FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2892339408> ?p ?o ?g. }

• W2892339408 abstract "Background We previously reported initial Phase 2 study results for 60 gout patients treated with SEL-212, a novel combination treatment comprised of pegsiticase (pegylated uricase) co-administered with a synthetic vaccine particle encapsulating rapamycin (SVP-R).1 SEL-212 was well-tolerated, mitigated the formation of anti-drug antibodies, and enabled sustained control of serum uric acid (sUA) levels in most subjects.1 In this ongoing study, new treatment cohorts involving higher SVP-R dose levels and extended combination regimens were introduced. Objectives To assess the tolerability and impact on sUA levels and ADA formation of escalated and expanded doses of SEL-212, designed to be the first non-immunogenic uricase therapy for refractory gout. Methods Patients with symptomatic gout (≥1 tophus, gout flare within 6 months or gouty arthropathy) and elevated sUA (≥6 mg/dL) were enrolled to SEL-212 treatment (n=6–12 pts/cohort) of fixed doses of pegsiticase (0.2 mg/kg or 0.4 mg/kg) alone or co-administered with SVP-R (0.05, 0.08, 0.1, 0.125, and 0.15 mg/kg). SEL-212 was infused in 28 day cycles x3 doses followed by challenge with pegsiticase alone on 28 day cycles x2 doses. In addition, 2 cohorts were added that extended the combination treatment with SVP-R to all five q28 doses of pegsiticase. ADAs and sUA were assessed at baseline and 7, 14, 21, and 30 days after each dose to Day 140. Safety was monitored continuously. Results As previously reported, 5 of 6 patients dosed with pegsiticase alone developed ADAs after a single dose, correlating with loss of sUA control by 30 days. The addition of SVP-R to pegsiticase showed a dose-dependent inhibition of ADAs, enabling prolonged control of sUA levels. At a mid-dose of 0.1 mg/kg SVP-R, combined with either 0.2 or 0.4 mg/kg pegsiticase, the majority of patients showed sustained control of SUA through 18 weeks. However, control of ADAs and sUA tapered off in some patients by week 20, after two injections of pegsiticase alone. Preliminary results of treatment at increased SVP-R doses (0.125–0.15 mg/kg) are consistent with Phase 1b data indicating that higher doses of the SVP-R will increase the percentage of patients that remain ADA free. These results also suggest that extending treatment to 5 doses of SVP-R and pegsiticase may enable more subjects to complete the 5 month treatment with sustained reductions in sUA. In addition to mitigating immunogenicity, patients treated with SVP-R experienced a low rate of gout flares, with less than 25% of patients experiencing flares during the first month after treatment, despite profound drop in sUA level, and continued reduction was observed during months 2–5. SEL-212 has been generally well tolerated at clinically active dose levels and infusion reactions observed with repeat dosing were reduced with increasing doses of SVP-R. Conclusions SEL-212 has been well tolerated, mitigated immunogenicity, and sustained control of sUA levels. Escalation of the SVP-R component of SEL-212 may enhance the duration of sUA and ADA suppression without increased risk. Reference [1] Sands, et al. EULAR Annual European Congress2017. Poster THU0402. Disclosure of Interest E. Sands Employee of: Selecta Biosciences, A. Kivitz: None declared, L. Johnston PhD Employee of: Selecta Biosciences, W. DeHaan Employee of: Selecta Biosciences, T. Kishimoto Employee of: Selecta Biosciences" @default.
• W2892339408 created "2018-09-27" @default.
• W2892339408 creator A5027938783 @default.
• W2892339408 creator A5048492584 @default.
• W2892339408 creator A5059736360 @default.
• W2892339408 creator A5082669130 @default.
• W2892339408 creator A5086215911 @default.
• W2892339408 date "2018-06-01" @default.
• W2892339408 modified "2023-09-26" @default.
• W2892339408 title "FRI0234 Sel-212: selective mitigation of anti-drug antibodies against pegsiticase to control serum uric acid in hyperuricemic subjects" @default.
