TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
Medical Information
Real-World Evidence with TREMFYA in Adult Patients with Plaque Psoriasis - Retrospective Studies
Last Updated: 08/05/2024
- Please refer to the local labeling for relevant information on the use of TREMFYA in plaque psoriasis (PsO).
- Real-world retrospective1
- 13 (≥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 are described below.14 -33
- Real-world evidence in patients with plaque PsO treated with TREMFYA is described in the Table: Summary of Retrospective and Registry-Based Real-World Studies in Adult Patients with Plaque PsO.
| Retrospective Studies (Results specific to TREMFYA are summarized below) |
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| Gargiulo et al (2024)1 evaluated the drug survival of interleukin (IL)-inhibitors, including TREMFYA, in 5300 patients with plaque PsO from January 01, 2012 to December 31, 2022 across 15 Italian Dermatology Units. The follow-up period was 4 years and drug survival was assessed using the KM estimator at 6, 12, 24, 36, and 48 months. A total of 849 patients with a mean±SD age of 51.84±14.98 years who received TREMFYA were included. At baseline, the mean±SD BMI was 27.26±5.46 kg/m2 Drug Survival Overall probability (95% CI) of drug survival for TREMFYA throughout the study period was:
Overall probability (95% CI) of drug survival for TREMFYA analyzing only treatment discontinuations due to ineffectiveness throughout the study period was:
Note: Click on Abbreviations to view all abbreviations. |
| Sullivan et al (2023)2 evaluated treatment persistence in adult patients (N=878) with chronic plaque psoriasis who were prescribed ≥1 biologic of interest (TREMFYA, adalimumab, secukinumab or ustekinumab) from September 01, 2015 to December 31, 2021 using data from the Australian Department of Human Services Pharmaceutical Benefit Scheme (PBS) 10% sample. The KM method was used to determine treatment persistence which was defined as the time from the index date to the time of treatment discontinuation or censoring. A total of 385 patients were treated with TREMFYA (bio-naive, n=201; bio-experienced, n=184) and the median follow-up time was 21 months. Treatment Persistence
Note: Click on Abbreviations to view all abbreviations. |
| Galluzzo et al (2023)3 Patients (N=122) who received ≥2 doses of TREMFYA for >12 weeks were included. At baseline, the mean±SD duration of disease was 24±15.9 years, the mean±SD BMI was 28.6±6.1 kg/m2, 11.5% of patients were affected by PsA, the mean±SD PASI score was 16.2±12.9, and 64.8% of patients had prior exposure to biologics. Efficacy
Drug Survival and Discontinuation
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Bardazzi et al (2022)4 Patients (N=141) who received ≥1 dose of TREMFYA and had a minimum follow-up of 12 weeks were included. At baseline, the mean±SD BMI was 28.90±6.09 kg/m2, 29.1% of patients were affected by PsA, 14.9% of patients were biologic-naïve, 61.0% of patients had prior exposure to ≥2 biologics, and the median (IQR) PASI and NAPSI scores were 13.3 (10-15) and 32.5 (25-40), respectively. Efficacy
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Del Alcázar et al (2022)5 A total of 360 patients were included. At baseline, the mean±SD BMI was 29.2±6.5 kg/m2, 15.6% of patients were affected by PsA, 10.5% of patients were biologic-naïve, and mean±SD PASI score was 10.9±7.6. Treatment Persistence and Drug Survival
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Galluzzo et al (2022)6 A total of 307 patients who received treatment for ≥12 weeks were included. At baseline, the mean±SD duration of disease was 20.1±13.6 years, the mean±SD PASI score was 14.9±9.1, 35.5% of patients were biologic-naïve, and 22.5% of patients were affected by PsA. Efficacy
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes |
| Jung et al (2022)7 Biologic-naïve adult patients with moderate to severe PsO (PASI ≥10 and BSA involvement ≥10%) refractory to nonbiologic systemic immunosuppressive therapies (cyclosporine or methotrexate) or phototherapy (narrow band ultraviolet B) for >6 months were included. The primary outcomes included proportion of patients achieving PASI 75 or PASI 90 at week 16 for rapid response, PASI 90 response at week 56 for long-term response, and PASI 100 response at week 56 for complete remission. A total of 23 patients who received TREMFYA were included. At baseline, the mean±SD PASI score was 20.0±9.2. Efficacy
Drug Survival
