YOSEMITE and RHINE

Eter, Nicole; Singh, Rishi P.; Abreu, Francis; Asik, Kemal; Basu, Karen; Baumal, Caroline R.; Chang, Andrew; Csaky, Karl G.; Hašková, Zdenka; Lin, Hugh; Ruiz, Carlos Quezada; Ruamviboonsuk, Paisan; Silverman, David G.; Wykoff, Charles C.; Willis, Jeffrey R.

doi:10.1016/j.xops.2021.100111

Cited by 31 publications

(17 citation statements)

References 32 publications

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“…11,27,55 Tapering, or otherwise dubbed similar means of dose reduction, is well-practiced in the clinical application of biological therapies, in a broad spectrum of diseases. [56][57][58][59][60][61][62][63] Often costly, optimization of cost efficacy is strived for, as is risk reduction in agents with sometimes wide-ranging effects, not all predictable or intended for. 64 Increase of interdose interval of dupilumab likely benefits patient burden.…”

Section: 9mentioning

confidence: 99%

Two‐year results of tapered dupilumab for CRSwNP demonstrates enduring efficacy established in the first 6 months

Lans

Otten

Adriaensen

et al. 2023

Allergy

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BackgroundDupilumab is an anti‐T2‐inflammatory biological registered for chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP), indicated by integrated CRS‐care pathways when optimal medico‐surgical treatment yields insufficient CRS control. This study aims to evaluate long‐term results with focus on established therapeutic efficacy while tapering dupilumab.MethodsReal‐life, prospective observational cohort study in single tertiary referral center with add‐on dupilumab as primary biological treatment in adult (≥18 years) biological‐naïve CRSwNP patients per the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS)2020‐indication with a 2‐year follow‐up. Tapering (increasing interdose interval) applied every 24 weeks, conditional to sufficient treatment response and CRS control.ResultsMean scores (s.d.) of all co‐primary outcomes improved significantly from baseline ( 228) to the 48 ( 214) and 96‐weeks ( 99) timepoints: Nasal Polyp Score (0–8) improved from 5,3 (1,9) to 1,4 (1,8) and 1,3 (1,7); SinoNasal Outcome Test (SNOT)‐22 (0–110) improved from 53,6 (19,6) to 20,2 (15,4) and 21,2 (15,6); Sniffin’Sticks‐12 identification test (0–12; 0–6 anosmia, 7–10 hyposmia, 11–12 normosmia) improved from 3,7 (2,4) to 7,7 (2,9) and 7,3 (3,04); Asthma Control Test (5–25; >19 indicating well‐controlled asthma) improved from 18,5 (4,8) to 21,8 (3,8) and 21,4 (3,9). Tapering was feasible in 79,5% of the patients at the 24‐weeks timepoint, and in 93,7% and 95,8% at the 48‐ and 96‐weeks timepoints, respectively. One‐way repeated‐measures ANOVA demonstrated no significant alterations of individual co‐primary outcome mean‐scores from 24 weeks onward.ConclusionThis first long‐term real‐life prospective observational cohort study shows high therapeutic efficacy of dupilumab for severe CRswNP in the first 2 years. Therapeutic efficacy is principally established within 24 weeks and endures while tapering dupilumab conditional to treatment response and CRS control.

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Section: 9mentioning

confidence: 99%

Two‐year results of tapered dupilumab for CRSwNP demonstrates enduring efficacy established in the first 6 months

Lans

Otten

Adriaensen

et al. 2023

Allergy

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“…a Total number of AEs and SAEs includes nonocular events and ocular events in the study or fellow eye b Ocular AEs in the study eye only are presented c Ocular AEs of special interest were defined as events associated with severe IOI, events requiring surgical or medical intervention to prevent permanent loss of sight, or events associated with BCVA loss of ≥ 30 ETDRS letters for > 1 hour d Includes serious and nonserious IOI events; excludes endophthalmitis events. Most IOI events occurred after the initial Q4W dosing phase for each treatment arm, and approximately 4-6 weeks after the most recent dose of faricimab or aflibercept e APTC events were externally adjudicated; all other events were investigator reported treat-and-extend-based methods common in clinical practice [16]; however, real-world studies are needed to explore whether faricimab may reduce treatment burdens and optimize outcomes in Japan, where more flexible dosing regimens are tolerated [1,20,21]. As previously described [10], YOSEMITE and RHINE were not designed to compare the durability of faricimab with aflibercept, which was administered according to a fixed Q8W regimen consistent with its globally aligned label [22].…”

Section: Discussionmentioning

confidence: 99%

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial

et al. 2023

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Purpose To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME). Study design Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 trials (YOSEMITE, NCT03622580; RHINE, NCT03622593). Methods Patients with DME were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W through week 100. Primary endpoint was bestcorrected visual acuity (BCVA) change from baseline at 1 year, averaged over weeks 48, 52, and 56. This is the first time 1-year outcomes between Japanese patients (only enrolled into YOSEMITE) and the pooled YOSEMITE/RHINE cohort (N = 1891) have been compared. ResultsThe YOSEMITE Japan subgroup included 60 patients randomized to faricimab Q8W (n = 21), faricimab PTI (n = 19), or aflibercept Q8W (n = 20). Consistent with global results, the adjusted mean (95.04% confidence interval) BCVA change at 1 year in the Japan subgroup was comparable with faricimab Q8W (+11. 1 [7.6-14.6] letters), faricimab ] letters), and aflibercept Q8W (+6.9 [3.3-10.5] letters). At week 52, 13 (72%) patients in the faricimab PTI arm achieved ≥ Q12W dosing, including 7 (39%) patients receiving Q16W dosing. Anatomic improvements with faricimab were generally consistent between the Japan subgroup and pooled YOSEMITE/RHINE cohort. Faricimab was well tolerated; no new or unexpected safety signals were identified. Conclusion Consistent with global results, faricimab up to Q16W offered durable vision gains and improved anatomic and disease-specific outcomes among Japanese patients with DME.

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“…VEGF-A inhibition suppresses endothelial cell proliferation, neovascularization, and vascular permeability, while Ang-2 inhibition contributes to vascular stability and desensitization of vessels to VEGF (Shirley 2022 ). Faricimab is administered through intravitreal injection, and it is non-inferior to aflibercept used as a comparator control (Khanani et al 2021 ; Eter et al 2022 ). Conjunctival hemorrhage is its most common side effect.…”

Section: Othermentioning

confidence: 99%

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

Kaykı-Mutlu

Aksoyalp

Wojnowski

et al. 2023

Naunyn-Schmiedeberg's Arch Pharmacol

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While new drug approvals by the U.S. Food and Drug Administration (FDA) had remained stable or even increased in the first 2 years of the COVID-19 pandemic, the 37 newly approved drugs in 2022 are considerably less than the 53 and 50 new drugs approved in 2020 and 2021, respectively, and less than the rolling 10-year average of 43. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition (“first-in-indication”), first drug using a novel molecular mechanism (“first-in-class”), and “next-in-class,” i.e., a drug using an already exploited molecular mechanism. We identify two “first-in-indication” (ganaxolon and teplizumab), 20 (54%) “first-in-class,” and 17 (46%) “next-in-class” drugs. By treatment area, rare diseases and cancer drugs were once again the most prevalent (partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics).

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YOSEMITE and RHINE

Cited by 31 publications

References 32 publications

Two‐year results of tapered dupilumab for CRSwNP demonstrates enduring efficacy established in the first 6 months

Two‐year results of tapered dupilumab for CRSwNP demonstrates enduring efficacy established in the first 6 months

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

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