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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

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Real-world Evidence with TREMFYA in Adult Patients with Plaque Psoriasis - Prospective Studies

Last Updated: 06/24/2024

Summary

Please refer to the local labeling for relevant information on the use of TREMFYA for plaque psoriasis (PsO).
Real-world prospective¹^-⁴ (≥100 patients and a follow-up duration of ≥1 year) and registry-based studies⁵^-²⁴ that evaluated the use of TREMFYA in adult patients with plaque PsO are described below.

Real-world EVIDENCE

Real-world evidence in adult patients with plaque PsO treated with TREMFYA is described in Table: Summary of Prospective and Registry-Based Real-world Studies in Adult Patients with Plaque PsO.

Summary of Prospective and Registry-Based Real-world Studies in Adult Patients with Plaque PsO

Prospective Studies
PERSIST
Gerdes et al (2022, 2021)¹^,²^,⁴ reported results from a 2-year, noninterventional, multicenter study (PERSIST) investigating the long-term efficacy, safety, and HRQoL outcomes of TREMFYA and ustekinumab. Adult patients (N=303) in Germany with moderate to severe plaque PsO for ≥2 years were included for evaluation between January 2018 and May 2019. The primary endpoint was the proportion of patients with a DLQI score of ≤1 at week 28, and the secondary endpoints were HRQoL at week 52 (measured by DLQI), the effectiveness of TREMFYA at week 52 (measured by PASI, area-specific PGA, and target NAPSI scores), and severity of symptoms and signs measured by PSSD at week 28. At baseline, the mean±SD duration of disease was 21.0±14.0 years, mean±SD BMI was 29.7±6.3 kg/m², mean±SD PASI score was 16.4±10.8, and 51.6% of patients had prior exposure to 1 biologic. Efficacy Through week 28²: The mean PASI score decreased from 16.4 at baseline (n=303) to 3.0 (95% CI, 2.3-3.6) by week 28 (n=266). An aPASI score of ≤1 was achieved by 50.8% of patients. The PASI 75, 90, and 100 responses were achieved by 76.7%, 55.3%, and 28.9% of patients, respectively. Among patients with an area-specific PGA score of ≥2 at baseline, 23.5% (n/N=47/200), 18.5% (n/N=15/81), and 9.3% (n/N=11/118) had severe scalp, palmoplantar, and anogenital PsO, respectively. By week 28, 1.1% (n/N=2/177), 1.3% (n/N=1/76), and 0% of patients had severe scalp, palmoplantar, and anogenital PsO, respectively. At week 28, a PGA score of ≤1 (complete or almost complete clearance) was achieved by 87% (n=154), 85.6% (n=65), and 84.3% (n=86) of patients with scalp, palmoplantar, and anogenital PsO, respectively. The mean (95% CI) target NAPSI score decreased from 4.2 (3.8-4.6) at baseline to 1.7 (1.3-2.1) at week 28. Through week 104³^,⁴: The mean±SD PASI score decreased from 15.7±9.8 at baseline (n=302) to 2.4±4.7 by week 104 (n=219). The proportion of patients who achieved an aPASI score of ≤1 increased overall to 57.5% at week 104. The PASI 90 and 100 responses were achieved by 64.7% and 43.6% of patients, respectively. Among patients with an area-specific PGA score of ≥1 at baseline, 79.1% (n/N=238/301), 34.8% (n/N=105/302), and 51.2% (n/N=153/299) had scalp, palmoplantar, and anogenital PsO, respectively.⁴ At week 104, a PGA score of ≤1 (complete or almost complete clearance) was achieved by 90.3%, 93.2%, and 93.1% of patients with scalp, palmoplantar, and anogenital PsO, respectively. Among patients with ≥1 nail affected at baseline, the mean±SD target NAPSI score decreased from 4.2±2.2 at baseline to 1.0±1.5 at week 104. Patient-Reported Outcomes Through week 28²: At week 28, 56.8% (n=150) of patients had a DLQI score of ≤1. The mean DLQI score decreased from 13.7 at baseline to 3.6 (95% CI, 3.0-4.2) by week 16 and 2.8 (95% CI, 2.3-3.2) by week 28. The mean PSSD symptom score decreased from 51.9 at baseline to 12.5 (95% CI, 10.3-14.7) at week 28, and the mean PSSD sign score decreased