Patient Satisfaction Using Guselkumab Self-administered Using the One-Press Device for Treatment of Moderate-to-Severe Psoriasis: Results from a National, Prospective, Real-World Study in Portugal (CERES Study).

  • Abstract
  • Literature Map
  • Similar Papers
Abstract
Translate article icon Translate Article Star icon
Take notes icon Take Notes

Guselkumab, a selective p19 subunit-targeted IL-23 inhibitor, has shown high efficacy and a favorable safety profile in clinical trials of moderate-to-severe plaque psoriasis (PsO). However, real-world data on patient satisfaction with the guselkumab One-Press device, particularly in Portuguese clinical practice, are limited. This real-world, prospective, multicenter, nationwide study evaluated patient satisfaction with self-administration of guselkumab using the One-Press device over 52weeks in adults with moderate-to-severe plaque PsO. A total of 101 patients from 10 dermatology centers were enrolled between September 2022 and November 2023. Patient satisfaction was assessed using the Self-Injection Assessment Questionnaire (SIAQ) at baseline and week 20. Using the SIAQ, patients rated the One-Press device's acceptability across six domains predose and postdose (feeling about injections, self-confidence, and satisfaction with self-injection; postdose only: self-image, pain and skin reactions during or after the injection, and ease of self-injection device use). Quality of life (Dermatology Life Quality Index [DLQI]), clinical effectiveness (Investigator Global Assessment [IGA]), and safety were evaluated through week 52. Mean SIAQ PRE Module score increased significantly from 6.9 ± 1.8 at baseline to 8.3 ± 1.5 at week 20 (p < 0.001), indicating improved self-injection experience. Injection-related anxiety decreased from 63.4% to 48.9%. Mean DLQI score improved from 8.5 ± 6.9 at baseline to 1.5 ± 2.8 at week 20 and 1.1 ± 3.0 at week 52; 70.8% of patients achieved DLQI 0/1 by week 52. Despite nearly 90% having prior biologic or systemic therapy exposure, IGA 0/1 ("clear" or "almost clear") was achieved by 86.3% of patients at week 20 and 91.0% at week 52. A total of 198 adverse events (AEs) were reported in 62.4% of patients and were mainly mild, localized injection-site reactions. One serious AE was considered related to guselkumab. In routine clinical practice in Portugal, guselkumab self-administered using the One-Press device demonstrated high patient satisfaction, substantial quality-of-life improvement, robust clinical effectiveness, and a favorable safety profile. These real-world findings support the usability and benefit-risk profile of self-administered guselkumab for patients with moderate-to-severe plaque PsO.

Similar Papers
  • Research Article
  • Cite Count Icon 12
  • 10.1111/dth.15285
Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial.
  • Jan 8, 2022
  • Dermatologic Therapy
  • Bardur Sigurgeirsson + 12 more

Convenient administration is an important factor for treatment adherence in patients with psoriasis. MATURE study reports the efficacy, safety, tolerability, and pharmacokinetics (PKs) of secukinumab 300 mg 2ml autoinjector (AI) from MATURE trial (NCT03589885). Eligible patients were randomized to secukinumab 300 mg 2ml AI or 2× 1ml prefilled syringe (PFS) or placebo. The co-primary endpoints were psoriasis area and severity index (PASI) 75 and investigator's global assessment (IGA) 0/1 response rates at Week 12 versus placebo. Other endpoints included PASI90/100 response, dermatology life quality index (DLQI) 0/1, PKs, 2ml AI usability rated using self-injection assessment questionnaire (SIAQ), and safety. The study met both co-primary and secondary endpoints (p< 0.0001). Secukinumab 300 mg 2 ml AI and 2× 1 ml PFS treatments led to superior PASI75/90/100 (2 ml AI: 95.1%/75.6%/43.9%; 2× 1 mL PFS: 83.2%/62.6%/37.5% and placebo: 10%/5.0%/0.0%, respectively), IGA, and DLQI 0/1 responses compared with placebo, and efficacy was sustained through 52 weeks. SIAQ results showed high usability of self-injection with 2 mL AI device. No new safety signals were observed. Study design may bias the interpretation of safety profile after Week 12, due to different exposure of secukinumab versus placebo. Secukinumab 300 mg administered with the 2mL AI demonstrated superior efficacy over placebo, good tolerability, and convenient administration.

