Efficacy and Safety of Iguratimod for the Treatment of Rheumatoid Arthritis

Table 1

Characteristics of the included studies with iguratimod (T-614) for rheumatoid arthritis.

Study	Method	Participants	Intervention	Duration	Outcomes	Allocation concealment
Hara et al. (2007) [14]	Double-blind,; randomized, placebo-controlled trial	Country: Japan; Site: multicenter; Number: 376; Iguratimod group (𝑛=147); SASP group (𝑛=156); Placebo group (𝑛=73); Sex: female/male = 306 : 70	T-614 group: iguratimod 25 mg daily for the first 4 weeks and 50 mg daily for the subsequent 24 weeks; SASP group: salazosulfapyridine (SASP) 1000 mg daily; Placebo group: placebo tablets	28 weeks of clinical assessment at 0, 4, 6, 12, 18, 24, and 28 weeks.	ACR20, ACR50, tender joint count, swollen joint count, rest pain, physician's and patient's global assessment of disease activity (VAS, mm), physician's global assessment of disease activity, HAQ score, ESR, CRP, and adverse events.	Described in article but not validated because the author could not be reached via email.
Lü et al. (2008) [2]	Double-blind, randomized, placebo-controlled trial	Country: China; Site: multicenter; Number: 280; T-614 group 1 (𝑛=93); T-614 group 2 (𝑛=92); Placebo group (𝑛=95); Sex: female/male = 231 : 49	Group 1: T-614 25 mg daily for the first 4 weeks and 50 mg daily for the subsequent 20 weeks; Group 2: T-614 50 mg daily; Placebo group: placebo tablets	24 weeks of clinical assessment; at 0, 2, 4, 6, 12, 18, and 24 weeks.	ACR20, ACR50, ACR70, tender joint count, swollen joint count, tender joint score (TJS), swollen joint score (SJS), rest pain, duration of morning stiffness, grip strength, physician and patient global assessment of disease activity, ESR, CRP, rheumatoid factor, HAQ score, radiological damage, and adverse events.	Detailed in article and validity ascertained through telephone.
Lü et al. (2009) [15]	Double-blind, randomized, controlled trial	Country: China; Site: multicenter; Number: 489; T-614 group 1 (𝑛=163); T-614 group 2 (𝑛=163); MTX group (𝑛=163); Sex: female/male = 418 : 81	T-614 group 1: T-614 25 mg daily for the first 4 weeks and 50 mg daily for the subsequent 20 weeks; T-614 group 2: T-614 50 mg per day; MTX group: MTX 10 mg weekly for the first 4 weeks and 15 mg weekly for the subsequent 20 weeks	24 weeks of; clinical assessment; at 0, 4, 10, 17, and 24 weeks.	ACR20, ACR50, ACR70, tender joint count, swollen joint count, tender joint score (TJS), swollen joint score (SJS), rest pain, duration of morning stiffness, grip strength, physician and patient global assessment of disease activity, ESR, CRP, and adverse events.	Detailed in article and validity ascertained through telephone.
Ishiguro (2013) [16]	Double-blind, randomized, controlled trial	Country: Japan; Site: multicenter; Number: 252; T-614 + MTX group (𝑛=164); MTX + placebo group (𝑛=88); Sex: female/male = 204 : 48	T-614 + MTX group: T-614 25 mg daily for the first 4 weeks and 50 mg daily for the subsequent 20 weeks; Placebo + MTX group: MTX at low dosages of 6 or 8 mg weekly and folic acid at dosage of 5 mg weekly	28 weeks of; clinical assessment; at 0, 4, 6, 8, 20, 12, 16, 20, and 24 weeks.	ACR20, ACR50, ACR70, tender joint count, swollen joint count, patient's and physician's global assessment of disease activity, HAQ score, DAS28-CRP, ESR, CRP, and adverse events.	Described in article but not validated because the author could not be reached via email.