ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2800

Long-Term Safety and Efficacy of Biosimilar Infliximab (CT-P13) after Switching from Originator Infliximab: Results from the 26-Week Open Label Extension of a Randomized Norwegian Trial

Guro Løvik Goll1, Kristin Kaasen Jørgensen2, Joe Sexton1, Inge C Olsen3, Nils Bolstad4, Merete Lorentzen5, Espen A. Haavardsholm6, Cato Mork7, Jorgen Jahnsen8 and Tore K Kvien9, 1Dept Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 2Dept Gastroenterology, Akershus University Hospital, Lørenskog, Norway, 3Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 4Department of Medical Biochemistry,, OUS-Radiumhospitalet, Oslo, Norway, 5Dept of Dermatology, Rikshospitalet, Oslo, Norway, 6Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 7Dept of cancer and Molecular medicine, Norwegian University of Science and Technology, Trondheim, Norway, 8Dept of Gastroenterology, Akershus University Hospital, Lorenskog, Norway, 9Diakonhjemmet Hospital, Oslo, Norway

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: , , ,

Session Information

Date: Tuesday, November 7, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III: Biosimilars Therapy

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose:

TNF-inhibitors (TNFi) have improved treatment of rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA) , Crohn’s disease (CD), ulcerative colitis (UC), and chronic plaque psoriasis (Ps). The NOR-SWITCH study was funded by the Norwegian government to investigate if switching from originator infliximab (Remicade®, INX) to CT-P13 (biosimilar infliximab, Remsima®) is safe .

Methods:

The study was designed as a 52-week randomized, double-blind, non-inferiority, phase IV trial with a 26 week open label extension in which all patients received CT-P13. Adult patients with a diagnosis of RA, SpA, PsA ,CD, UC, or Ps on stable treatment with originator infliximab were randomized 1:1 to either continued INX or switch to CT-P13 treatment in the main study 1. Patients on CT-P13 throughout the 78-week study period (maintenance group) and patients switched to CT-P13 at week 52 (switch group) were assessed for treatment efficacy, safety and immunogenicity. The primary endpoint was disease worsening during follow-up according to disease-specific composite measures and/or a consensus between investigator and patient leading to major change in treatment1. Exploratory subgroup analyses were performed to examine disease worsening within each of the six diagnoses. The primary endpoint was analysed using logistic regression, adjusted for diagnosis and treatment duration at baseline.

Results:

Between October 2014 and July 2016, 481 patients (INX 241, CT-P13 240, Full Analysis Set, FAS) were randomized, received treatment and were followed for 52 weeks. Results from the main trial showed that CT-P13 is non-inferior to continued treatment with originator infliximab1. 380 patients entered the extension phase of the trial. The main demographic and baseline (52w) characteristics of the extension study population are shown in the table. Disease worsening occurred in 16.8% and 11.6 % of patients in the maintenance and switch arms, respectively (Per Protocol Set, PPS). The frequency of disease worsening in each specific diagnosis is shown in the table (exploratory analyses). Changes in the generic disease variables and disease specific composite measures were similar in both arms (table). During the extension study, 3/197 and 5/183 patients in the maintenance and switch groups (FAS), respectively, developed anti-drug antibodies. Trough drug levels and the frequencies of reported adverse events were comparable between the two groups (data not shown).

Conclusion:

The open-label extension of the NOR-SWITCH trial did not show any difference between patients who maintained CT-P13 vs patients who switched from INX to CT-P13.

Maintenance group

Switch group

Number of patients (FAS)

197

183

Demographics and baseline characteristics

Age (years)

47.8 (14.9)

47 (14.3)

Females

64 (32.5%)

78 (42.6%)

Disease duration (years)

17.1 (10.6)

16.3 (10.4)

Duration of ongoing infliximab treatment (years)

6.7 (3.8)

6.4 (3.5)

Concomitant immunosuppressive therapy

103 (52.3%)

82 (44.8 %)

Diagnoses

Rheumatoid arthritis

27 (13.7%)

28 (15.3%)

Spondyloarthritis

38 (19.3%)

29 (15.8%)

Psoriatic arthritis

9 (4.6%)

11 (6%)

Crohn’s disease

65 (33%)

62 (33.9%)

Ulcerative colitis

42 (21.3%)

38 (20.8%)

Psoriasis

16 (8.1%)

15 (8.2%)

Disease characteristics

DAS 28 (RA and PsA)

2.3 (1.0)

2.8 (1.2)

ACPA positive (RA)

13/27 (48.1%)

18/28( 64.3%)

ASDAS (SpA)

1.9 (0.8)

1.7 (0.7)

BASDAI (SpA)

3.2 (1.8)

2.6 (1.6)

Harvey-Bradshaw Index

1 (0 – 4)

1 (0.2 – 4)

Partial Mayo Score

0 (0 – 0)

0 (0 – 1)

Erythrocyte sedimentation rate (mm/h) (all)

8 (4-17)

7 (4-15)

C-reactive protein (mg/L) (all)

2 (1 – 5)

2 (1 – 5)

Number of patients (PPS)

190

173

Risk difference (95% CI)

Disease worsening

All

32 (16.8%)

20 (11.6%)

-5.9% (-12.9-1.1)

Rheumatoid arthritis

9 (34.6%)

6 (22.2%)

-10.5% (-34.6-13.6)

Spondyloarthritis

3 (7.9%)

2 (7.1%)