  • Discussion
  • Cite Count Icon 8
  • 10.1097/cm9.0000000000002563
Updates in psoriasis diagnosis and treatment status in China: results from the National Psoriasis Center Registry.
  • Dec 5, 2023
  • Chinese medical journal
  • Zhihui Yang + 4 more

Updates in psoriasis diagnosis and treatment status in China: results from the National Psoriasis Center Registry.

  • Research Article
  • Cite Count Icon 8
  • 10.1007/s12325-023-02672-1
Safety and Efficacy of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: A Prospective, Multicenter, Observational Study.
  • Oct 12, 2023
  • Advances in Therapy
  • Li Ying + 13 more

Psoriasis, an incurable chronic inflammatory disease, affects over 6 million people in China. Ixekizumab, a monoclonal antibody against interleukin-17A, has demonstrated efficacy and safety for the treatment of moderate-to-severe plaque psoriasis, although limited data are available regarding its use in routine clinical practice in China. We investigated the real-world application of ixekizumab in China. Adults (≥18 years) with moderate-to-severe plaque psoriasis prescribed ixekizumab in routine clinical practice were enrolled in this prospective, observational, single-arm, multicenter, post-marketing surveillance study. The primary endpoint was the safety of ixekizumab at week 12. The effectiveness of ixekizumab, based on the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), was assessed as a secondary endpoint. In total, 666 patients were enrolled; 663 were included in the safety analysis, and 612 in the effectiveness analysis. At least one adverse event (AE) was reported by 42.7% (283/663) of patients, most of which were mild (242/283, 85.5%), and 32.7% (217/663) of patients reported AEs related to study treatment. The most frequently reported AEs were injection site reactions. AEs led to discontinuation in five patients (0.8%). Only three patients had a serious AE. Mean±standard deviation (SD) change from baseline in PASI score was reduction in 10.79±9.55 at week 2 and 16.80±12.15 at week 12. At week 2, 63.7% of patients achieved PASI 50. At week 12, 93.2%, 77.4%, and 45.1% of patients achieved PASI 75, PASI 90, and PASI 100, respectively. Mean±SD change from baseline in DLQI was reduction in 5.91±6.27 at week 2 and 9.76±7.16 at week 12. DLQI 0/1 was achieved by 19.8% and 59.9% of patients at week 2 and 12, respectively. Ixekizumab was well tolerated and effective in real-world clinical practice in Chinese adults with moderate-to-severe plaque psoriasis.

  • Abstract
  • Cite Count Icon 1
  • 10.1136/annrheumdis-2023-eular.442
AB0419 OUTCOMES OF THE SELF-INJECTION ASSESSMENT QUESTIONNAIRE IN RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS PATIENTS RECEIVING GP2015 (ETANERCEPT BIOSIMILAR) IN A REAL-WORLD STUDY: FINAL RESULTS FROM COMPACT STUDY
  • May 30, 2023
  • Annals of the Rheumatic Diseases
  • M Schmalzing + 5 more

BackgroundCOMPACT is an international, non-interventional cohort study evaluating the effectiveness, safety and quality of life in patients (pts) with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) treated with...

  • Research Article
  • Cite Count Icon 1
  • 10.1093/bjd/ljae266.025
645 - Effectiveness and safety of upadacitinib in adolescent and adult patients with atopic dermatitis: an analysis of long-term (week 52) data from a real-world multicenter retrospective review
  • Aug 8, 2024
  • British Journal of Dermatology
  • Siddhartha Sood + 11 more

