Toggle Main Menu Toggle Search

Open Access padlockePrints

Safety and Tolerability of Subcutaneous Methotrexate in Routine Clinical Practice

Lookup NU author(s): Matthew Li, Dr Ken BakerORCiD, Tania Jones, Professor Fraser Birrell


Full text for this publication is not currently held within this repository. Alternative links are provided below where available.


© 2020, American College of Rheumatology. Objective: To show the safety and efficacy of subcutaneous (SC) methotrexate (MTX) compared to oral MTX, alternative disease-modifying antirheumatic drugs (DMARDs) monotherapy, biologic monotherapy, and combinations (conventional and biologic combination groups) in routine clinical practice. Methods: Clinical and laboratory data were retrospectively analyzed for rheumatology clinic attendances at a large Northeast England hospital trust between January 2014 and January 2018. Rates of adverse events and stop events (transaminitis [serum alanine aminotransferase level of >80 units/liter] or neutropenia [neutrophil count of <2.0 × 109/liter]) were calculated, with adjustment for duration of DMARD exposure. Results: In the present study, 8,394 patients received DMARDs, with 2,093 patients receiving oral MTX and 949 patients receiving SC MTX. The median dose was 15 mg (interquartile range [IQR] 10–20 mg) for oral MTX, and 20 mg (IQR 15–25 mg) for SC MTX (P < 0.0001). Continuation rates were higher for SC MTX therapy when adjusted for follow-up duration, with a rate ratio (RR) of 1.54 (95% confidence interval [95% CI] 1.40–1.70) (P < 0.0001). For the time period assessed, 2,382 patients experienced 4,358 adverse events, with 1,711 incidents of transaminitis and 2,647 incidents of neutropenia recorded. Significantly fewer adverse events were observed in patients who received SC MTX monotherapy versus those who received biologic and combination DMARD therapies (P < 0.01). Compared to oral MTX, SC MTX was associated with a nonsignificant trend toward lower rates of neutropenia, but only a slightly higher rate of transaminitis (RR 1.26 [95% CI 1.07–1.48]) (P = 0.006), despite significantly higher doses of MTX. Conclusion: Subcutaneous MTX is safe in routine clinical practice. This is the largest study yet reported on SC MTX and provides observational data that SC MTX is continued longer and better tolerated in patients compared to other therapy groups, especially oral MTX.

Publication metadata

Author(s): Li CKH, Baker K, Jones T, Coulson E, Roberts A, Birrell F

Publication type: Article

Publication status: Published

Journal: Arthritis Care and Research

Year: 2021

Volume: 73

Issue: 9

Pages: 1306-1311

Print publication date: 01/09/2021

Online publication date: 31/05/2020

Acceptance date: 19/05/2020

ISSN (print): 2151-464X

ISSN (electronic): 2151-4658

Publisher: John Wiley and Sons Inc.


DOI: 10.1002/acr.24334

PubMed id: 32475009


Altmetrics provided by Altmetric