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- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
SUBCUTANEOUS INFLIXIMAB EFFECTIVELY MANAGES CLINICAL OUTCOMES OF INFLAMMATORY BOWEL DISEASE INDEPENDENTLY OF VARIOUS CONFOUNDING FACTORS (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5367;
Clin Gastroenterol Hepatol 2023 [3] Rahmany et al. Gastroenterology 2023.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB SWITCH MAY REDUCE THE RISK OF IMMUNOGENICITY RELATED TREATMENT FAILURE AND CAN BE USED TO FACILITATE IMMUNOMODULATOR WITHDRAWAL (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5354;
All those who stopped IMM were successfully maintained on monotherapy at 1 year. 15/17 people treated with escalated IV dosing were successfully switched to standard SC IFX dosing with improvement in mean IFX DLs and without loss of clinical effect.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
EFFECTIVENESS OF SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS INFLIXIMAB IN INFLAMMATORY BOWEL DISEASE PATIENTS: A COMBINED ANALYSIS OF REAL-WORLD EVIDENCE (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5352;
Clin Gastroenterol Hepatol 2023 [3] Rahmany et al. Gastroenterology 2023.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
SUBCUTANEOUS INFLIXIMAB IN CROHN'S DISEASE PATIENTS WITH IMMUNOGENIC FAILURE OF INTRAVENOUS INFLIXIMAB: A RETROSPECTIVE TWO-CENTER STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5341;
Gastroenterology 2023. Subcutaneous infliximab after previous failure and immunogenicity of intravenous infliximab was well tolerated and effective in a cohort of patients with refractory Crohn's disease.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
CLINICAL EFFICACY AND DURABILITY OF SUBCUTANEOUS INFLIXIMAB IN PATIENTS WITH MODERATE-TO-SEVERE INFLAMMATORY BOWEL DISEASE: A REAL-WORLD MULTICENTER PROSPECTIVE COHORT STUDY IN KOREA (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5336;
Conclusions : IFX-SC appears to be an effective therapeutic option for patients with moderate-to-severe UC or CD in real-world settings. With a favorable drug survival and a tolerable safety profile, it may facilitate individualized treatment and ensure good compliance.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
CLINICAL EFFICACY AND DURABILITY OF SUBCUTANEOUS INFLIXIMAB IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AFTER SWITCHING FROM INTRAVENOUS INFLIXIMAB: A REAL-WORLD MULTICENTER PROSPECTIVE COHORT STUDY IN KOREA (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5335;
Conclusions : In real-world settings, IFX-SC administration presents a viable strategy for maintenance therapy subsequent to IFX-IV treatment. Given the favorable drug survival rate, low relapse rate, and tolerable safety profile, IFX-SC may facilitate more tailored and individualized therapeutic approaches
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
ONE-YEAR CLINICAL OUTCOMES OF SWITCHING TO SUBCUTANEOUS INFLIXIMAB IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE ON MAINTENANCE OF INTRAVENOUS INFLIXIMAB THERAPY WITH OR WITHOUT REMISSION: A MULTI-CENTER COHORT STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5324;
Switching to SC IFX from IV IFX maintenance therapy demonstrated high treatment persistence and favorable safety profiles, irrespective of remission status at the time of switching. Patients in both remission or non-remission states showed significant improvement in pharmacokinetics and biomarkers, and/or stable disease activity indices.