Introduction While clinical trial data demonstrates the efficacy and safety of upadacitinib (UPA), an oral Janus kinase inhibitor (JAKi) for atopic dermatitis (AD), long-term real-world evidence remains limited. Objectives Our study evaluated the real-world effectiveness and safety of UPA for AD at week 52±6. Methods We conducted a multicenter retrospective review of 3 practices in Canada. Effectiveness endpoints were evaluated at weeks 52±6 and including the following: Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) as well as improvements in Eczema Area and Severity Index (EASI), body surface area (BSA), IGAxBSA, and Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI). Safety was determined via incidence of treatment-related adverse events (AEs). Results A total of 102 patients with AD were included in the analysis; mean age was 44.2 (range: 12-79) years and 52.9% (54/102) were female. Initial UPA doses were 15 mg (UPA15: 41.2%, 42/102) or 30 mg (UPA30: 58.8%, 60/102) once daily. Previous systemic therapies included conventional non-biologics (72.5%), biologics (30.4%), and JAKi (2.9%). At week 52±6: 78.4% (80/102) of patients achieved Investigator Global Assessment (IGA) 0/1; 87.5% (49/56), 78.6% (44/56), and 50.0% (28/56) achieved Eczema Area and Severity Index (EASI) improvements of 75% (EASI75), 90% (EASI90), and 100% (EASI100), respectively; 75.0% (42/56) achieved EASI90 + IGA 0/1; mean EASI was reduced from 12.9 to 0.8 (mean EASI improvement = 91.4%); 91.9% (52/56), 92.9% (52/56), 82.1% (46/56), and 75.0% (42/56) achieved absolute EASI scores &amp;lt;7, &amp;lt;5, &amp;lt;3, and &amp;lt;1, respectively; mean body surface area (BSA) was reduced from 17.0% to 0.6% (mean BSA improvement=87.8%); mean IGAxBSA was reduced from 52.1 to 0.8 (mean IGAxBSA improvement=90.7%); and mean Dermatology Life Quality Index (DLQI)/Children’s DLQI was reduced from 13 to 1.8 (mean DLQI/CDLQI improvement=86%), with 66.0% (33/50) of patients achieving DLQI/CDLQI 0/1. For patients not achieving IGA 0/1, EASI75, EASI90, and EASI100 at weeks 8-20, these responses were subsequently achieved in 60.0% (6/10), 88.9% (8/9), 84.6% (11/13), and 38.1% (8/21) of patients at week 52±6. Dose alterations occurred in 13 patients (12.7%) (escalation: 6.9%, 7/102; reduction: 5.9%, 6/102). Concomitant systemic therapies were used in 1.0% (1/102) of patients. We noted higher statistically significant achievement of endpoints for systemic biologic/JAKi-naïve vs -experienced patients (EASI75; EASI&amp;lt;7; EASI&amp;lt;5; DLQI/CDLQI &amp;gt;4-point improvement). No significant differences in outcomes were identified between dosing regimens. Frequent AEs included: acne (19.6%, 20/102), hypertriglyceridemia (17.6%, 18/102), elevated creatine phosphokinase (13.7%, 14/102), neutropenia (7.8%, 8/102), and transaminitis (7.8%, 8/102). Seven patients (6.8%) discontinued UPA owing to treatment-related AEs, including one case of venous thromboembolism; four patients (3.9%) discontinued UPA due to patient preference, and one patient (1%) discontinued UPA due to lack of efficacy. No serious infections, tuberculosis, major adverse cardiovascular events, gastrointestinal perforation, malignancy, or deaths were observed in 102.5 patient-years of follow-up. Conclusions In contrast to 52-week data from the Measure Up 1/2 and AD Up clinical trials, our results were superior for several outcome parameters (IGA 0/1, EASI90, EASI100, and DLQI 0/1), possibly owing to a patient population with less extensive baseline disease severity. Additionally, we noted similar achievement of these endpoints versus comparable long-term real-world studies. Safety was consistent with existing data, highlighting acne as a common AE (5.3%-20.3% versus 19.6%). Study limitations include its sample size and retrospective nature.

  • Discussion
  • Cite Count Icon 3
  • 10.1097/cm9.0000000000002390
Efficacy and safety of ixekizumab in Chinese patients with plaque psoriasis.
  • Feb 5, 2023
  • Chinese Medical Journal
  • He Huang + 13 more

Efficacy and safety of ixekizumab in Chinese patients with plaque psoriasis.

