PFIZER SHARES CO-PRIMARY ENDPOINT RESULTS FROM POST-MARKETING REQUIRED SAFETY STUDY OF XELJANZ? (TOFACITINIB) IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA)
Tofacitinib 5 mg BID |
Tofacitinib 10 mg BID** |
Tofacitinib Doses Combined |
TNFi |
|
Total number of subjects |
1455 |
1456 |
2911 |
1451 |
Number of subjects with first event within the risk period*** (%) |
47 (3.23) |
51 (3.50) |
98 (3.37) |
37 (2.55) |
Person-years |
5166.32 |
4871.96 |
10038.28 |
5045.27 |
IR (95% CI) (number of subjects with event/100 person-years) |
0.91 (0.67, 1.21) |
1.05 (0.78, 1.38) |
0.98 (0.79, 1.19) |
0.73 (0.52, 1.01) |
HR (95% CI) for tofacitinib vs TNFi |
1.24 (0.81, 1.91) |
1.43 (0.94, 2.18) |
1.33 (0.91, 1.94)**** |
Tofacitinib 5 mg BID |
Tofacitinib 10 mg BID** |
Tofacitinib Doses Combined |
TNFi |
|
Total number of subjects |
1455 |
1456 |
2911 |
1451 |
Number of subjects with first event within the risk period*** (%) |
62 (4.26) |
60 (4.12) |
122 (4.19) |
42 (2.89) |
Person-years |
5491.48 |
5311.71 |
10803.19 |
5482.30 |
IR (95% CI) (number of subjects with event/100 person-years) |
1.13 (0.87, 1.45) |
1.13 (0.86, 1.45) |
1.13 (0.94, 1.35) |
0.77 (0.55, 1.04) |
HR (95% CI) for tofacitinib vs TNFi |
1.47 (1.00, 2.18) |
1.48 (1.00, 2.19) |
1.48 (1.04, 2.09)**** |
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
- XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
- Limitations of Use: Use of XELJANZ in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
- XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
- Limitations of Use: Use of XELJANZ/XELJANZ Oral Solution in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ use.
- Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
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