Methotrexate/Hydroxychloroquine Combo Beats MTX Alone in Rheumatoid Arthritis Treatment

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Methotrexate (MTX) plus hydroxychloroquine (HCQ) combination therapy has demonstrated greater efficacy in treating rheumatoid arthritis (RA) than MTX alone, with a statistically similar safety profile.¹

“According to previous research, the combination of MTX and HCQ could improve the therapeutic efficacy of RA18... Nonetheless, evidence on the exact result of whether MTX + HCQ outperforms MTX monotherapy is still inconclusive, lacking analyses on serum biomarkers and reviews on the quality of life of patients,” lead investigator Jiasheng Ma, Department of Rheumatology, Puyang Oilfield General Hospital, Puyang, China, and colleagues wrote.¹

Ma and colleagues conducted a study of 60 participants without prior RA treatments randomized to receive with MTX + HCQ or MTX alone. They conducted a comparative analysis on measures including visual analogue scale (VAS), the disease activity score in 28 joints (DAS), serum inflammatory factors (including serum C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]), interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), World Health Organization Quality of Life Brief Version questionnaire (WHOQOL-BREF) scores, and treatment-emergent adverse events (TEAEs) after 12 weeks.

The investigators found that after 12 weeks, the MTX + HCQ group had a VAS score of 1.80 (standard deviation [SD], 1.80) compared with the MTX group’s score of 2.57 (SD, 0.90; P <.05) and a DAS score of 2.29 (SD, 0.67) compared with the MTX group’s score of 2.97 (SD, 0.65; P <.05). The MTX + HCQ group had a lowered CRP of 6.91 (SD, 1.43) compared with the control group’s 8.10 (SD, 2.28; P <.05) and ESR of 12.83 mm/h (SD, 3.05) compared with 16.70 mm/h (SD, 3.01; P <.05). IL-6 was downregulated to 19.13 ng/L (SD, 3.90) in the combination group, compared with 21.98 mg/L (SD, 2.44; P <.05) in the control group, along with TNF-α, which was 3.80 ng/L (SD, 1.28) in the combo group and 5.84 (SD, 1.25; P <.05) in the control group.¹

WHOQOL-BREF scores were better improved in the combination group on physical (85.40; SD, 4.87), psychological (85.03; SD, 4.93), environmental (84.43; SD, 4.33), and social relationship-related (85.30; SD, 4.51) domains compared with the control group (78.00; SD, 4.81 [P <.05]; 78.47; SD, 4.49 [P <.05]; 80.00; SD, 3.41 [P <.05]; 77.20; SD, 4.29 [P <.05], respectively).¹

The MTX + HCQ group experienced TEAEs of nausea (n = 1) and dizziness (n = 2) in 10% of participants, compared with 6.67% of participants in the MTX monotherapy group, participants in which experienced diarrhea (n = 1) and vomiting (n = 1). However, the difference in incidence rates was found to be insignificant (P > .05).¹

“Our analysis revealed a significant amelioration in the pain score, disease activity score, inflammatory indices, and overall quality of life of patients from both groups. Of note, the combined therapeutic approach led to a more remarkable outcome and insignificant drug-related adverse events compared with the MTX monotreatment,” Ma and colleagues concluded.¹

REFERENCES

1. Ma J, Zeng M, Hsu CJ, et al. Efficacy and safety of methotrexate plus hydroxychloroquine combination therapy vs. methotrexate monotherapy in the treatment of rheumatoid arthritis: A randomized controlled clinical trial. Int J Rheum Dis. Published online September 2, 2024. doi: 10.1111/1756-185X.15319
2. Schapink L, van den Ende C, Gevers LAHA, van Ede A, den Broeder A. The effects of methotrexate and hydroxychloroquine combination therapy vs methotrexate monotherapy in early rheumatoid arthritis patients. Rheumatol (Oxford). 2019; 58(1): 131-134.