Tofacitinib (6) – Xeljanz®

• Clinical trials
  • Furthermore, no indirect comparisons were presented to address the research question of the benefit assessment.

a1) Patients aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to previous treatment with conventional DMARDs (including MTX); tofacitinib as monotherapy in cases of MTX intolerance or where MTX is unsuitable

• For patients aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to prior treatment with conventional DMARDs (including MTX), the additional benefit of tofacitinib (as monotherapy in cases of MTX intolerance or unsuitability for MTX) there is no proof that it is better than the appropriate comparator therapy.
• Overall, for this patient group, the additional benefit of tofacitinib as monotherapy compared with the appropriate comparator therapy is not proven.

a2) Patients aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to prior treatment with conventional DMARDs (including MTX); tofacitinib in combination with MTX

• Overall, for this patient group, the additional benefit of tofacitinib in combination with MTX compared with the appropriate comparator therapy is not proven.

b1) Patients aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to prior treatment with one or more bDMARDs; tofacitinib as monotherapy in cases of MTX intolerance or when MTX is unsuitable

• For patients aged 2 years and over with active pJIA (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis), who have shown an inadequate response to prior treatment with one or more bDMARDs, the additional benefit of tofacitinib (as monotherapy in cases of MTX intolerance or unsuitability for MTX) compared with the appropriate comparator therapy is not proven.
• Overall, for this patient group, the additional benefit of tofacitinib as monotherapy compared with the appropriate comparator therapy is not proven.

b2) Patients aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to prior treatment with one or more bDMARDs; tofacitinib in combination with MTX

• Overall, for this patient group, the additional benefit of tofacitinib in combination with MTX compared with the appropriate comparator therapy is not proven.

c) Patients aged 2 years and over with juvenile psoriatic arthritis who have responded inadequately to prior DMARD therapy

• For patients aged 2 years and over with juvenile psoriatic arthritis who have responded inadequately to previous DMARD therapy, the additional benefit of tofacitinib compared with the appropriate comparator therapy is not proven.
• Overall, the additional benefit of tofacitinib compared with the appropriate comparator therapy is not proven for these patients.

Courtesy translation only, please refer to the German original.