PMID- 33432358
OWN - NLM
STAT- MEDLINE
DCOM- 20210823
LR  - 20210823
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 60
IP  - 8
DP  - 2021 Aug 2
TI  - Real-world experience of effectiveness of non-medical switch from originator to 
      biosimilar rituximab in rheumatoid arthritis.
PG  - 3679-3688
LID - 10.1093/rheumatology/keaa834 [doi]
AB  - OBJECTIVE: To evaluate the impact of non-medical switch from rituximab originator 
      (RTX-O) to biosimilar (RTX-B) in patients with RA. METHODS: Between October 2017 
      and October 2019, all patients on RTX-O in our centre requiring re-treatment were 
      switched to RTX-B unless declined by the patient or specified by the treating 
      clinician. Switch strategy effectiveness was assessed retrospectively using 
      DAS28-CRP(3) and RTX retention, with patients remaining on RTX-O as a comparator 
      group. RESULTS: The number of patients switching to RTX-B was 255/337 (75.7%) 
      while 82 (24.3%) remained on RTX-O. There was no difference in DAS28-CRP(3) 
      4 months post-RTX-B switch vs the same time point post-RTX-O previous cycle 
      (paired data available in 60%). Eighteen-month retention estimates were 75.6% 
      (95% CI: 69.4, 80.7%) for RTX-B group and 82.3% (95% CI: 70.4, 89.8%) for RTX-O 
      [adjusted hazard ratio 1.52 (95% CI: 0.85, 2.73)]. The number of patients who 
      discontinued RTX-B for loss of effectiveness (LOE) was 42/255 (16.5%), five 
      (2.0%) for adverse effects (AEs). Risk of RTX-B discontinuation was associated 
      with comorbidities and >/=2 previous biologic DMARDs. Risk of adverse outcome RTX 
      cessation was associated with comorbidities, and reduced risk with number of 
      previous RTX-O cycles and pre-switch cycle B cell depletion. The number of 
      patients who switched back to RTX-O was 34/255 (13.3%) (LOE: 30, AEs: 4), while 
      13/255 (5.1%) started other biologic/targeted synthetic DMARDs. Of patients who 
      switched back for LOE, 28/30 remained on RTX-O at a mean 7.7 months follow-up. 
      CONCLUSION: Non-medical switch to RTX-B was largely effective. Factors associated 
      with RTX-B discontinuation, including comorbidities, previous biologic DMARDs, 
      and RTX-O treatment history, may inform switch decisions. Most patients who 
      switched back to RTX-O for LOE remained on treatment at short-term follow-up.
CI  - (c) The Author(s) 2021. Published by Oxford University Press on behalf of the 
      British Society for Rheumatology. All rights reserved. For permissions, please 
      email: journals.permissions@oup.com.
FAU - Melville, Andrew R
AU  - Melville AR
AUID- ORCID: 0000-0002-2604-9123
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Chapel Allerton Hospital, Leeds, UK.
AD  - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, 
      UK.
FAU - Md Yusof, Md Yuzaiful
AU  - Md Yusof MY
AUID- ORCID: 0000-0003-3131-9121
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Chapel Allerton Hospital, Leeds, UK.
AD  - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, 
      UK.
FAU - Fitton, John
AU  - Fitton J
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Chapel Allerton Hospital, Leeds, UK.
AD  - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, 
      UK.
FAU - Garcia-Montoya, Leticia
AU  - Garcia-Montoya L
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Chapel Allerton Hospital, Leeds, UK.
AD  - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, 
      UK.
FAU - Bailey, Lynda
AU  - Bailey L
AD  - Rheumatology Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
FAU - Dass, Shouvik
AU  - Dass S
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Chapel Allerton Hospital, Leeds, UK.
AD  - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, 
      UK.
FAU - Emery, Paul
AU  - Emery P
AUID- ORCID: 0000-0002-7429-8482
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Chapel Allerton Hospital, Leeds, UK.
AD  - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, 
      UK.
FAU - Buch, Maya H
AU  - Buch MH
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 
      Chapel Allerton Hospital, Leeds, UK.
AD  - Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of 
      Biology, Medicine & Health, University of Manchester, Manchester, UK.
FAU - Saleem, Benazir
AU  - Saleem B
AD  - Rheumatology Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 4F4X42SYQ6 (Rituximab)
SB  - IM
MH  - Aged
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy/physiopathology
MH  - Biosimilar Pharmaceuticals/*therapeutic use
MH  - *Drug Substitution
MH  - Female
MH  - Humans
MH  - Male
MH  - Medication Adherence
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Retrospective Studies
MH  - Rituximab/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - B cells
OT  - bDMARDs
OT  - biosimilars
OT  - rheumatoid arthritis
OT  - rituximab
EDAT- 2021/01/13 06:00
MHDA- 2021/08/24 06:00
CRDT- 2021/01/12 06:12
PHST- 2020/08/17 00:00 [received]
PHST- 2020/11/14 00:00 [revised]
PHST- 2021/01/13 06:00 [pubmed]
PHST- 2021/08/24 06:00 [medline]
PHST- 2021/01/12 06:12 [entrez]
AID - 6086019 [pii]
AID - 10.1093/rheumatology/keaa834 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2021 Aug 2;60(8):3679-3688. doi: 
      10.1093/rheumatology/keaa834.