from 60.8 at baseline to 15.9 (95% CI, 13.5-18.3) at week 28. Through week 104³^,⁴: At week 104 (n=214), 63.6% (n=136) of patients achieved a DLQI score of ≤1 compared with 4.1% at baseline. The mean±SD DLQI score decreased from 13.6±7.5 (n=296) at baseline to 2.0±3.5 (n=214) at week 104. The mean±SD PSSD symptom score decreased from 51.6±25.8 at baseline to 10.5±18.5 at week 104, and the mean±SD PSSD sign score decreased from 60.8±22.4 at baseline to 13.2±19.6 at week 104. Safety and Drug Survival Through week 28²: Thirty-nine (12.9%) patients experienced ≥1 TRAE. The most common TRAEs were viral upper respiratory tract infection (2.6%), diarrhea (1.3%), and pruritus (1.3%). No deaths or myocardial infarctions were observed. Cerebrovascular accident: 1 (0.3%) TIA: 1 (0.3%) Through week 104³^,⁴: By week 104, the cumulative probability of drug survival was 90.0%. Fifty-four (17.9%) patients experienced ≥1 TRAE; the majority of TRAEs were mild (n=34) or moderate (n=23) in severity. The most frequent TRAEs were viral upper respiratory tract infection (3.0%) and diarrhea (1.7%). Treatment discontinuation due to AEs was reported in 4.0% (n=12) of patients. Treatment-related SAEs were reported in 1.0% (n=3) of patients (1 case each of bronchitis, Epstein-Barr virus infection, anal cancer, and prostate cancer). Note: Click on Abbreviations to view all abbreviations and footnotes.
Registry-Based Studies
BADBIR
Yiu et al (2022)⁵ evaluated drug survival associated with the effectiveness and safety of treatment with TREMFYA, ixekizumab, adalimumab, ustekinumab, and secukinumab and identified the effect modifiers for these biologics and their survival using data from the BADBIR pharmacovigilance registry. Adult patients (N=16,122) in the UK and Republic of Ireland with chronic plaque PsO were included for evaluation between September 2007 and August 1, 2021. At baseline, 26% of patients had concomitant PsA, 23.6% were biologic-naïve, and 50% had prior exposure to ≥2 biologics. The median (IQR) follow-up time for TREMFYA was 1.1 years (0.6-1.7). Drug Survival Based on the adjusted survival curves from the multivariable model for effectiveness, TREMFYA showed the highest drug survival. Based on the biologic survival curves stratified by the line of biologic therapy, biologic-naïve patients and patients on second-line treatment receiving TREMFYA showed the highest treatment survival. TREMFYA was discontinued by 75/408 patients in year 1 (survival function, 0.88; 95% CI, 0.85-0.90) and 23/99 in year 2 (survival function, 0.80; 95% CI, 0.76-0.84). Discontinuations due to ineffectiveness were reported in 34/406 patients in year 1 (survival function, 0.94; 95% CI, 0.92-0.96) and 6/99 in year 2 (survival function, 0.92; 95% CI, 0.89-0.94). Safety Discontinuations due to AEs were reported in 23/407 patients in year 1 (survival function, 0.96; 95% CI, 0.94-0.98) and 10/99 in year 2 (survival function, 0.93; 95% CI, 0.91-0.95). Note: Click on Abbreviations to view all abbreviations and footnotes.
Gillespie et al (2021)²² evaluated the real-world effectiveness of TREMFYA after 6 months of treatment in adult patients with moderate to severe chronic plaque PsO. Adult patients with chronic plaque PsO who had initiated TREMFYA and had recorded measurements for aPASI and DLQI at baseline and the 6-month follow-up were included. At baseline, 161 (84.2%) patients were biologic-naïve. Treatment Outcomes at Follow-up The aPASI scores of ≤1, ≤3, and ≤5 were achieved by 93 (48.7%), 132 (69.1%), and 151 (79.1%) patients, respectively. Among biologic-naïve patients, the aPASI scores of ≤1, ≤3, and ≤5 were achieved by 82 (51.2%), 112 (70.0%), and 129 (80.6%) patients, respectively. The total mean±SD DLQI scores in patients who achieved the aPASI scores of ≤1, ≤3, and ≤5 were 1.11±2.20, 1.48±2.67, and 2.08±3.50, respectively. Note: Click on Abbreviations to view all abbreviations and footnotes.
