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Abstract Number: 951

A Nationwide Non-Medical Switch from Originator to Biosimilar Infliximab in Patients with Inflammatory Arthritis. Eleven Months’ Clinical Outcomes from the Danbio Registry

Bente Glintborg1, Inge Juul Sørensen2, Dorte Vendelbo Jensen2, Niels Steen Krogh3, Anne Gitte Loft4, Jakob Espesen2, Jimmi Olsen2, Oliver Hendricks5, Jolanta Grydehøj2, Inger Marie Jensen Hansen2, Michael Veedfald Sørensen2, Stavros Chrysidis2, Birgitte Lange Andersen2, Natalia Manilo2, Mette Klarlund2, Lis Smedegaard Andersen2, Henrik Nordin2, Salome Kristensen2, Jesper Nørregaard2 and Merete Lund Hetland1, 1Danish Rheumatologic Biobank and DANBIO registry, Rigshospitalet, Glostrup, Gentofte and Herlev University Hospital, Copenhagen, Denmark, 2The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, 3ZiteLab ApS, Copenhagen, Denmark, 4Departments of Rheumatology at Vejle and Aarhus Hospitals, Vejle and Aarhus, Denmark, 5Dep. of Rheumatology, King Christians Hospital for Rheumatic Diseases, Copenhagen, Denmark

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Biologic drugs, biosimilars and infliximab

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Session Information

Date: Sunday, November 13, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy I: Treatment Strategies

Session Type: ACR Concurrent Abstract Session

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

Background/Purpose: According to national guidelines issued in May 2015, a non-medical switch from originator infliximab (IFX) (Remicade) to biosimilar Remsima was conducted in all Danish patients with inflammatory rheumatic diseases treated in routine care. We aimed to investigate the clinical outcomes in Remicade-treated patients (pts) with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthrits (AxSpA) who were switched to Remsima and monitored prospectively in the Danish nationwide quality registry, DANBIO.

Methods: Patients who switched from Remicade to Remisma before Feb 1st 2016 and who had available data on treatment outcomes in DANBIO were included.  In each patient, disease activity at 3 mths before switch (pre-switch) (defined as between minus 180 and minus 30 days before switch), at the time of switch (-30 days before to 6 days after), after 3 mths (70 to 120 days after switch) (post-switch) and changes over time (Dpre-switch and Dpost-switch) were calculated. Disease flare was defined as DDAS28≥0.6, DDAS28≥1.2 (in RA and PsA) or DASDAS≥1.3 (AxSpA). Reasons for withdrawal (adverse events (AE), lack of effect (LOE) or other) were registered. Multivariable Cox regression analyses stratified according to diagnosis (RA, PsA or AxSpA) were used to identify baseline characteristics (gender, age,  use of methotrexate (yes-no),  Remsima dosing interval, Remsima dose (mg/kg),  patient’s global score (Visual analogue scale from 0-100mm, VAS)) associated with Remsima treatment adherence.  Numbers are medians (interquartile ranges) unless otherwise stated.

Results: 768 of 792 switching pts (97%) had available data regarding disease activity after switching. 52% were women, age (56 (46-66)yrs) (Table). Prior Remicade treatment duration was 6.6 (3.9-9.4) yrs, and in 75% of patients it was the first biological treatment. Median follow-up time after switching was 336 (297-357) days. Disease activity and disease flare rates remained largely unchanged 3 months prior to versus after the switch (Table 1). At the latest visit after switch, disease activity was for RA: DAS28 2.2 (1.7-3.0) and for axSpA: ASDAS 2.0 (1.2-2.9). Proportion of patients with disease flare pre-/post switch was 25%/21% (DDAS28≥0.6, RA+PsA)(p=0.4), 10%/10% (DDAS28≥1.2,RA+PsA) (p=0.8) and 2%/2% (AxSpA)(p=1.0) (related samples McNemar test). Overall, 117 patients (15%) stopped Remsima treatment between switch and end of follow-up (AE 34, LOE 51, remission 1, death 2, cancer 1, pregnancy 1, other 27). Prior Remicade treatment duration in those who withdrew was 6.0 (2.6-8.9) years and disease activity in those who stopped due to LOE was for RA: DAS28 4.3 (3.1-4.9) and for AxSpA: ASDAS 3 (2.6-3.8). Treatment adherences were similar in RA, PsA and AxSpA (Figure). In multivariable Cox regression analysis, lower baseline VAS patient’s global and use of methotrexate was associated with better treatment adherence in RA (Table 2) whereas in AxSpA it was lower baseline VAS global and lower IFX doses (Table 2). No significant baseline predictors were found in PsA.

Conclusion: In 768 patients with inflammatory rheumatic diseases treated with Remicade for >4 years, disease activity was largely unaffected in the majority of patients after non-medical switch to biosimilar Remsima, and the fluctuations 3 months after the switch were comparable to the fluctuations observed in the 3 months prior to the switch.  However, several patients (15%) stopped treatment. This warrants further investigation before such a non-medical switch can be recommended.

