Tofacitinib is used to treat selected immune-mediated inflammatory conditions. Approved indications vary by jurisdiction, age group, formulation and regulatory update.
Rheumatoid arthritis
Current U.S. labeling includes tofacitinib for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
Psoriatic arthritis
Current U.S. labeling includes active psoriatic arthritis in adults after inadequate response or intolerance to one or more TNF blockers. The U.S. label also includes pediatric patients aged 2 years and older with active psoriatic arthritis under specified conditions.
Ankylosing spondylitis
For adults with active ankylosing spondylitis, current U.S. labeling covers patients who have had an inadequate response or intolerance to one or more TNF blockers.
Ulcerative colitis
Tofacitinib is used for adults with moderately to severely active ulcerative colitis under the conditions specified in applicable labeling. The current U.S. indication requires inadequate response or intolerance to one or more TNF blockers.
Clinical trials such as the OCTAVE program demonstrated efficacy of tofacitinib for induction and maintenance of remission in selected adults with moderate-to-severe ulcerative colitis.
Polyarticular-course juvenile idiopathic arthritis
The current U.S. label includes patients aged 2 years and older with active polyarticular-course juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
Regulatory differences
European authorization includes rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis, with authorization wording and treatment positioning that can differ from the current U.S. label.
Treatment should therefore be based on the applicable local authorization.