Hampton et al (2020)²⁴ described the baseline characteristics, as of October 2019, of patients treated with TREMFYA through its first year of availability in the UK. Adult patients (N=199) from BADBIR were included. Baseline Characteristics The mean (range) age was 44.8 years (19-80). Majority of the patients were male (59.8%; n/N=119/199) and White (87.1%; n/N=74/85). The mean (range) body weight was 92.2 kg (44.8-139.6); most patients were obese (52.5%; n/N=42/80) or overweight (27.5%; n/N=22/80) and none were underweight. Majority of the patients (73.3%; n/N=63/86) had spent >10 years before receiving the first treatment for PsO; 23.3% (n/N=20/86) had spent >30 years. Biologic-naïve patients comprised 84.9% (n/N=169/199) of the population. The mean (range) PASI score was 11.4 (0-42), with 81.4% (n/N=35/43) of patients having an aPASI score of >5 and 35.2% (n/N=70/199) of patients having large chronic plaques. Many patients were affected in difficult-to-treat areas such as the scalp (28.1%; n/N=56/199), nails (18.6%; n/N=37/199), flexures (17.1%; n/N=34/199), and palms (7.5%; n/N=15/199). Majority of the patients worked full-time (62%; n/N=52/84) or part-time (14.3%; n/N=12/84). Majority of the patients had comorbidities, including hypertension (28%; n/N=16/58), depression (22%; n/N=15/68), asthma (18%; n/N=12/68), and PsA (10.6%; n/N=21/199). Note: Click on Abbreviations to view all abbreviations and footnotes.
Rogers et al (2020)⁶ evaluated the association between baseline characteristics and DLQI using data from BADBIR among biologic-naïve and biologic-experienced patients who received TREMFYA. Adult patients (N=199) with PsO who received ≥1 dose of TREMFYA and had baseline characteristics recorded were included. At baseline, the mean duration of disease was 20.6 years, mean PASI score was 11.4 (moderate to severe PsO), and mean DLQI score was 13.0. DLQI Among the 43 patients with available data at the 6-month follow-up, 17 reported a DLQI at baseline and 26, at the 6-month follow-up. In these patients, the mean DLQI score at baseline vs at the 6-month follow-up was 15.2 vs 2.7. Note: Click on Abbreviations to view all abbreviations and footnotes.
BioCAPTURE
van der Schoot et al (2022)⁷ determined the differential effect of biologics, including TREMFYA, on the risk of respiratory tract infections and all serious infections using data from BioCAPTURE. Adult patients (N=714; treatment episodes=1325; TREMFYA, treatment episodes=51) in the Netherlands with PsO were included for evaluation between 2005 and 2020 (follow-up of 54.8 PY). For each biologic, the total number of treatment episodes was extracted from the registry. One treatment episode represented the time of active treatment with a biologic, with acceptable interruptions of up to 90 days. If a patient used different biologics over time, they could contribute to >1 treatment episode. At baseline, the median (IQR) duration of disease was 20.6 years (14.8-28.0), median (IQR) PASI score was 8.3 (4.8-15.0), 90.2% of patients had prior exposure to biologics, and 23.5% of patients had concomitant PsA. Respiratory Tract Infections and Serious Infections In the TREMFYA group, respiratory tract infections were reported in 29 patients (incidence rate, 52.9 per 100 PY [95% CI, 36.1-75.0]) and serious infections in 1 patient (incidence rate, 1.8 per 100 PY [95% CI, 0.1-9.0]). Respiratory tract infections included upper respiratory tract infections/flu-like symptoms (n=24), lung infections (pneumonia; n=4), and general airway infection (n=1).⁷ Serious infections included lower respiratory tract and lung infection (n=1).⁷ Note: Click on Abbreviations to view all abbreviations and footnotes.
Van Muijen et al (2022)⁸ evaluated and compared the effectiveness of biologics, including TREMFYA, using data from BioCAPTURE. Adult patients (N=700) with PsO in the Netherlands were included for evaluation between 2005 and 2021. Data were evaluated using absolute and relative PASI measures with confounder correction. Biologics with <50 treatment episodes and those with ≥50 treatment episodes without a baseline PASI score or single follow-up PASI score within the first year of treatment were excluded. At baseline, the median (IQR) duration of disease was 21.2 years (12.2), median (IQR) PASI score was 8.5 (8.8), 32.4% of patients had concomitant PsA, and 9.1% of patients were biologic-naïve. Efficacy Until 1 year of treatment with TREMFYA, mean±SD PASI scores at baseline (n=44), week 6 (n=36), week 12 (n=31), week 26 (n=29), week 39 (n=24), and week 52 (n=20) were 10.9±6.6, 5.8±3.8, 4.0±3.0, 3.5±3.0, 2.4±2.4, and 2.5±2.7, respectively.⁹ Note: Click on Abbreviations to view all abbreviations and footnotes.