TABLE 1
BASELINE DEMOGRAPHICS AND OUTCOMES ACCORDING TO DIAGNOSIS
 

RA

PsA

AxSpA

Other

Number of patients included, n

364

119

256

29

Baseline Remsima dose, mg/kg

3.8 (3.1-4.9)

4.9 (3.8-5.1)

4.9 (4.1-5.2)

4.8 (3.1-5-5)

Baseline dose interval, wks

8 (7-8)

7 (6-8)

8 (6-8)

8 (7-8)

Concomitant methotrexate,  n (%)

307 (84%)

81 (68%)

80 (31%)

9 (31%)

Withdrawal of Remsima during follow-up N (%) Prior Remicade treatment duration in withdrawers (years)

60 (16%)

7.2 (4.1-9.8)

13 (10%)

7.7 (2.6-10.2)

39 (15%)

3.8 (1.6-6.1)

5 (17%)

3.3 (0.5-4.6)

DISEASE ACTIVITY 3 months prior to vs. 3 months after the switch
 

Disease activity

Delta-values

P*

3 months

pre-switch

Switch

3 months

post-switch

Pre-switch

Post-switch

RA and PSA
DAS28

2.3 (1.7-3.0)

2.3 (1.8-3.1)

2.3 (1.8-3.2)

0.0 (-0.3-0.5)

0.0 (-0.3-0.3)

0.4

HAQ (0-3)

0.6 (0.1-1.1)

0.6 (0.1-1.1)

0.6 (0.1-1.1)

0.0 (0.0-0.1)

0.0 (0.0-0.1)

0.9

CRP, mg/l (<10mg/L)

4 (2-8)

4 (2-8)

5 (2-9)

0 (-1-2)

0 (-2-3)

0.09

VAS pt’s global, mm

28 (10-53)

27 (12-57)

27 (11-56)

0 (-7-8)

0 (-7-9)

0.2

AxSpA
BASDAI, mm

26 (11-46)

26 (11-46)

24 (10-47)

0 (-4-5)

0 (-3-6)

0.5

CRP, mg/l

4 (1-7)

4 (1-9)

4 (1-8)

0 (-1-1)

0 (-2-2)

0.4

Pt’s global VAS, mm

27 (13-55)

33 (16-58)

24 (11-58)

1 (-6-9)

-1 (-8-4)

0.4

ASDAS

1.9 (1.3-2.7)

2.0 (1.4-2.7)

1.9 (1.3-2.7)

0 (-3-4)

0 (-4-2)

0.6

*delta values for disease activity pre-switch vs. post-switch, Wilcoxon matched-pair signed rank test. Numbers are medians (interquartile ranges) unless otherwise stated.

 

TABLE 2
BASELINE FACTORS ASSOCIATED WITH TREATMENT ADHERENCE Multivariable Cox regression analyses stratified by diagnosis
 

Rheumatid arthritis

AxSpA

Hazard Ratio

p

Hazard Ratio

p

Gender, women vs. men

1.08 (0.51-2.17)

0.8

1.68 (0.65-4.37)

0.3

Methotrexate use, no vs. yes

2.47 (1.22-5.01)

0.01

2.87 (0.88-9.41)

0.08

Age, years

1.00 (0.97-1.02)

0.9

1.01 (0.97-1.05)

0.7

VAS patient’s global, mm

1.02 (1.00-1.03)

0.03

1.02 (1.00-1.04)

0.04

Remisma interval, weeks

0.97 (0.76-1.23)

0.8

0.72 (0.50-1.03)

0.07

Remisma dose, mg/kg

1.06 (0.80-1.41)

0.7

1.76 (1.12-2.79)

0.02

Multivariable Cox regression analyses stratified by diagnosis. Numbers are Hazard ratios (95% confidence intervals). Age, VAS patient’s global, Remsima interval and dose are continuous variables. PsA: no significant baseline predictors were found, data not shown


Disclosure: B. Glintborg, None; I. Juul Sørensen, None; D. V. Jensen, None; N. Steen Krogh, None; A. G. Loft, MSD, UCB, AbbVie, Pfizer., 8; J. Espesen, None; J. Olsen, None; O. Hendricks, None; J. Grydehøj, None; I. M. Jensen Hansen, None; M. Veedfald Sørensen, None; S. Chrysidis, None; B. Lange Andersen, None; N. Manilo, None; M. Klarlund, None; L. Smedegaard Andersen, None; H. Nordin, None; S. Kristensen, None; J. Nørregaard, None; M. Lund Hetland, AbbVie, BMS, MSD, Roche, Pfizer, UCB, Crescendo, 2.

To cite this abstract in AMA style:

Glintborg B, Juul Sørensen I, Jensen DV, Steen Krogh N, Loft AG, Espesen J, Olsen J, Hendricks O, Grydehøj J, Jensen Hansen IM, Veedfald Sørensen M, Chrysidis S, Lange Andersen B, Manilo N, Klarlund M, Smedegaard Andersen L, Nordin H, Kristensen S, Nørregaard J, Lund Hetland M. A Nationwide Non-Medical Switch from Originator to Biosimilar Infliximab in Patients with Inflammatory Arthritis. Eleven Months’ Clinical Outcomes from the Danbio Registry [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/a-nationwide-non-medical-switch-from-originator-to-biosimilar-infliximab-in-patients-with-inflammatory-arthritis-eleven-months-clinical-outcomes-from-the-danbio-registry/. Accessed .
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