  • Research Article
  • Cite Count Icon 8
  • 10.1111/dth.15886
Real world experience of brodalumab treatment in patients with moderate-to-severe plaque psoriasis in the Greek population: Results from an interim analysis of the BrIDGE study.
  • Nov 1, 2022
  • Dermatologic Therapy
  • Dimitrios Rigopoulos + 18 more

Brodalumab's clinical efficacy and favorable safety profile have been demonstrated during controlled clinical trials, but real-world data remain scarce. BrIDGE, an ongoing 104 week, observational, prospective, multicenter study conducted in Greece, enrolled moderate-to-severe plaque psoriasis patients, with body surface area (BSA) > 10 or psoriasis area severity index score (PASI) > 10 and dermatology life quality index (DLQI) > 10, based on European consensus, initiating brodalumab treatment as per routine clinical practice. This interim analysis includes evaluations 12-16 weeks following treatment initiation. Key efficacy endpoints included proportion of patients achieving static Physician's Global Assessment (sPGA) score of "clear/almost clear" (0/1) and a reduction ≥75%, 90%, 100% from baseline in PASI (PASI75, PASI90, and PASI100) at weeks 12-16. Other endpoints included time to achieve PASI100, changes in self-reported DLQI and psoriasis symptom inventory (PSI) at weeks 12-16. From 200 patients (mean age 51.4 years, 70% male, mean disease duration 13.8 years) enrolled, 72.8% achieved sPGA of 0/1, whereas 70.2%, 47.5%, and 32.0% achieved corresponding PASI75, PASI90, and PASI100 responses following 12-16 weeks of brodalumab treatment, according to the "as-observed" analysis. The mean time to achieve PASI100 was 13.7 ± 1.2 weeks for the 32% who achieved PASI100. Concurrent decreases in mean DLQI and PSI were observed. Furthermore, 90% adherence to brodalumab was noted and nine adverse events were reported. Brodalumab confers substantial clinical improvements short-term as reflected by high levels of skin clearance in moderate-to-severe plaque psoriasis patients within 12-16 weeks of treatment under everyday clinical conditions, followed by improvements in symptoms and quality of life and a favorable safety profile.

  • Research Article
  • 10.3724/zdxbyxb-2025-0432
A real world study on the effectiveness and safety of deu-cravacitinib in the treatment of moderate-to-severe plaque psoriasis in China
  • Sep 1, 2025
  • Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences
  • 谊 张 + 3 more

To evaluate the effectiveness and safety of deucravacitinib in Chinese patients with moderate-to-severe plaque psoriasis. This retrospective study included 41 patients with moderate-to-severe plaque psoriasis treated with deu-cravacitinib 6 mg once daily for 16 weeks at the First Affiliated Hospital of Wenzhou Medical University between January and September 2024. Effectiveness was assessed by the psoriasis area and severity index (PASI), static physician's global assessment (sPGA), palmoplantar psoriasis area and severity index (PPASI), modified nail psoriasis severity index (mNAPSI), and dermatology life quality index (DLQI) at baseline, 4, 8, 12 and 16 weeks after treatment. Adverse events during treatment were recorded. Laboratory parameters, including complete blood count, liver and kidney function, electrolytes, and lipids, were assessed at baseline, 8, 16 weeks after treatment to evaluate safety. Univariate and multivariate logistic regression analyses were performed to explore factors associated with achieving PASI75 at week 16, using baseline characteristics as independent variables. Significant reductions from baseline in PASI and DLQI scores were observed from week 4 through week 16 (all P<0.01). Overall response rates for PASI75, PASI90, PASI100, sPGA 0 or 1 grade, and DLQI 0 or 1 point increased progressively over the treatment period. 75, 90, and 100 refer to a score reduction of at least 75%, at least 90%, and 100%, respectively, from baseline. Response rates of PASI75, PASI90, PASI100 for the scalp, limbs, and trunk, PPASI75, PPASI90, PPASI100 for palmoplantar lesions, and mNAPSI75, mNAPSI90 for nail lesions increased progressively over time but with different trends. Scalp lesions improved most markedly from week 4, followed by the limbs, whereas improvements in trunk and palmoplantar lesions were relatively slower. Nail lesions responded more slowly, with only 20% of patients achieving marked improve-ment at week 16. Deucravacitinib demonstrated good tolerability and compatibility with concomitant medications. No severe adverse events were reported, indicating a favorable safety profile. Multivariate logistic regression analysis revealed no significant association between the achievement of PASI75 response at week 16 and patient age, body mass index, disease duration, or baseline PASI, sPGA, or DLQI scores (all P>0.05). In this real world study of Chinese patients with moderate-to-severe plaque psoriasis, deucravacitinib demonstrated favorable effectiveness and safety over 16 weeks of treatment.