Van Muijen et al (2022)¹⁰ evaluated the 1- and 2-year drug survival of TREMFYA and elucidated predictors of shorter drug survival using data from BioCAPTURE. Adult patients (N=195; 288.4 actively treated PY) with plaque PsO in the Netherlands from the BioCAPTURE registry (prospective data) and 4 other centers (retrospective data) were included for evaluation between November 2020 and July 2021. Temporary treatment interruptions were allowed for up to 90 days for any reason and up to 1 year if patients discontinued treatment from fear of COVID-19 or owing to remission. At baseline, 29.7% of patients were biologic-naïve, and 20.5% of patients had concomitant PsA. Drug Survival Drug survival rates for TREMFYA after 1 and 2 years were 85.5% and 77.8%, respectively. The 1- and 2-year discontinuation rates related to ineffectiveness were 92.8% and 88.7%, respectively, and those related to side effects were 94.3% and 92.1%, respectively. Multivariable analyses for predictors of ineffectiveness-related drug survival showed a significant association between diabetes mellitus type 2 and shorter drug survival (HR, 3.69; 95% CI, 1.14-11.98; P=0.030). Multivariable analyses for predictors of side-effect-related drug survival showed a significant association between PsA and shorter drug survival (HR, 7.51; 95% CI, 2.26-24.95; P=0.001). Treatment Discontinuation Reasons for treatment discontinuation included ineffectiveness (8.7%; n=17), side effects (n=12), ineffectiveness and side effects (n=1), pregnancy wish (n=1), fear of COVID-19 (n=2), other reasons (n=4), and unknown (n=1) reasons.¹⁰ The most common reason for discontinuation owing to side effects was musculoskeletal complaints (n=8); 6 of these 8 patients had a history of PsA.¹⁰ Note: Click on Abbreviations to view all abbreviations and footnotes.
CorEvitas Psoriasis Registry
Armstrong et al (2023)²³ characterized the effectiveness of 9-12 months of TREMFYA treatment among patients with moderate to severe plaque PsO with a baseline IGA score of ≥3 in the CorEvitas Psoriasis Registry. Adult patients (N=113) with moderate to severe plaque PsO (IGA score of ≥3; BSA ≥10%) were included if they had registry visits between July 18, 2017, and March 10, 2020; initiated TREMFYA at or after registry enrolment during a registry visit (index date); received persistent treatment with TREMFYA for ≥9 months after the index date; and had a follow-up registry visit between 9 and 12 months after the index date. At baseline, the mean±SD duration of disease was 17.5±13.5 years, mean±SD IGA score was 3.3±0.5, mean±SD PASI score was 13.6±8.2, mean±SD DLQI score was 9.6±6.2, 30.9% of patients had concomitant dermatologist-diagnosed PsA, and 66% of patients had received ≥1 previous biologic. Disease Severity Markers After 9-12 months of treatment with TREMFYA: The proportion of patients who achieved an IGA score of 0/1 was 62.2%. The proportion of patients who achieved an IGA score of 0 was 39.6%. The mean change (95% CI) from baseline in the IGA score was -2.1 (-2.3 to -1.8; P<0.001). The mean change (95% CI) from baseline in BSA involvement was -16.2 (-18.8 to -13.6; P<0.001). The proportion of patients who achieved PASI 75, 90, and 100 responses was 69.4%, 56.8%, and 39.6%, respectively. The mean change (95% CI) from baseline in the PASI score was -10.7 (-12.3 to -9.1; P<0.001). Patient-Reported Outcomes After 9-12 months of treatment with TREMFYA: Among the 106 patients with a DLQI score of >1 at baseline, 58 (54.7%) achieved a DLQI score of 0/1. The mean change (95% CI) in DLQI score was -7.0 (-8.3 to -5.8; P<0.001). Similar improvements were seen with the mean change in the VAS-100 (all PRO measures, P<0.001) and WPAI (% impairment while working, % work hours affected, and % daily activities affected, P<0.001; % work hours missed, P<0.05) scores. Note: Click on Abbreviations to view all abbreviations and footnotes.