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Mälkönen et al (2022)8 The primary objectives were exploration of persistence of TREMFYA treatment and clinical outcomes at 9-14 months after treatment initiation. The secondary objectives included characterization of patients who received TREMFYA, assessment of TREMFYA dosing patterns, reasons for treatment discontinuation, and evaluation of clinical outcomes over short (3-6 months) and longer terms (15-18 months). A total of 181 patients were included. At baseline, median (IQR) BMI was 30.3 (26-36.4) kg/m2, median (IQR) duration of disease was 18.8 (11.9-29.8) years, 21.6% of patients were affected by PsA, median (IQR) BSA involvement was 7% (5-11), median (IQR) PASI score was 7.0 (5.0-10.2), and median (IQR) DLQI score was 14 (7-18). Efficacy
Drug Persistence
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Ruiz-Villaverde et al (2022)9 Patients who were diagnosed ≥1 year ago and experienced primary or secondary failure or had AEs due to previous biologics, including anti-TNFα, anti-IL17, and anti-IL12/23 agents were included. Primary failure was defined as the inability to achieve PASI 90 response or PASI <3, and secondary failure was defined as the inability to achieve PASI 90 or PASI <3 after 12 weeks of treatment. A total of 103 patients (prior treatment with anti-TNFα [n=29; 28.2%], anti-IL17 [n=29; 28.2%], and anti-IL12/23 [n=45; 43.7%]) were included. At baseline, mean±SD duration of PsO was 21.6±10.3 years, mean±SD BMI was 29.2±5.8 kg/m2, 20% of patients were affected by PsA, mean±SD PASI score was 13.5±7.7, mean±SD BSA (% involvement) was 20.2±15.9, mean±SD VAS score for pruritus was 5.7±2.7, mean±SD DLQI score was 14.2±6.9, and 46% of patients had prior exposure to ≥3 biologics. Efficacy
Treatment Survival
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Torres et al (2021)10 Drug survival was defined as the period during which a patient received a certain drug from its initiation to its definitive discontinuation (due to loss of effectiveness, safety, patient decision, loss of follow-up, or others) or last clinical observation. Primary failure was defined as drug discontinuation due to lack of effectiveness at the end of the induction phase for the respective drug. Secondary failure was defined as definitive drug discontinuation due to loss of response during the maintenance phase of treatment. A total of 879 patients who received TREMFYA were included. The time of exposure for TREMFYA was 1445 PY, the mean±SD duration of disease was 17.9±12.9 years, and 18.3% of patients were affected by PsA. Drug Survival and Discontinuation
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Ghislain et al (2021)11 A total of 308 patients were included. At baseline, the mean (range) duration of PsO was 18.5 (1-64) years, mean (range) PASI score was 17.7 (3.4-37), and 42.2% of patients were biologic-naïve. Efficacy
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes |
| Lytvyn et al (2021)12 Discontinuation was defined as the interruption of TREMFYA treatment due to any cause (nonresponder imputation). A total of 264 patients were included. At baseline, mean±SD duration of PsO in total population was 17.3±11.7 years, 25.4% of the total population was affected by PsA, 67 patients were biologic-naïve, and 114 and 83 patients had previously failed 1 and ≥2 biologic therapies, respectively. The mean±SD PGA scores were 2.6±0.9, 3.1±0.7, 2.4±1.0, and 2.6±0.8 among total population, biologic-naïve, those with exposure to 1 previous biologic, and ≥2 previous biologics, respectively. The mean±SD PASI scores were 10.9±8.5, 16.7±8.4, 7.5±7.4, and 10.3±7.1 among total population, biologic-naïve (n=39), those with exposure to 1 previous biologic (n=55), and ≥2 previous biologics (n=34), respectively. Drug Survival
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Ruiz-Villaverde et al (2021)13 conducted an observational, longitudinal study to evaluate the efficacy of TREMFYA by baseline characteristics among patients with moderate to severe PsO who received treatment between February 2019 and February 2022 in Spain. A total of 107 patients were included. At baseline, mean±SD PASI score was 14.73±6.95, mean±SD BSA (% involvement) was 21.76±15.71, mean±SD VAS score for pruritus was 6.18±2.25, and mean±SD DLQI score was 15.45±5.51. Efficacy
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Registry-Based Studies (Results specific to TREMFYA are summarized below) |
| Australasian Psoriasis Registry |
| Ismail et al (2023)14 evaluated the effectiveness and drug survival of TREMFYA among specific subgroups of patients with severe PsO who received treatment between 2019 and October 1, 2022. At baseline, the median (IQR) BMI was 31.3 (26.1-36.2) kg/m2, the median (IQR) duration of disease was 26.0 (17.0-34.0) years, 27.5% of patients were affected by PsA, the median (IQR) PASI score was 24.0 (17.9-32.2), 12.7% of patients were biologic-naïve, and 87.3% of patients were biologic-experienced. Efficacy
Drug Survival
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| BADBIR |
| Savage et al (2022)15 Efficacy