- NETWORK META-ANALYSIS TO EVALUATE THE COMPARATIVE EFFICACY OF ADVANCED THERAPIES AS FIRST LINE FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH MODERATE-TO-SEVERE CROHN'S DISEASE (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_4916;
Background Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn's disease (CD)...Methods Eligible studies, identified by systematic literature review (PROSPERO no.: CRD42023413752), evaluated the efficacy of maintenance therapy using intravenous (IV) or SC infliximab, SC adalimumab, IV or SC vedolizumab, SC ustekinumab, SC risankizumab or oral upadacitinib, in patients with moderate-to-severe CD who responded to induction therapy...2 Barberio B et al . Gut 2023; 72:264
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
A PROSPECTIVE EVALUATION OF CLINICAL OUTCOMES OF SUBCUTANEOUS INFLIXIMAB FOLLOWING INTRAVENOUS INDUCTION THERAPY IN PATIENTS WITH CROHN'S DISEASE (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3281;
Conclusion Maintenance treatment with SC IFX for patients with CD showed a favorable effectiveness outcomes up to approximately one year. IFX TL tended to be higher in remitters compared with non-remitters in terms of endoscopy, CRP, and FC.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
PHARMACOKINETICS OF SUBCUTANEOUS INFLIXIMAB INDUCTION AND MAINTENANCE IN MODERATE-TO-SEVERELY ACTIVE CROHN'S DISEASE PATIENTS: WEIGHT MATTERS (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3269;
These data implicate the importance of body weight in SC IFX dosing strategies. Based on these findings, SC IFX induction and maintenance treatment is changed to a weight-based dosing scheme in the ongoing DIRECT-CD trial.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) FOR ULCERATIVE COLITIS: 2-YEAR EXTENSION RESULTS OF THE LIBERTY-UC STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3236;
P3
17 (Supplement_1), i623-i624. [2] Colombel et al., Journal of Crohn's and Colitis, 2023.17.Supplement_1: i161-i162
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
SUPER-RESPONDERS IN PATIENTS WITH MODERATE-TO-SEVERE CROHN'S DISEASE TREATED WITH SUBCUTANEOUS INFLIXIMAB MAINTENANCE THERAPY: A POST HOC ANALYSIS OF THE LIBERTY-CD STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3224;
P3
Super-responders with rapid and sustained improvements during SC IFX therapy had a higher likelihood of achieving desirable long-term outcomes, with substantial individual benefit (comprehensive disease control). Baseline characteristics and TLI were associated with super-response.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
IMPACT OF IMMUNOGENICITY ON CLINICAL OUTCOMES IN PATIENTS WITH CROHN'S DISEASE RECEIVING MAINTENANCE TREATMENT WITH SUBCUTANEOUS INFLIXIMAB: A POST HOC ANALYSIS OF THE LIBERTY-CD STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3222;
P3
These findings could be explained by the relatively high trough serum infliximab concentrations achieved by ADA-positive patients. Further studies are warranted focusing on long-term effects of immunogenicity and optimal drug concentrations in patients receiving maintenance therapy with SC CT-P13.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) AS MAINTENANCE THERAPY FOR CROHN'S DISEASE: 2 YEARS RESULTS OF THE LIBERTY-CD STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3219;
Overall, 85.6% (154/180) completed extension phase. Compared to the Week 54 results, efficacy results in the CT-P13 SC arm based on the non-responder imputation for missing or invalid data (i.e., patients who had missing or invalid data were considered as non-remitter/non-responder) were generally maintained in clinical remission , clinical response, endoscopic remission, endoscopic response, clinical remission (alternative definition), and corticosteroid-free remission at Week 102 (Figure 1.A).
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
IMPACT OF BODY MASS INDEX ON CLINICAL OUTCOMES AND DRUG LEVELS IN PATIENTS WITH CROHN'S DISEASE RECEIVING MAINTENANCE TREATMENT WITH SUBCUTANEOUS INFLIXIMAB: A POST HOC ANALYSIS OF THE LIBERTY-CD STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3212;
P3
1 Yarur A et al . Gastroenterology 2023; 165:963
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
RAPID SYMPTOMATIC IMPROVEMENT WITH SUBCUTANEOUS INFLIXIMAB INDUCTION TREATMENT FOR PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE: FIRST RESULTS FROM THE DIRECT-CD STUDY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_1162;
P3/4
CDAI, CRP and FC decreased significantly at the earliest time point of evaluation (Week 2-8). DIRECT-CD is an ongoing clinical trial.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Budget Impact of Infliximab Subcutaneous from the US Healthcare Perspective () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_2202;
Infliximab is considered as a potent treatment compared to the recently developed biologics. The model, based on the assumption that analyzed molecules have similar efficacy, suggests that treatment with Zymfentra will yield cost savings while improving patient convenience and offering intangible benefits.
