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Randomized Controlled Trial
. 2019 Jun;285(6):653-669.
doi: 10.1111/joim.12880. Epub 2019 Apr 12.

Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial

G L Goll  1 , K K Jørgensen  2 , J Sexton  1 , I C Olsen  1   3 , N Bolstad  4 , E A Haavardsholm  1   5 , K E A Lundin  5   6   7 , K S Tveit  8 , M Lorentzen  9 , I P Berset  10 , B T S Fevang  11 , S Kalstad  12 , K Ryggen  13 , D J Warren  4 , R A Klaasen  4 , Ø Asak  14 , S Baigh  15 , I M Blomgren  16 , Ø Brenna  17 , T J Bruun  12 , K Dvergsnes  18 , S O Frigstad  19 , I M Hansen  20 , I S H Hatten  21 , G Huppertz-Hauss  22 , M Henriksen  23 , S S Hoie  24 , J Krogh  25 , I P Midtgard  26 , P Mielnik  27 , B Moum  5   28 , G Noraberg  29 , A Poyan  30 , U Prestegård  31 , H U Rashid  32 , E K Strand  33 , K Skjetne  13 , K A Seeberg  34 , R Torp  35 , C M Ystrøm  36 , C Vold  37 , C C Zettel  38 , K Waksvik  39 , B Gulbrandsen  40 , J Hagfors  41 , C Mørk  42 , J Jahnsen  2   5 , T K Kvien  1   5
Affiliations
Randomized Controlled Trial

Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial

G L Goll et al. J Intern Med. 2019 Jun.

Abstract

Background and objectives: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures.

Methods: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis.

Results: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.

Conclusion: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.

Trial registration: ClinicalTrials.gov NCT02148640.

Keywords: biosimilar; chronic inflammatory disease; drug costs; health economics; infliximab; switching.

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Conflict of interest statement

GLG reports personal fees from AbbVie, Biogen, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Orion Pharma, Celltrion and Boehringer Ingelheim. KKJ reports personal fees from Tillott, Intercept and Celltrion. NB reports personal fees received from Orion Pharma, Roche, Napp Pharmaceuticals, Pfizer and Takeda. ICO reports grants from Norwegian Ministry of Health and Care Services during the conduct of the study and personal fees from Pfizer. EAH reports grants from AbbVie, Pfizer, UCB, Roche and MSD. IPB reports personal fees from AbbVie, MSD, Takeda, Hospira and Ferring. KEAL reports grants from MSD and personal fees from Takeda, Orion, AbbVie, Pfizer and MSD. KST reports personal fees and nonfinancial support from AbbVie, Orion, Novartis, Janssen, Celgene, Mundipharma, Pfizer, MSD and Shire and nonfinancial support from CSL Behring. CM reports personal fees from Novartis Norge AS, LEO Pharma AS, ACO Hud Norge AS, Celgene AS, AbbVie and Galderma Nordic AB. JJ reports personal fees from MSD, AbbVie, Celltrion, Orion Pharma, Takeda, Napp Pharm, AstroPharma, Hikma and Pfizer. TKK reports grants from Norwegian Ministry of Health and Care Services during the conduct of the study and personal fees from AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck‐Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB Pharma.

Figures

Figure 1
Figure 1
Patient disposition in the NOR‐SWITCH main and extension study.
Figure 2
Figure 2
Forest plot of risk difference according to disease. The figure shows data for the per‐protocol set. Risk difference is adjusted for treatment duration of infliximab originator at extension study baseline (week 52).
Figure 3
Figure 3
Change in disease‐specific composite measures during 78 weeks of follow‐up in the NOR‐SWITCH main and extension study in the per‐protocol set. (a) HBI for Crohn's disease. (b) PMS for UC. (c) Ankylosing Spondylitis Disease Activity Score for SpA. (d) Disease Activity Score in 28 joints with CRP for RA and PsA. (e) Clinical Disease Activity Index for RA and PsA. (f) Simplified Disease Activity Index for RA and PsA. (g) PASI for psoriasis. The coloured areas display the 95% confidence intervals from a mixed model adjusted for treatment duration of infliximab originator at main study baseline (week 0).
See this image and copyright information in PMC

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