EULAR 2016 | Daily Highlights
THREE MONTHS’ CLINICAL OUTCOMES FROM A NATIONWIDE NON-MEDICAL SWITCH FROM ORIGINATOR TO BIOSIMILAR INFLIXIMAB IN PATIENTS WITH INFLAMMATORY ARTHRITIS.
RESULTS FROM THE DANBIO REGISTRY
Authors: B. Glintborg1,*, I. Juul Sørensen1, D. Vendelbo Jensen1, N. S. Krogh1, A. G. Loft1, A. Colic1, J. Espesen1, J. Olsen1, O. Hendricks1, J. Grydehøj1, I. M. J. Hansen1, M. V. Sørensen1, S. Chrysidis1, N. Manilo1, M. Klarlund1, L. S. Andersen1, H. Nordin1, S. Kristensen1, M. L. Hetland1
Co Authors: 1The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark
According to national guidelines issued in 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.
To investigate 3 months’ clinical outcomes in Remicade-treated patients (pts) with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthrits (SpA) who switched to Remsima and were monitored prospectively in the DANBIO registry.
Disease activity at 3 mths before switch (pre-switch), at the switch and after 3 mths (70-120 days) (post-switch) and changes over time (?pre-switch and ?post-switch) were calculated. Disease flare was defined as ?DAS28?1.2 (RA/PsA) or ?ASDAS?1.3 (SpA). Reasons for withdrawal (adverse events (AE), lack of effect (LOE) or other) were registered.
647 of 693 switching pts (300 RA, 96 PsA, 219 SpA, 32 other) had available data (52% women, age (median(IQR) 56(45-66)yrs)). Prior Remicade treatment duration was 6.7(4.1-9.4)yrs and in 77% it was the first biological treatment. Remsima dose was in RA+PSA 3.3(3.0-4.8)mg/kg every 7(6-8)wks and in SpA 4.8(3.6-5.1)mg/kg every 6(6-9)wks. Concomitant MTX was given in 69% (RA+PsA)/25% (SpA). Median follow-up time was 139(98-160)days.
Disease activity remained largely unchanged 3 months prior to vs. after the switch (Table). The proportion of patients with disease flare pre-/post switch was 10%/10% (RA+PsA)(p=1.0) and 10%/0% (SpA)(p=1.0) (related samples McNemar test).
Overall, 45 ptts (7%) stopped Remsima treatment during follow-up (AE 16 (allergic 3, infection 2, rash 2, unspecific 9), LOE 20, remission 3, cancer 2, other 4). Prior Remicade treatment duration in these patients was 5.9(3.5-9.1)yrs.
|Table||Disease activity, median (IQR)||Delta-values, median (IQR)||P*|
|3 months pre-switch||Switch||3 months post-switch||Pre-switch||Post-switch|
|DAS28||2.3 (1.8-3.0)||2.3 (1.8-3.2)||2.3 (1.9-3.2)||0.0 (-0.3-0.5)||0.1 (-0.2-0.5)||0.07|
|HAQ||0.6 (0.1-1.1)||0.6 (0.1-1.1)||0.5 (0.3-1.1)||0.0 (0.0-0.1)||0.0 (-0.1-0.1)||0.5|
|CRP, mg/l||4 (2-7)||4 (2-8)||6 (3-9)||0 (-2-1)||0 (-1-3)||0.03|
|VAS pt’s global,mm||26 (11-52)||27 (11-56)||26 (11-55)||0 (-7-8)||0 (-7-9)||0.04|
|BASDAI, mm||26 (12-47)||23 (7-41)||23 (7-41)||0 (-4-5)||0 (-3-3)||0.5|
|CRP, mg/l||4 (1-8)||2 (1-5)||5 (1-9)||0 (-2-2)||0 (-2-2)||0.5|
|VAS pt’s global,mm||28 (15-57)||31 (15-56)||24 (10-52)||1 (-4-8)||-2 (-9-2)||0.3|
|ASDAS||2.0 (1.3-2.7)||1.9 (0.7-3.2)||1.8 (1.2-2.7)||0.0 (-0.3-0.5)||0.0 (-0.4-0.2)||0.8|
*delta values for disease activity pre-switch vs. post-switch, Wilcoxon matched-pair signed rank test
In 647 patients with inflammatory rheumatic diseases treated with Remicade for >4 years, disease activity was largely unaffected in the majority of patients 3 months after non-medical switch to biosimilar Remsima and comparable to the fluctuations observed in the 3 months prior to the switch. However, several patients (~6%) stopped treatment due to LOE or AE. This warrants further investigation before such a non-medical switch can be recommended.
Disclosure of Interest
None declared DOI: 10.1136/annrheumdis-2016-eular.1785
Biosimilars of infliximab have recently also become available in Switzerland. While randomized trial have established that this medication has comparable effectiveness, little evidence is available about the safety of intechangeability of the original bDMARD versus the biosimilar. This study takes advantage of a centrally ordered, non-medical switch from originator infliximab (IFX) (Remicade®) to biosimilar Remsima® in all Danish patients with inflammatory rheumatic diseases, which constitutes something like a natural experiment. Overall , the results are reassuring, with disease activity measures largely unaffected 3 months after the switch. However, about 1 out of 20 of these mostly long-term infliximab users had to stop their therapy due to a new adverse event or a loss of effectiveness. It remains to be determined if this proportion is higher than what would been expected in this population, had they continued their original infliximab.
Prof. Dr. Axel Finckh
Geneva University Hospital
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