ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1549

A Non-Medical Switch from Originator Infliximab to Biosimilar CT-P13 in 36 Patients with Ankylosing Spondylitis:  6 – Months Clinical Outcomes from the Czech Biologic Registry Attra

Šárka Forejtová1, Jakub Zavada1, Lenka Szczukova2, Katerina Jarosova1, Tom Philipp3 and Karel Pavelka4, 1Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Czech Republic, Prague, Czech Republic, 2Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Brno, Czech Republic, 3Department of Rheumatology and Physiotherapy, Thomayer Hospital, Prague, Praha 4, Czech Republic, 4Institute of Rheumatology, Prague, Czech Republic, Prague, Czech Republic

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: , , ,

Session Information

Date: Monday, November 6, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: A non-medical switch from originator (INX, Remicade) to biosimilar infliximab (CT-P13, Remsima) was conducted in 36 patients with ankylosing spondylitis (AS) in one clinical center. The aim of the study was to compare measures of disease activity 3 months before and 3 months after the switch, and to monitor effectiveness and safety of treatment within 6 months after the switch.

Methods: Measures of disease activity (BASDAI, CRP) 3 months before and 3 months after switch were compared. Measures of disease activity (BASDAI, ASDAS, CRP, ESR), quality of life (HAQ, RAPID 3, EUROQOL) and patient satisfaction with treatment assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire were evaluated in month 0, 3 and 6 after the switch. Mean ±SD and absolute/relative frequencies were used to describe continuous and categorical variables. P-value of Wilcoxon pair test was used when assessing significance of 3 and 6 months change.

Results: 36 patients with AS were switched from Remicade to Remsima. Prior INX treatment duration was 86.2±34.7 months. The baseline characteristics are shown in table 1. Comparison of change in BASDAI and CRP 3 months before and after the switch is shown in table 2. The evolution of disease activity measures and patient reported outcomes (PROMs) and TSQM over 6 months after the switch is shown in table 3. There was no serious adverse event. One patient had a reverse switch to INX because of his request.

Table 1 Baseline characteristics.

Parameter

Descriptive statistics

Number of patients

Sex (women)

N (%)

6 (15.8 %)

38

Age at diagnosis (years)

Mean ± SD

27 ± 8

38

Median (5.; 95. perc.)

27 (12; 39)

Disease duration (to treatment with Remsima)

Mean ± SD

16 ± 9

38

Median (5.; 95. perc.)

15 (5; 40)

Age at the start of treatment (with Remsima)

Mean ± SD

44 ± 10

38

Median (5.; 95. perc.)

42 (28; 68)

Remicade – line of biologic treatment

38

1

N (%)

34 (89.5 %)

2

N (%)

3 (7.9 %)

3

N (%)

1 (2.6 %)

Glucocorticoids – previous therapy

N (%)

3 (7.9 %)

38

Number of sDMARD – previous therapy

36

0

N (%)

11 (30.6 %)

1

N (%)

21 (58.3 %)

2

N (%)

4 (11.1 %)

Glucocorticoids – concomitant therapy

N (%)

3 (7.9 %)

38

sDMARD – concomitant therapy

N (%)

4 (10.5 %)

38

HLA-B27 positivity

N (%)

34 (89.5 %)

38

Number of swollen joints

Mean ± SD

0 ± 0

38

Median (5.; 95. perc.)

0 (0; 0)

Table 2 Comparison of parameters 3 months before and after switch

Parameter

Descriptive statistics

3 months before

start of Remsima (M-3)

Start of

Remsima (M0)

3 months after start

of Remsima (M3)

Change before start of Remsima

Change after start of Remsima

p-value*

BASDAI

Mean ± SD

0.92 ± 1.35

1.71 ± 1.27

1.35 ± 1.32

0.8 ± 1.3

-0.4 ± 0.9

<0.001

Number of patients

38

38

36

CRP

Mean ± SD

2.41 ± 2.46

2.91 ± 2.06

3.89 ± 8.65

0.6 ± 3.4

0.9 ± 8.9

0.162

Number of patients

38

38

36

*Wilcoxon pair test for difference between changes M-3 → 0M and 0M → M3.

