Arun Tiwari MD, DM
Assistant Professor, People’s College of Medical Sciences and Research Centre, Bhopal, MP
Consultant, Apollo Sage Hospital, Bhopal, MP
The SMILE study was a 52-week, multicenter, double-blind, randomised, non-inferiority trial conducted across 28 centres in China to evaluate the efficacy and safety of iguratimod (IGU) alone or in combination with methotrexate (MTX) in Methotrexate-Naïve patients with early rheumatoid arthritis.
A total of 911 patients were randomised to receive MTX monotherapy (n = 293), IGU monotherapy (n = 297), or IGU + MTX (n = 305). Clinical response and radiographic progression were assessed at week 52. Both IGU monotherapy and IGU plus MTX produced significantly higher ACR20, ACR50, and ACR70 responses compared with MTX alone, with improvements emerging as early as week 12 and sustained throughout the 52 weeks. IGU monotherapy met non-inferiority criteria versus MTX for ACR20 and radiographic progression (vdH-mTSS), and was superior to MTX for ACR20. While IGU+MTX demonstrated superior ACR responses, superiority for radiographic inhibition was not statistically significant. IGU-based regimens showed numerically lower radiographic progression and a higher proportion of patients without radiographic progression. Functional outcomes (HAQ-DI) favoured IGU monotherapy and the combination regimen. Safety profiles were comparable across groups, with no new safety signals identified.
IGU, alone or in combination with MTX, achieves greater and earlier improvements than MTX monotherapy, as reflected in higher ACR20, ACR50, and ACR70 responses, as well as better functional outcomes. IGU monotherapy is a viable first-line csDMARD for MTX-naïve patients, especially when MTX escalation is limited, and may decrease reliance on bridging NSAIDs or steroids. IGU+MTX delivers the most robust overall response when tolerated.
The BASICS study was a 24-week, prospective, open-label randomised trial evaluating baricitinib 4 mg, 2 mg, and control in systemic sclerosis. Forty-eight patients were assigned across three groups. At week 12, baricitinib 4 mg showed the most significant improvement in modified Rodnan Skin Score (−8.9 vs −3.8 with 2 mg and −3.6 with control; P=0.019). Secondary measures, including ACR-CRISS, FVC, digital ulcers, and quality-of-life scores, generally favoured the 4 mg dose over the 24-week period. Gene expression analysis indicated modulation of cytokine and immune-activation pathways. Safety profiles were similar across groups.
Baricitinib 4 mg may offer a meaningful improvement in skin fibrosis and systemic involvement in early SSc. Its favourable safety and biological signals support further evaluation of JAK1/2 inhibition as a potential therapeutic option in systemic sclerosis.
