Antirheumatic Medication Calendar Significantly Improves Adherence in First-Time Methotrexate Users: A Prospective, Single-Blind, Randomized Controlled Trial.

Purpose: Methotrexate is widely used to treat rheumatoid arthritis; however, the adherence rate greatly varies due to its weekly dosing schedule. Incorrect administration can lead to disease progression and toxicity. To design a graphic-based medication calendar aiming to improve adherence in first-time methotrexate users.

Patients and methods: This prospective, single-blind, randomized controlled trial included participants aged 18-75 years who were starting methotrexate for the first time or resuming it after a 3-month break. Seventy-nine participants from October 1, 2023, to January 30, 2024, were randomly assigned in a 1:1 ratio to the calendar (38 participants) or control (41 participants) group for 6 weeks and followed up for 2, 6, and 10 weeks. The primary outcome was methotrexate adherence, assessed by the proportion of patients with a PDC value of 100%.

Results: After 6 and 10 weeks, the calendar group had a higher proportion of patients with a PDC value of 100% compared with the control group (97.2% vs 73.2%, P < 0.004; 88.9% vs 68.9%, P < 0.03, respectively) and a higher correct medication adherence rate within 10 weeks (87.81% vs 69%, P = 0.0307). Compared with the control group, the calendar group had a significantly higher rate of on-time return visits during both follow-up visits (97.2% vs 78.0% and 91.7% vs 70.7%, respectively). Additionally, 94.74% of the calendar group patients believed the intervention improved their adherence and wished to continue using it.

Conclusion: The antirheumatic medication calendar improved initial methotrexate adherence; however, its effect diminished following its discontinuation.

Clinical trial registration: ChiCTR2300076228 (2023-09-27).