Armstrong et al (2023)²¹ characterized the effectiveness of TREMFYA treatment among patients with plaque PsO with a baseline IGA score of ≥2 in the CorEvitas Psoriasis Registry. Adult patients (N=130) with plaque PsO (IGA score of ≥2) were included if they had registry visits between July 18, 2017, and July 10, 2019; initiated TREMFYA at or after registry enrolment during a registry visit (index date); received persistent treatment with TREMFYA for ≥9 months after the index date; and had a follow-up registry visit between 9 and 12 months after the index date. At baseline, the mean±SD IGA score was 3.0±0.6, mean±SD PASI score was 9.9±7.7, mean±SD DLQI score was 8.0±6.0, 19.2% of patients had concomitant rheumatologist-confirmed PsA, and 79.2% of patients had received ≥1 previous biologic. Disease Severity Markers After 9-12 months of treatment with TREMFYA: The proportion (95% CI) of patients who achieved an IGA score of 0/1 was 64.6% (56.1-72.3). The proportion (95% CI) of patients who achieved an IGA score of 0 was 36.2% (28.4-44.7). The mean change (95% CI) from baseline in the IGA score was -1.8 (-2.0 to -1.6; P<0.001). The mean change (95% CI) in BSA involvement was -9.5 (-11.1 to -8.0; P<0.001). The proportion (95% CI) of patients who achieved PASI 75, 90, and 100 responses was 61.5% (53.0-69.5), 46.9% (38.6-55.5), and 36.9% (29.1-45.5), respectively. The mean change (95% CI) from baseline in the PASI score was -7.6 (-8.8 to -6.4; P<0.001). Patient-Reported Outcomes After 9-12 months of treatment with TREMFYA: The proportion (95% CI) of patients who maintained or achieved a DLQI score of 0/1 was 55.4% (46.8-63.7). Mean change (95% CI) in the DLQI score was -5.1 (-6.1 to -4.1; P<0.001). Similar improvements were seen with mean change in the VAS-100 (PtGA, skin pain and overall itch, P<0.001; EQ-VAS and fatigue, P<0.05) and WPAI (% impairment while working, % work hours affected, and % daily activities affected, P<0.001) scores. Note: Click on Abbreviations to view all abbreviations and footnotes.
Walsh et al (2022)¹¹ conducted a study to describe the baseline characteristics of patients with plaque PsO who initiated TREMFYA at or after enrolment in the CorEvitas Psoriasis Registry. Patients with plaque PsO and the first use of TREMFYA on or after enrolment (incident users; N=687) in North America were included for evaluation between July 18, 2017, and November 6, 2018. At baseline, 55.3% of patients had a BMI of >30 kg/m²,themean±SD PASI score was 8.0±7.5, 37.0% of patients had concomitant PsA, the mean±SD duration of PsO was 16.8±13.3 years, mean±SD duration of PsA was 9.3±9.1 years, and 81.5% of patients were biologic-experienced. Among the 251 (37.0%) patients with concomitant dermatologistdiagnosed PsA, 17 (6.8%) were biologic-naïve. Patient-Reported Outcome Measures at Baseline Based on the WPAI questionnaire, among patients employed at the index date, the productivity of those in the biologic-naïve and ≥4 prior biologic groups was most affected by PsO. The biologic-naïve group demonstrated the highest (mean±SD) percentage of impairment while working (23.1%±25.4%; P<0.001), percentage of work hours affected (24.3%±26.5%; P<0.001), and percentage of daily activities impaired (28.8%±29.3%; P<0.001). Based on the DLQI questionnaire, QoL was most impaired among patients in the biologic-naïve and ≥4 prior biologic groups. The biologic-naïve and ≥4 prior biologic groups demonstrated mean±SD DLQI scores of 9.4±5.5 and 9.2±6.7, respectively (P<0.001), and the highest proportion of patients whose scores showed a moderate or greater impact of PsO on QoL (72.0% and 64.1%, respectively; P=0.001). A significant difference was observed in the EQ-5D-VAS scores (0-100) across groups (P<0.001), and more prior biologic therapies were associated with a general decline in the mean score. The mean±SD score was the lowest in the ≥4 prior biologic group (65.0±24.2), indicating the worst perceived health state across groups, and the highest in the 1 prior biologic group (75.8±18.1). Most EQ-5D-3L categorical domains differed significantly across groups (P<0.05 for all domains except anxiety/depression). The proportion of patients who reported at least some problems in each domain was the highest in the ≥4 prior biologic group, and a greater number of prior biologic therapies was associated with an increased proportion of patients reporting issues. No significant difference was observed across groups for problems with sleeping (P=0.84). Note: Click on Abbreviations to view all abbreviations and footnotes.
