1.65; 95% CI 1.48-1.64) and systemic (RR 1.37; 95% CI 1.15-1.64) AE were higher with AIT vs placebo.

Study details: Findings are from a meta-analysis of 23 randomized controlled trials including 1957 adult and pediatric patients with moderate-to-severe AD who were randomly assigned to adjunctive AIT (subcutaneous or sublingual immunotherapy) or no AIT (placebo or standard care).

Disclosures: This study was supported by the American Academy of Allergy, Asthma, & Immunology and other sources. The authors declared no conflicts of interest.

Source: Yepes-Nuñez JJ et al. Allergen immunotherapy for atopic dermatitis: A systematic review and meta-analysis of benefits and harms. J Allergy Clin Immunol. 2022 (Sep 30). Doi: 10.1016/j.jaci.2022.09.020

Key clinical point: Patients with atopic dermatitis (AD) who received adjunctive allergen immunotherapy (AIT) reported improvements in disease severity and quality of life despite an increase in the rate of adverse events (AE).

Major finding: AIT vs no AIT improved disease severity (risk ratio [RR] 1.53; 95% CI 1.31-1.78) and the Dermatology Life Quality Index by at least 4 points (RR 1.44; 95% CI 1.03-2.01). The rates of local (RR 1.65; 95% CI 1.48-1.64) and systemic (RR 1.37; 95% CI 1.15-1.64) AE were higher with AIT vs placebo.

Study details: Findings are from a meta-analysis of 23 randomized controlled trials including 1957 adult and pediatric patients with moderate-to-severe AD who were randomly assigned to adjunctive AIT (subcutaneous or sublingual immunotherapy) or no AIT (placebo or standard care).

Disclosures: This study was supported by the American Academy of Allergy, Asthma, & Immunology and other sources. The authors declared no conflicts of interest.

Source: Yepes-Nuñez JJ et al. Allergen immunotherapy for atopic dermatitis: A systematic review and meta-analysis of benefits and harms. J Allergy Clin Immunol. 2022 (Sep 30). Doi: 10.1016/j.jaci.2022.09.020

Key clinical point: Patients with atopic dermatitis (AD) who received adjunctive allergen immunotherapy (AIT) reported improvements in disease severity and quality of life despite an increase in the rate of adverse events (AE).

Major finding: AIT vs no AIT improved disease severity (risk ratio [RR] 1.53; 95% CI 1.31-1.78) and the Dermatology Life Quality Index by at least 4 points (RR 1.44; 95% CI 1.03-2.01). The rates of local (RR 1.65; 95% CI 1.48-1.64) and systemic (RR 1.37; 95% CI 1.15-1.64) AE were higher with AIT vs placebo.

Study details: Findings are from a meta-analysis of 23 randomized controlled trials including 1957 adult and pediatric patients with moderate-to-severe AD who were randomly assigned to adjunctive AIT (subcutaneous or sublingual immunotherapy) or no AIT (placebo or standard care).

Disclosures: This study was supported by the American Academy of Allergy, Asthma, & Immunology and other sources. The authors declared no conflicts of interest.

Source: Yepes-Nuñez JJ et al. Allergen immunotherapy for atopic dermatitis: A systematic review and meta-analysis of benefits and harms. J Allergy Clin Immunol. 2022 (Sep 30). Doi: 10.1016/j.jaci.2022.09.020

Key clinical point: Rate of COVID-19 hospitalizations varied by treatment modalities in patients with atopic dermatitis (AD) who received immunomodulatory drugs.

Major finding: Rate of COVID-19 hospitalizations was higher among patients who received topical treatment vs dupilumab (adjusted odds ratio [aOR] 4.99; 95% CI 1.4-20.84) or combination therapy with systemic corticosteroids vs monotherapy with nonsteroidal immunosuppressants (aOR 45.75; 95% CI 4.54-616.22).

Study details: Findings are from the SECURE-AD registry including 442 patients with AD and a diagnosis of COVID-19 who received immunomodulatory treatments.

Disclosures: This study is funded by the University of Amsterdam and other sources. Some authors declared serving as employees or receiving grants, consulting fees, honoraria, or travel support from several sources.

Source: Musters AH et al. The effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis: Results from the global SECURE-AD registry. J Eur Acad Dermatol Venereol. 2022 (Sep 28). Doi: 10.1111/jdv.18613

Key clinical point: Rate of COVID-19 hospitalizations varied by treatment modalities in patients with atopic dermatitis (AD) who received immunomodulatory drugs.

Major finding: Rate of COVID-19 hospitalizations was higher among patients who received topical treatment vs dupilumab (adjusted odds ratio [aOR] 4.99; 95% CI 1.4-20.84) or combination therapy with systemic corticosteroids vs monotherapy with nonsteroidal immunosuppressants (aOR 45.75; 95% CI 4.54-616.22).

Study details: Findings are from the SECURE-AD registry including 442 patients with AD and a diagnosis of COVID-19 who received immunomodulatory treatments.