- |||||||| Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
New P3 trial: PASSPORT: Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC (clinicaltrials.gov) - Feb 22, 2024
P3, N=130, Not yet recruiting, Sponsor: CMC Ambroise Par
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
The East Kent experience of switching from intravenous infliximab to subcutaneous, benefits to the patients, the service and financial implications (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_2133;
Results Before organising this, we had 14 patients on infliximab subcutaneous injections...We only switched back 3 patients due to side effects and flares. We will continue with this initiative so we can promote patient independence, decrease waiting times for loading doses and to improve cost savings to the Trust.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Safety and effectiveness of subcutaneous infliximab formulation in difficult-to-treat Crohn (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1946;
Conclusion This is the first report showing that SC IFX reinduction in CD patients previously exposed to IV IFX is safe, even after a long drug holiday. It might be regarded as a rescue option in difficult-to-treat patients, either alone or combined with other immunosuppressants.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Intravenous to subcutaneous infliximab switch may reduce the risk of immunogenicity related treatment failure and can be used to facilitate immunomodulator withdrawal (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1945;
All those who stopped IMM were successfully maintained on monotherapy at 1 year. 15/17 people treated with escalated IV dosing were successfully switched to standard SC IFX dosing with improvement in mean IFX DLs and without loss of clinical effect.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Subcutaneous infliximab effectively manages clinical outcomes of Inflammatory Bowel Disease independently of various confounding factors (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1919;
Clin Gastroenterol Hepatol 2023 [3] Rahmany et al. Gastroenterology 2023.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Treatment of patients with moderate-to-severe Crohn (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1899;
5 Hanauer SB et al . Gastroenterology 2023;164(S6):S220
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Subcutaneous infliximab (CT-P13 SC) for ulcerative colitis: 2-year extension results of the LIBERTY-UC study (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1878;
P3
17 (Supplement_1), i623-i624. [2] Colombel et al., Journal of Crohn's and Colitis, 2023.17.Supplement_1: i161-i162
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Rapid symptomatic improvement with subcutaneous infliximab induction treatment for patients with moderate-to-severe Crohn (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1862;
P3/4
CDAI, CRP and FC decreased significantly at the earliest time point of evaluation (Week 2-8). DIRECT-CD is an ongoing clinical trial.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Persistence, efficacy and tolerance of subcutaneous Infliximab after switch from intravenous infliximab in IBD patients in remission: one-year results from a multicenter prospective cohort (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1843;
Three patients (0.7%) had IBD-related surgery and 8 (1.9%) IBD-related hospitalization. Conclusion In this large multicenter prospective cohort of IBD patients in remission, one-year persistence of SC-IFX after switch from IV-IFX was 95.3%, supporting excellent efficacy and tolerance of SC-IFX.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1842;
[1] Colombel et al., Journal of Crohn's and Colitis, 2023. [2] Sands et al., Journal of Crohn's and Colitis, 2023.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Transition from intravenous to subcutaneous infliximab: effectiveness in a cohort of patients with inflammatory bowel disease (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1835;
No serious AEs were reported and no patient was hospitalized. Conclusion Effectiveness of switching from intravenous to subcutaneous infliximab administration in IBD patients is confirmed in our real world cohort of patients.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Usefulness of subcutaneous Infliximab in patients with Inflammatory Bowel Disease in clinical practice: are increased levels associated with clinical benefit? (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1833;
No adverse events we reported. Conclusion Switching to IFXsc in patients with previous therapy with intensified IFXiv is not only associated with a more favorable pharmacokinetic profile but also with a greater effectiveness.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Impact of immunogenicity on clinical outcomes in patients with Crohn (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1825;
P3
These findings could be explained by the relatively high trough serum infliximab concentrations achieved by ADA-positive patients. Further studies are warranted focusing on long-term effects of immunogenicity and optimal drug concentrations in patients receiving maintenance therapy with SC CT-P13.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Effectiveness and safety of subcutaneous infliximab in perianal Crohn's disease: a multicentre cohort study (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1816;
Conclusion Our results are in line with those reported in the literature on the effectiveness of IV IFX in pCD. The SC formulation appears to be effective and safe for active pCD, and for maintaining remission in inactive pCD
