“Early Use of Subcutaneous MTX Monotherapy Vs. MTX Oral or Combination Therapy Significantly Delays Time to Initiating Biologics in Early RA

Stephanie Gottheil¹, J Carter Thorne², Orit Schieir³, Gilles Boire⁴, Boulos Haraoui⁵, Carol Hitchon⁶, Diane Tin⁷, Cheryl Barnabe⁸, Glen Hazlewood⁸, Edward Keystone⁹, Vivian P. Bykerk¹⁰, Janet E. Pope¹¹, Susan J. Bartlett¹² and Canadian Early Arthritis Cohort, ¹University of Western Ontario, LONDON, ON, Canada, ²Southlake Regional Health Centre, Newmarket, ON, Canada, ³McGill University, Montreal, ON, Canada, ⁴Rheumatology Division, CHUS - Sherbrooke University, Sherbrooke, QC, Canada, ⁵Institute de Rheumatologie, Montreal, QC, Canada, ⁶University of Manitoba, Winnipeg, MB, Canada, ⁷The Arthritis Program, Southlake Regional Health Centre, Newmarket, ON, Canada, ⁸Division of Rheumatology, University of Calgary, Calgary, AB, Canada, ⁹Mt. Sinai Hospital, University of Toronto, Toronto, ON, Canada, ¹⁰Divison of Rheumatology, Hospital for Special Surgery, New York, NY, ¹¹University of Western Ontario, St Joseph's Health Care, London, ON, Canada, ¹²Department of Medicine, Division of ClinEpi, Rheumatology, Respirology, McGill University, Montreal, QC, Canada

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Biologics, methotrexate (MTX) and rheumatoid arthritis (RA)

Session Information

Date: Wednesday, November 16, 2016

Title: Rheumatoid Arthritis – Clinical Aspects VI: Management of Early Rheumatoid Arthritis

Session Type: ACR Concurrent Abstract Session

Session Time: 9:00AM-10:30AM

Background/Purpose:

Optimal treatment for moderate-severe early rheumatoid arthritis involves using a methotrexate-based, treat-to-target strategy aiming for remission. Achieving remission without using biologics may be preferable due to their high cost and potential risk of infection. However, it is still unknown which initial treatment strategy is preferable. Our objective was to compare effects of initial treatment with MTX oral monotherapy, MTX subcutaneous (sc) monotherapy, and MTX combination therapy on time to first use of biologic DMARDs in a large national early RA cohort.

Methods:

Data were obtained from a multi-center prospective cohort study of patients with early RA. The present analysis included participants who met 1987 or 2010 ACR criteria for RA, with <12 months symptom duration, moderate or high disease activity based on the DAS28 at baseline and treated with MTX. Patients treated with a biologic at baseline were excluded. Patients were followed until they started a biologic or they were censored due to loss to follow up or the end of the 3-year study period. Cox proportional hazards survival analysis was used to estimate effects of oral MTX monotherapy, sc MTX monotherapy, and MTX combination therapy adjusting for age, gender, education level, symptom duration, comorbidities, baseline erosions, baseline DAS28, and corticosteroid use. Logistic regression analysis was used to determine predictors of ever vs. never biologic use.

Results: 1189 patients were included and 212 first events of biologic use. At baseline, 865 (71%) were female with mean (sd) age of 54 (15) years, symptom duration 6 (3) months, and DAS28 of 5.45 (1.2). Oral MTX monotherapy was used as initial treatment in 230 (20%), sc MTX monotherapy in 226 (20%), and MTX combination therapy in 664 (60%). In fully adjusted Cox regression models, patients treated with subcutaneous MTX monotherapy had a significantly delayed time to first biologic use (HR = 0.53, p = 0.02). There was no difference between MTX combination therapy and oral MTX monotherapy (HR = 0.95). In logistic regression models of ever vs. never biologic use, there were no significant differences between treatment strategies. Predictors of biologic use included younger age, use of corticosteroids, longer symptom duration, and higher baseline DAS28.

Conclusion:

Treatment with sc MTX monotherapy was associated with a delayed time to biologics. This may be due to increased treatment efficacy compared to oral MTX. Combination DMARD therapy was not associated with longer time to biologic initiation, potentially due to provincial regulations requiring a trial of combination DMARD therapy before initiating biologics. This study suggests that early use of sc MTX can potentially delay the need for more expensive biologic therapies.

Disclosure: S. Gottheil, None; J. C. Thorne, abbvie, 5,Amgen, 5,AstraZeneca, 5,Bristol-Myers Squibb, 5,Centocor, Inc., 5,Celgene, 5,Genzyme Corporation, 5,hospira, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,Genzyme Corporation, 8,Medac Pharma, 8,Antares, 8,Abbvie, 2,Amgen, 2,AstraZeneca, 2,Celgene, 2,Eli Lilly and Company, 2,Novartis Pharmaceutical Corporation, 2,Pfizer Inc, 2; O. Schieir, None; G. Boire, None; B. Haraoui, Abbvie, 5,Amgen, 5,Bristol-Myers Squibb, 5,Celgene, 5,Eli Lilly and Company, 5,Janssen Pharmaceutica Product, L.P., 5,Merck Pharmaceuticals, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,UCB, 5; C. Hitchon, None; D. Tin, None; C. Barnabe, None; G. Hazlewood, None; E. Keystone, Abbott, Amgen, AstraZeneca, BMS, Hoffman-LaRoche, Janssen, Eli Lilly and Company, Novartis, Pfizer, Sanofi-Aventis, UCB, 2,Abbott, AstraZeneca, Biotest, BMS, Crescendo, Hoffmann-LaRoche, Genentech, Janssen, Eli Lilly and Company, Merck, Pfizer, UCB, 5,Abbott, AstraZeneca, BMS Canada, Hoffmann-LaRoche, Janssen, Pfizer, UCB, Amgen, 9; V. P. Bykerk, AbbVie, Bristol-Myers Squibb, Pfizer, Roche/Genentech, Regeneron, and UCB Pharma, 5; J. E. Pope, Abbvie, 5,Actelion Pharmaceuticals US, 5,Amgen, 5,Bayer, 5,Bristol-Myers Squibb, 5,Genzyme Corporation, 5,Hospira, 5,Eli Lilly and Company, 5,Merck Pharmaceuticals, 5,Novartis Pharmaceutical Corporation, 5,Pfizer Inc, 5,Regeneron, 5,Roche Pharmaceuticals, 5,Sanofi-Aventis Pharmaceutical, 5,UCB, 5,Amgen, 2,Bristol-Myers Squibb, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,UCB, 2; S. J. Bartlett, None.

To cite this abstract in AMA style:

Gottheil S, Thorne JC, Schieir O, Boire G, Haraoui B, Hitchon C, Tin D, Barnabe C, Hazlewood G, Keystone E, Bykerk VP, Pope JE, Bartlett SJ. “Early Use of Subcutaneous MTX Monotherapy Vs. MTX Oral or Combination Therapy Significantly Delays Time to Initiating Biologics in Early RA [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/early-use-of-subcutaneous-mtx-monotherapy-vs-mtx-oral-or-combination-therapy-significantly-delays-time-to-initiating-biologics-in-early-ra/. Accessed .

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