  • PDF Download Icon
  • Research Article
  • Cite Count Icon 5
  • 10.1111/1346-8138.16519
Calcipotriol/betamethasone aerosol foam (Enstilum) for the topical treatment of psoriasis vulgaris in routine practice in Korea: A prospective, noninterventional, multicenter study of treatment outcomes and patient satisfaction.
  • Jul 18, 2022
  • The Journal of Dermatology
  • Seong Jin Jo + 10 more

An innovative foam formulation for the fixed-dose combination of calcipotriol and betamethasone dipropionate (Cal/BD) has recently become available for the treatment of psoriasis vulgaris. Observational studies of patients treated with Cal/BD foam in routine practice have been conducted in several Western countries, but there are limited data on outcomes in Asian patients. We performed a prospective, open-label, noncomparative, noninterventional study to investigate treatment outcomes and satisfaction in adult patients receiving Cal/BD foam for psoriasis vulgaris in dermatological centers and outpatient clinics in Korea. Data were collected at the time of enrollment (Visit 1) and at a routine clinic visit ~4 weeks later (Visit 2). In total, 218 patients were enrolled, of whom 175 were included in the safety analysis set (58.9% male; mean age ± standard deviation 46.7± 15.1 years; use of Cal/BD foam at least once daily 74.3%). Of the safety analysis set, 166 patients had at least mild psoriasis (Investigator Global Assessment [IGA] ≥ 2) and were analyzed for treatment outcomes and satisfaction. Of the 166 patients, 71.7% had mild psoriasis (IGA 2) at baseline. The majority (57.8%) achieved an IGA of 0/1 (clear/almost clear) at Visit 2. The Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) showed significant improvements from Visit 1 to Visit 2 (PASI -2.4± 3.0, DLQI -4.5± 5.2, both P< 0.0001). Most of the patients were satisfied with the Cal/BD foam treatment; 77.0%, 60.0%, and 73.9% were satisfied in terms of effectiveness, ease of use, and global satisfaction, respectively. In the safety analysis set, adverse events were reported in 13 patients (7.4%). In conclusion, this first Korean real-world study of Cal/BD foam shows improvement of lesions and health-related quality of life after 4 weeks of treatment, with high global satisfaction and good overall tolerability and safety.

  • Research Article
  • 10.25251/mextwf19
Bimekizumab long-term efficacy in patients with plaque psoriasis from BE BRIGHT: Improvements in mean absolute clinical outcome scores over 4 years
  • Nov 10, 2025
  • SKIN The Journal of Cutaneous Medicine
  • Sascha Gerdes + 9 more

Introduction: Bimekizumab (BKZ) has demonstrated long-term efficacy in patients (pts) with moderate to severe plaque psoriasis.1 Measuring response using absolute outcome scores may be clinically beneficial, as they are not influenced by baseline (BL) disease severity and provide a direct measure of current disease severity.2 We report improvements in absolute scores for psoriasis clinical outcomes through 4 years of BKZ treatment. Procedure: Data were pooled from BE VIVID/BE READY/BE SURE (NCT03370133/NCT03410992/NCT03412747) and their open-label extension (OLE) BE BRIGHT (NCT03598790). Included pts received BKZ 320 mg every 4 weeks (wks; Q4W) to Wk16, then Q4W or Q8W into OLE. Mean absolute Psoriasis Area and Severity Index (PASI), Investigator’s Global Assessment (IGA), body surface area (BSA) affected by psoriasis, and Dermatology Life Quality Index (DLQI) scores are reported to OLE Wk144 (Year4), using multiple imputation. Data were reported in all pts (BKZ Total), and in pts who received BKZ Q4W to Wk16 then Q8W (Q4W/Q8W). Results: Among 771 BKZ Total pts, mean BL scores were: PASI 21.1; IGA 3.3; BSA 27.0; DLQI 10.5 (Q4W/Q8W: PASI 20.4; IGA 3.3; BSA 24.5; DLQI 10.8). Mean Wk16/Year4 scores were: PASI 0.6/0.7; IGA 0.4/0.5; BSA 1.4/1.2; DLQI 1.3/0.9. Scores in the 197 Q4W/Q8W pts at Wk16/Year4 were similar (PASI 0.3/0.6; IGA: 0.3/0.3; BSA: 0.7/1.2; DLQI: 1.3/0.7). Conclusion: Improvements in mean absolute PASI, IGA, BSA, and DLQI were high by Wk16 and sustained through 4 years with BKZ.

