Impact of secukinumab on patient-reported outcomes in biologic-naive patients with psoriasis in a US real-world setting.

OBJECTIVE: To describe real-world baseline characteristics and patient-reported outcomes (PROs) at 6-month and 12-month follow-up visits among patients with psoriasis who initiated and maintained secukinumab, stratified by prior exposure to biologics. METHODS: This real-world study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry who initiated and maintained secukinumab through 6-month and/or 12-month follow-up. Demographics, clinical characteristics, and PROs were collected. PROs included Dermatology Life Quality Index (DLQI); itch, skin pain, fatigue, and EuroQol visual analog scales; and Work Productivity and Activity Impairment. Mean (SD) differences between baseline and follow-up visits were calculated for all outcomes. RESULTS: Overall, 652 patients had a 6-month follow-up visit, 460 (70.6%) were biologic experienced and 192 (29.4%) were biologic naive. Biologic-experienced and biologic-naive patients reported mean (SD) improvements in all PROs measured at 6-month follow-up. Similar improvements were seen among patients with a 12-month follow-up visit (n = 390) and both 6-month and 12-month follow-up visits (n = 326). CONCLUSIONS: Biologic-experienced and biologic-naive patients with psoriasis who initiated and maintained secukinumab treatment reported improvements in PROs at 6-month and/or 12-month follow-up visits. These findings suggest that secukinumab is a potential biologic for psoriasis at any point along the patient treatment journey.

Utilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting.

INTRODUCTION: Real-world evidence has demonstrated the effectiveness of secukinumab in the treatment of psoriasis; however, limited data are available on patient profiles of US secukinumab initiators over time and clinical outcomes in biologic-naive patients. This study describes clinical characteristics of secukinumab initiators by year, and the clinical outcomes in patients after 6- and/or 12-month follow-up visits, stratified by prior biologic use. METHODS: This observational study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry. Analyses were conducted in two patient cohorts: (1) all secukinumab initiators, stratified by year, and (2) those who initiated and maintained secukinumab through a 6- and/or 12-month follow-up visit. For all secukinumab initiators, patient characteristics at initiation were described per calendar year; in initiators with follow-up visits, mean (SD) differences in percentage affected body surface area (BSA), five-point Investigator's Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI) scores between baseline and follow-up visits were calculated. Analyses were conducted separately for biologic-naive and biologic-experienced patients. RESULTS: Between 2015 and 2020, the proportion of secukinumab initiators in the registry who were biologic-naive increased each year from 12.5% to 49.7%. Overall, 1518 patients initiated secukinumab at or after enrollment; 980 (64.6%) were biologic experienced, and 538 (35.4%) were biologic naive. At 6 months, biologic-experienced and biologic-naive patients reported mean (SD) decreases in BSA (-9.3 [14.5] versus -11.7 [16.6]), IGA (-1.4 [1.3] versus -1.7 [1.4]), and PASI (-5.2 [6.6] versus -6.7 [7.8]). The proportion of patients with an IGA score of clear/almost clear (0/1) increased over fivefold, irrespective of biologic experience. At 12 months, similar improvements were seen. CONCLUSIONS: The proportion of biologic-naive secukinumab initiators increased over time. Biologic-naive patients demonstrated similar improvements in clinical outcomes compared with biologic-experienced patients, suggesting that secukinumab may be considered as a first-line therapy for psoriasis.

Real-World Satisfaction with Secukinumab in Clearing the Skin of Patients with Plaque Psoriasis through 24 Months of Follow-Up: Results from US Dermatology Electronic Medical Records.

