Background: In general, the effectiveness of Janus kinase (JAK) inhibitors with or without concomitant methotrexate (MTX) is considered not much different. However, its effectiveness in real-world daily practice is unknown.

Objectives: This study aimed to compare the therapeutic efficacy of JAK inhibitors with or without MTX in real world data.

Methods: The patients were 291 RA patients from Osaka Metropolitan University Team RA database who were treated with JAK inhibitors and could be followed up for more than 52 weeks. The JAK inhibitors used included Tofacitinib in 103 cases, Baricitinib in 92 cases, Peficitinib in 25 cases, Upadacitinib in 46 cases and Filgotinib in 25 cases. Of these 291 patients, 167 patients were treated with MTX (combination group), and 124 were treated without MTX (monotherapy group). We compared the continuation rate at 24 and 52 weeks in the two groups. In addition, 183 patients who were able to continue JAK inhibitors until week 52 were divided into 109 patients in combination group and 74 patients in monotherapy group and compared their effectiveness.

Results: The continuation rate of JAK inhibitors up to 24 week were 75.4% and 76.6%, and 52 weeks was 65.2% and 59.7% in the combination group and monotherapy group, respectively. The monotherapy group was older (62.0 vs 70.4 years, p<0.001) and had lower renal function (eGFR: 74.0 vs 63.0, p<0.001). The DAS (Disease activity score) 28-ESR at 0, 4, 12, 24, 36 and 54 weeks was 4.9, 3.8, 3.5, 3.6, 3.5 and 3.5 in the combination group and 5.0, 4.2, 4.0, 3.9, 4.0 and 4.2 in the monotherapy group. DAS28-ESR was significantly lower at 12 (p=0.029), 36 (p=0.012) and 52 weeks (p=0.002) in the combination group. CDAI (Clinical Disease Activity Index) was 19.2, 11.1, 8.3, 8.8, 8.5 and 8.5 in the combination group and 21.2, 14.3, 12.0, 11.1, 11.6 and 13.5 in the MTX-naive group. CDAI was significantly lower at 4 (p=0.047), 12 (p=0.016), 36 (p=0.041) and 52 weeks (p=0.005) in the combination group.

Conclusion: This result of real-world data showed that the combination with JAK inhibitor and MTX was superior to JAK inhibitor monotherapy in both the continuation rate and therapeutic efficacy of JAK inhibitors.

Table 1. Patients characteristics of both groups.

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Figure 1.

The change of disease activity during 52 weeks. *: P<0.05

REFERENCES: [1] Liu L, Yan Y-D, Shi F-H, et al. Comparative efficacy and safety of JAK inhibitors as monotherapy and in combination with methotrexate in patients with active rheumatoid arthritis: A systematic review and meta-analysis. Front. Immunol. (2022) 13:977265. doi: 10.3389/fimmu.2022.977265

Acknowledgements: NIL.

Disclosure of Interests: Tadashi Okano Abbvie, Asahi Kasei, Chugai, Eisai, Eli Lilly, Janssen, Novartis Pharma, and Tanabe Mitsubishi., Chika Yoshimura: None declared, Kenji Mamoto: None declared, Yutaro Yamada: None declared, Takahito Kojima: None declared, Kentaro Inui: None declared, Masahiro Tada: None declared, Kazuki Orita: None declared, Shohei Anno: None declared, Takahiro Iida: None declared, Tatsuya Koike: None declared.