PMID- 35296993
OWN - NLM
STAT- MEDLINE
DCOM- 20220503
LR  - 20220716
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 39
IP  - 5
DP  - 2022 May
TI  - Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and 
      Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational 
      Real-World Study Among Patients with Inflammatory Bowel Disease in the US and 
      Canada (the ONWARD Study).
PG  - 2109-2127
LID - 10.1007/s12325-022-02104-6 [doi]
AB  - INTRODUCTION: To date, there are limited real-world studies published on the use 
      of infliximab-dyyb, a biosimilar to reference product (RP) infliximab approved 
      for the treatment of moderate to severe inflammatory bowel disease (IBD), 
      including Crohn's disease (CD) and ulcerative colitis (UC) in North America. This 
      study examined utilization patterns and the effects of infliximab-dyyb on 
      clinical outcomes, patient-reported outcomes (PROs), and healthcare resource use 
      (HCRU) in IBD patients in a real-world setting. METHODS: In this prospective, 
      observational study, adult IBD patients in the US and Canada were recruited to 
      initiate treatment with infliximab-dyyb and followed for 12 months. Patients 
      included biologic-naive users of infliximab-dyyb and patients switching from RP 
      infliximab or other biologics to infliximab-dyyb. Partial Mayo (pMAYO) and Harvey 
      Bradshaw Index (HBI) scores measured clinical outcomes for the UC and CD cohorts, 
      respectively. Key PRO measures included the SIBDQ, EQ-VAS, and psychological 
      outcomes. In addition, work productivity, HCRU, and adverse events (AEs) were 
      assessed. RESULTS: A total of 67 CD and 48 UC patients were enrolled (51% female; 
      mean age 44 years; 87% Caucasian; mean BMI 27.9). Thirty-nine patients were 
      biologic-naive, 57 switched from RP infliximab, and 19 switched from other 
      biologics. Among UC biologic-naive users, pMAYO decreased from 5.67 to 1.09 
      (p < 0.0001) and the remission rate increased from 5.6 to 90.9% (p = 0.0015). For 
      UC patients switching from RP infliximab, pMAYO decreased from 1.38 to 0.29 
      (p = 0.0103). For CD biologic-naive users, HBI scores and remission rates did not 
      significantly change. The scores on all the PROs significantly improved from 
      baseline to 12 months. A total of 22 AEs occurred consistent with the known AE 
      profile for infliximab. CONCLUSIONS: Clinical outcomes among biologic-naive users 
      of infliximab-dyyb improved for UC and were maintained for CD patients. 
      Biologic-naive users of infliximab-dyyb showed significant improvements in PROs. 
      Patients switching from RP infliximab to infliximab-dyyb maintained their 
      clinical outcomes and PROs. TRIAL REGISTRATION: ClinicalTrials.gov Registration 
      Number: NCT03801928 (February 23, 2018).
CI  - (c) 2022. The Author(s).
FAU - Abraham, Bincy
AU  - Abraham B
AD  - Houston Methodist Hospital, Houston, TX, USA.
FAU - Eksteen, Bertus
AU  - Eksteen B
AD  - Aspen Woods Clinic, Calgary, AB, Canada.
FAU - Nedd, Khan
AU  - Nedd K
AD  - Infusion Associates, Grand Rapids, MI, USA.
FAU - Kale, Hrishikesh
AU  - Kale H
AD  - OPEN Health, 4350 East-West Hwy #1100, Bethesda, MD, 20814, USA.
FAU - Patel, Dipen
AU  - Patel D
AD  - OPEN Health, 4350 East-West Hwy #1100, Bethesda, MD, 20814, USA.
FAU - Stephens, Jennifer
AU  - Stephens J
AD  - OPEN Health, 4350 East-West Hwy #1100, Bethesda, MD, 20814, USA. 
      jenniferstephens@openhealthgroup.com.
FAU - Shelbaya, Ahmed
AU  - Shelbaya A
AD  - Mailman School of Public Health, Columbia University, New York, NY, USA.
AD  - Pfizer, New York, NY, USA.
FAU - Chambers, Richard
AU  - Chambers R
AD  - , Pfizer, PA, USA.
FAU - Soonasra, Arif
AU  - Soonasra A
AD  - , Pfizer, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03801928
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220316
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Gastrointestinal Agents)
RN  - B72HH48FLU (Infliximab)
MH  - Adult
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - Chronic Disease
MH  - *Colitis, Ulcerative/drug therapy
MH  - *Crohn Disease/drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Gastrointestinal Agents/adverse effects
MH  - Humans
MH  - *Inflammatory Bowel Diseases/drug therapy
MH  - Infliximab/therapeutic use
MH  - Male
MH  - Patient Reported Outcome Measures
MH  - Prospective Studies
PMC - PMC9056488
OTO - NOTNLM
OT  - Biosimilars
OT  - Exploratory Treatment Effectiveness Study
OT  - Inflammatory bowel disease
OT  - Infliximab
OT  - Real-world outcomes
EDAT- 2022/03/18 06:00
MHDA- 2022/05/04 06:00
PMCR- 2022/03/16
CRDT- 2022/03/17 05:34
PHST- 2022/02/17 00:00 [received]
PHST- 2022/02/22 00:00 [accepted]
PHST- 2022/03/18 06:00 [pubmed]
PHST- 2022/05/04 06:00 [medline]
PHST- 2022/03/17 05:34 [entrez]
PHST- 2022/03/16 00:00 [pmc-release]
AID - 10.1007/s12325-022-02104-6 [pii]
AID - 2104 [pii]
AID - 10.1007/s12325-022-02104-6 [doi]
PST - ppublish
SO  - Adv Ther. 2022 May;39(5):2109-2127. doi: 10.1007/s12325-022-02104-6. Epub 2022 
      Mar 16.