Lebwohl et al (2022)¹² conducted a study to compare treatment persistence among biologic-experienced patients from the CorEvitas Psoriasis Registry initiating TREMFYA vs ixekizumab, secukinumab, or adalimumab over a 24-month follow-up period. Adult patients (N=1584; TREMFYA, n=546) in North America with a history of plaque PsO and prior biologic exposure were included for evaluation between July 13, 2017, and January 10, 2022. At baseline, the mean±SD duration of disease was 18.0±13.2 years, mean±SD PASI score of 0-72 was 7.5±7.7, and 38.5% of patients had concomitant PsA. Treatment Persistence The 24-month SMR-W average treatment persistence for TREMFYA was 17.6 months (95% CI, 16.9-18.4). Note: Click on Abbreviations to view all abbreviations and footnotes.
Strober et al (2022)¹³ compared treatment persistence among biologic-naïve patients from the CorEvitas Psoriasis Registry initiating TREMFYA vs ixekizumab, secukinumab, or adalimumab over a 24-month follow-up period. Adult patients (N=1007; TREMFYA, n=227) in North America with a history of plaque PsO and no prior biologic exposure were included for evaluation between July 13, 2017, and January 10, 2022. At baseline, mean±SD duration of PsO was 8.4±9.9 years, and 12.3% of patients had concomitant PsA. Treatment Persistence The 24-month SMR-W average treatment persistence for TREMFYA was 20.3 months (95% CI, 19.4-21.3). Note: Click on Abbreviations to view all abbreviations and footnotes.
Strober et al (2022)¹⁴ evaluated the long-term effectiveness of persistent TREMFYA use for 18-24 months on clinical disease activity using data from the CorEvitas Psoriasis Registry. Adult patients (N=183) with moderate to severe plaque PsO (BSA ≥3% and IGA score of ≥3 at the index visit) were included for evaluation between July 2017 and September 2021. At baseline, the mean±SD duration of PsO was 16.1±13.4 years, and 58% of patients were biologic-experienced. Efficacy Clinical disease activities among persistent users at 18-24 months: The BSA decreased from 16.4 at baseline to 2.2 (mean change, -14.2; 95% CI, -16.4 to -12.0). The IGA score decreased from 3.3 at baseline to 1.1 (mean change, -2.2; 95% CI, -2.4 to -2.0). The PASI score decreased from 11.2 at baseline to 1.5 (mean change, -9.7; 95% CI, -10.8 to ‑8.6). The IGA 0/1 and 0 scores were achieved by 69.2% (95% CI, 62.0-75.8) and 41.8% (95% CI, 34.5-49.3) of patients, respectively. The PASI 90 and 100 responses were achieved by 57.7% (95% CI, 50.2-65.0) and 42.9% (95% CI, 35.6-50.4) of patients, respectively. The NPF acceptable (BSA ≤3% or ≥75% improvement from baseline) and NPF target (BSA ≤1%) responses were achieved by 87.4% (95% CI, 81.6-91.8) and 67.0% (95% CI, 59.7-73.8) of patients, respectively. Note: Click on Abbreviations to view all abbreviations and footnotes.
