Alice Bendix Gottlieb
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Alice Bendix Gottlieb has a total of 382 co-authors. Here are the top co-authors by number of shared publications:
- Joseph F. Merola
Department of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, USA
19 shared publications - Phillip J. Mease
Providence Swedish Medical Center and University of Washington Seattle
13 shared publications Joseph F. Merola
Brigham And Women’s Hospital, Harvard Medical School, Boston, USA
12 shared publications- April W. Armstrong
University of California, Los Angeles, USA
11 shared publications - Lourdes Maria Perez-Chada
Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
11 shared publications - Alexis Ogdie
Perelman School of Medicine University of Pennsylvania Philadelphia
9 shared publications
Latest Publications
- Open Access
- 10 October 2026
- Published by Oxford University Press (OUP) in Rheumatology
Bimekizumab efficacy across GRAPPA domains to 3 years in patients with psoriatic arthritis: a post hoc analysis of two phase 3 studies
Objectives: To evaluate the long-term efficacy of bimekizumab in patients with psoriatic arthritis (PsA) across the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains, PsA-related conditions, and comorbidities. Methods: Post hoc analysis of pooled data from BE OPTIMAL (NCT03895203; biologic-naïve patients) and BE COMPLETE (NCT03896581; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors) phase 3 studies, and their open-label extension BE VITAL (NCT04009499), which assessed subcutaneous bimekizumab 160 mg every 4 weeks in patients with active PsA. Efficacy was assessed to 3 years (Week 148) across GRAPPA core domains, PsA-related conditions (inflammatory bowel disease [IBD] and uveitis), and inflammatory markers of cardiovascular risk. Results: Among 1,112 bimekizumab-treated patients with PsA, improvements were sustained across the GRAPPA core domains to 3 years. Resolution of swollen and tender joint count at 3 years was achieved by 59.2% and 34.6% of patients, respectively, while 54.8% achieved ≥50% improvement from baseline in American College of Rheumatology response criteria (modified non-responder imputation [mNRI]). Enthesitis (LEI=0) and dactylitis (LDI=0) resolution was also achieved by 56.6% (mNRI) and 68.6% (NRI) of patients, respectively. A high proportion of patients achieved skin and nail psoriasis clearance (PASI100: 64.6%; mNAPSI=0: 68.0%; mNRI). IBD and uveitis events were rare, and inflammatory cardiovascular risk marker improvements were sustained. Conclusion: Bimekizumab provided long-term, sustained disease control across GRAPPA domains and systemic inflammation markers in patients with PsA, with low rates of IBD and uveitis, supporting its use as a long-term treatment for the heterogeneous manifestations of PsA. Clinical trial registration: BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499
- 10 October 2026
- Published by Oxford University Press (OUP) in Rheumatology
Open AccessBimekizumab efficacy across GRAPPA domains to 3 years in patients with psoriatic arthritis: a post hoc analysis of two phase 3 studies
Objectives: To evaluate the long-term efficacy of bimekizumab in patients with psoriatic arthritis (PsA) across the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains, PsA-related conditions, and comorbidities. Methods: Post hoc analysis of pooled data from BE OPTIMAL (NCT03895203; biologic-naïve patients) and BE COMPLETE (NCT03896581; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors) phase 3 studies, and their open-label extension BE VITAL (NCT04009499), which assessed subcutaneous bimekizumab 160 mg every 4 weeks in patients with active PsA. Efficacy was assessed to 3 years (Week 148) across GRAPPA core domains, PsA-related conditions (inflammatory bowel disease [IBD] and uveitis), and inflammatory markers of cardiovascular risk. Results: Among 1,112 bimekizumab-treated patients with PsA, improvements were sustained across the GRAPPA core domains to 3 years. Resolution of swollen and tender joint count at 3 years was achieved by 59.2% and 34.6% of patients, respectively, while 54.8% achieved ≥50% improvement from baseline in American College of Rheumatology response criteria (modified non-responder imputation [mNRI]). Enthesitis (LEI=0) and dactylitis (LDI=0) resolution was also achieved by 56.6% (mNRI) and 68.6% (NRI) of patients, respectively. A high proportion of patients achieved skin and nail psoriasis clearance (PASI100: 64.6%; mNAPSI=0: 68.0%; mNRI). IBD and uveitis events were rare, and inflammatory cardiovascular risk marker improvements were sustained. Conclusion: Bimekizumab provided long-term, sustained disease control across GRAPPA domains and systemic inflammation markers in patients with PsA, with low rates of IBD and uveitis, supporting its use as a long-term treatment for the heterogeneous manifestations of PsA. Clinical trial registration: BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499
- 7 July 2026
- Published by The Journal of Rheumatology in The Journal of Rheumatology
- Vol. 53 (Suppl 2) , 1-3
Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2025 Annual Meeting
The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2025 annual meeting was held from July 10 to 12, 2025, in Bogotá, Colombia. It was attended by 206 rheumatologists, dermatologists, trainees, patient research partners, representatives of patient organizations, industry partners, and others. Here we provide an overview of the workshops and symposia featured at the GRAPPA 2025 annual meeting and introduce the manuscripts published together in this supplement as a meeting report.