  • Research Article
  • Cite Count Icon 10
  • 10.1016/j.jaad.2022.05.047
Secukinumab is effective in the treatment of recalcitrant palmoplantar psoriasis and palmoplantar pustular psoriasis in a daily practice setting
  • May 28, 2022
  • Journal of the American Academy of Dermatology
  • Alejandra Reolid + 16 more

Secukinumab is effective in the treatment of recalcitrant palmoplantar psoriasis and palmoplantar pustular psoriasis in a daily practice setting

  • Research Article
  • 10.1093/bjd/ljae266.023
643 - Effectiveness and safety of upadacitinib in adolescent and adult patients with atopic dermatitis: an analysis of short-term (week 8-20) data from a real-world multicenter retrospective review
  • Aug 8, 2024
  • British Journal of Dermatology
  • Brian D Rankin + 11 more

Introduction Upadacitinib (UPA), an oral, selective Janus kinase inhibitor (JAKi), is approved for moderate-to-severe atopic dermatitis (AD). While its efficacy and safety are supported by clinical trial data1-3, real-world evidence is limited. Objectives Our study evaluated the real-world effectiveness and safety of UPA for AD between weeks 8-20. Methods We conducted a multicenter retrospective review at three practices in Canada. Effectiveness endpoints measured between weeks 8-20 included: Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) and improvements in Eczema Area and Severity Index (EASI), body surface area (BSA), IGAxBSA, and Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI) improvements. Safety was assessed via treatment-related adverse events (AEs). Results A total of 179 patients were included in the analysis. . The mean age was 44.6 ± 17.5 (range: 12-79) years; 53.6% (96/179) were female. Previous treatments included: topicals (100%, 179/179), light (29.1%, 52/179), systemic non-biologics (74.9%, 134/179), and systemic biologics/JAKi (37.4%, 67/179). Initial UPA doses were 15 mg (44.7%, 80/179) or 30 mg (55.3%, 99/179) once daily. At weeks 8-20: 87.2% (156/179) of patients achieved IGA 0/1; 83.3% (85/102), 74.5% (76/102), and 57.8% (59/102) of patients achieved EASI improvements from baseline of 75% (EASI75), 90% (EASI90), and 100% (EASI100), respectively; mean EASI was reduced from 13.4 to 1.0 (p=0.0001; mean EASI improvement = 88.5%); 98% (100/102), 96.1% (98/102), 88.2% (90/102), and 70.6% (72/102) of patients achieved absolute EASI scores &amp;lt;7, &amp;lt;5, &amp;lt;3, and &amp;lt;1, respectively; mean BSA was reduced from 18.2% to 1.1% (p=0.0001; mean BSA improvement=92.2%); mean IGAxBSA was reduced from 60.9 to 2.1 (p=0.0001; mean IGAxBSA improvement=94.7%); and mean DLQI/CDLQI was reduced from 13.6 to 1.4 (p=0.0001; mean DLQI/CDLQI improvement=87.1%), with 75.9% (63/83) of patients achieving DLQI/CDLQI 0/1. UPA monotherapy was utilized in 39.7% (71/179) of cases. Common concomitant therapies included topical corticosteroids (55.3%, 99/179), topical calcineurin inhibitors (6.7%, 12/179), and intramuscular triamcinolone acetonide (2.2%, 4/179). Statistically significantly higher achievement of endpoints was noted for patients using concomitant therapies (EASI75; EASI90; EASI&amp;lt;1) and systemic biologic/JAKi-naïve patients (EASI75; EASI&amp;lt;5; IGA 0/1; DLQI/CDLQI &amp;gt;4-point improvement). Outcomes were not significantly different between dosing regimens. Frequent AEs included: acne (16.2%, 29/179), hypertriglyceridemia (14%, 25/179), elevated creatinine phosphokinase (10.1%, 18/179), herpes simplex virus (6.7%, 12/179), and transaminitis (4.5%, 8/179). Three patients (1.7%) discontinued treatment (myalgia/arthralgia [n=2]; gastrointestinal discomfort [n=1]). No serious infections, tuberculosis, venous thromboembolism, major adverse cardiovascular events, gastrointestinal perforation, or malignancy were observed in 44.7 patient-years of safety follow-up for the treatment period being analyzed. Conclusions Our study included 75.4% (135/179) of patients with follow-up at weeks ≥12 to ≤16. Interestingly, we found more favourable results than Measure Up 1/2 and AD Up clinical trials at week 16 for IGA 0/1, EASI75, EASI90, EASI100, and DLQI 0/1, likely owing to a patient population with less extensive baseline disease severity, while the safety profile was commensurate. Additionally, we noted higher achievement of IGA 0/1, EASI75, and EASI90 endpoints versus similar real-world studies. Study limitations include its retrospective nature and short follow-up duration. Nonetheless, our results support clinical trial findings suggesting UPA is effective and safe for AD.