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| BIOREP |
| Hugo et al (2023)16 A total of 333 patients who received ≥1 dose of TREMFYA 100 mg SC were included. At baseline, the mean±SD duration of disease was 22.1±13.2 years, the mean±SD BMI was 30.3±6.6 kg/m2, 21.0% of patients were affected by PsA, the mean±SD PASI score was 16.0±7.7, 48.6% of patients were biologic-naïve, and the mean±SD DLQI score was 14.2±6.5. Efficacy and Drug Survival
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| IBM MarketScan® |
| Fitzgerald et al (2023)17 Patients were included in the study if they had ≥2 claims with a diagnosis of PsO (ICD-10-CM) during the most recent period of continuous eligibility, with ≥1 claim during the baseline period or on the index date (July 13, 2017); had ≥1 claim for TREMFYA, adalimumab, secukinumab, or ixekizumab, with the first observed claim on or after July 13, 2017; had ≥12 months of continuous health plan eligibility before the index date; and were ≥18 years old on the index date. Therapy exposure gaps for TREMFYA per primary (exposure gap >2 times the per-label dosing frequency after the induction phase or mode of days of supply) and secondary definitions (exposure gap >1 time the per-label dosing frequency after the induction phase or mode of days of supply) were >120 days and >60 days, respectively. Complete remission was defined as no claims for any PsO-related treatment after the index biologic discontinuation (per primary definition) among patients with ≥6 months of follow-up after discontinuation. With remission of moderate to severe disease, patients were allowed to have claims for topical therapies after discontinuation of the index biologic. Among 3408 patients who received TREMFYA, the mean follow-up duration was 16.5 months, 16.7% of patients were affected by PsA, and 47.8% of patients were biologic-experienced. Efficacy Overall population
Biologic-naïve patients (n=1779)
Biologic-experienced patients (n=1629)
Drug Persistence Discontinuation of index biologic based on the primary definition for therapy-exposure gap
Discontinuation of index biologic based on the secondary definition for therapy-exposure gap
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Zhdanava et al (2023)18 Patients included were: patients with first observed claim (index date) for TREMFYA, secukinumab, or ixekizumab between July 13, 2017 - May 01, 2021; continuous health plan eligibility for ≥12 months before the index date; ICD-10-CM diagnoses of PsO on ≥2 dates during the baseline period or on the index date; no claims on the index date for other biologics indicated for PsO; and ≥1 claim during the baseline period for any other psoriasis-indicated biologic agent (bio-experienced). Pairwise analyses comparing TREMFYA to each comparator were conducted using IBM MarketScan Research Databases from January 01, 2016, to October 31, 2021. Persistence was defined as the absence of treatment supply gaps of over twice the labeled dosing interval for TREMFYA (>120 days) or secukinumab and ixekizumab (>60 days). Probability of persistence was described by KM analysis. Treatment Persistence TREMFYA versus weighted secukinumab analysis
TREMFYA versus weighted ixekizumab analysis
Switch to Non-Index Biologic TREMFYA versus weighted secukinumab
TREMFYA versus weighted ixekizumab
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Blauvelt et al (2022)19 Patients with ≥1 claim for TREMFYA or ixekizumab after the first diagnosis of PsO Treatment adherence was measured by PDC and MPR during follow-up. PDC and MPR were defined as the number of days’ supply divided by the total number of days during the follow-up period. When there was an overlap in the periods covered by consecutive fills, PDC considered the actual or concurrently covered days; MPR considered all days supplied. High adherence was defined as MPR or PDC ≥80%. Treatment persistence was defined as a prescription refill within up to 60 or 90 days of the last day of supply. The end date of persistence was defined as the last day’s supply of the prescription before the permissible gap. Drug discontinuation was defined as a treatment gap of ≥90 days, and reinitiation was defined as a new claim for the index drug after meeting the criteria for discontinuation and not switching to other therapies. Switching from index therapy was defined as prescription of a new medication when the days’ supply of the new therapy (including biologics, systemic therapy, and phototherapy) extended beyond the last day supplied by the index medication. A total of 740 patients were included. At baseline, 45.7% of patients were biologic-naïve and 53.2% of patients had prior exposure to 1 biologic. Medication Adherence
Treatment Persistence
Monotherapy, Discontinuation, Switching, and Concomitant Medications