- 7 July 2026
- Published by The Journal of Rheumatology in The Journal of Rheumatology
- Vol. 53 (Suppl 2) , 1-3
Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2025 Annual Meeting
The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2025 annual meeting was held from July 10 to 12, 2025, in Bogotá, Colombia. It was attended by 206 rheumatologists, dermatologists, trainees, patient research partners, representatives of patient organizations, industry partners, and others. Here we provide an overview of the workshops and symposia featured at the GRAPPA 2025 annual meeting and introduce the manuscripts published together in this supplement as a meeting report.
- Open Access
- 5 June 2026
- Published by Springer Nature in Dermatology and Therapy
- Vol. 16 (7) , 3315-3329
Association Between Bimekizumab’s Clinical Response and Patient-Reported Benefits on Health-Related Quality of Life: Results from BE HEARD I and II
Introduction Hidradenitis suppurativa (HS) is a chronic skin disease that greatly affects patients’ health-related quality of life (HRQoL). Bimekizumab, a humanised monoclonal antibody that inhibits interleukin (IL)-17A and IL‑17F, has demonstrated efficacy in HS. This study aimed to assess the association between clinical response and patient-reported benefits on HRQoL, using pooled 48-week data from BE HEARD I&II, in moderate to severe HS. Methods Patients received (initial/maintenance; treatment switch at Week 16) bimekizumab 320 mg every 2 weeks (Q2W)/Q2W, Q2W/every 4 weeks (Q4W), Q4W/Q4W or placebo/Q2W. Data are reported for patients randomised to bimekizumab from baseline (bimekizumab Total group) and Q2W/Q4W (Supplement). Patients were grouped into Week 16 HS Clinical Response (HiSCR) bands (HiSCR<50/50–<75/75–<90/90–100). Proportions of patients meeting pre-defined thresholds in HRQoL outcomes are reported at Weeks 16/48: meaningful improvements in HS QoL questionnaire (HiSQOL) total response and domain scores, no/mild impact of HS on HRQoL and Dermatology Life Quality Index (DLQI) scores 0/1 and 0–5. Results At Weeks 16/48, greater proportions of patients achieved HiSQOL total score responses with higher Week 16 HiSCR bands (HiSCR<50: 28.2%/35.9%; HiSCR50–< 75: 34.6%/37.2%; HiSCR75–< 90: 36.1%/47.5%; HiSCR90–100: 57.4%/66.2%). Similar patterns were observed across HiSQOL domains and in the proportions of patients who reported no/mild impact on HRQoL (HiSQOL total score ≤14). At Weeks 16/48, greater proportions of patients who achieved Week 16 HiSCR75–<90/HiSCR90–100 reported DLQI 0/1 (HiSCR75–< 90: 19.1%/27.3%; HiSCR90–100: 34.8%/43.3%) compared with patients who achieved HiSCR<50/HiSCR50–<75 (HiSCR<50: 16.1%/19.6%; HiSCR50–<75: 12.9%/17.2%). Similar trends were observed in the proportions of patients reporting DLQI scores of 0–5. Across HiSCR bands, HiSQOL/DLQI outcomes were maintained or improved from Weeks 16–48. Conclusions For patients with HS, achievement of greater lesion reduction with bimekizumab (at Week 16) translated into greater clinically meaningful improvements in HRQoL over the longer term. Trial registration ClinicalTrials.gov identifiers, NCT04242446; NCT04242498.