INTRODUCTION: Information on the long-term treatment satisfaction with secukinumab for patients with plaque psoriasis in real-world settings is limited. The objective of this study was to describe real-world treatment satisfaction in patients with plaque psoriasis who initiated secukinumab using data from an electronic medical records-based dermatology database. METHODS: Patients aged ≥ 18 years with plaque psoriasis in Modernizing Medicine Data Services' affiliate's database who received secukinumab 3/1/2018-1/21/2020 were included. Satisfaction with the treatment's effectiveness in clearing the skin of psoriasis was evaluated using a 5-point Likert scale during the 12-month baseline period and at 6-, 12-, 18-, and 24-month postindex visits for the overall population and at 6-, 12-, and 18-month postindex visits for subgroups stratified by prior biologic and systemic therapy use. Additionally, satisfaction levels were assessed among patients who were unsatisfied with treatment at baseline. RESULTS: Overall, 82.3% agreed that secukinumab was effective in clearing their skin at 6 months, which was maintained through 12 (81.7%), 18 (83.3%), and 24 months (81.4%). Similar results were observed in biologic-experienced/naive and systemic-experienced/naive patients. Overall mean (SD) treatment satisfaction improved from 2.49 (1.36) at baseline to 1.77 (1.06) at 6 months, with similar improvements in satisfaction scores reported at each follow-up period up through 24 months. Of the patients who were not satisfied at baseline, 77.9% reported being satisfied with their treatment at 6 months, which continued through 12 (74.4%), 18 (82.8%), and 24 months (71.4%). Patients receiving secukinumab experienced meaningful changes in percent affected body surface area and Physician Global Assessment scores that were sustained through 24 months, regardless of prior treatment experience. CONCLUSIONS: These real-world findings highlight the high level of sustained satisfaction with secukinumab treatment for improving and maintaining skin clearance in patients with moderate-to-severe disease, regardless of prior treatment experience.

Treating moderate plaque psoriasis: prospective 6-month chart review of patients treated with apremilast.

Purpose: Apremilast, an oral phosphodiesterase 4 inhibitor, was effective in clinical trials in patients with moderate plaque psoriasis (affected body surface area [BSA] 5% to 10%). However, findings from real-world clinical practice are limited. Materials and methods: An online survey and chart review was conducted among US dermatologists during October 2015 to identify clinical characteristics and 6-month treatment outcomes among patients with moderate psoriasis treated with apremilast. Results: A total of 83 dermatologists provided patient chart information at the initial and 6-month follow-up time points for 70 patients with moderate plaque psoriasis initially receiving apremilast, of whom 65 were receiving it as their primary therapy (mean age: 47.3 years; 45% were men). Among apremilast-treated patients, 91% (64 of 70) remained on apremilast and 54% were rated as having improved to mild psoriasis at follow-up; mean BSA decreased from 9.9% at initial chart review to 4.9%. There were 8 of 66 (12%) patients who experienced ≥1 side effect, including diarrhea (7.6%), nausea (4.5%), headache (1.5%), and abdominal pain (4.5%). Most dermatologists (68%) stated that apremilast exceeded or met their expectations. Conclusions: Most patients with moderate psoriasis receiving apremilast had improved at 6-month follow-up. Safety and tolerability were consistent with the safety profile of apremilast.

Defining and treating moderate plaque psoriasis: a dermatologist survey.

PURPOSE: Patients with moderate plaque psoriasis are often undertreated and may experience unsatisfactory clinical outcomes. Undertreatment may stem partly from a lack of consensus on the definition of moderate psoriasis and appropriate treatments for patients with moderate disease severity. MATERIALS AND METHODS: An online survey was conducted during October 2015 to determine how US dermatologists in the clinical setting define and treat moderate psoriasis. RESULTS: A total of 150 dermatologists responded to the survey (mean time in practice: 13.5 years). On average, they saw 72 patients with psoriasis per month; 40% of these patients were considered to have moderate psoriasis. Most (95%) reported assessing disease severity based on the percentage of psoriasis-affected body surface area (BSA); 59% also considered location of the affected area. BSA cutoffs used to define moderate psoriasis varied widely (median low and high cutoffs: 5-10%; range: 1-70%). Similarly, wide variation in cutoff ranges was observed for the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), and Dermatology Life Quality Index (DLQI). Primary therapy comprised biologics (47%), prescription topicals (28%), and oral systemics (18%). CONCLUSIONS: The current findings indicate lack of consensus surrounding the definition of moderate psoriasis among US dermatologists.

Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL.

BACKGROUND: Many patients with moderate plaque psoriasis are undertreated despite broadening treatment options. In the phase IV UNVEIL study, oral apremilast demonstrated efficacy and safety in systemic-naive patients with chronic moderate plaque psoriasis with lower psoriasis-involved body surface area (BSA; 5%-10%) during the 16-week, double-blind, placebo-controlled phase. We describe efficacy and safety of apremilast in this population through week 52 in UNVEIL.

