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Abstract Number: 557

The Impact of Comedication with Conventional Synthetic Dmards on Drug Retention and Clinical Effectiveness of Tofacitinib, Anti–Tumor Necrosis Factor Therapy and Biologics with an Alternative Mode of Action in Patients with Rheumatoid Arthritis. a Cohort Study

Axel Finckh1, Christophe Tellenbach2, Almut Scherer2, Burkhard Moeller3, Adrian Ciurea4, Ines von Mühlenen5, Cem Gabay6, Diego Kyburz7, Ruediger Mueller8, Paul Hasler9 and Pascal Zufferey10, 1University Hospital of Geneva, Geneva, Switzerland, 2SCQM Foundation, Zurich, Switzerland, 3Rheumatology, Immunology and Allergology, Inselspital, University Hospital of Bern, Bern, Switzerland, 4Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland, 5Rheuma-Basel, Basel, Switzerland, 6University Hospitals of Geneva, Geneva, Switzerland, 7Rheumatology, University Hospital Basel, Basel, Switzerland, 8Division of Rheumatology, Kantonsspital St Gallen, St. Gallen, Switzerland, 9Kantonsspital Aarau AG, Aarau, Switzerland, 10Department of Rheumatology, University Hospital Lausanne, Lausanne, Switzerland

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy, comparative effectiveness and harms and rheumatoid arthritis, Janus kinase (JAK), treatment

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Session Information

Date: Sunday, October 21, 2018

Session Title: Rheumatoid Arthritis – Treatments Poster I: Strategy and Epidemiology

Session Type: ACR Poster Session A

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

Background/Purpose:

Co-medication with conventional synthetic DMARDs (csDMARDs) is currently recommended with all targeted therapies (bDMARDs and tsDMARDs) for the management of rheumatoid arthritis (RA). However, targeted DMARDs are often used as monotherapy,

primarily because of intolerance to methotrexate and other csDMARDs. Our aim was to analyze the impact of comedication with csDMARDs on the effectiveness of tofacitinib (TOFA), Tumor Necrosis Factor inhibitors (TNFi) and biologic agents with an alternative mode of action (OMA, abatacept or tocilizumab) in a large cohort of patients with RA.

Methods:

In an observational cohort study (SCQM), we included all RA patients initiating a new therapy with TOFA, TNFi, or OMA between August 2013 and March 2018, who had at least one follow-up visit. We analyzed whether the effectiveness of TOFA, TNFi and OMA was modified by concomitant csDMARDs therapy at baseline (COMBI) compared to monotherapy (MONO). The primary outcome was drug maintenance, defined as the time from initiation to discontinuation of treatment. A secondary outcome was low disease activity (LDA) state based on the CDAI at 12 months.

We used Kaplan Meier curves to display drug maintenance and Cox proportional hazard models to analyze the hazard for treatment discontinuation. We adjusted for potential confounders (gender, age, disease duration, seropositivity, BMI, smoking, baseline CDAI number of distinct previous bDMARDs). We applied multiple imputation to account for missing baseline covariate data.

 

Results:

A total of 2503 treatment courses were included, 436 on TOFA, 1244 on TNFi, and 823 on OMA. On average, patients on TNFi were younger, less prior bDMARD and received more COMBI. MTX was by far the most commonly prescribed COMBI with all three targeted therapies (88%-90%).(Table)

In multivariable adjusted models, TOFA maintenance was not different in MONO- compared to COMBI-therapy (Hazard Ratio (HR)-MONO: 1.05 (95%CI: 0.77 – 1.45)), nor was OMA maintenance (HR-MONO: 1.04 (95%CI: 0.84 – 1.30)). On the contrary, TNFi maintenance was significantly decreased in MONO (HR-MONO: 1.28 (95%CI: 1.07 – 1.53)).

Low disease activity (LDA) at 12 months was achieved in 47%, 44% and 40% of patients treated respectively with TOFA, OMA or TNFi. The likelihood of reaching LDA with TOFA or with OMA was not significantly modified by MONO (OR-MONO: 1.13 (95%CI: 0.70 – 1.83), OR-MONO: 1.04 (95%CI: 0.84 – 1.30), respectively), while the likelihood of LDA was significantly reduced for TNFi in MONO (OR-MONO: 0.66 (95% CI: 0.49 – 0.89)).

 

Conclusion:

In this ‘real world’ cohort, combination therapy with csDMARDs did not improve drug-maintenance and effectiveness of TOFA or OMA, whereas TNFi appeared to require comedication for optimal treatment results. Our results suggest that usefulness of concomitant csDMARDs varies according to the type of targeted therapy.

 

Table – Patient and disease characteristics at treatment initiation

 

TOFA
(N=436)

TNFi
(N=1244)

OMA
(N=823)

p value

Female sex [%]

80

75

76

NS

Age [yrs]

59

54

59

< 0.001

Tobacco Smoking ever [%]

31

30

27

NS

BMI [kg/m2]

26.5

26

26.3

NS

Seropositivity [%]

69

66

75

< 0.001

Disease duration [yrs]

12

9

11

< 0.001

CDAI (bl)

22

21

21

NS

Concomitant csDMARDs (@ bl)

–          None [%] (= MONO)

–          Including MTX [%]

–          Other csDMARDs [%]

 

45

49

6

 

29

64

7

 

40

53

7

<0.001

Concomitant csDMARDs (@ 1 yr)

–          None [%] (= MONO)

–          Including MTX [%]

–          Other csDMARDs [%]

 

49

42

9

 

29

64

7

 

44

49

6

<0.001

Prior bDMARD use

–          None [%] (= Bio-naive)

–          1 prior bDMARD [%]

–          ≥ 2 prior bDMARDs  [%]

 

33

26

41

 

60

25

15

 

38

32

30

<0.001

 


Disclosure: A. Finckh, Pfizer, Inc., 2, 8,MSD, 2, 8,Roche, 8,AB2 Bio Ltd., 5,Eli-Lilly, 5, 8,BMS, 7,AbbVie Inc., 5; C. Tellenbach, None; A. Scherer, None; B. Moeller, None; A. Ciurea, None; I. von Mühlenen, None; C. Gabay, AB2 Bio, Pfizer and Roche, 2,AB2 Bio, AbbVie, Bristol Myers Squibb, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB, 5, 8; D. Kyburz, None; R. Mueller, Pfizer, Inc., 5; P. Hasler, Pfizer, Inc., 5; P. Zufferey, None.

To cite this abstract in AMA style:

Finckh A, Tellenbach C, Scherer A, Moeller B, Ciurea A, von Mühlenen I, Gabay C, Kyburz D, Mueller R, Hasler P, Zufferey P. The Impact of Comedication with Conventional Synthetic Dmards on Drug Retention and Clinical Effectiveness of Tofacitinib, Anti–Tumor Necrosis Factor Therapy and Biologics with an Alternative Mode of Action in Patients with Rheumatoid Arthritis. a Cohort Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/the-impact-of-comedication-with-conventional-synthetic-dmards-on-drug-retention-and-clinical-effectiveness-of-tofacitinib-anti-tumor-necrosis-factor-therapy-and-biologics-with-an-alternative/. Accessed April 13, 2021.
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