- 5 June 2026
- Published by Springer Nature in Dermatology and Therapy
- Vol. 16 (7) , 3315-3329
Open AccessAssociation Between Bimekizumab’s Clinical Response and Patient-Reported Benefits on Health-Related Quality of Life: Results from BE HEARD I and II
Introduction Hidradenitis suppurativa (HS) is a chronic skin disease that greatly affects patients’ health-related quality of life (HRQoL). Bimekizumab, a humanised monoclonal antibody that inhibits interleukin (IL)-17A and IL‑17F, has demonstrated efficacy in HS. This study aimed to assess the association between clinical response and patient-reported benefits on HRQoL, using pooled 48-week data from BE HEARD I&II, in moderate to severe HS. Methods Patients received (initial/maintenance; treatment switch at Week 16) bimekizumab 320 mg every 2 weeks (Q2W)/Q2W, Q2W/every 4 weeks (Q4W), Q4W/Q4W or placebo/Q2W. Data are reported for patients randomised to bimekizumab from baseline (bimekizumab Total group) and Q2W/Q4W (Supplement). Patients were grouped into Week 16 HS Clinical Response (HiSCR) bands (HiSCR<50/50–<75/75–<90/90–100). Proportions of patients meeting pre-defined thresholds in HRQoL outcomes are reported at Weeks 16/48: meaningful improvements in HS QoL questionnaire (HiSQOL) total response and domain scores, no/mild impact of HS on HRQoL and Dermatology Life Quality Index (DLQI) scores 0/1 and 0–5. Results At Weeks 16/48, greater proportions of patients achieved HiSQOL total score responses with higher Week 16 HiSCR bands (HiSCR<50: 28.2%/35.9%; HiSCR50–< 75: 34.6%/37.2%; HiSCR75–< 90: 36.1%/47.5%; HiSCR90–100: 57.4%/66.2%). Similar patterns were observed across HiSQOL domains and in the proportions of patients who reported no/mild impact on HRQoL (HiSQOL total score ≤14). At Weeks 16/48, greater proportions of patients who achieved Week 16 HiSCR75–<90/HiSCR90–100 reported DLQI 0/1 (HiSCR75–< 90: 19.1%/27.3%; HiSCR90–100: 34.8%/43.3%) compared with patients who achieved HiSCR<50/HiSCR50–<75 (HiSCR<50: 16.1%/19.6%; HiSCR50–<75: 12.9%/17.2%). Similar trends were observed in the proportions of patients reporting DLQI scores of 0–5. Across HiSCR bands, HiSQOL/DLQI outcomes were maintained or improved from Weeks 16–48. Conclusions For patients with HS, achievement of greater lesion reduction with bimekizumab (at Week 16) translated into greater clinically meaningful improvements in HRQoL over the longer term. Trial registration ClinicalTrials.gov identifiers, NCT04242446; NCT04242498.