-0.6% (-13.5-12.2)

Psoriatic arthritis

1 (12.5%)

3 (33.3%)

20.8% (-17.6-59.1)

Crohn’s disease

13 (20.6%)

8 (13.1%)

-7.9%(-21-5.2)

Ulcerative colitis

6 (15.1%)

1 (2.9%)

-12.4% (-25-0.1)

Psoriasis

0 (0%)

0 (0%)

0% (0-0)

Disease measures at week78

Adjusted difference

week 78

(95% CI)

Week 78

Week 78

Physician Global Assessment of Disease Activity (0-10)

1.45 (1.55)

1.15 (1.51)

0.13 (-0.13-0.4)

Patient Global Assessment of Disease Activity (0-10)

2.58 (2.26)

1.88 (1.96)

0.48 (0.16-0.8)

Log10 erythrocyte sedimentation rate (mm/h)

0.89 (0.4)

0.86 (0.38)

0 (-0.05-0.05)

Log10 C-reactive protein (mg/L)

0.31 (0.48)

0.33 (0.4)

-0.02 (-0.1-0.05)

Harvey-Bradshaw Index (CD)

2.93 (3.24)

2.44 (3.28)

0.57 (-0.2-1.33)

Partial Mayo Score (UC)

0.88 (1.55)

0.47 (0.82)

0.44 (-0.13-1.01)

ASDAS (SpA)

2.13 (0.85)

1.79 (0.61)

0.2 (-0.06-0.46)

DAS28 (RA, PsA)

2.48 (1.54)

2.62 (1.16)

0.19 (-0.33-0.71)

CDAI (RA, PsA)

6.81 (7.47)

6.45 (6.74)

1.92 (-1.07-4.91)

SDAI (RA, PsA)

7.41 (7.95)

6.84 (6.79)

2.13 (-1.86-6.12)

PASI (Ps)

1.49 (0.89)

1.25 (0.88)

-0.28 (-0.87-0.31)

Data are n (%), mean (SD) or median (25 – 75 percentiles). 95% CI, 95% confidence interval of the adjusted treatment difference. BASDAI, Bath Ankylosing Spondylitis Disease Activity Index. ASDAS, Ankylosing Spondylitis Disease Activity Score. DAS28, Disease Activity Score in 28 joints. CDAI, Clinical Disease Activity Index. SDAI, Simplified Disease Activity Index. PASI, Psoriasis Area and Severity Index.

1Jørgensen KK, Olsen IC, Goll GL et al. Switching from originator infliximab to biosimilar CT-P13 compared to maintained treatment with originator infliximab (NOR-SWITCH): a 52-week randomised double-blind non-inferiority trial. Lancet, 2017 Jun10;389 (10086):2304-2316. Epub 2017 May11.


Disclosure: G. L. Goll, AbbVie, 5,Boehringer Ingelheim, 5,Novartis Pharmaceutical Corporation, 5,Orion Pharma, 5,Sandoz, 5,Pfizer Inc, 5; K. K. Jørgensen, Intercept, 5,Celltrion, 5,Tillott, 5,Sandoz, 5,Meda pharmaceuticals, 5; J. Sexton, None; I. C. Olsen, Pfizer Inc, 5; N. Bolstad, Orion Pharma, 5,Napp Pharma, 5,Pfizer Inc, 5,Takeda, 5,Janssen Pharmaceutica Product, L.P., 5; M. Lorentzen, Novartis Pharmaceutical Corporation, 5; E. A. Haavardsholm, None; C. Mork, Novartis Pharmaceutical Corporation, 5,LEO Pharma, 5,ACO hud, 5,AbbVie, 5,Galderma Nordic, 5,Cellgene, 5; J. Jahnsen, Orion Pharma, 5,celltrion, 5,Janssen Pharmaceutica Product, L.P., 5,Pfizer Inc, 5,MSD, 5,AbbVie, 5,Takeda, 5,Napp Pharma, 5,Roche Pharmaceuticals, 5,Boehringer Ingelheim, 5,Astro Pharma, 5,Mundi Pharma, 5,Sandoz, 5; T. K. Kvien, AbbVie, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,UCB, 2,BMS, 2,MSD, 2,AbbVie, 5,Pfizer Inc, 5,BMS, 8,Sandoz, 8,Roche Pharmaceuticals, 8,UCB, 8,AbbVie, 8,Novartis Pharmaceutical Corporation, 5,Biogen Idec, 5,Eli Lilly and Company, 5,Janssen Pharmaceutica Product, L.P., 5,Orion Pharma, 5,Samsung, 5,Celltrion, 5,Merck-Serono, 5,Oktal, 5.

To cite this abstract in AMA style:

Goll GL, Jørgensen KK, Sexton J, Olsen IC, Bolstad N, Lorentzen M, Haavardsholm EA, Mork C, Jahnsen J, Kvien TK. Long-Term Safety and Efficacy of Biosimilar Infliximab (CT-P13) after Switching from Originator Infliximab: Results from the 26-Week Open Label Extension of a Randomized Norwegian Trial [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-biosimilar-infliximab-ct-p13-after-switching-from-originator-infliximab-results-from-the-26-week-open-label-extension-of-a-randomized-norwegian-trial/. Accessed .

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-biosimilar-infliximab-ct-p13-after-switching-from-originator-infliximab-results-from-the-26-week-open-label-extension-of-a-randomized-norwegian-trial/