Is There Any Difference in RA Patients for Methotrexate Use Vs. Leflunomide Use As a Concomitant Treatment with Biological and Targeted Synthetic Dmards in Turkbio Registry?

Nevsun Inanc¹, Gulsen Ozen², Yasemin Yalçınkaya¹, Ediz Dalkilic³, Suleyman Serdar Koca⁴, Gerçek Can⁵, Ahmet Karatas⁶, Yavuz Pehlivan⁷, Ayten Yazici⁸, Ayse Cefle⁹, Abdurrahman Tufan¹⁰, Servet Akar¹¹, Soner Senel¹², Burak Oz¹³, Nurullah Akkoc¹⁴ and Fatos Onen¹⁵, ¹Departement of İnternal Medicine, Division of Rheumatology, Marmara University, Istanbul, Turkey, ²Rheumatology, Marmara University, School of Medicine, Rheumatology, Istanbul, Turkey, ³Department of Internal Medicine, Division of Rheumatology, Uludag University, School of Medicine, Rheumatology, Bursa, Turkey, ⁴Department of Rheumatology, Firat University School of Medicine, Elazig, Turkey, ⁵Rheumatology, Dokuz Eylul University Faculty of Medicine, İzmir, Turkey, ⁶Department of Rheumatology, Firat University, School of Medicine, Rheumatology, Elazig, Turkey, ⁷Department of Rheumatology, Uludag University, Bursa, Turkey, ⁸Rheumatology, Kocaeli University, Kocaeli, Turkey, ⁹Rheumatology, Kocaeli University, School of Medicine, Rheumatology, Kocaeli, Turkey, ¹⁰Internal Medicine-Rheumatology, Gazi University Medical School, Rheumatology, Ankara, Turkey, ¹¹Rheumatology, Izmir Katip Celebi University, School of Medicine, Rheumatology, Izmir, Turkey, ¹²Rheumatology, Kayseri Erciyes University, School of Medicine, Rheumatology, Kayseri, Turkey, ¹³Rheumatology, Firat University, School of Medicine, Rheumatology, Elazig, Turkey, ¹⁴Rheumatology, Private Practice, Rheumatology, İzmir, Turkey, ¹⁵Rheumatology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

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

Session Information

Date: Sunday, November 5, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I: Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules

Session Type: ACR Poster Session A

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

Background/Purpose: TURKBIO registry is the Turkish version of Danish DANBIO rheumatologic database which has been established in 2011. Demographic and clinical data including age, sex, disease type, disease duration, and previous or current treatment with conventional (csDMARD) and targeted synthetic (tsDMARD), and biological DMARDs (bDMARDs) were collected. In this study, we aimed to investigate the efficacy and safety status of methotrexate (MTX) vs. leflunomide (LEF) use as a concomitant treatment with bDMARDs and tsDMARD in this registry.

Methods: Frequencies of achievement of remission or remission+low disease activity (LDA) at the 6^th month of bDMARD or tsDMARD treatment were compared between patients who were on these medications with MTX vs. LEF as a concomitant treatment. Similarly, patients who were on TNF inhibitors (TNFi), abatacept (ABA), rituximab (RTX), tocilizumab (TCZ), and tofacitinib (TOFA) with MTX vs. LEF were also assessed separately for the achievement of remission and remission+LDA. Drug survival and switch rates of bDMARDs and tsDMARD treatments either with MTX or LEF were compared. The adverse effects with MTX and LEF concomitant use were evaluated as well.

Results:

The study included 725 bDMARD or tsDMARD receiving RA patients from 8 participating centers of the TURKBIO registry. Of these patients, 462 (63.7%) were receiving concomitant MTX and 263 (36.3%) LEF. Demographic findings are given in the Table. Achievement of remission and remission+LDA at the 6^th month of bDMARD or tsDMARD initiation was similar in concomitant MTX vs LEF groups (51.4% vs. 53%, P=0.683). When each bDMARD and tsDMARD was evaluated separately, achievement of remission were again similar in MTX and LEF concomitant users (TNFi: 53% vs. 54%; ABA: 50% vs. 59%; RTX: 53% vs. 61%; TCZ: 42% vs. 35%; P>0.05 for all). For TOFA, although remission+LDA rate was numerically higher in MTX concomitant group than LEF group (42% vs. 21%), the difference was not statistically significant due to the smaller sample size of TOFA (N=33). The results were similar for all DMARD groups when remission was evaluated alone. Drug survival (17±12 vs. 16±11 months, p>0.05 ) and drug discontinuation (42,2 vs 38, p>0.05 ) rates of bDMARDs or tsDMARD were also not different in MTX vs. LEF concomitant users. Adverse effects rate (19.5% vs 20.5%, p>0.05) were similar between MTX vs. LEF concomitant users as well.

Conclusion: Achievement of remission or remission+LDA was not different with the concomitant use of MTX vs. LEF with any bDMARD or tsDMARD treatment in RA patients with a similar safety profile. LEF might be an alternative as a concomitant DMARD in MTX-intolerant RA patients initiating bDMARDs or tsDMARD.

Table. Demographic findings of patients.


Sex, n (%)	Female	596 (82,2)
	Male	129 (17,8)
Age, Median (Q1-Q3)		55 (45-62)
Age, Mean±SD		54±13
Disease duration, Ortanca (Q1-Q3)		12 (8-17)
Disease duration, Ort±SD		13±8
Biological and targeted synthetic drugs, n (%)	TNFi*	354 (48,8)
	RITUXIMAB	144 (19,9)
	ABATACEPT	127 (17,5)
	TOCILIZUMAB	61 (8,4)
	TOFACITINIB	36 (5,0)
	ANAKINRA	3 (0,4)
Biological+MTX, n (%)		462 (63,7)
Biological+LEF, n (%)		263 (36,3)

*TNFi: ETANERCEPT, ADALIMUMAB, CERTOLIZUMAB, GOLIMUMAB, INFLIXIMAB, REMSIMA.

Disclosure: N. Inanc, None; G. Ozen, None; Y. Yalçınkaya, None; E. Dalkilic, AbbVie, 2,AbbVie, MSD, Roche, UCB and Pfizer, 9; S. S. Koca, None; G. Can, None; A. Karatas, None; Y. Pehlivan, None; A. Yazici, None; A. Cefle, None; A. Tufan, None; S. Akar, None; S. Senel, None; B. Oz, None; N. Akkoc, None; F. Onen, None.

To cite this abstract in AMA style:

Inanc N, Ozen G, Yalçınkaya Y, Dalkilic E, Koca SS, Can G, Karatas A, Pehlivan Y, Yazici A, Cefle A, Tufan A, Akar S, Senel S, Oz B, Akkoc N, Onen F. Is There Any Difference in RA Patients for Methotrexate Use Vs. Leflunomide Use As a Concomitant Treatment with Biological and Targeted Synthetic Dmards in Turkbio Registry? [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/is-there-any-difference-in-ra-patients-for-methotrexate-use-vs-leflunomide-use-as-a-concomitant-treatment-with-biological-and-targeted-synthetic-dmards-in-turkbio-registry/. Accessed .

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