- Open Access
- 16 April 2026
- Published by Wiley in Arthritis & Rheumatology
- Vol. 78 (8) , 1674-1686
Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week‐24 Results of a Phase 3, Randomized, Placebo‐Controlled Study
Objective: To evaluate the efficacy and safety of guselkumab, an interleukin‐23p19 subunit inhibitor, in participants with active psoriatic arthritis (PsA) and inadequate response (inadequate efficacy and/or intolerance) to one prior tumor necrosis factor (TNF) inhibitor. Methods: In SOLSTICE (phase 3b, randomized, multicenter, double‐blind, placebo‐controlled study), enrolled adults with active PsA (three or more swollen joints; three or more tender joints; C‐reactive protein ≥ 0.3 mg/dL) and inadequate response to one prior TNF inhibitor were randomized to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo with crossover to guselkumab Q4W at week 24. The primary endpoint was ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50, ACR70, Investigator's Global Assessment of psoriasis (IGA) score of 0 or 1 with ≥2‐grade improvement, ≥90% improvement in Psoriasis Area and Severity Index (PASI90), and minimal disease activity (MDA) at week 24 and were analyzed by intention‐to‐treat. Results: Analyses included 451 randomized participants (Q4W n = 150; Q8W n = 151; placebo n = 150). At week 24, significantly greater proportions of guselkumab (Q4W/Q8W)‐treated participants versus placebo‐treated participants, respectively, achieved ACR20 (primary endpoint: 58.6%/62.2% vs 34.8%), ACR50 (31.4%/32.1% vs 12.2%), ACR70 (17.5%/17.3% vs 2.0%), IGA 0/1 response (50.0%/57.3% vs 17.4%), PASI90 (49.4%/45.5% vs 12.0%), and MDA (18.8%/23.9% vs 5.4%) (all P < 0.001). Through week 24, 46.7%, 53.6%, and 48.3% of participants receiving guselkumab Q4W, guselkumab Q8W, and placebo, respectively, had one or more adverse event. One death occurred (myocardial infarction). Conclusion: Comparable efficacy was observed with both guselkumab regimens in participants with active PsA and inadequate response to one prior TNF inhibitor; safety findings were consistent with the known profile of guselkumab in patients with psoriatic disease. image
- 16 April 2026
- Published by Wiley in Arthritis & Rheumatology
- Vol. 78 (8) , 1674-1686
Open AccessEfficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week‐24 Results of a Phase 3, Randomized, Placebo‐Controlled Study
Objective: To evaluate the efficacy and safety of guselkumab, an interleukin‐23p19 subunit inhibitor, in participants with active psoriatic arthritis (PsA) and inadequate response (inadequate efficacy and/or intolerance) to one prior tumor necrosis factor (TNF) inhibitor. Methods: In SOLSTICE (phase 3b, randomized, multicenter, double‐blind, placebo‐controlled study), enrolled adults with active PsA (three or more swollen joints; three or more tender joints; C‐reactive protein ≥ 0.3 mg/dL) and inadequate response to one prior TNF inhibitor were randomized to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then Q8W, or placebo with crossover to guselkumab Q4W at week 24. The primary endpoint was ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50, ACR70, Investigator's Global Assessment of psoriasis (IGA) score of 0 or 1 with ≥2‐grade improvement, ≥90% improvement in Psoriasis Area and Severity Index (PASI90), and minimal disease activity (MDA) at week 24 and were analyzed by intention‐to‐treat. Results: Analyses included 451 randomized participants (Q4W n = 150; Q8W n = 151; placebo n = 150). At week 24, significantly greater proportions of guselkumab (Q4W/Q8W)‐treated participants versus placebo‐treated participants, respectively, achieved ACR20 (primary endpoint: 58.6%/62.2% vs 34.8%), ACR50 (31.4%/32.1% vs 12.2%), ACR70 (17.5%/17.3% vs 2.0%), IGA 0/1 response (50.0%/57.3% vs 17.4%), PASI90 (49.4%/45.5% vs 12.0%), and MDA (18.8%/23.9% vs 5.4%) (all P < 0.001). Through week 24, 46.7%, 53.6%, and 48.3% of participants receiving guselkumab Q4W, guselkumab Q8W, and placebo, respectively, had one or more adverse event. One death occurred (myocardial infarction). Conclusion: Comparable efficacy was observed with both guselkumab regimens in participants with active PsA and inadequate response to one prior TNF inhibitor; safety findings were consistent with the known profile of guselkumab in patients with psoriatic disease. image
- Open Access
- 8 March 2026
- Published by Springer Nature in Dermatology and Therapy
- Vol. 16 (4) , 2091-2102
