Real-world data reinforce benefit of optimizing methotrexate before starting biologics
medwireNews: Patients with rheumatoid arthritis (RA) who have an inadequate response to initial methotrexate therapy achieve comparable improvements in disease activity with treatment optimization as with biologic (b)DMARD therapy initiation, suggest data from the STRATEGE study.
The study authors write in Rheumatology that “the guidelines only allow addition of [bDMARDs] or other conventional synthetic DMARDs (csDMARDs) to [methotrexate] treatment when monotherapy has been fully optimized (dose and route).”
Despite this, they note that in their study, “at the moment of bDMARD initiation, [methotrexate] was still sub-optimally dosed and that the [subcutaneous] route was underutilized, leaving room for improvement, potentially leading to biologic treatment sparing and/or delay.”
For their retrospective study, the team analyzed data for 722 patients with RA who were taking methotrexate monotherapy (68% oral, 30% subcutaneous, 2% intramuscular) and required a treatment modification, most commonly due to active disease (75%) and/or worsening of clinicobiologic parameters (33%).
The majority (63%) of patients had medium disease activity according to DAS28 when recruited to the study between 2014 and 2015 and the mean disease duration was 5.5 years.
The researchers identified two main treatment modification strategies. The majority (72%) of patients had their methotrexate monotherapy dose or route of administration optimized, while 16% of patients were instead given their first biologic with or without methotrexate. The remaining 12% of patients were either prescribed a csDMARD other than methotrexate (5%) or maintained their methotrexate treatment and had their corticosteroid prescription modified (7%).
The two main treatment strategies resulted in a comparable improvement in disease activity over 6 months of follow-up. The mean DAS28 score decreased from 4.00 to 2.95 points among patients who underwent dose optimization and from 4.58 to 3.17 points among those were given a bDMARD. On average, DAS28 improved from active disease to low disease activity in both treatment groups.
Additionally, patients who received either strategy had similar improvements in disability according to HAQ-DI scores, from a mean of 1.10 points at baseline to 0.80 points at 6 months in the methotrexate optimization group, and from 1.30 to 0.89 points in the bDMARD group.
The VAS-measured improvements in pain were similarly comparable, decreasing from a mean of 45.5 to 26.0 points in patients who underwent methotrexate optimization and from 52.7 to 23.4 points among those initiating a bDMARD.
Cécile Gaujoux-Viala (CHU de Nîmes, France) and colleagues warn that due to fewer patients starting biologics than optimizing methotrexate treatment, “[t]he two most common therapeutic strategies should be compared with caution.”
The rate of adverse events (AEs) also did not significantly differ among patients according to treatment strategy; in total, 3% of patients had a serious AE, most commonly hepatic cytolysis, neutropenia, or leukopenia.
Gaujoux-Viala et al say: “The STRATEGE study has shown an important role for [methotrexate] treatment optimization before initiation of a biological treatment and emphasizes the importance of a [treat-to-target] strategy.”
And they conclude: “By enhancing our knowledge of the use of [methotrexate] for RA, we will be able to optimize the use of this key drug in clinical practice and improve the well-being of our patients.”
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