• W2892339408 doi "https://doi.org/10.1136/annrheumdis-2018-eular.7396" @default.
• W2892339408 hasPublicationYear "2018" @default.
• W2892339408 type Work @default.
• W2892339408 sameAs 2892339408 @default.
• W2892339408 citedByCount "0" @default.
• W2892339408 crossrefType "proceedings-article" @default.
• W2892339408 hasAuthorship W2892339408A5027938783 @default.
• W2892339408 hasAuthorship W2892339408A5048492584 @default.
• W2892339408 hasAuthorship W2892339408A5059736360 @default.
• W2892339408 hasAuthorship W2892339408A5082669130 @default.
• W2892339408 hasAuthorship W2892339408A5086215911 @default.
• W2892339408 hasBestOaLocation W28923394081 @default.
• W2892339408 hasConcept C121332964 @default.
• W2892339408 hasConcept C126322002 @default.
• W2892339408 hasConcept C142424586 @default.
• W2892339408 hasConcept C197934379 @default.
• W2892339408 hasConcept C2778375690 @default.
• W2892339408 hasConcept C2779721657 @default.
• W2892339408 hasConcept C2779881121 @default.
• W2892339408 hasConcept C2780035454 @default.
• W2892339408 hasConcept C2780402116 @default.
• W2892339408 hasConcept C71924100 @default.
• W2892339408 hasConcept C87355193 @default.
• W2892339408 hasConcept C90924648 @default.
• W2892339408 hasConcept C98274493 @default.
• W2892339408 hasConceptScore W2892339408C121332964 @default.
• W2892339408 hasConceptScore W2892339408C126322002 @default.
• W2892339408 hasConceptScore W2892339408C142424586 @default.
• W2892339408 hasConceptScore W2892339408C197934379 @default.
• W2892339408 hasConceptScore W2892339408C2778375690 @default.
• W2892339408 hasConceptScore W2892339408C2779721657 @default.
• W2892339408 hasConceptScore W2892339408C2779881121 @default.
• W2892339408 hasConceptScore W2892339408C2780035454 @default.
• W2892339408 hasConceptScore W2892339408C2780402116 @default.
• W2892339408 hasConceptScore W2892339408C71924100 @default.
• W2892339408 hasConceptScore W2892339408C87355193 @default.
• W2892339408 hasConceptScore W2892339408C90924648 @default.
• W2892339408 hasConceptScore W2892339408C98274493 @default.
• W2892339408 hasLocation W28923394081 @default.
• W2892339408 hasOpenAccess W2892339408 @default.
• W2892339408 hasPrimaryLocation W28923394081 @default.
• W2892339408 hasRelatedWork W1638582063 @default.
• W2892339408 hasRelatedWork W2036840908 @default.
• W2892339408 hasRelatedWork W2041808598 @default.
• W2892339408 hasRelatedWork W2290560590 @default.
• W2892339408 hasRelatedWork W2313927615 @default.
• W2892339408 hasRelatedWork W2317048960 @default.
• W2892339408 hasRelatedWork W2332047378 @default.
• W2892339408 hasRelatedWork W2354398360 @default.
• W2892339408 hasRelatedWork W2414418896 @default.
• W2892339408 hasRelatedWork W2418364144 @default.
• W2892339408 hasRelatedWork W2559223451 @default.
• W2892339408 hasRelatedWork W2559743688 @default.
• W2892339408 hasRelatedWork W2561050760 @default.
• W2892339408 hasRelatedWork W2755815881 @default.
• W2892339408 hasRelatedWork W2801696506 @default.
• W2892339408 hasRelatedWork W2808687603 @default.
• W2892339408 hasRelatedWork W2951387792 @default.
• W2892339408 hasRelatedWork W2980058317 @default.
• W2892339408 hasRelatedWork W3032403053 @default.
• W2892339408 hasRelatedWork W2508647555 @default.
• W2892339408 isParatext "false" @default.
• W2892339408 isRetracted "false" @default.
• W2892339408 magId "2892339408" @default.
• W2892339408 workType "article" @default.