Real-World Burden of Generalized Pustular Psoriasis in a French Observational Study: Prevalence, Incidence, Healthcare Resource Utilization, Comorbidities, Treatment Use, and Mortality
Introduction Generalized pustular psoriasis (GPP) is rare, chronic, and associated with life-threatening complications. We investigated the burden of GPP in France. Methods Using data from 2010 to 2021 in the Système National des Données de Santé database, healthcare resource utilization (HCRU), costs, comorbidities, mortality, and treatments were compared among GPP (N = 4351), plaque psoriasis (N = 12,945), and general population (N = 12,981) cohorts, matched for sex, age, Charlson Comorbidity Index (CCI) score, and region. GPP prevalence and incidence were also investigated. Results Annually, there were 0.5–0.8 new GPP cases per 100,000 people. Across the cohorts, 54.5–54.7% of people were male, with mean age 58.7–59.5 years and mean CCI score 1.98–2.06. The GPP cohort incurred significantly greater HCRU and costs versus the plaque psoriasis and general population cohorts, including greater proportions of patients receiving emergency care (78% vs 63% and 55%) and intensive care (28% vs 17% and 14%), longer hospitalizations (mean 38.5 vs 26.2 and 22.4 days per patient), and higher medication costs (€4360 vs €1991 and €1543 per patient-year), respectively. Despite similar CCI scores, GPP was associated with more cardiometabolic and psychological comorbidities versus the plaque psoriasis and general population cohorts, e.g., hypertension (37% vs 21% and 20%), obesity (21% vs 9% and 6%), depression (13% vs 4% and 4%), alcohol abuse (16% vs 3% and 3%), and sleep disorders (8% vs 4% and 3%), respectively. Treatments in the GPP cohort were those used for plaque psoriasis, including topical steroids (77%), systemic steroids (50%), and biologics (23%). Twelve-month survival was 86.9% (GPP), 97.5% (plaque psoriasis), and 90.0% (the general population). Conclusion HCRU, costs, and comorbidities with GPP were often double those for comparator cohorts, and mortality was higher. These findings highlight the need to use GPP-targeted treatments that improve patient outcomes and may reduce the burden on healthcare systems.
- 8 March 2026
- Published by Springer Nature in Dermatology and Therapy
- Vol. 16 (4) , 2091-2102
Open AccessReal-World Burden of Generalized Pustular Psoriasis in a French Observational Study: Prevalence, Incidence, Healthcare Resource Utilization, Comorbidities, Treatment Use, and Mortality
Introduction Generalized pustular psoriasis (GPP) is rare, chronic, and associated with life-threatening complications. We investigated the burden of GPP in France. Methods Using data from 2010 to 2021 in the Système National des Données de Santé database, healthcare resource utilization (HCRU), costs, comorbidities, mortality, and treatments were compared among GPP (N = 4351), plaque psoriasis (N = 12,945), and general population (N = 12,981) cohorts, matched for sex, age, Charlson Comorbidity Index (CCI) score, and region. GPP prevalence and incidence were also investigated. Results Annually, there were 0.5–0.8 new GPP cases per 100,000 people. Across the cohorts, 54.5–54.7% of people were male, with mean age 58.7–59.5 years and mean CCI score 1.98–2.06. The GPP cohort incurred significantly greater HCRU and costs versus the plaque psoriasis and general population cohorts, including greater proportions of patients receiving emergency care (78% vs 63% and 55%) and intensive care (28% vs 17% and 14%), longer hospitalizations (mean 38.5 vs 26.2 and 22.4 days per patient), and higher medication costs (€4360 vs €1991 and €1543 per patient-year), respectively. Despite similar CCI scores, GPP was associated with more cardiometabolic and psychological comorbidities versus the plaque psoriasis and general population cohorts, e.g., hypertension (37% vs 21% and 20%), obesity (21% vs 9% and 6%), depression (13% vs 4% and 4%), alcohol abuse (16% vs 3% and 3%), and sleep disorders (8% vs 4% and 3%), respectively. Treatments in the GPP cohort were those used for plaque psoriasis, including topical steroids (77%), systemic steroids (50%), and biologics (23%). Twelve-month survival was 86.9% (GPP), 97.5% (plaque psoriasis), and 90.0% (the general population). Conclusion HCRU, costs, and comorbidities with GPP were often double those for comparator cohorts, and mortality was higher. These findings highlight the need to use GPP-targeted treatments that improve patient outcomes and may reduce the burden on healthcare systems.
