Similar Effectiveness of Both Formulations of Tocilizumab (TCZ) in Patients with Rheumatoid Arthritis (RA) Switching from Intravenous (IV) to Subcutaneous (SC) at 6 Months in Real Life

Jean Darloy¹, René-Marc Flipo¹, Nicolas Segaud², Jean-Paul Eschard³, Vincent Goeb⁴, Jean-Hugues Salmon³, Eric Houvenagel⁵, Clément Chopin³, Samuel Gally⁶, David Pau⁷, Isabelle Idier⁸ and Guy Baudens⁹, ¹Rheumatology, Rheumatology Department CHU Teaching Hospital Lille, Lille, France, ²Internal medicine, Internal Medicine Departement Armentières Hospital, Armentières, France, ³Rheumatology, Rheumatology Department CHU Teaching Hospital Reims, Reims, France, ⁴Rheumatologie, Rheumatology Department CHU Teaching Hospital Amiens, Amiens, France, ⁵Rheumatology, Groupe Hospitalier de l'Institut Catholique de Lille, Lomme, France, ⁶Clinical Operations, Roche SAS, Boulogne Billancourt, France, ⁷Statistics, Roche SAS, Boulogne Billancourt, France, ⁸Medical department, Chugai Pharma France, Paris La Defense, France, ⁹Rheumatology, Rheumatology Department CHR Valenciennes, Valenciennes, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Biologic agents, rheumatoid arthritis (RA) and tocilizumab

Session Information

Date: Tuesday, November 7, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars

Session Type: ACR Poster Session C

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

Background/Purpose:

It has been proven, in a pivotal RCT, that SC TCZ was non-inferior to IV TCZ [1]. However, the effectiveness of the SC TCZ formulation has not been evaluated in “real life”.

The objective was to describe the effectiveness and the characteristics of RA patients switching from IV to SC TCZ formulation in current practice.

Methods:

We analysed all the RA patients of the shared medical file “RIC Nord de France” with at least 1 DAS 3 months before inclusion, treated with TCZ, switching or not from IV to SC TCZ, between April 30th 2015 and January 15th 2016. The primary efficacy endpoint was the proportion of patients remaining in their DAS28-ESR category remission/LDA or moving to an inferior DAS28-ESR category at 24 weeks (W24). DAS28-ESR was calculated at inclusion and at W24 for switch patients (IV-SC) and for non-switch patients (IV-IV). Permanent discontinuation of TCZ before W24 was considered as failure.

Results:

From the 263 patients included, 30% switched from IV to SC TCZ.

At baseline, there were 77.6% females, mean BMI was 27.46±6.40, and mean RA duration was 15.11±9.38 years in the whole population. Mean IV TCZ duration before inclusion was 35.2±24.3 months in switch and 24.7±22.1 months in non-switch patients. 51.1% of the switch patients were treated in monotherapy, 49.1% in the non-switch group. Mean DAS28-ESR were 2.23±1.16 in the switch and 3.07±1.70 in the non-switch patients. 79.3% of the switch patients were in DAS28-ESR category remission or LDA, and 20.7% in MDA. 53.8% of the non-switch patients were in DAS28-ESR category remission or LDA, 33.3% in MDA, and 12.9% in HDA.

At W24, 73.9% (CI _95% =[63.4% – 82.7%]) of the switch patients, and 72% (CI_95% =[64.4% – 78.8%]) of the non-switch patients stayed in DAS28-ESR category remission/LDA or move to an inferior DAS28-ESR category (Table).

Table: DAS28-ESR at W24

		Switch N=92	No switch N=171	All N=263
Primary criterion: patients moving to a fewer DAS28 category (or staying in the category LDA/remission) with imputation *	N	88	161	249
	Missing	4	10	14
	No	23 (26.1%) [ 17.3% – 36.6%]	45 (28.0%) [ 21.2% – 35.6%]	68 (27.3%) [ 21.9% – 33.3%]
	Yes	65 (73.9%) [ 63.4% – 82.7%]	116 (72.0%) [ 64.4% – 78.8%]	181 (72.7%) [ 66.7% – 78.1%]
*Permanent discontinuation of treatment was considered as failure

Conclusion:

In that “real life” population, the proportion of RA patients treated with TCZ in remission or LDA remains similar at W24 for switch patients (IV-SC) and for non-switch patients (IV-IV). Proportions of patients moving to an inferior DAS category were also comparable in both groups. Switch patients appear to have less active disease at baseline. Factors associated to switch will be investigated.

Reference:

1. Burmester GR, et al. Ann Rheum Dis. 2014 Jan;73(1):69-74.

Disclosure: J. Darloy, None; R. M. Flipo, Roche SAS, 5,Chugai Pharma France, 5; N. Segaud, None; J. P. Eschard, None; V. Goeb, Roche SAS, 5,Chugai Pharma France, 5; J. H. Salmon, None; E. Houvenagel, Roche SAS, 5; C. Chopin, None; S. Gally, Roche SAS, 3; D. Pau, Roche SAS, 3; I. Idier, Chugai Pharma France, 3; G. Baudens, Roche SAS, 5,Chugai Pharma France, 5.

To cite this abstract in AMA style:

Darloy J, Flipo RM, Segaud N, Eschard JP, Goeb V, Salmon JH, Houvenagel E, Chopin C, Gally S, Pau D, Idier I, Baudens G. Similar Effectiveness of Both Formulations of Tocilizumab (TCZ) in Patients with Rheumatoid Arthritis (RA) Switching from Intravenous (IV) to Subcutaneous (SC) at 6 Months in Real Life [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/similar-effectiveness-of-both-formulations-of-tocilizumab-tcz-in-patients-with-rheumatoid-arthritis-ra-switching-from-intravenous-iv-to-subcutaneous-sc-at-6-months-in-real-life/. Accessed .

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