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Background: SB2 is approved in the EU as an infliximab (IFX) biosimilar, having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the reference. PERFUSE is an ongoing non-interventional study of 1233 patients (496 with rheumatology diagnoses, 737 with gastroenterology diagnoses) receiving SB2 as routine therapy.
Objectives: The aim of the study is to provide data on long-term outcomes in patients initiating SB2 in the real-world setting.
Methods: Adult patients eligible for inclusion in the rheumatology study cohorts have a diagnosis of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Axial Spondyloarthritis (axSpA) and had initiated SB2 in routine clinical practice after September 2017, either as their first IFX or transitioning from treatment with IFX reference or another IFX biosimilar. Outcome measures include SB2 dose, disease activity scores and persistence on SB2, over time and up to 24 months after initiation. This interim analysis is the first complete analysis of 12 month data on all rheumatology patients enrolled into the study at 9 specialist sites and followed up to the data extract date of 29th October 2020. The analysis provides an overview of baseline characteristics, disease scores, SB2 dose and persistence at 12 months post-initiation of SB2.
Mean Disease Activity Score-28 erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAI) over the course of ICHIBAN. BL, baseline; SD, standard deviation.
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axSpA cohort
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RA cohort
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PsA cohort
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| Baseline characteristics | ||||||
| Age in years, mean (SD): | ||||||
| IFX-naïve | 43.1 (11.1) | 53.1 (15.9) | 48.5 (12.2) | |||
| Transitioned from IFX | 48.9 (12.4) | 57.3 (13.1) | 53.1 (13.0) | |||
| Disease duration in years, mean (SD): | ||||||
| IFX-naïve | 7.2 (9.3) | 11.3 (9.8) | 4.2 (3.9) | |||
| Transitioned from IFX | 16.6 (11.6) | 17.3 (8.8) | 12.9 (11.3) | |||
| Women, n (%): | ||||||
| IFX-naïve | 26 (32.1) | 16 (72.7) | 6 (42.9) | |||
| Transitioned from IFX | 79 (31.0) | 60 (78.9) | 15 (31.3) | |||
| SB2 Dose: n, mean mg/kg (SD ) | ||||||
| IFX-naïve: | ||||||
| Baseline | 81 | 383.8 (85.5) | 22 | 266.2 (145.9) | 14 | 395.4 (108.9) |
| Month 12 | 47 | 436.8 (153.3) | 13 | 285.5 (90.7) | 6 | 508.0 (147.6) |
| Transitioned from IFX: | ||||||
| Baseline | 255 | 396.7 (109.6) | 76 | 291.8 (103.4) | 48 | 408.5 (91.3) |
| Month 12 | 195 | 392.1 (105.5) | 60 | 287.8 (106.6) | 41 | 421.4 (101.6) |
| Disease score, mean (SD ) | ||||||
| IFX-naïve: | n | BASDAI | n | DAS28 | n | DAS28 |
| Baseline | 54 | 5.8 (2.1) | 14 | 4.3 (1.6) | -* | -* |
| Month 12 | 30 | 3.5 (2.7) | 9 | 3.2 (1.2) | ||
| Transitioned from IFX: | ||||||
| Baseline | 206 | 3.0 (2.0) | 62 | 2.6 (1.2) | 20 | 2.2 (1.2) |
| Month 12 | 151 | 3.0 (2.1) | 47 | 2.7 (1.2) | 19 | 2.1 (0.9) |
| KM estimate of persistence on SB2 by Month 12; proportion, (95% CI ) | ||||||
| IFX-naïve | 56.26 (44.43; 66.51) | 59.09 (36.10; 76.21) | 64.29 (34.33; 83.31) | |||
| Transitioned from IFX | 79.86 (74.37; 84.30) | 80.26 (69.42; 87.60) | 85.04 (71.11; 92.58) | |||
*Blank as disease score data for both baseline and Month 12 were provided by a single patient who was IFX-naïve and had PsA; IFX = infliximab; axSpA = Axial Spondyloarthritis; RA = Rheumatoid Arthritis; PsA = Psoriatic Arthritis; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; DAS28 = Disease Activity Score 28; CI = confidence interval; SD = standard deviation; KM = Kaplan Meier.
Conclusion: This 12-month analysis indicates that patients with axSpA or RA can be successfully initiated on SB2 as the first infliximab therapy, and patients with axSpA, RA or PsA can be transitioned from originator or biosimilar IFX to SB2 without loss of disease control and with no dose penalty over 12 months post-transition. Over 56% of IFX- naïve patients and over 79% of patients transitioned from prior IFX remained on SB2 at 12 months post-initiation. With follow-up of patients ongoing to 24 months post-initiation of SB2, the study will continue to provide pertinent information about clinical outcomes of initiation on SB2 as first IFX or after transition from reference or IFX biosimilar to SB2.
Acknowledgements: Data management for the study was provided by Sanoïa E-health services, Digital CRO, Gémenos, France; funding was provided by Biogen International GmbH.
Disclosure of Interests: Bruno Fautrel Speakers bureau: AbbVie, Biogen, Boehringer-Ingelheim, BMS, Celgene, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, SOBI, UCB., Consultant of: AbbVie, Biogen, Boehringer-Ingelheim, BMS, Celgene, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, SOBI, UCB., Grant/research support from: AbbVie, MSD, Pfizer., Yoram Bouhnik Speakers bureau: AbbVie, Biogaran, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, ICON, Inception IBD, Janssen, Lilly, Mayoly Spindler, Merck, Merck Sharp & Dohme, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire, Takeda, UCB, Vifor Pharma., Consultant of: AbbVie, Biogaran, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, ICON, Inception IBD, Janssen, Lilly, Mayoly Spindler, Merck, Merck Sharp & Dohme, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire, Takeda, UCB, Vifor Pharma., Maxime Dougados Grant/research support from: Biogen, Ulrich Freudensprung Shareholder of: Biogen, Employee of: Biogen, Janet Addison Shareholder of: Biogen, Employee of: Biogen