One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

Conditions

Arthritis, Psoriatic, Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn's Disease, Spondylitis, Ankylosing

Brief summary

A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) \[adults and children\] and Ulcerative Colitis (UC) \[adults for both treatments and children only for Flixabi\].

Bruno Fautrel, Carine Salliot, Christophe Bernardeau, Yves Maugars, Fabienne Coury et al. (9 authors)

The Open Rheumatology Journal2024-12-10

10.2174/0118743129328661241128114825

Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study.

Fautrel B, Bouhnik Y, Salliot C, Carbonnel F, Fumery M, Bernardeau C, Maugars Y, Flamant M, Coury F, Braithwaite B, Hateb S, Addison J, PERFUSE investigators.

2024-10-101 citations

10.1007/s40801-024-00459-6

Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study

Bruno Fautrel, Yoram Bouhnik, Philippe Dieudé, Pascal Richette, Maxime Dougados et al. (8 authors)

Rheumatology Advances in Practice2023-01-014 citations

10.1093/rap/rkad031

Interventions

DRUGInfliximab

Administered as specified in the treatment arm.

DRUGAdalimumab

Administered as specified in the treatment arm.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Inclusion/

Exclusion criteria

Key Inclusion Criteria: * Adult participant (18 years and over) * treated for one of the following conditions: RA, AS, PsA, CD, UC. * either active substance naïve or treated with the originator or another biosimilar at baseline. * for whom the treating physician has decided to treat by (naïve) or switch from originator or another biosimilar to Flixabi or Imraldi. * participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort. * Paediatric participants (6-17 years): * treated for one of the following conditions: CD, UC. * either active substance naïve or treated with another biosimilar at baseline. * for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (for both indications) or Imraldi (only for Crohn's disease). * participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort. Key

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months	Up to 12 months	Percentage of participants, either infliximab naïve or switched from Remicade or CT-P13 to Flixabi, who are still treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi, who are still treated with Imraldi, at 12 months for RA, AS, PsA, CD (adults and children), and UC (adults for both treatments and children only for Flixabi) will be reported.

Countries

France

Outcome results

None listed