METHODS: Patients with moderate plaque psoriasis (BSA 5%-10%; static Physician's Global Assessment [sPGA] score of 3 [moderate]) and naive to systemic therapies for psoriasis were randomized (2:1) to receive apremilast 30 mg twice daily or placebo for 16 weeks. At week 16, patients continued on apremilast (apremilast/apremilast) or were switched from placebo to apremilast (placebo/apremilast) through week 52 (open-label apremilast treatment phase). Efficacy assessments included the product of sPGA and BSA (PGAxBSA) (mean percentage change from baseline; ≥75% reduction from baseline [PGAxBSA-75]), sPGA response (achievement of score of 0 [clear] or 1 [almost clear]), and the Dermatology Life Quality Index (DLQI; mean change from baseline).

RESULTS: A total of 136 patients completed the 52-week analysis period (placebo/apremilast, n=50/64; apremilast/apremilast, n=86/121). At week 52, improvements in all efficacy end points observed at week 16 were maintained in the apremilast/apremilast group (mean percentage change from baseline in PGAxBSA: -55.5%; PGAxBSA-75: 42.1%; sPGA response: 33.1%; mean change from baseline in DLQI score: -4.4); similar improvements emerged in the placebo/apremilast group after switching to apremilast. The most common adverse events (≥5% of patients) through week 52 were diarrhea (28.0%), nausea (19.0%), headache (15.2%), nasopharyngitis (10.4%), upper respiratory tract infection (7.1%), vomiting (5.7%), and decreased appetite (5.2%).

CONCLUSIONS: Apremilast was effective in systemic-naive patients with moderate plaque psoriasis with BSA 5%-10%; efficacy was sustained through week 52. No new safety signals emerged with continued apremilast exposure.

ClinicalTrials.gov: NCT02425826

J Drugs Dermatol. 2018;17(2):221-228.

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Real-World Clinical Experience With Apremilast in a Large US Retrospective Cohort Study of Patients With Moderate to Severe Plaque Psoriasis.

OBJECTIVE: To examine real-world use and patient outcomes with apremilast, an oral PDE4 inhibitor, in the dermatology practice set-ting for treatment of patients with moderate to severe plaque psoriasis.

METHODS: This retrospective, multicenter, longitudinal, observational cohort study used Modernizing Medicine's electronic medi-cal record (EMR) database of 5000 US dermatology providers. There were 7517 adults aged ≥18 years with a psoriasis diagnosis (ICD-9, ICD-10) who received apremilast therapy from October 1, 2015, to January 31, 2016, and were included in efficacy and safety analyses. Among patients who switched from non-apremilast to apremilast monotherapy, the majority (74.2%) switched from prior topical treatment. RESULTS: At apremilast initiation, in systemic-naive and systemic-experienced patients, mean (SD) Physician Global Assessment (PGA) was 2.79 (0.13) and 2.48 (0.15); mean (SD) psoriasis-affected body surface area (BSA) was 17.85% (2.27) and 12.93% (2.59); and mean itch numeric rating scale (NRS; 0=no itch, 10=worst itch possible) score was 4.14 and 3.82, respectively. Within 6 months of apremilast initiation, PGA decreased (mean [SD]) in systemic-naive patients (-1.71 [0.19], P less than0.001) and systemic-experienced patients (-1.02 [0.18], P less than 0.001); 26.8% (systemic-naive) and 25.5% (systemic-experienced) of patients achieved a PGA score of 0 or 1. Likewise, statistically significant reductions in BSA were noted in systemic-naive patients (~62% reduction from baseline; P less than 0.01) and systemic-experienced patients (~60% reduction from baseline; P=0.002). Mean itch NRS decreased to 2.38 in systemic-naive patients (P=0.139) and 0.0 in systemic-experienced patients (P=0.034). Of 160 patients with ≥1 assessment of patient-perceived overall treatment effectiveness, 138 (86.2%) strongly/somewhat agreed apremilast was effective in clearing their skin of psoriasis. For safety analyses, body weight was available in the EMR database and decreased in systemic-naive patients (-1.75 kg) and systemic-experienced patients (-1.09 kg). CONCLUSIONS: Findings support the effectiveness of apremilast in patients with moderate to severe psoriasis in dermatology clinical practices. Patients perceived apremilast to be effective.

Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study.

INTRODUCTION: Many options are available for patients with moderate to severe plaque psoriasis. Patients with moderate disease, however, are often undertreated and do not achieve satisfactory clearance. UNVEIL (NCT02425826) assessed efficacy and safety of apremilast in patients with chronic moderate plaque psoriasis.

METHODS: Patients with psoriasis body surface area (BSA) 5% to 10% and static Physician's Global Assessment (sPGA) score of 3 (moderate) without prior exposure to systemics were randomized (2:1) to apremilast 30 mg twice daily or placebo for 16 weeks. The primary efficacy endpoint was mean percentage change in the product of sPGA and BSA scores (PGAxBSA).

RESULTS: Of 221 patients (placebo, n=73; apremilast, n=148), >80% had received prior topical therapy. At week 16, apremilast yielded a significantly greater percentage change from baseline in PGAxBSA (-48.1%) vs placebo (-10.2^; P less than 0.0001). Dermatology Life Quality Index scores were significantly improved with apremilast (-4.8) vs placebo (-2.4; P=0.0008). Mean improvements in the Treatment Satisfaction Questionnaire for Medication, version II, were greater with apremilast vs placebo for global satisfaction (63.2 vs 48.7; P less than 0.0001) and treatment effectiveness (57.3 vs 38.8; P less than 0.0001). Most adverse events were mild or moderate; most common were diarrhea, headache, nausea, upper respiratory tract infection, decreased appetite, and vomiting.

CONCLUSION: Apremilast was effective and well tolerated, significantly improved quality of life, and was associated with high patient satisfaction in systemic-naive, post-topical patients with moderate plaque psoriasis.

ClinicalTrials.gov: NCT02425826

J Drugs Dermatol. 2017;16(8):801-808.

Evaluation of the Physician Global Assessment and Body Surface Area Composite Tool for Assessing Psoriasis Response to Apremilast Therapy: Results from ESTEEM 1 and ESTEEM 2.

BACKGROUND: The Physician Global Assessment and Body Surface Area (PGAxBSA) composite tool is a simple, effective alternative for measuring psoriasis severity. OBJECTIVE: To evaluate the product of PGAxBSA as a sensitive alternative to the Psoriasis Area and Severity Index (PASI) for assessing disease severity and therapeutic response with data collected from the phase 3 ESTEEM 1 and 2 trials. METHODS: This post hoc analysis included 836 patients randomized to apremilast 30 mg BID at baseline (ESTEEM 1, n=562; ESTEEM 2, n=274). Spearman correlation coefficients were used to compare PGAxBSA, PASI, and the Dermatology Life Quality Index (DLQI). Concordance between PGAxBSA and PASI was evaluated for 50%/75%/90% improvement from baseline at week 16. RESULTS: In ESTEEM 1 and 2, PGAxBSA and PASI exhibited significant positive correlations for measuring disease severity at baseline (r≥0.757) and week 16 (r≥0.807). At week 16, ≥79% concordance was observed between PGAxBSA and PASI for 75% and 90% improvement from baseline; greater concordance (>88.0%) was observed using 50% improvement from baseline. At week 16, PGAxBSA and PASI were moderately correlated with DLQI. LIMITATIONS: Analysis was limited to patients with baseline BSA ≥10% and static PGA ≥3. CONCLUSIONS: In patients with moderate to severe psoriasis, PGAxBSA is correlated with PASI and sensitive to therapeutic response.

J Drugs Dermatol. 2017;16(2):147-153.

First-Line Fixed-Combination Psoriasis Treatment Is Associated With Lower Healthcare Costs.

Treatment of psoriasis is associated with significant healthcare-related costs. A retrospective, observational study was conducted to investigate whether first-line treatment with calcipotriene/betamethasone dipropionate (CBD) fixed-combination topical products would lower the cost impact of psoriasis compared with using the fixed-combination product later in the course of treatment. Patients were classified as being initially treated with CBD combination products (cohort A, n=7307) or other topical psoriasis medications (cohort B, n=9670). We included only patients who, at some point after diagnosis, were prescribed a CBD fixed-combination product. During the 1-year followup, the mean±standard deviation values and number of total office visits and psoriasis-related office visits were significantly lower in cohort A (13.36±14.39; 2.79±7.60) than in cohort B (16.08±16.68; 4.25±10.23) (both P<.0001). Mean total healthcare costs were also significantly lower for cohort A ($7785.80±$15,255.60; median, $3411.30) than for cohort B ($11,757.20±$19,747.60; median, $5595.80) (P<.0001). Compared with other topical psoriasis medications, first-line treatment with CBD fixed-combination topical products was associated with fewer office visits and lower total healthcare costs.

