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Abstract Number: 634

Use of Biosimilars in Clinical Practice: A Swedish National Register-Based Assessment

Daniela Di Giuseppe1, Thomas Frisell2, Sofia Ernestam3,4, Helena Forsblad D’Elia5, E. Lindqvist6, Ulf Lindström7, Johan Askling8,9 and ARTIS, 1Clinical Epidemiology Unit, Dept. of Medicine, K2, Karolinska institutet, Stockholm, Sweden, 2Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, 3Centre of Rheumatology, Stockholm County Council, Stockholm, Sweden, Stockholm, Sweden, 4Clinical Epidemiology unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden, 5Department of Public Health and Clinical Medicine, Rheumatology, Umeå University, Umeå, Sweden, 6Department of Rheumatology, Lund University, Lund, Sweden, 7Department of Rheumatology and Inflammation Research, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, 8Rheumatology Unit, Karolinska University Hospital, Stockholm, Sweden, 9Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Biologics and biosimilars

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Session Information

Date: Sunday, November 13, 2016

Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster I

Session Type: ACR Poster Session A

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

Background/Purpose: In March 2015 the first infliximab biosimilars CT-P13 (Remsima™; Inflectra™), entered the Swedish market. The aim of this study was to evaluate the uptake and factors associated with use of the originator product (Remicade®) and its biosimilars.

Methods: Data from the Swedish Rheumatology Quality register (SRQ) was used to identify all patients with a rheumatic disease who started a treatment with the originator product or with its biosimilars between 1st March 2015 and 29th February 2016. Demographic and disease characteristics were collected and tabulated; and differences were assessed using linear and logistic regression models adjusted for age, gender and residential region. Kaplan-Meier curves were used to visualize survival on drug.

Results: During the study period, 1044 patients started treatment with infliximab; 318 started Remicade, 118 started Inflectra and 608 started Remsima (Table 1). Most patients (68%) who started a biosimilar did so following a switch from the originator product. There were large geographical variations in the relative use of originator vs. the biosimilars. Comparing the relative use across indications, the odds of being treated with a biosimilar was higher among patients with RA (OR: 1.54 (1.09-2.17)) as compared to all the other rheumatic diagnosis. There was no statistically significant difference between patients treated with originator vs.  biosimilar regarding age, gender, DAS28 at start of treatment, and duration between start of symptoms and disease diagnosis. By contrast, there was a 35% decreased odds of receiving biosimilar for each unit increase in HAQ (OR: 0.64 (0.44-0.94)), that was not statistically significant after stratification by line of treatment. Biosimilars were preferred over the originator product as second or third line of treatment (OR: 1.69 (1.18-2.41)) compared to other lines of treatment and they were more likely to be prescribed among patients whose most recent biologic was Remicade as compared to other biologic drugs (OR: 4.96 (2.98-8.39)). The Kaplan-Meier curve did not show any difference in survival on drug between the originator product and the biosimilars.

Conclusion: In Sweden, during the 1st year of marketing, most prescriptions of infliximab were made up by the biosimilars products than by the originator product. The choice to prescribe a biosimilar instead of the originator product varied more with contextual factors than with the disease.  

Table 1. Baseline characteristics of Swedish patients initiating a biological DMARD Infliximab or a biosimilar CT-P13 therapy, 1 March 2015- 29 February 2016
 

Original (Remicade)

Biosimilar (Remsima or Inflectra)

N patients

318

726

Demographics

318 (30.5%)

726 (69.5%)

Age at start of follow-up (median, IQR)

51 (38-63)

53 (42-65)

Gender (% males)

194 (61.0)

416 (57.3)

Indication (%)

 

 

RA

117 (27.4)

310 (72.6)

PsA

50 (26.3)

140 (73.7)

SpA

65 (32.5)

135 (67.5)

AS

54 (40.0)

81 (60.0)

Other

32 (34.8)

60 (65.2)

Swedish Region (%)

 

 

Norra

20 (74.1)

7 (25.9)

Stockholm

30 (17.0)

146 (83.0)

Sydöstra

65 (62.5)

39 (37.5)

Södra

35 (8.7)

366 (91.3)

Uppsala-Örebro

78 (41.1)

112 (58.9)

Västsvenska

90 (61.6)

56 (38.4)

Number of previous biologics

 

 

0

216 (67.9)

289 (39.8)

1-2

73 (23)

358 (49.3)

3+

29 (9.1)

79 (10.9)

Type of last biologic

 

 

Original (Remicade)

20 (19.6)

297 (68.1)

Biosimilar (Remsima or Inflectra)

11 (10.8)

1 (0.2)

Other TNFi

62 (60.8)

111 (25.5)

Non-TNFi

9 (8.8)

27 (6.2)

Reason for discontinuing previous biologic

 

 

Safety, of those with information  (%)

17 (16.7)

22 (5.5)

Inefficacy, of those with information (%)

46 (45.1)

84 (20.8)

Other, of those with information  (%)

39 (38.2)

297 (73.7)

 

 

 

Disease characteristics

1st biological (n=216)

≥2nd biological (n=102)

1st biological (n=289)

≥2nd biological (n=437)

Disease duration (median, IQR)

6.7 (1.8-16.1)

13.8 (7.9-23.4)

5.4 (2.1-13.7)

15.6 (8.6-25.2)

HAQ (median, IQR)

0.9 (0.5-1.4)

1.0 (0.8-1.3)

0.9 (0.4-1.3)

0.9 (0.4-1.4)

DAS28-ESR (median, IQR)

4.0 (3.0-5.6)

4.3 (3.3-5.1)

4.1 (3.3-4.9)

2.9 (2.2-4.2)

Concomitant MTX (%)

99 (63.1)

31 (47.0)

123 (61.5)

160 (56.5)

Concomitant non-MTX DMARDs (%)

27 (17.2)

4 (6.1)

34 (17.0)


25 (8.8)

Oral steroids (%)

51 (32.5)

24 (36.4)

61 (30.5)

68 (24.0)

NSAIDs (%)

42 (26.8)

29 (43.9)

55 (27.5)

89 (31.4)

 


Disclosure: D. Di Giuseppe, None; T. Frisell, None; S. Ernestam, None; H. Forsblad D’Elia, None; E. Lindqvist, None; U. Lindström, None; J. Askling, UCB, Roche, Merck, Pfizer, and Abbvie, 2.

To cite this abstract in AMA style:

Di Giuseppe D, Frisell T, Ernestam S, Forsblad D’Elia H, Lindqvist E, Lindström U, Askling J. Use of Biosimilars in Clinical Practice: A Swedish National Register-Based Assessment [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/use-of-biosimilars-in-clinical-practice-a-swedish-national-register-based-assessment/. Accessed January 21, 2021.
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