Pfizer Inc. — Xeljanz EMA EPAR variation assessment report (EMEA/H/C/004214, 2017)

Pfizer Inc. · 2017 · EMA EPAR variation assessment report · company profile →

Report summary

This report summarizes Pfizer's Type II variation application for Xeljanz (tofacitinib) to update sections 4.8 and 5.1 of its Summary of Product Characteristics (SmPC). The updates incorporate long-term safety and efficacy data from Study A3921145, focusing on polyarticular course Juvenile Idiopathic Arthritis (pJIA) and psoriatic arthritis (PsA) patients. Key safety updates include incidence rates for serious infections, herpes zoster (including multidermatomal HZ), and liver enzyme elevations. Efficacy data is also included to provide a more accurate long-term performance assessment. The report concludes that Xeljanz maintains a positive benefit-risk balance and recommends approval of the variation.

Key findings — cited to the page

Variation type	Type II	· p.3
Multidermatomal herpes zoster cases	2	Study A3921145 · p.4
JIA ACR30 response rate (observed)	88.9 %	Study A3921145 · p.10
Multidermatomal herpes zoster incidence rate	0.21 events per 100 patient-years	Study A3921145 · p.4
ALT elevations > 5 × ULN at 2 consecutive visits	1	Study JIA-I · p.4
ALT elevations > 5 × ULN at 2 consecutive visits (%)	0.4 %	Study JIA-I · p.4
AST or ALT elevations > 5 × ULN at 2 consecutive visits	2	Study A3921145 · p.4
AST or ALT elevations > 5 × ULN at 2 consecutive visits (%)	0.66 %	Study A3921145 · p.4
Patients remaining in study	25 %	Study A3921145 · p.6
Discontinuation due to protocol-defined study completion	51.9 %	Study A3921145 · p.6
Discontinuation for reasons other than AEs or insufficient efficacy	20.5 %	Study A3921145 · p.6
JIA ACR50 response rate (observed)	91.9 %	Study A3921145 · p.10

Source: Pfizer Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →