Sun Pharma (United States)

People with plaque psoriasis are more likely to live with obesity relative to individuals without psoriasis, which can affect response to biologic treatment. This pooled analysis of the phase III reSURFACE 1 and reSURFACE 2 trials explored efficacy and safety of tildrakizumab 100 mg and 200 mg in patients with plaque psoriasis who were living with obesity for up to 244 weeks of treatment. Both doses of tildrakizumab were effective long-term, with comparable safety profiles in patients who were living with obesity and those who were not. Patients who were not living with obesity experienced more improvement with treatment than those with obesity, and those living with obesity had more long-term improvement after treatment with tildrakizumab 200 mg vs. tildrakizumab 100 mg.

Abstract Pancreatic ductal adenocarcinoma (PDA) is a highly lethal malignancy with a poor prognosis. Current therapies, including immunotherapy, have demonstrated limited efficacy, highlighting the urgent need for novel therapeutic agents. This study aimed to evaluate the therapeutic potential of a novel taxoid (DHA-SBT1214) formulated in an oil-in-water nanoemulsion (RP-001), administered alone or in combination with immune checkpoint inhibition, in enhancing immune cell infiltration and improving outcomes in preclinical models of PDA. To this end, four-month-old female LSL-KrasG12D/+; LSL-Trp53R172H/+; Pdx1-Cre (KPC) mice (n=6/group) were randomized to receive vehicle control (empty nanoemulsion, IV weekly), RP-001 (10 mg/kg, IV weekly), anti-PD-1 antibody (200 µg, IP twice weekly), or a combination of RP-001 and anti-PD-1 for three weeks. Following treatment, pancreatic tissues were collected for comprehensive immunophenotyping of tumor-infiltrating lymphocytes using flow cytometry, with markers including CD45, CD3, CD4, CD8, and PD-1. RP-001 efficacy was assessed in an orthotopic model of pancreatic cancer (n=10/group) and in a survival study involving male and female KPC mice treated with vehicle or RP-001 (10 mg/kg, IV weekly) for four weeks. In KPC mice, combination treatment with RP-001 and anti-PD-1 significantly increased CD4+ T cell infiltration compared to control. Both RP-001 monotherapy and combination therapy enhanced CD8+ T cell infiltration, indicating a direct immunomodulatory effect. Importantly, no significant body weight loss was observed in any treatment group, supporting the safety of these regimens. In the orthotopic model, RP-001 significantly reduced tumor weight by 41.2% after three weeks. Additionally, RP-001 treatment significantly prolonged median survival in KPC mice compared to vehicle-treated controls in both males and females. In conclusion, RP-001 exhibits strong antitumor activity, enhances immune cell infiltration, and is well-tolerated in multiple preclinical models of PDA. These findings support further investigation of RP-001 as a promising therapeutic candidate for PDA. Acknowledgement: [NCI R01 grant] Citation Format: Laura Musumeci, Irena Krga, Lizbeth Flores, Allison Ehrlich, Satveer Jagwani, Edward Kim, James E. Egan, Mansoor M. Amiji, Gerardo G. Mackenzie. A novel nano-formulated taxoid (RP-001) enhances T-cell infiltration and prolongs survival in preclinical models of pancreatic ductal adenocarcinoma [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer Research—Emerging Science Driving Transformative Solutions; Boston, MA; 2025 Sep 28-Oct 1; Boston, MA. Philadelphia (PA): AACR; Cancer Res 2025;85(18_Suppl_3):Abstract nr A074.

Background Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. This report describes final primary results of a 64-week real-world study of the effect of tildrakizumab on patients’ health-related quality of life (HRQoL). Materials and methods In this open-label phase 4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter through week 52. The primary endpoint was improvement from baseline in HRQoL measured by Psychological General Well-Being Index (PGWBI) total score at weeks 28 and 52. Secondary HRQoL endpoints included change from baseline in Dermatology Life Quality Index (DLQI) score through week 64. Missing data were not imputed. Results Of 55 patients enrolled, 45 were assessed at week 64. Mean ± standard deviation (SD) total PGWBI score improved from 78.1 ± 14.1 at baseline to 85.2 ± 12.0 at week 52 (p < .001). Mean ± SD DLQI score improved from 9.4 ± 5.2 at baseline to 2.0 ± 2.6 (p < .001) at week 64 with 62.2% of patients having a DLQI score of 0 or 1 at week 64. Conclusions Tildrakizumab improved long-term HRQoL in patients with psoriasis in a real-world setting.

Plaque psoriasis is a chronic condition that may impact patients' work productivity. Tildrakizumab, an interleukin-23 p19 inhibitor, is approved for treatment of moderate-to-severe plaque psoriasis in adults. However, the effect of tildrakizumab treatment on work productivity in patients with psoriasis is not well characterized. In this multicenter, open-label, uncontrolled phase4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100mg at week0, week4, and every 12weeks thereafter through week52. Patients completed the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) at baseline and every 12weeks from week16 through week64. The following four domains of the WPAI:PSO were examined: absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduction of productivity while at work due to psoriasis), total activity impairment (percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Missing data were not imputed. Of the 55 patients enrolled, 31 patients completed all domains of the WPAI:PSO at week64. From baseline to week64, respectively, mean ± standard deviation (SD) scores improved for presenteeism (20.5 ± 21.7 to 2.6 ± 5.8; P < 0.001), total activity impairment (29.5 ± 26.6 to 4.4 ± 9.4; P < 0.001), and total work productivity impairment (20.9 ± 22.2 to 2.6 ± 5.8; P < 0.001). The mean ± SD score for absenteeism decreased from 1.1 ± 5.7 at baseline to 0.0 ± 0.0 at week64, but this change was not statistically significant. Tildrakizumab treatment mitigated work productivity loss due to psoriasis as measured by the presenteeism, total activity impairment, and total work productivity impairment domains of the WPAI:PSO. ClinicalTrials.gov identifier, NCT03718299.

Objectives This study documents real-world patterns and additional costs of above-label (≥10% above the recommended maintenance dose) use of biologics in patients with plaque psoriasis. Materials and methods This was a descriptive, retrospective cohort analysis using the IBM MarketScan Commercial and Medicare Supplemental Databases. Adult patients diagnosed with plaque psoriasis initiating treatment with etanercept, adalimumab, ixekizumab, or secukinumab between 1 January 2015 and 30 November 2019 (index) were eligible. Only biologics approved prior to 2017 were included to ensure data for all agents was available throughout the study period. Patients had no other indications for biologics of interest. Outcomes were measured in the 12-month follow-up period after start of maintenance dosing. Results Of 6453 patients included, 708 (11.0%) received etanercept, 4654 (72.1%) received adalimumab, 228 (3.5%) received ixekizumab, and 863 (13.4%) received secukinumab. Above-label dosing was recorded in 326 (46.0%) patients receiving etanercept, 513 (11.0%) receiving adalimumab, 40 (17.5%) receiving ixekizumab, and 79 (9.2%) receiving secukinumab. Mean time to above-label use for all treatments was 50.7–99.5 days; the median was 21–37 days. Mean duration of above-label use for all treatments was 130–196 days; the median was 35–175 days. Mean total additional annual psoriasis-related medical/pharmacy costs associated with above-label use were $312/$16,475 for etanercept, $278/$9,773 for adalimumab, $124/$5,202 for ixekizumab, and $277/$9,288 for secukinumab. Above-label use was generally not associated with safety concerns; however, gastrointestinal and combined “other” nonrespiratory infections were significantly more frequent in patients receiving adalimumab above-label. Conclusions Above-label use of biologics for psoriasis treatment was most frequent for patients receiving etanercept, followed by ixekizumab, adalimumab, and secukinumab. Above-label vs on-label use resulted in additional costs but few significant safety concerns.

BackgroundOTX-101 is approved for treatment of keratoconjunctivitis sicca (KCS). We present results of a phase 3 worse-eye efficacy analysis and 1-year safety extension.MethodsDuring the double-masked treatment phase, patients with bilateral KCS were randomized 1:1 to 12 weeks OTX-101 or vehicle 1 drop per eye twice daily. Efficacy assessments included Schirmer’s test and corneal and conjunctival staining. All patients who completed the treatment phase were eligible for enrollment in the open-label extension and received 1 drop OTX-101 twice daily for up to 52 weeks. Safety endpoints included adverse event (AE) monitoring, Snellen visual acuity (VA), intraocular pressure (IOP), slit-lamp examination (SLE), and dilated fundoscopy.ResultsOverall, 745 and 258 patients enrolled in the treatment and safety extension phases, respectively. At 12 weeks, number (%) of patients with Schirmer’s score increase of ≥10 mm from baseline was 76 (20.5%) vs. 42 (11.3%) for OTX-101 vs. vehicle (P=0.0005). OTX-101 significantly improved total conjunctival staining vs. vehicle at week 12 (least squares mean change from baseline −1.65 [0.12] vs. −1.12 [0.12], P=0.0013), and number (%) of patients with clear central corneas vs. vehicle at week 12 (222 [64.0%] vs. 199 [55.3%], P=0.0179). In the 1-year safety extension, AEs were mostly mild; instillation site pain was most common in 59 (22.9%) patients (17 [13.2%] vs. 42 [32.6%] patients receiving prior OTX-101 and vehicle). No safety concerns were raised by VA, IOP, SLE, and fundoscopy.ConclusionOTX-101 efficacy was confirmed in the eye with lower baseline Schirmer’s score. OTX-101 was well tolerated long term.Clinical TrialRegistered at ClinicalTrials.gov on July 27, 2016. NCT02845674 https://clinicaltrials.gov/ct2/show/NCT02845674?term=OTX-101&draw=2&rank=1.