  • Research Article
  • Cite Count Icon 5
  • 10.1007/s13555-022-00865-0
Effectiveness of Guselkumab Therapy among Patients with Plaque Psoriasis with Baseline IGA Score ≥ 2 in the CorEvitas Psoriasis Registry
  • Dec 9, 2022
  • Dermatology and Therapy
  • April W Armstrong + 9 more

IntroductionIn clinical trials, treatment with the interleukin-23 inhibitor guselkumab was associated with significantly improved disease severity and patient-reported outcome measures (PROMs) among patients with moderate-to-severe plaque psoriasis. However, limited information is available regarding the real-world effectiveness of guselkumab among patients with psoriasis of mild, moderate, and severe Investigator’s Global Assessment (IGA) severities living in the USA and Canada.MethodsPatients participating in the CorEvitas Psoriasis Registry between 18 July 2017 and 10 July 2019 who met the following criteria were included: IGA ≥ 2 (mild or greater disease severity), initiated guselkumab at a registry (index) visit, and had a registry follow-up visit after persistent guselkumab treatment for 9 to 12 months. Data were collected for patient demographics, disease characteristics, treatment history, disease activity, and PROMs. At follow-up, outcome measure response rates and mean changes from the index visit were calculated.ResultsAmong 130 patients, the mean age was 50.2 years, 39.2% were female, and 56.9% had a body mass index ≥ 30 kg/m2. Mean psoriasis duration was 17.5 years and 79.2% of patients had previously received one or more biologic therapy. At the index visit, mean IGA, Psoriasis Area Severity Index (PASI), and Dermatology Life Quality Index (DLQI) scores were 3.0, 9.9, and 8.0, respectively. At follow-up, IGA 0/1 and IGA 0 were achieved by 64.6% and 36.2% of patients, respectively. PASI 75, 90, and 100 were achieved by 61.5%, 46.9%, and 36.9% of patients; 55.4% had maintained or achieved DLQI 0/1. Mean improvements were observed in all evaluated disease activity outcomes and PROMs, with all differing significantly from zero except for the percent of work hours missed due to psoriasis.ConclusionIn this real-world study, patients with a baseline IGA score ≥ 2 experienced improvements in disease activity and PROMs after 9–12 months of persistent guselkumab treatment.