Armstrong et al (2021)¹⁵^,¹⁶ assessed the effectiveness of persistent TREMFYA use for 9-12 months and characterized its impact on patient-reported outcomes using data from the CorEvitas Psoriasis Registry. Adult patients (N=113) with moderate to severe plaque PsO (BSA ≥10%; IGA score of ≥3) were included for evaluation between July 18, 2017, and March 10, 2020.¹⁵ At baseline, mean±SD duration of disease was 17.5±13.5 years, mean±SD PASI score of 0-72 was 13.6±8.2, and 35% of patients were biologic-naïve. Disease Severity Measures After 9-12 months of persistent TREMFYA use: The IGA 0/1 and 0 scores were achieved by 62% and 40% of patients, respectively. The PASI 75, 90, and 100 scores were achieved by 69%, 57%, and 40% of patients, respectively.¹⁵ The mean (95% CI) change from baseline in IGA and PASI scores, and BSA involvement was 2.1 (2.3 to -1.8), -10.7 (-12.3 to -9.1), and -16.3 (-18.8 to -13.6), respectively.¹⁵ Patient-Reported Outcomes The mean (95% CI) change in DLQI from baseline was -7.0 (-8.3 to -5.8).¹⁶ DLQI 0/1 was achieved by 52% of patients. At follow-up, the mean (95% CI) change in overall itch, fatigue, skin pain, PtGA, and EQ-5D-VAS scores was -39.2 (-46.0 to -32.4), -10.8 (-16.2 to -5.3), -28.2 (-34.4 to -22.0), -36.6 (-42.3 to -30.5), and 7.8 (3.8-11.9), respectively.¹⁶ An improvement from baseline was observed in all WAPI domains (mean change [95% CI]) such as absenteeism (-4.9% [-9.6 to -0.2]), presenteeism (-13.7% [-20.5 to -6.9]), work productivity loss (-12.2% [-18.3 to -6.0]), and daily activity impairment (-20.6% [-26.0 to -15.3]).¹⁶ Note: Click on Abbreviations to view all abbreviations and footnotes.
Armstrong et al (2023)¹⁷ characterized the disease activity and patient-reported outcomes of TREMFYA treatment by BMI categories using data from the CorEvitas Psoriasis Registry. Adult patients (N=180) in North America with moderate to severe plaque PsO (IGA score of ≥3) who initiated TREMFYA at or after enrolment were included for evaluation between July 18, 2017, and March 10, 2020. At baseline, in the BMI <25 kg/m² (n=27), 25 to <30 kg/m² (n=52), and ≥30 kg/m² (n=101) groups, respectively, the mean±SD duration of disease was 12.7±11.1, 20.8±14.2, and 16.8±13.5 years; the mean±SD DLQI score was 9.1±5.9, 7.9±6.6, and 9.3±6.2; and 41%, 23%, and 26% of patients were biologic-naïve.^a Disease Severity Markers After 9-12 months of treatment with TREMFYA, in the BMI <25 kg/m², 25 to <30 kg/m², and ≥30 kg/m² groups: The proportion (95% CI) of patients who achieved an IGA score of 0/1 was 72% (52-86), 58% (44-70), and 57% (48-67), respectively. The proportion (95% CI) of patients who achieved an IGA score of 0 was 48% (30-67), 35% (23-48), and 33% (24-42), respectively. The mean IGA score was 0.96, 1.29, and 1.38, respectively. The mean change (95% CI) from baseline in the IGA score was -2.2 (-2.7 to -1.6), -1.9 (-2.2 to ‑1.6), and -2.0 (-2.2 to -1.7), respectively; P<0.001 for all. The mean BSA involvement was 1.56, 2.51, and 4.51, respectively. The mean change (95% CI) in BSA involvement was -13.3 (-19.6 to -7.1), -11.7 (-15.1 to -8.2), and -10.4 (-12.9 to -7.9), respectively; P<0.001 for all. The proportion of patients who achieved PASI 75 response was 72%, 58%, and 64%; PASI 90 response was 56%, 46%, and 46%; and PASI 100 response was 48%, 35%, and 33%, respectively. The mean change (95% CI) from baseline in the PASI score was -7.5 (-9.8 to -5.3), -7.3 (-9.2 to 5.5), and -8.5 (-10.2 to -6.7), respectively; P<0.001 for all. Patient-Reported Outcomes After 9-12 months of treatment with TREMFYA, in the BMI <25 kg/m², 25 to <30 kg/m², and ≥30 kg/m² groups: The proportion of patients who achieved a DLQI score of 0/1 was 63%, 61%, and 55%, respectively. The mean DLQI score was 2.78, 3.15, and 2.91, respectively. The mean change (95% CI) in DLQI score was -6.3 (-9.4 to -3.3), -4.9 (-6.6 to -3.1), and -6.4 (-7.6 to -5.1), respectively; P<0.001 for all. Improvements were also seen with the mean changes in the PtGA-VAS, VAS-symptoms, and WPAI scores for all BMI groups. Significant mean changes were noted in 2 BMI subgroups for the fatigue VAS (BMI ≥30, P<0.001; BMI <25, P<0.05), all BMI subgroups for skin pain and overall itch (P<0.001), and 3 of the 4 WPAI measures (% impairment while working [BMI ≥30 and BMI 25 to <30, P<0.05], % work hours affected [BMI ≥30, P<0.001; BMI 25 to <30, P<0.05]; % daily activities affected [BMI ≥30 and BMI 25 to <30, P<0.001; BMI <25, P<0.05]). Note: Click on Abbreviations to view all abbreviations and footnotes.