- 1 October 2025
- Published by The Journal of Rheumatology in The Journal of Rheumatology
- Vol. 52 (Suppl 3) , 1-3
Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2024 Annual Meeting
The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2024 annual meeting was held from July 11 to July 13, 2024, in Seattle, Washington, USA, and was attended by 256 rheumatologists, dermatologists, trainees, patient research partners, patient organization representatives, industry partners, and others. The meeting featured several workshops on various topics including epidemiology, new educational initiatives, use of artificial intelligence for both education and clinical management of disease, use of magnetic resonance imaging in the diagnosis and management of psoriatic disease (PsD), and many more. Young-GRAPPA held a workshop and business meeting about their projects, and many of the young GRAPPiAns contributed as coauthors of the articles in this supplement. Debates focused on whether clinical enthesitis indices reflect true enthesitis and whether they should be discontinued, and whether musculoskeletal symptoms in PsD should be managed by dermatologists or rheumatologists. Here we provide an overview of the features of the GRAPPA 2024 annual meeting and introduce the manuscripts published together in this supplement as a meeting report.
- 1 October 2025
- Published by The Journal of Rheumatology in The Journal of Rheumatology
- Vol. 52 (Suppl 3) , 1-3
Prologue: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2024 Annual Meeting
The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2024 annual meeting was held from July 11 to July 13, 2024, in Seattle, Washington, USA, and was attended by 256 rheumatologists, dermatologists, trainees, patient research partners, patient organization representatives, industry partners, and others. The meeting featured several workshops on various topics including epidemiology, new educational initiatives, use of artificial intelligence for both education and clinical management of disease, use of magnetic resonance imaging in the diagnosis and management of psoriatic disease (PsD), and many more. Young-GRAPPA held a workshop and business meeting about their projects, and many of the young GRAPPiAns contributed as coauthors of the articles in this supplement. Debates focused on whether clinical enthesitis indices reflect true enthesitis and whether they should be discontinued, and whether musculoskeletal symptoms in PsD should be managed by dermatologists or rheumatologists. Here we provide an overview of the features of the GRAPPA 2024 annual meeting and introduce the manuscripts published together in this supplement as a meeting report.
- Open Access
- 30 August 2025
- Published by Elsevier in Journal of the American Academy of Dermatology
- Vol. 94 (1) , 104-112
Real-world treatment patterns in patients with generalized pustular psoriasis: A US-based claims study
- 30 August 2025
- Published by Elsevier in Journal of the American Academy of Dermatology
- Vol. 94 (1) , 104-112
Open AccessReal-world treatment patterns in patients with generalized pustular psoriasis: A US-based claims study
- Open Access
- 28 August 2025
- Published by Oxford University Press (OUP) in British Journal of Dermatology
- Vol. 194 (1) , 25-36
SPECTREM phase IIIb clinical trial results through week 16: guselkumab efficacy and safety for the treatment of low body surface area, moderate psoriasis with high-impact site involvement
Background: Patients with psoriasis affecting a low percentage of their body surface area (BSA) are under-represented in clinical studies and may face substantial disease burden if high-impact sites are affected. Objectives: To evaluate in a phase IIIb randomized placebo-controlled study (SPECTREM; NCT06039189) the efficacy and safety of guselkumab in participants with low BSA (2–15%), moderate [Investigator’s Global Assessment (IGA) = 3] plaque psoriasis involving one or more high-impact site (scalp, face, genitals, intertriginous areas). Methods: Eligible participants were randomized 2 : 1 to receive guselkumab 100 mg or placebo at week 0 and week 4, then every 8 weeks. The primary endpoint was the proportion of participants achieving IGA 0/1 (cleared/minimal) at week 16. Major secondary endpoints included the proportion of participants achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90), IGA 0 and 100% improvement in PASI (PASI 