One-Year Clinical Outcomes in 1623 Patients with Inflammatory Arthritis Who Switched from Originator to Biosimilar Etanercept - an Observational Study from the Danish Danbio Registry

Bente Glintborg¹, Emina Omerovic¹, Kamilla Danebod¹, Dorte Vendelbo Jensen¹, Henrik Nordin¹, Anne Gitte Loft¹, Stavros Chrysidis¹, Johnny Lillelund Raun¹, Oliver Hendricks¹, Hanne Lindegaard¹, Jakob Espesen¹, Susanne Jakobsen¹, Inger Marie J. Hansen¹, Jolanta Grydehøj¹, Emil Dalgaard¹, Dorte Dalsgaard Pedersen¹, Natalia Manilo², Lis Smedegaard Andersen³, Salome Kristensen¹, Asta Linauskas¹, Niels Steen Krogh⁴ and Merete Lund Hetland⁵, ¹The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, ²Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Frederiksberg, Copenhagen, Denmark, ³Department of Rheumatology, The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, ⁴The DANBIO Registry, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ⁵The DANBIO registry and the Danish Departments of Rheumatology, Glostrup, Denmark

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Biologic agents, biosimilars, outcomes and registry

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:

According to Danish national guidelines issued in April 2016, a non-medical switch from originator (ETA, Enbrel) to biosimilar Etanercept (SB4, Benepali) (50 mg s.c.) was conducted for economic reasons in patients with inflammatory rheumatic diseases treated in routine care. Changes in disease activity 3-months pre-switch and 0-3 months after the switch were comparable.¹⁾

We aimed to investigate the 1-year retention rates and reasons for withdrawal in ETA-treated patients (pts) with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthrits (SpA) who switched to SB4 (“switchers”) and to characterize ETA treated patients, who did not switch to SB4 (“non-switchers”).

Methods:

Patients were monitored prospectively in the DANBIO registry. Reasons for SB4 withdrawal were categorized as adverse events (AE), lack of effect (LOE) or other. Baseline characteristics associated with SB4 withdrawal were explored by multivariable Cox regression analyses stratified by diagnosis(RA/PsA/SpA) and included gender/age/concomitant methotrexate(MTX)/SB4 dose/patient’s global score(PGS). Comparisons of switchers (at baseline = first SB4 treatment) versus non-switchers (per April 1^st 2016) were by Chi-square/Mann-Whitney.

Results:

A total of 2.030 ETA treated patients were identified, of which 1623(80%) were switched to SB4.

In switchers, 276 patients (18%) stopped SB4 treatment during follow-up, mainly due to LOE (54%) or AE (28%) (Table). In RA, characteristics associated with withdrawal were no concomitant MTX and higher PGS (all p<0.05) whereas gender, age and SB4 dose were insignificant. In PsA, associated factors were female gender, higher PGS and lower SB4 doses, whereas no significant factors were found in SpA.

Compared to non-switchers, switchers more frequently had PsA (22%/12%), received co-medication with methotrexate (48%/42%), were men (40%/35%), were rarely treated with 25 mg ETA (1%/43%) doses and had lower PGS (29(13-54)mm /33(14-62)mm) (median(IQR)), (all p<0.05) whereas age was similar.

Conclusion:

Of 2030 ETA treated patients, 80% conducted a nationwide, non-medical switch from originator ETA to biosimilar SB4. 18% of switchers withdrew during 1-year follow-up. Comparison of the withdrawal rate with a historic ETA treated patient cohort is ongoing and will be presented at the ACR. In RA and PsA withdrawal was associated with higher patient’s global scores. Some channeling to non-medical switching was observed, since non-switchers differed in baseline characteristics and often received 25 mg ETA.

References: ¹⁾ Glintborg et al. 10.1136/annrheumdis-2017-eular

Table. Baseline demographics and 1-year treatment outcomes among ETA switchers

	Switchers from ETA to SB4
	Rheumatoid arthritis	Psoriatic arthritis	Axial spondyloarthritis
Number, n	937	351	335
Female, n (%)	692 (74%)	160 (46%)	113 (34%)
Baseline demographics according to diagnosis*
Age, years	60 (48-69)	52 (43-61)	48 (39-57)
bDMARD treatment number (SB4)	2 (2-3)	2 (2-3)	3 (2-3)
Concomitant MTX	59%	48%	15%
In remission**	65%	70%	28%
Patient’s global score (VAS), mm	29 (13-55)	30 (12-53)	30 (12-53)
HAQ	0.8 (0.1-1.3)	0.5 (0.0-1.0)	0.4 (0.0-0.8)
Prior ETA treatment duration, yrs	6.1 (3.7-8.8)	4.5 (3.0-7.5)	4.7 (2.9-6.9)
1-year treatment outcomes***
Withdrawal during follow-up, n (%)	177 (19%)	52 (15%)	47 (14%)
Prior ETA treatment duration in withdrawers, yrs	5.6 (2.8-8.9)	3.7 (2.7-6.3)	3.2 (1.5-5.2)
Reasons for withdrawal (total n=276): Lack of effect 45%, adverse events 28%, other 5%, several reasons 3%, cancer 3%, remission 2%, pregnancy 2%, death 1%, infection 1%, surgery <1%, not stated 10%
Numbers are medians (interquartile ranges) unless otherwise stated. Abbreviations: VAS: visual analogue scale, ETA: originator Etanercept, SB4: biosimilar etanercept * Baseline is according to first SB4 dose DAS28<2.6, ASDAS<1.3 * Median follow-up was 316(254-345)days

Disclosure: B. Glintborg, Abbvie, Biogen, 2; E. Omerovic, None; K. Danebod, None; D. V. Jensen, None; H. Nordin, None; A. G. Loft, AbbVie, MSD, Novartis, Pfizer, Roche, UCB, 2; S. Chrysidis, None; J. L. Raun, None; O. Hendricks, Abbvie, Roche, Novartis, 2; H. Lindegaard, None; J. Espesen, None; S. Jakobsen, None; I. M. J. Hansen, Roche Pharmaceuticals, 2; J. Grydehøj, None; E. Dalgaard, None; D. Dalsgaard Pedersen, None; N. Manilo, None; L. Smedegaard Andersen, None; S. Kristensen, None; A. Linauskas, None; N. S. Krogh, None; M. Lund Hetland, Orion, BMS, AbbVie, Biogen, Pfizer, MSD, 2.

To cite this abstract in AMA style:

Glintborg B, Omerovic E, Danebod K, Jensen DV, Nordin H, Loft AG, Chrysidis S, Raun JL, Hendricks O, Lindegaard H, Espesen J, Jakobsen S, Hansen IMJ, Grydehøj J, Dalgaard E, Dalsgaard Pedersen D, Manilo N, Smedegaard Andersen L, Kristensen S, Linauskas A, Krogh NS, Lund Hetland M. One-Year Clinical Outcomes in 1623 Patients with Inflammatory Arthritis Who Switched from Originator to Biosimilar Etanercept – an Observational Study from the Danish Danbio Registry [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/one-year-clinical-outcomes-in-1623-patients-with-inflammatory-arthritis-who-switched-from-originator-to-biosimilar-etanercept-an-observational-study-from-the-danish-danbio-registry/. Accessed .

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