Armstrong et al (2019)¹⁸ evaluated the effectiveness of TREMFYA based on disease activity measures using data from the CorEvitas Psoriasis Registry. Adult patients (N=130) in North America with plaque PsO (IGA score of ≥2) who initiated TREMFYA on or after registry enrolment and had a follow-up visit after 9-12 months of persistent TREMFYA treatment were included for evaluation between July 2017 and July 2019. At baseline, the mean±SD duration of disease was 17.50±13.38 years, mean±SD PASI score was 9.92±7.71, and 56.92% of patients had prior exposure to ≥2 biologics.^a Efficacy At 9-12 months of follow-up, the IGA 0/1 and 0 scores were achieved by 65% and 36% of patients, respectively; at least a 1-grade improvement in the IGA score was achieved by 84% of patients; and PASI 75, 90, and 100 responses were achieved by 62%, 47%, and 37% of patients, respectively. At 9-12 months of follow-up, the mean±SD values for the PASI score, IGA score, and BSA involvement were 2.30±4.13 (a decrease of 7.62±6.99), 1.17±1.14 (a decrease of 1.82±1.14), and 2.81±5.70 (a decrease of 9.54±9.11), respectively. Note: Click on Abbreviations to view all abbreviations and footnotes.
DANBIO and DERMBIO Registries
Egeberg et al (2022)¹⁹ evaluated drug survival among patients with RA, axial spondylocross, PsA, and PsO who received biologics or novel small-molecule therapies, including TREMFYA. Adult Danish patients (N=2577; TREMFYA, n=68)²⁰ were evaluated between January 2015 and May 2021 (for DANBIO) and November 2009 and November 2019 (for DERMBIO). At baseline, the median (IQR) duration of disease was 18.83 years (11.11-28.51), and 17.38% of patients had concomitant PsA. Drug Survival Based on the Kaplan-Meier curves, TREMFYA showed the highest drug survival among non-naïve patients. Note: Click on Abbreviations to view all abbreviations and footnotes.
Abbreviations: AE, adverse event; aPASI, absolute Psoriasis Area and Severity Index; BADBIR, British Association of Dermatologists Biologic and Immunomodulators Register; BioCAPTURE, Continuous Assessment of Psoriasis Treatment Use Registry with Biologics; BMI, body mass index; BSA, body surface area; CI, confidence interval; COVID-19, coronavirus disease 2019; DLQI, Dermatology Life Quality Index; EQ-5D-3L, European Quality of Life-5 Dimensions 3-Level version; EQ5DVAS, European Quality of Life-5 Dimensions self-rated health status visual analog scale; EQ-VAS, EuroQoL 5 Dimensions visual analog scale; HR, hazard ratio; HRQoL, health-related quality of life; IGA 0/1, Investigator’s Global Assessment clear/almost clear; IQR, interquartile range; NAPSI, Nail Psoriasis Severity Index; NPF, National Psoriasis Foundation; PASI, Psoriasis Area and Severity Index; PASI 75, ≥75% improvement in the PASI score from baseline; PASI 90, ≥90% improvement in the PASI score from baseline; PASI 100, 100% improvement in the PASI score from baseline; PGA, Physician Global Assessment; PRO, patient-reported outcome; PsA, psoriatic arthritis; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary; PtGA, Patient Global Assessment; PY, patient-year; QoL, quality of life; RA, rheumatoid arthritis; SAE, serious adverse event; SD, standard deviation; SMR-W, standardized mortality ratio weighting; TIA, transient ischemic attack; TRAE, treatment-related adverse event; UK, United Kingdom; VAS, visual analog scale; WPAI, Work Productivity and Activity Impairment. ^aPrior biologics did not include the patient’s current biologics.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^®(and/or other resources, including internal/external databases) was conducted on 21 May 2024.

Summarized in this response are the available data from real-world prospective (≥100 patients and a follow-up duration of ≥1 year) and registry-based studies that evaluated the use of TREMFYA in adult patients with plaque PsO.

References

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