100); mean percentage improvements from baseline to week 16 in BSA and PASI; and proportions of participants achieving site-specific IGA or Physician’s Global Assessment (PGA) 0/1 among those with scalp, facial, genital or intertriginous site-specific IGA/PGA ≥ 3 at baseline. Results: Among the 338 randomized participants (guselkumab, n = 225; placebo, n = 113), mean (SD) baseline BSA was 7.6% (3.7) and PASI was 9.0 (3.8). At week 16, all primary and major secondary endpoints were met, with guselkumab demonstrating superiority vs. placebo (all P < 0.001) in the proportions of participants achieving IGA 0/1 (74.2% vs. 12.4%), IGA 0 (40.4% vs. 3.5%), PASI 90 (52.9% vs. 6.2%) and PASI 100 (32.4% vs. 2.7%), and mean percentage improvement from baseline in BSA (80.6% vs. 6.1%) and PASI (82.6% vs. 13.7%). Site-specific IGA/PGA 0/1 response rates for guselkumab vs. placebo were as follows: scalp 75.0% (n = 114/152) vs. 14.5% (n = 11/76); face 87.8% (n = 79/90) vs. 28.6% (n = 12/42); genital 78.0% (n = 64/82) vs. 37.5% (n = 15/40) and intertriginous 86.5% (n = 96/111) vs. 28.8% (n = 15/52). In the guselkumab and placebo groups, respectively, 37.8% and 39.8% experienced one or more adverse event; no new safety signals were identified. Conclusions: Through week 16, guselkumab was effective and well tolerated in participants with low BSA, moderate plaque psoriasis with involvement of high-impact sites. Statistically significant improvements across multiple clearance measures, irrespective of baseline BSA, support the effectiveness of guselkumab across a broad range of patients.
- 28 August 2025
- Published by Oxford University Press (OUP) in British Journal of Dermatology
- Vol. 194 (1) , 25-36
Open AccessSPECTREM phase IIIb clinical trial results through week 16: guselkumab efficacy and safety for the treatment of low body surface area, moderate psoriasis with high-impact site involvement
Background: Patients with psoriasis affecting a low percentage of their body surface area (BSA) are under-represented in clinical studies and may face substantial disease burden if high-impact sites are affected. Objectives: To evaluate in a phase IIIb randomized placebo-controlled study (SPECTREM; NCT06039189) the efficacy and safety of guselkumab in participants with low BSA (2–15%), moderate [Investigator’s Global Assessment (IGA) = 3] plaque psoriasis involving one or more high-impact site (scalp, face, genitals, intertriginous areas). Methods: Eligible participants were randomized 2 : 1 to receive guselkumab 100 mg or placebo at week 0 and week 4, then every 8 weeks. The primary endpoint was the proportion of participants achieving IGA 0/1 (cleared/minimal) at week 16. Major secondary endpoints included the proportion of participants achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90), IGA 0 and 100% improvement in PASI (PASI 100); mean percentage improvements from baseline to week 16 in BSA and PASI; and proportions of participants achieving site-specific IGA or Physician’s Global Assessment (PGA) 0/1 among those with scalp, facial, genital or intertriginous site-specific IGA/PGA ≥ 3 at baseline. Results: Among the 338 randomized participants (guselkumab, n = 225; placebo, n = 113), mean (SD) baseline BSA was 7.6% (3.7) and PASI was 9.0 (3.8). At week 16, all primary and major secondary endpoints were met, with guselkumab demonstrating superiority vs. placebo (all P < 0.001) in the proportions of participants achieving IGA 0/1 (74.2% vs. 12.4%), IGA 0 (40.4% vs. 3.5%), PASI 90 (52.9% vs. 6.2%) and PASI 100 (32.4% vs. 2.7%), and mean percentage improvement from baseline in BSA (80.6% vs. 6.1%) and PASI (82.6% vs. 13.7%). Site-specific IGA/PGA 0/1 response rates for guselkumab vs. placebo were as follows: scalp 75.0% (n = 114/152) vs. 14.5% (n = 11/76); face 87.8% (n = 79/90) vs. 28.6% (n = 12/42); genital 78.0% (n = 64/82) vs. 37.5% (n = 15/40) and intertriginous 86.5% (n = 96/111) vs. 28.8% (n = 15/52). In the guselkumab and placebo groups, respectively, 37.8% and 39.8% experienced one or more adverse event; no new safety signals were identified. Conclusions: Through week 16, guselkumab was effective and well tolerated in participants with low BSA, moderate plaque psoriasis with involvement of high-impact sites. Statistically significant improvements across multiple clearance measures, irrespective of baseline BSA, support the effectiveness of guselkumab across a broad range of patients.
