Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial

At 6 months, ACR50 was achieved by 173/376 (46%) patients receiving tofacitinib with methotrexate and 169/386 (44%) patients receiving adalimumab with methotrexate, which met non-inferiority criteria. Adverse events were similar between groups.

To date, the ORAL Strategy study is the first head-to-head non-inferiority study assessing a JAK inhibitor with or without methotrexate directly compared with a TNF inhibitor therapy plus methotrexate in rheumatiod arthritis.

Additionally, this study is the first head-to-head non-inferiority comparison of tofacitinib monotherapy versus tofacitinib in combination with methotrexate.

 

An accompanying commentary notes three benefits from the combination of tofacitinib and methotrexate in active rheumatoid arthritis:

 

1. “First, this combination's efficacy and toxicity are similar to injectable biologics such as adalimumab.
   
2. Second, the onset of action of these drugs seems equally rapid.
   
3. Third, most patients are able to remain on tofacitinib therapy for 12 months.”

 

However, caution is still required with routine use of oral JAK inhibitors, since they also increase serious infections.