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Fitzgerald et al (2022)20 Patients included were: adult patients with first observed claim for TREMFYA or apremilast (index therapy) between July 13, 2017 and May 01, 2021; continuous health plan eligibility for ≥12 months before the index date; ICD-10-CM diagnoses of PsO on ≥2 dates during the baseline period or on the index date; no claims on the index date for biologic agents indicated for PsO except the index therapy; and no claims on the preindex date for TREMFYA or apremilast within the most recent period of continuous eligibility. Persistence was defined as absence of gaps in the supply of index therapy of over twice the labeled dosing interval for TREMFYA (>120 days) or more days of supply for apremilast (>60 days). The discontinuation date was the last day with supply of index therapy before the gap. Restart among patients who discontinued index therapy was defined as a new claim for the index therapy after the end of the therapy-exposure gap (subset of patients who discontinued was not reweighted). Switch was defined as a claim for a biologic indicated for PsO that is different from the index therapy. A total of 3379 patients were included. At baseline, 50.2% of patients were biologic-experienced. Treatment Persistence
Restart of Index Therapy
Switch to Nonindex Biologic Therapy
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Xu et al (2020)21 The following patients were included: patients indexed on biologics for PsO during the intake period; patients with ≥1 PsO diagnosis, patients ≥18 years (pregnant women were excluded); patients without the diagnoses of ankylosing spondylitis, juvenile chronic polyarthritis, rheumatoid arthritis, hidradenitis suppurativa, CD, and UC; patients who had continuous enrollment for 6-month preindex and 9-month postindex. Index date was defined as the claim date of the patient’s first observed biologic fill for PsO for the medication of interest. The primary cohort consisted of patients with ≥9 months of continuous enrollment, and a 12-month subcohort consisted of a subset of this population with an additional 3 months of continuous enrollment. PDC was defined as the total days covered during follow-up with respect to the fixed follow-up periods (ie, 3, 6, 9, or 12 months). Patients with PDC ≥80% were considered adherent. Persistence was defined as being on the index biologic continuously for the first ≥80% of the follow-up period in the 3-, 6-, 9-, or 12-month follow-up time frames. A total of 821 patients who received TREMFYA were included. At baseline, 15.3% of patients were affected by PsA. Outcome Measures
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Xu et al (2020)22 The following patients were included: patients indexed on biologics for PsO during the intake period; patients with ≥1 PsO diagnosis; patients ≥18 years old (pregnant women excluded); patients without the diagnoses of ankylosing spondylitis, juvenile chronic polyarthritis, rheumatoid arthritis, hidradenitis suppurativa, CD, and UC; and patients with continuous enrollment for 6-month preindex and 9-month postindex. Index date: The claim date of the patient’s first observed biologic fill for PsO for the medication of interest. The outcome variables included total healthcare cost (measured in the 9-month follow-up time frame), healthcare utilization (measured using average prescription fills for all medications for PsO, including biologics), average number of outpatient visits, proportion of patients with ≥1 ER visit, and proportion of patients with ≥1 inpatient visit in the 9-month follow-up time frame. Outcome Measures
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Japan Medical Data Center Payer-Based Database |
| Pinter et al (2022)23 The Japan Medical Data Center Payer-Based Database includes health insurance claims across the continuum of care (eg, inpatient, outpatient, outpatient pharmacy, carve-out behavioral healthcare) as well as enrollment data. The following patients were included: patients with ≥1 medical claim for PsO based on ICD-10 L40.X codes for an IL inhibitor approved to treat patients with moderate to severe PsO in Japan; patients with ≥3 months of continuous eligibility prior to the earliest IL-inhibitor claim (baseline period); patients with ≥1 IL-inhibitor claim within 7 days following the induction period on each product’s label (earliest maintenance claim defined as the index date); patients with ≥6-12 months of continuous eligibility following the index date (follow-up period); patients who qualified for and were stratified as biologic-naïve or biologic-experienced based on observed preindex biologic claims. Dose escalation was defined as a ≥20% increase in the observed average daily dose over the expected daily dose with ≥2 claims during the escalated period and was evaluated at 6 and 12 months following the index date. The expected daily dose for TREMFYA was evaluated by dividing the label-recommended maintenance dose by the treatment interval. The maintenance strength was 100 mg with a maintenance interval of 56 days. The expected daily dose was 1.79 mg/day, and the 20% and 30% dose-escalation thresholds were 2.14 mg/day and 2.33 mg/day, respectively. A total of 184 patients who received TREMFYA were included. At baseline, 52.9% of patients were biologic-naïve. Dose Escalation