Disclosures: This study is funded by the University of Amsterdam and other sources. Some authors declared serving as employees or receiving grants, consulting fees, honoraria, or travel support from several sources.

Source: Musters AH et al. The effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis: Results from the global SECURE-AD registry. J Eur Acad Dermatol Venereol. 2022 (Sep 28). Doi: 10.1111/jdv.18613

Key clinical point: Rate of COVID-19 hospitalizations varied by treatment modalities in patients with atopic dermatitis (AD) who received immunomodulatory drugs.

Major finding: Rate of COVID-19 hospitalizations was higher among patients who received topical treatment vs dupilumab (adjusted odds ratio [aOR] 4.99; 95% CI 1.4-20.84) or combination therapy with systemic corticosteroids vs monotherapy with nonsteroidal immunosuppressants (aOR 45.75; 95% CI 4.54-616.22).

Study details: Findings are from the SECURE-AD registry including 442 patients with AD and a diagnosis of COVID-19 who received immunomodulatory treatments.

Disclosures: This study is funded by the University of Amsterdam and other sources. Some authors declared serving as employees or receiving grants, consulting fees, honoraria, or travel support from several sources.

Source: Musters AH et al. The effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis: Results from the global SECURE-AD registry. J Eur Acad Dermatol Venereol. 2022 (Sep 28). Doi: 10.1111/jdv.18613

Key clinical point: Tralokinumab, with or without topical corticosteroids (TCS), demonstrated significant efficacy in reducing disease severity and was well-tolerated in North American patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index in ECZTRA 1/2 (40.1% vs 19.4%; P < .001) and ECZTRA 3 (58.1% vs 37.0%; P  =  .012) studies. Tralokinumab with or without TCS was also well-tolerated in the North American population.

Study details: Findings are from a post hoc analysis of three tralokinumab trials including patients with moderate-to-severe AD who were randomly assigned to receive tralokinumab or placebo, both with TCS as needed (ECZTRA 3; n = 160) or without TCS (ECZTRA 1 and 2; n = 559).

Disclosures: The ECZTRA trials were sponsored by LEO Pharma A/S. Three authors declared being current or former employees of LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Blauvelt A et al. Tralokinumab efficacy and safety, with or without topical corticosteroids, in North American adults with moderate-to-severe atopic dermatitis: A subanalysis of phase 3 trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 (Sep 24). Doi: 10.1007/s13555-022-00805-y

Key clinical point: Tralokinumab, with or without topical corticosteroids (TCS), demonstrated significant efficacy in reducing disease severity and was well-tolerated in North American patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index in ECZTRA 1/2 (40.1% vs 19.4%; P < .001) and ECZTRA 3 (58.1% vs 37.0%; P  =  .012) studies. Tralokinumab with or without TCS was also well-tolerated in the North American population.

Study details: Findings are from a post hoc analysis of three tralokinumab trials including patients with moderate-to-severe AD who were randomly assigned to receive tralokinumab or placebo, both with TCS as needed (ECZTRA 3; n = 160) or without TCS (ECZTRA 1 and 2; n = 559).

Disclosures: The ECZTRA trials were sponsored by LEO Pharma A/S. Three authors declared being current or former employees of LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Blauvelt A et al. Tralokinumab efficacy and safety, with or without topical corticosteroids, in North American adults with moderate-to-severe atopic dermatitis: A subanalysis of phase 3 trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 (Sep 24). Doi: 10.1007/s13555-022-00805-y

Key clinical point: Tralokinumab, with or without topical corticosteroids (TCS), demonstrated significant efficacy in reducing disease severity and was well-tolerated in North American patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index in ECZTRA 1/2 (40.1% vs 19.4%; P < .001) and ECZTRA 3 (58.1% vs 37.0%; P  =  .012) studies. Tralokinumab with or without TCS was also well-tolerated in the North American population.

Study details: Findings are from a post hoc analysis of three tralokinumab trials including patients with moderate-to-severe AD who were randomly assigned to receive tralokinumab or placebo, both with TCS as needed (ECZTRA 3; n = 160) or without TCS (ECZTRA 1 and 2; n = 559).

Disclosures: The ECZTRA trials were sponsored by LEO Pharma A/S. Three authors declared being current or former employees of LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Blauvelt A et al. Tralokinumab efficacy and safety, with or without topical corticosteroids, in North American adults with moderate-to-severe atopic dermatitis: A subanalysis of phase 3 trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 (Sep 24). Doi: 10.1007/s13555-022-00805-y

Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.

Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P  =  .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P  =  .02) and 18 (P  =  .000001) were different in children who developed vs did not develop AD.

Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.

Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.

Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518

Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.

Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P  =  .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P  =  .02) and 18 (P  =  .000001) were different in children who developed vs did not develop AD.

Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.

Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.

Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518

Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.

Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P  =  .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P  =  .02) and 18 (P  =  .000001) were different in children who developed vs did not develop AD.

Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.

Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.

Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518

Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).

Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.

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

Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042

Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).

Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.

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

Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042

Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).

Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.

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

Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042

Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.

Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.

Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.

Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010

Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.

Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.

Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.

Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010

Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.

Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.

Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.

Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010

Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.

Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.

Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.

Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2

Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.

Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.

Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.

Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2

Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.

Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.

Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.

Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Individuals who are middle-aged and older and who sleep 5 hours or less a night may be at risk for an array of serious and chronic health conditions, ranging from heart disease to cancer, results of a large study show.

Researchers at University College London and Université Paris Cité found that beginning at age 50, those who slept 5 hours or fewer a night had a 30% higher risk of developing multiple chronic diseases over time than those who slept at least 7 hours a night. By the time the participants were aged 70 years, that risk had increased to 40%.

Diseases for which there was a higher risk included diabetes, cancer, coronary heart disease, stroke, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, depression, dementia, Parkinson’s disease, and arthritis.

“It is important to take care of our sleep,” lead investigator Séverine Sabia, PhD, said in an interview. Dr. Sabia is a researcher and epidemiologist at Université Paris Cité and INSERM in Paris, and the University College London.

She noted that the source of the sleep problem must be addressed, but in cases in which there is no medical reason for sleep paucity, “healthy sleep habits are a must. These include keeping a regular sleep schedule, a healthy lifestyle – physical activity and light exposure during the day, and a light dinner – and avoidance of screens for a half hour before sleep.”

The study was published online in PLOS Medicine.
 

Risk of multiple chronic diseases

Prior research suggests that sleeping for 5 hours or less or 9 hours or more is associated with cancer and cardiovascular disease (CVD).

For the current study, Dr. Sabia and her team asked nearly 8,000 civil servants in the United Kingdom as part of the Whitehall II cohort study to report the amount of sleep they received beginning at age 50 every 4 to 5 years for the next 25 years. Study participants were free of chronic disease at age 50 and were mostly male (67.5%) and White (90%).

The investigators found that at age 50, those who slept 5 hours or less were 30% more likely to be diagnosed with multiple chronic diseases over time, (hazard ratio, 1.30; 95% confidence interval, 1.12-1.50; P < .001) compared with their peers who slept 7 hours.

At age 60, those who slept 5 hours or less had a 32% greater risk of developing more than one chronic disease (HR, 1.32; 95% CI, 1.13-1.55; P < .001), and by age 70, this risk increased to 40% compared with their peers who slept 7 hours a night (HR, 1.40; 95% CI, 1.16-1.68; P < .001).

For participants who slept 9 or more hours per night, only those aged 60 (HR, 1.54; 95% CI, 1.15-2.06; P = .003) and 70 (HR, 1.51; 95% CI, 1.10-2.08; P = .010) were at increased risk of developing more than one chronic disease.

Dr. Sabia noted that previous studies have shown that those who slept less than 5 hours a night were more likely to develop diabetes, hypertension, CVD, or dementia. “However, chronic diseases often coexist, particularly at older ages, and it remains unclear how sleep duration may be associated with risk of multimorbidity,” she said. She noted that several biological hypotheses have been proposed as underlying the association.

“Sleep is important for the regulation of several body functions, such as metabolic, endocrine, and inflammatory regulation over the day, that in turn, when dysregulated, may contribute to increased risk of several chronic conditions.”

The authors acknowledge several study limitations, including the fact that the data were obtained via participant self-reports, which may be affected by reporting bias. There was also a lack of diversity within the study sample, as the civil servants were mostly male and White. In addition to this, the investigators note that the study population of British civil servants tended to be healthier than the general population.
 

Chicken or egg?

Commenting on the findings for this article, Charlene Gamaldo, MD, urged caution in interpreting the findings. She noted that self-reporting of sleep has been established as “potentially problematic” because it doesn’t always correlate with actual sleep.

Dr. Gamaldo, who is professor of neurology and psychiatry at Johns Hopkins University in Baltimore and the medical director of the JHU Center for Sleep and Wellness, said previous studies have shown that underestimation of sleep can occur among those suffering with insomnia and that overestimation can be seen among individuals with behaviorally based chronic, insufficient sleep.

Dr. Gamaldo also raised the issue of sleep quality.

“Getting 5 hours of high-quality sleep is less worrisome than one getting 8 hours of terrible-quality, based on untreated sleep apnea, for instance,” she noted.

In addition, she pointed out that chronic health problems can interrupt sleep. “Which is the chicken, and which is the egg?” she asked.

“For me, the take-home of current literature and supported by this paper is that individuals with sleep quality complaints, short duration, or related impact in daytime function should address them with their treating provider to assess for the underlying cause.

“Those sleeping under 5 hours without complaints should consider whether 5 hours really represents the amount of sleep they need to wake rested and function at their best. If answer is no, they should prioritize getting more sleep,” she concluded.

The study was funded by the National Institute on Aging, the National Institute of Health, the UK Research Medical Council, the British Heart Foundation, the Wellcome Trust, and the French National Research Agency. The investigators and Dr. Gamaldo report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

A version of this article first appeared on Medscape.com.

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

A version of this article first appeared on Medscape.com.

The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.

The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.

Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”

Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.

The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.

Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.

Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.

A version of this article first appeared on Medscape.com.