Tofacitinib (6) – Xeljanz®
Polyarticular juvenile idiopathic arthritis, RF+ or RF polyarthritis and dilated oligoarthritis, and juvenile psoriatic arthritis, ≥ 2 years
Characteristics
| Start date | 15.09.2021 – Marketing authorisation: 18.08.2021 |
|---|---|
| Resolution | 03.03.2022 |
| INN | Tofacitinib |
| Brand name | Xeljanz® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-729 |
| ATC code | L04AF01 IMMUNOSUPPRESSANTS (L04A) |
| ICD-10 codes (AIS) | L40.5Arthropathic psoriasis, M08.3Juvenile rheumatoid polyarthritis (seronegative), M08.49, M08.90Juvenile arthritis, unspecified, unspecified site, M08.99Juvenile arthritis, unspecified, multiple sites |
| Alpha-ID codes (AIS) | I119798Juvenile idiopathic arthritis, I120124Juvenile oligoarthritis, I126529Juvenile rheumatoid factor-negative polyarthritis, I128130Juvenile rheumatoid factor-positive polyarthritis, I130694Juvenile idiopathic arthritis in several locations |
| DDD | 10 mg O |
| Therapeutic area | Musculoskeletal system diseases Juvenile idiopathic arthritis / Enthesitis-related arthritis, Psoriatic Arthritis (PA) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a1) | Patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and widened oligoarthritis) who have responded inadequately to previous treatment with classical DMARDs (including MTX); tofacitinib in monotherapy in case of MTX intolerance or MTX unsuitability. | A bDMARD (adalimumab or etanercept or tocilizumab) as monotherapy |
| a2) | Patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and dilated oligoarthritis) who have responded inadequately to previous treatment with classical DMARDs (including MTX); tofacitinib in combination with MTX | A bDMARD (adalimumab or etanercept or golimumab or tocilizumab) in combination with MTX |
| b1) | Patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and oligoarthritis) who have responded inadequately to previous treatment with one or more bDMARDs; tofacitinib monotherapy in MTX-intolerant or MTX-naïve patients or intolerance or MTX ineligibility. | Change in bDMARD therapy (adalimumab or etanercept or tocilizumab) as monotherapy depending on previous therapy. |
| b2) | Patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and oligoarthritis) who have responded inadequately to previous treatment with one or more bDMARDs. Tofacitinib in combination with MTX | Change in bDMARD therapy (abatacept or adalimumab or etanercept or golimumab or tocilizumab) in combination with MTX depending on the previous therapy. |
| c) | Patients aged 2 years and older with juvenile psoriatic arthritis who have had an inadequate response to previous DMARD therapy. | Therapy to physician's choice |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
| Reason for dividing into subpopulations (G-BA) | Number of medications, Previous treatment, Gene/mutation specifics |
- 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.
Associated procedures
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