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Puig et al (2022)24 The following patients were included: patients with ≥1 medical claim for PsO based on ICD-10 L40.X codes occurring on or before the date of the earliest claim for an IL-inhibitor approved to treat PsO in Japan; patients with ≥1 claim for an IL-inhibitor approved for treatment of PsO in Japan (earliest claim for each product was considered as the index date); and patients with ≥6 months of continuous eligibility prior to the earliest IL-inhibitor claim (baseline period). Patients were included in each treatment cohort for which they qualified. Switching was defined as a claim for another biologic approved for PsO in Japan anytime after the index date. Discontinuation was defined as a gap in treatment equal to 150% of the days’ supply of the last prescription fill. A total of 263 patients were included. At baseline, 72.5% of patients were biologic-naïve. Treatment Switch and Drug Discontinuation
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Merative® MarketScan® Commercial and Medicare Supplemental Research Databases (Results specific to TREMFYA are summarized below) |
| Zhdanava et al (2024)25 Patients included in the persistence analysis were: adult patients with first observed claim for TREMFYA, secukinumab, or ixekizumab between July 13, 2017 and May 01, 2021; continuous health plan eligibility for ≥12 months before the index date; ICD-10-CM diagnoses of PsO on ≥2 dates during the baseline period or on the index date; no claims on the index date of biologic agents indicated for PsO except the index therapy; and no claims for index biologic during the most recent period of continuous eligibility and before index date.
Persistence Analysis Persistence was based on the absence of gaps in index therapy supply of ≥2 times the labeled maintenance dosing interval for TREMFYA (>120 days) or secukinumab and ixekizumab (>60 days). To analyze persistence, the index date was defined as the first observed claim for the index biologic. The discontinuation date was the last day with supply of index therapy before the gap. A total of 3516 vs 6066 patients were included in the TREMFYA vs weighted secukinumab cohort and 3805 vs 4674 patients in the TREMFYA vs weighted ixekizumab cohort. At baseline, 37.4% of patients in the TREMFYA vs secukinumab cohort, and 41.1% of patients in the TREMFYA vs ixekizumab cohort, had prior biologic use.
Adherence Analysis Adherence was defined as the PDC, which is the recommended measure for assessing adherence to chronic therapies. PDC is calculated as the sum of nonoverlapping days of supply of the index agent divided by a fixed period (ie, 6, 12, 18, and 24 months) among patients who were followed up for at least the same fixed duration. To analyze adherence, a fixed follow-up period was established after the index date (i.e., 6, 12, 18, and 24 months), and only patients who were followed for at least the same duration were included in the analysis. TREMFYA vs weighted secukinumab cohort:
TREMFYA vs weighted ixekizumab cohort:
Remission Analysis Remission was defined as the absence of any PsO-related inpatient admissions or claims for psoriasis-related topical, non-biologic systemic, or other biologic agents during the 6-month period following the discontinuation date of the index biologic. Partial remission or remission of moderate-to-severe PsO was defined similarly but allowed patients to have claims for topical agents for milder disease. To analyze remission, the index date was defined as the date when patients discontinued their index biologic for a period of ≥6 months. A total of 915 vs 2694 patients were included in the TREMFYA vs weighted secukinumab cohort, and 1019 vs 1434 patients in the TREMFYA vs weighted ixekizumab cohort. Twelve months prior to index treatment, 41.3% of patients in both the TREMFYA and weighted secukinumab cohorts, and 45.9% of patients in both the TREMFYA and weighted ixekizumab cohorts, were biologic-experienced. TREMFYA vs weighted secukinumab cohort:
TREMFYA vs weighted ixekizumab cohort:
Switch to Nonindex Biologic Therapy27 Switch was defined as a claim for a biologic indicated for PsO that is different from the index therapy.