- 5 August 2025
- Published by The Journal of Rheumatology in The Journal of Rheumatology
- Vol. 52 (Suppl 3) , 8-11
Report of the IDEOM Meeting Adjacent to the GRAPPA 2024 Annual Meeting
The International Dermatology Outcome Measures (IDEOM) organization presented updates on its patient-reported outcome measures (PROMs) for psoriasis (PsO), psoriatic arthritis (PsA), and other immune-mediated skin diseases at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2024 annual meeting. The Hidradenitis Suppurativa working group reported on the IDEOM Musculoskeletal Questionnaire (MSK-Q), a PROM for MSK manifestations of psoriatic disease. Advances in PsA screening included integrating the Psoriasis Epidemiology Screening Tool (PEST) and 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaires into the Epic electronic health record system to streamline detection and management of emerging PsA cases. The Connective Tissue Disease working group discussed upcoming trials and tools for addressing significant unmet needs in cutaneous lupus erythematosus. Finally, the Patient Satisfaction working group provided updates on the 7-item Dermatology Treatment Satisfaction Instrument (DermSat-7) and DermSat-11 for clinical trials and real-world studies. The DermSat-7 has been validated in a multicenter study of patients with PsO, whereas the DermSat-11 is currently undergoing validation. IDEOM continues to work to significantly improve patient outcomes and satisfaction in dermatology.
- 5 August 2025
- Published by The Journal of Rheumatology in The Journal of Rheumatology
- Vol. 52 (Suppl 3) , 8-11
Report of the IDEOM Meeting Adjacent to the GRAPPA 2024 Annual Meeting
The International Dermatology Outcome Measures (IDEOM) organization presented updates on its patient-reported outcome measures (PROMs) for psoriasis (PsO), psoriatic arthritis (PsA), and other immune-mediated skin diseases at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2024 annual meeting. The Hidradenitis Suppurativa working group reported on the IDEOM Musculoskeletal Questionnaire (MSK-Q), a PROM for MSK manifestations of psoriatic disease. Advances in PsA screening included integrating the Psoriasis Epidemiology Screening Tool (PEST) and 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaires into the Epic electronic health record system to streamline detection and management of emerging PsA cases. The Connective Tissue Disease working group discussed upcoming trials and tools for addressing significant unmet needs in cutaneous lupus erythematosus. Finally, the Patient Satisfaction working group provided updates on the 7-item Dermatology Treatment Satisfaction Instrument (DermSat-7) and DermSat-11 for clinical trials and real-world studies. The DermSat-7 has been validated in a multicenter study of patients with PsO, whereas the DermSat-11 is currently undergoing validation. IDEOM continues to work to significantly improve patient outcomes and satisfaction in dermatology.
- Open Access
- 7 March 2025
- Published by Elsevier in Journal of the American Academy of Dermatology
- Vol. 92 (6) , 1235-1242
Effect of spesolimab on sustained disease control in patients with generalized pustular psoriasis: Post hoc analysis of the EFFISAYIL 2 study
- 7 March 2025
- Published by Elsevier in Journal of the American Academy of Dermatology
- Vol. 92 (6) , 1235-1242
Open AccessEffect of spesolimab on sustained disease control in patients with generalized pustular psoriasis: Post hoc analysis of the EFFISAYIL 2 study