Approval of reimbursement for the “Treatment of adult active ankylosing spondylarthritis patients responding poorly to conventional treatment”.
Therapeutic improvement?
No therapeutic improvement, based on the data available.
Clinical Benefit
Low
The Committee deems that the clinical benefit of XELJANZ (tofacitinib) is low in the extension of the marketing authorisation indication.
Clinical Added Value
no clinical added value
Considering:
the evidence of the clinical benefit versus placebo in terms of ASAS 20 and 40 response percentages, disease activity, functional capacities and quality of life on 270 patients at week 16 and the suggested maintained effect at week 48 on the ASAS 20 outcome measure;
the lack of data on structural efficacy, clinically relevant outcome measure for this indication;
the lack of comparative data versus TNF inhibitors or IL17 inhibitors while comparison was feasible,
the lack of robust data on patients failing to respond to biological treatment (i.e. as a third and subsequent line),
and concerns in terms of long-term safety, particularly in relation to infection risks and the potential cardiovascular and carcinogenic risks,
the Committee deems thatXELJANZ (tofacitinib) provides no clinical added value (CAV V) in the current therapeutic strategy.
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