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Armstrong et al (2023)28 Switch rate was defined as the proportion of patients who switched to a new targeted immune modulator (biologic or apremilast) over the 24-month follow-up after treatment initiation. A total of 1400 patients who received TREMFYA were included.28 Treatment Switch Rates
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Wu et al (2023)29 Dose escalation was defined as ≥2 dosing intervals, with an average daily dose (total strength [mg] divided by days between subsequent doses) ≥30% higher than the expected daily dose (based on product-specific dosing per the FDA label) during the maintenance period. A total of 719 patients on TREMFYA were included in the analysis, of whom 24.3% were biologic-experienced. Dose Escalation
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Modernizing Medicine Data Services Database |
| Fitzgerald et al (2022)30 Patients included were adults with moderate-to-severe psoriasis newly treated with TREMFYA, secukinumab, or ixekizumab. At baseline, the mean±SD BMI was 31.6±7.6 kg/m2 and mean±SD BSA involvement was 23.1%±20.2. The mean±SD PGA score was 3.1±0.7. Patient Characteristics
Prior Treatments
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| PsoRA (Psoriasis Registry Austria) |
| Graier et al (2022)31 The effectiveness of biologic therapy was evaluated in terms of change in absolute PASI score and reduction in PASI response (defined as categories ranging from complete remission [ie, PASI 100] to partial remission [ie, PASI 90, PASI 75, PASI 50, PASI <50] to worsening) by status of biologic exposure (biologic-naïve or nonnaïve) and by the class of previous biologic therapy. For further analysis, irrespective of treatment discontinuation, change in PASI score was evaluated as observed and with respect to the LOCF worst-case scenario (ie, considering the last known PASI score or PASI reduction response to be continued or patients to be considered nonresponders [PASI <50 response]). A total of 127 treatment cycles of TREMFYA were included. At baseline, mean±SD PASI scores were 9.63±6.59 and 7.80±7.52 in biologic naïve and biologic nonnaive patients, respectively; 42.5% of patients were biologic naïve; and 55.4%, 18.9%, and 25.7% of patients had previously received 1, 2, and 3 biologic therapies, respectively. Efficacy
Safety
Note: Click on Abbreviations to view all abbreviations and footnotes. |
| Symphony Health Claims Database |
| Fitzgerald et al (2021)33 described baseline characteristics of patients with PsO in the US who were initiated on TREMFYA in the first year after FDA approval. The Symphony Health Claims database includes US pharmacy, diagnosis, and procedure claims collected through electronic claims processors, commercial sources, and government sources. The following patients were included: patients with ≥2 PsO diagnoses separated by ≥30 days between October 01, 2012 and August 31, 2018; patients with ≥1 approved claim for TREMFYA not coded as a pharmacy refill between July 13, 2017 and July 02, 2018; patients with index date ≥60 days before the end of study period; patients with age ≥18 years at index; patients who met proxy, ie, ≥1 claim more than 365 days before index date and ≥1 claim during the 365 days before index date; patients who met proxy, ie, ≥1 pharmacy claim of any kind after the index date; excluded patients with potential claim issues such as multiple claims for different biologics on index date, inconsistent pharmacy-entered day supplies, or uninterpretable quantities; index date: defined as date of first pharmacy claim for TREMFYA The baseline period was defined as the 365-day period prior to the index date. A total of 1520 patients were included; 63.9% of patients had ≥1 biologic drug claim during baseline period; 66.9% were prescribed topical corticosteroid/combinations during baseline period; most common non-PsO diagnoses among patients with ≥1 medical claim were hypertension (25.1%), type-2 diabetes (13.4%), and hyperlipidemia (13.4%). Note: Click on Abbreviations to view all abbreviations and footnotes. |
aData shown only for time points when ≥40 patients were at risk for drug discontinuation. bTime to treatment discontinuation (or persistence end) was measured from the index date until the discontinuation date. Patients who did not discontinue during the follow-up period were censored on the last day of index agent supply before the end of follow-up. cPatients at risk of having the event are the patients who have not had the event and have not been lost to follow-up at that point in time. dTime to restart was measured from the end of therapy-exposure gap until the restart date. Patients without restart during the follow-up period were censored at the end of follow-up. eTime to switch was measured from the index date until the switch date. Patients without switch during the follow-up period were censored at the end of follow-up. |
LITERATURE SEARCH
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, DERWENT® (and/or other resources, including internal/external databases) was conducted on 17 May 2024.
Summarized in this response are plaque PsO-specific data available from real world retrospective (≥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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