Table 3 Comparison of parameters at the start of treatment and after 3 and 6 months.

Parameter

Descriptive statistics

Start of treatment with Remsima

3 months

6 months

p-value*

p-value**

BASDAI

Mean ± SD

1.71 ± 1.27

1.35 ± 1.32

1.15 ± 1.19

0.004

0.012

Number of patients

38

36

24

ASDAS

Mean ± SD

1.34 ± 0.63

1.19 ± 0.70

1.13 ± 0.58

0.028

0.361

Number of patients

38

36

24

CRP

Mean ± SD

2.91 ± 2.06

3.89 ± 8.65

3.10 ± 3.93

0.041

0.841

Number of patients

38

36

24

Erytrocyte sedimentation rate

Mean ± SD

4.03 ± 2.89

7.25 ± 8.45

6.83 ± 5.88

0.011

0.007

Number of patients

38

36

24

Disease activity (VAS)

Mean ± SD

2.05 ± 1.49

2.03 ± 1.54

1.63 ± 1.28

0.716

0.135

Number of patients

38

36

24

Pain (VAS)

Mean ± SD

19.08 ± 14.61

15.69 ± 12.88

13.96 ± 11.70

0.195

0.035

Number of patients

38

36

24

Fatigue (VAS)

Mean ± SD

23.68 ± 20.09

22.50 ± 14.12

22.71 ± 19.00

0.609

0.585

Number of patients

38

36

24

HAQ

Mean ± SD

0.43 ± 0.44

0.38 ± 0.35

0.31 ± 0.34

0.384

0.360

Number of patients

38

36

24

MDHAQ – RAPID3

Mean ± SD

5.60 ± 3.73

4.48 ± 3.16

4.08 ± 3.23

0.063

0.026

Number of patients

38

36

24

EUROQOL

Mean ± SD

0.751 ± 0.185

0.805 ± 0.122

0.829 ± 0.123

0.021

0.033

Number of patients

37

36

24

TSQM questionnaire

Effectiveness

Mean ± SD

83.3 ± 18.3

73.3 ± 24.1

64.4 ± 25.2

0.002

< 0.001

Number of patients

38

37

24

Side-effects

Mean ± SD

75.0 ± 18.2

71.3 ± 25.6

58.3 ± 29.5

0.705

0.593

Number of patients

5

5

3

Convenience

Mean ± SD

78.8 ± 13.4

79.3 ± 13.8

74.5 ± 13.9

0.736

0.012

Number of patients

38

37

24

Global satisfaction

Mean ± SD

82.9 ± 13.0

80.3 ± 17.4

73.4 ± 22.4

0.371

0.095

Number of patients

38

37

24

*Wilcoxon pair test. difference between values at the start of the treatment and after 3 months.

**Wilcoxon pair test. difference between values at the start of the treatment and after 6 months.

Conclusion: We have observed no consistent trend of change in disease activity measures and PROMs that would suggest a decrease in efficacy in the limited time frame of our study. The mild decrease in patients’ satisfation assessed by TSQM that was not correlated with other PROMs may have been caused by a nocebo effect. Our study supports the results of other real life studies indicating no decrease of efficacy after a non-medical switch from originator to biosimilar infliximab.

Acknowledgements: Supported by project 00023728 from Ministry of Health in the Czech Republic

Disclosure: Š. Forejtová, None; J. Zavada, None; L. Szczukova, None; K. Jarosova, None; T. Philipp, None; K. Pavelka, None.

To cite this abstract in AMA style:

Forejtová Š, Zavada J, Szczukova L, Jarosova K, Philipp T, Pavelka K. A Non-Medical Switch from Originator Infliximab to Biosimilar CT-P13 in 36 Patients with Ankylosing Spondylitis:  6 – Months Clinical Outcomes from the Czech Biologic Registry Attra [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/a-non-medical-switch-from-originator-infliximab-to-biosimilar-ct-p13-in-36-patients-with-ankylosing-spondylitis-6-months-clinical-outcomes-from-the-czech-biologic-registry-attra/. Accessed .

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