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Evaluation of the efficacy and safety of the use of subcutaneous infliximab in the treatment of inflammatory bowel disease in na (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1772;
In our 9-month study, clinical scores and fecal calprotectin improved significantly, with low immunogenicity rates. Only 31.6% of patients discontinued treatment due to adverse effects or loss of response.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Pharmacokinetics of subcutaneous infliximab induction and maintenance in patients with moderate-to-severely active Crohn (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1761;
Conclusion These data implicate the importance of body weight in SC IFX dosing strategies. Based on these findings, SC IFX induction and maintenance treatment is changed to a weight-based dosing scheme in the ongoing DIRECT-CD trial.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Long-term effectiveness and acceptability of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases treated with intensified doses: the REMSWITCH-LT study (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1745;
Conclusion Switching from IV to SC infliximab 120mg eow is safe and well-accepted leading to a low long-term risk of relapse in IBD patients. Tight monitoring and escalated dose should be recommended for patients receiving 10mg/kg/6 weeks and 4 weeks, respectively.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Effectiveness of switching from intravenous to subcutaneous infliximab in Inflammatory Bowel Disease patients: A combined analysis of real-world evidence (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1734;
Clin Gastroenterol Hepatol 2023 [3] Rahmany et al. Gastroenterology 2023.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Transitioning Inflammatory Bowel Disease patients from an intravenous to a subcutaneous infliximab protocol: a single centre experience and patient satisfaction survey. (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1694;
Conclusion Our study showed that SC infliximab was a safe, well tolerated and efficacious treatment compared to IV infliximab. Our patient satisfaction survey showed that a large majority of patients preferred the SC method of administration and were satisfied with their treatment.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Subcutaneous infliximab cut-off points in a large cohort of Spanish patients with inflammatory bowel disease and factors associated with long-term outcomes. (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1610;
Our patient satisfaction survey showed that a large majority of patients preferred the SC method of administration and were satisfied with their treatment. Background Evidence suggests that subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) is capable to maintain clinical remission safely and to increase drug levels with a good acceptance in patients with Crohn
- ||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Enrollment closed, Trial primary completion date: PEREM: A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima (clinicaltrials.gov) - Jan 24, 2024
P=N/A, N=444, Active, not recruiting, Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Background Evidence suggests that subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) is capable to maintain clinical remission safely and to increase drug levels with a good acceptance in patients with Crohn Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Jun 2024
- || Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
PK/PD data, Journal: Subcutaneous infliximab CT-P13 without intravenous induction in psoriatic arthritis: A case report and pharmacokinetic considerations. (Pubmed Central) - Jan 12, 2024
SC infliximab was successfully used without previous IV infusion induction. Although, to date, the induction of PsA treatment via the SC route is not foreseen, the known pharmacokinetic properties and the outcome improvements observed in our patient show that subcutaneous treatment induction, as is already done in the treatment of rheumatoid arthritis, is also possible.
- | Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Journal: Transitioning patients from intravenous to subcutaneous infliximab and vedolizumab for inflammatory bowel disease: what is the opportunity cost of improving access to healthcare? (Pubmed Central) - Jan 12, 2024
Transitioning patients to SC administration results in improved access to infusion centres and substantial savings to state governments; however, switching results in a loss of i.v. biologic-generated WIES to health services. Alternative funding models are required to achieve sustainability in IBD care and reduce reliance on i.v. biologic-generated income.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Super-responders in patients with moderate-to-severe Crohn (Poster exhibition) - Dec 25, 2023 - Abstract #ECCOIBD2024ECCO_IBD_1244;
P3
Super-responders with rapid and sustained improvements during SC IFX therapy had a higher likelihood of achieving desirable long?term outcomes, with substantial individual benefit (CDC). Baseline characteristics and TLI were associated with super-response.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Persistence of subcutaneous infliximab after two years of the switch from intravenous infliximab to subcutaneous infliximab in Inflammatory Bowel Disease patients (Poster exhibition) - Dec 25, 2023 - Abstract #ECCOIBD2024ECCO_IBD_1242;
Higher drug levels are obtained with the subcutaneous formulation, despite removing the immunosupressor in over 50% of the patients. Switching from IV IFX to SC IFX is safe in IBD.