Real-life treatment profile of calcipotriene and betamethasone dipropionate topical suspension in patients with psoriasis vulgaris.

BACKGROUND: Treatment with calcipotriene plus betamethasone dipropionate (CBD) fixed-combination topical suspension has been shown to be effective and well tolerated in patients with psoriasis vulgaris. AIM: To document experiences with CBD topical suspension in a US clinical dermatology setting using patient-reported outcomes (PROs). METHODS: In total, 147 patients were enrolled in this 8-week, prospective, noninterventional, multicenter, one-arm study. Data were collected at baseline and week 8 at the office, and at one time at home (week 2). PROs were assessed using the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity (PtGA) using a 5-point Likert scale, patient-reported level of itching using a 0-100 graduated visual analog scale, and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Treatment adherence and adverse events (AEs) were assessed at week 8. RESULTS: After 8 weeks of treatment, DLQI score significantly improved compared with baseline (-5.5 ± 5.93; P<.0001), starting as early as week 2 (-4.2 ± 5.28; P<.0001). The level of itching was significantly reduced from baseline to week 2 (-19% ± 25.94%; P<.0001) and week 8 (-28.6% ± 29.14%; P<.0001). The percentage of patients with "controlled disease" (PtGA score of "clear" or "very mild") was 34.1% at week 2 and 60.2% at week 8. At the end of treatment, mean TSQM-9 scores for effectiveness, convenience, and satisfaction domains ranged from 68 to 74. Patients reported the need to use CBD topical suspension for an average of 53.62 ± 8.05 days. Treatment-emergent AEs occurred in 3 patients. CONCLUSION: The results of this noninterventional study are consistent with previously reported data from interventional trials and suggest that treatment with CBD topical suspension is efficacious and well tolerated and improves quality of life in patients with psoriasis vulgaris.

Using a single product (calcipotriene/betamethasone topical suspension) vs multiple products to manage body and scalp psoriasis: comparisons in resource utilization and costs.

OBJECTIVES: To compare resource utilization and costs among patients who used calcipotriene/betamethasone dipropionate topical suspension (Taclonex Scalp Topical Suspension, Leo Pharma A/S) vs those who used multiple body and scalp formulations for psoriasis. RESEARCH DESIGN AND METHODS: A retrospective study using Truven Health MarketScan Commercial Database from 2006-2011 was performed to identify patients with psoriasis (ICD code 696.1x). Two study cohorts analyzed were cohort A (used body-only formulations for psoriasis and switched on the index date to using calcipotriene/betamethasone dipropionate topical suspension alone) and cohort B (used multiple body and scalp formulations for psoriasis). Patients were required to be continuously enrolled during 180-days pre- and post-index periods. Multiple regression analyses adjusting for baseline demographic and clinical covariates were performed. MAIN OUTCOMES MEASURES: Number of psoriasis-related outpatient visits, total healthcare costs, psoriasis-related costs, and use of systemic agents during post-index period. RESULTS: A total of 1923 patients were identified with at least one prescription for calcipotriene/betamethasone dipropionate scalp topical suspension (cohort A = 367, cohort B = 1556). Patients using multiple medications (cohort B) were associated with 48% higher number of outpatient visits as compared with those who used a single formulation (cohort A) after controlling for baseline covariates (p < 0.001). A generalized linear model adjusting for baseline covariates showed significantly higher post-index total and psoriasis-related healthcare costs for cohort B as compared with cohort A (both p < 0.001). Patients in Cohort B also had twice the odds of using systemic agents as compared to patients in Cohort A (p < 0.001). CONCLUSIONS: Patients with body and scalp psoriasis using a single product had significantly lower overall and psoriasis-related healthcare costs, needed fewer psoriasis-related outpatient visits, and used less systemic agents during the post-index period. A lack of robust clinical measures to define the disease severity may have limited the interpretations from this study.