  • Research Article
  • 10.1155/2024/6530352
Real‐World Experience of Secukinumab Treatment in Patients with Moderate‐to‐Severe Plaque Psoriasis in Greece: 3‐Year Interim Results of the SERENA Study
  • Jan 1, 2024
  • Dermatologic Therapy
  • Dimitrios Ioannides + 18 more

SERENA is an ongoing European noninterventional longitudinal study evaluating retention, effectiveness, safety, and quality of life (QoL) in secukinumab‐treated patients with active moderate‐to‐severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Herein, 3‐year interim results among patients with psoriasis enrolled in Greece are presented. Consented adults receiving secukinumab according to the approved label for ≥16 weeks were included. Of 292 patients enrolled, 290 eligible patients (mean age 48.4 years, 71.7% male) were analyzed. At treatment initiation, 65.9% of patients were biologic‐naïve and mean total Psoriasis Area Severity Index (PASI) score was 29.0. At enrolment, mean treatment duration was approximately 1.0 year. The treatment retention rate at 1/2/3 years after enrolment was 94.4/87.3/85.9%; main reasons for discontinuation were lack of effectiveness and adverse events (AEs) (43.6% and 28.2% of discontinuations, respectively). At enrolment, the mean PASI score was 4.0, 61.3% of patients had PASI ≤ 3, 71.7% had Physician’s Global Assessment (PGA) score 0/1, 59.5% had Dermatology Life Quality Index (DLQI) score 0/1, while the mean EuroQoL Visual Analogue Scale (EQ‐VAS) score was 82.0. At 1/2/3 years postenrolment, the mean PASI score was 1.9/1.6/1.0, 86.6/89.4/90.0% had PASI ≤ 3, 89.5/94.8/97.5% had PGA 0/1, 71.1/75.9/81.8% had DLQI 0/1, and mean EQ‐VAS score was 85.7/90.0/92.0. Of enrolled patients, 7.2% experienced secukinumab‐related AEs, while special interest AEs (candida infections, malignancy, and major adverse cardiovascular events) were reported in ≤2 patients, each. These results demonstrate high secukinumab persistence in the Greek population up to three years after study enrolment, accompanied by sustained improvements in both clinical and QoL parameters and a favorable safety profile.

  • Research Article
  • Cite Count Icon 47
  • 10.1007/s40257-018-0396-z
Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies
  • Nov 12, 2018
  • American Journal of Clinical Dermatology
  • April W Armstrong + 7 more

BackgroundHealth-related quality of life (HRQoL) may be markedly impaired in patients with moderate-to-severe psoriasis.ObjectivesOur objectives were to compare improvements in Dermatology Life Quality Index (DLQI) and Psoriasis Symptoms and Signs Diary (PSSD) scores between patients receiving guselkumab compared with placebo or adalimumab and to correlate these improvements with skin clearance.MethodsPooled phase III VOYAGE 1 and VOYAGE 2 data were evaluated through week 24. At baseline, patients were randomized to guselkumab 100 mg, placebo, or adalimumab 40 mg. At week 16, patients receiving placebo switched to guselkumab. Assessment measures included DLQI percent change from baseline, DLQI 0/1, DLQI minimal clinically important difference (MCID), individual domain scores, PSSD symptoms and signs score = 0, DLQI association with PSSD, Investigator’s Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI).ResultsSignificantly greater improvements from baseline DLQI were observed with guselkumab versus placebo (weeks 8 and 16) and versus adalimumab (week 24; p < 0.001). The proportion of patients achieving DLQI 0/1 (“no impact”) at week 24 was higher with guselkumab than with adalimumab (58.9 vs. 40.2%; p < 0.001), and more patients attained a ≥ 4-point reduction in DLQI (MCID) at this timepoint (p < 0.001). Changes in individual DLQI domains were significantly greater for patients receiving guselkumab than for those receiving adalimumab, and among patients with individual baseline domain scores = 3 or 6 (severest impact), more guselkumab recipients than those receiving adalimumab achieved a score = 0 across all domains at week 24. DLQI 0/1 scores were associated with a PSSD symptom or sign score = 0 (no impact) and greater improvement of PASI and IGA (week 24).ConclusionsPooled VOYAGE 1/VOYAGE 2 data demonstrated that guselkumab was superior to adalimumab in improving HRQoL, which was associated with greater skin clearance.Clinical Trial RegistrationNCT02207231 and NCT02207244.

Save Icon
Up Arrow
Open/Close
  • Ask R Discovery Star icon
  • Chat PDF Star icon

AI summaries and top papers from 250M+ research sources.