- Network meta-analysis to evaluate the comparative efficacy of advanced therapies as first line for maintenance treatment of adult patients with moderate-to-severe Crohn (Poster exhibition) - Dec 25, 2023 - Abstract #ECCOIBD2024ECCO_IBD_1239;
Switching from IV IFX to SC IFX is safe in IBD. Background Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Understanding ZYMFENTRA (Exhibit Hall - Bellagio Las Vegas) - Dec 24, 2023 - Abstract #CCCongress2024CCCongress_413;
Background Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn Supported By: Celltrion USA, Inc
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
FROM RESISTANCE TO RESPONSE: 52 WEEKS OF SUBCUTANEOUS INFLIXIMAB IN REFRACTORY CROHN'S DISEASE PATIENTS AFTER THE MULTIPLE TREATMENT FAILURES (Bellagio Ballroom - Bellagio Las Vegas) - Dec 24, 2023 - Abstract #CCCongress2024CCCongress_365;
Baseline clinical, laboratory, and imaging markers did not demonstrate any predictive value for IFX-SC treatment failure, except for baseline high levels of anti-IFX (P = <0.0001).Conclusion In the cohort of refractory CD patients, over half achieved one-year treatment persistence on IFX-SC, displaying a highly favorable trend in all disease activity markers. The IFX-SC treatment appears to be effective and safe; however, further research is needed to identify potential predictors of therapeutic responsiveness.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) DOSE ESCALATION AS AN OPTION FOR MANAGING THE LOSS OF RESPONSE IN INFLAMMATORY BOWEL DISEASE POST HOC ANALYSIS OF LIBERTY-UC AND LIBERTY-CD STUDY (Bellagio Ballroom - Bellagio Las Vegas) - Dec 24, 2023 - Abstract #CCCongress2024CCCongress_202;
Safety profiles including immunogenicity results were generally comparable between patients with or without dose escalation. No new safety concerns were found after dose escalation.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
EFFICACY, SAFETY AND IMMUNOGENICITY OF SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) MONOTHERAPY VERSUS COMBINATION THERAPY WITH IMMUNOSUPPRESSANTS (Bellagio Ballroom - Bellagio Las Vegas) - Dec 24, 2023 - Abstract #CCCongress2024CCCongress_199;
Concomitant IS use was associated with less ADA formation, whereas more infections are seen for combination therapy during maintenance period in CD and UC patients. The overall safety profile during maintenance period was otherwise comparable between monotherapy and combination therapy in CD and UC patients.
- NETWORK META-ANALYSIS TO EVALUATE THE COMPARATIVE EFFICACY OF BIOLOGICS FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH CROHN (Bellagio Ballroom - Bellagio Las Vegas) - Dec 24, 2023 - Abstract #CCCongress2024CCCongress_195;
Phase 3 randomized controlled-trials (RCTs) evaluating biologics approved by the European Medicines Agency or United States Food and Drug Administration as of 31 March 2023 for maintenance treatment of adult patients with moderate-to-severe CD were included, i.e. infliximab (IFX) intravenous (IV) and SC, adalimumab (ADL) SC, vedolizumab (VDZ) IV and SC, ustekinumab (UST) SC, and risankizumab (RZB) SC... In this updated NMA on the comparative efficacy of licensed biologics, IFX SC 120 mg Q2W showed favorable efficacy in terms of clinical remission during maintenance treatment of 52
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion, Entyvio (vedolizumab) / Takeda
COMPARATIVE EFFICACY AND SAFETY OF SUBCUTANEOUS INFLIXIMAB AND VEDOLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH CROHN (Bellagio Ballroom - Bellagio Las Vegas) - Dec 24, 2023 - Abstract #CCCongress2024CCCongress_190;
Subcutaneous IFX showed a similar safety profile to VDZ, with limitations in duration of follow-up and number of patients. These findings align with the results of a network meta-analysis5 showing that SC IFX ranks highest among biologics for achieving clinical remission during maintenance therapy.
- Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Clinical efficacy and durability of subcutaneous infliximab in patients with inflammatory bowel disease after switching from intravenous in a Korean multicenter prospective cohort study (Poster exhibition) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_1089;
Conclusion In real-world settings, IFX-SC seems to be a feasible option for the maintenance therapy, following IFX-IV administration. Considering favorable drug survival rate, low relapse rate, and tolerable safety profile, it may facilitate individualized treatment.