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Pfizer Announces FDA Approval To Include Radiographic Data On Reduction Of Progression Of Structural Joint Damage For Adults With Moderately To Severely Active Rheumatoid Arthritis In Labeling For XELJANZ® (tofacitinib Citrate)

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the current label of XELJANZ ® (tofacitinib citrate) 5 mg tablets to include radiographic data from two Phase 3 studies, ORAL Scan (A3921044) and ORAL Start (A3921069). “XELJANZ is the first oral JAK inhibitor for moderately to severely active rheumatoid arthritis. The reduction of radiographic progression seen in ORAL Scan and ORAL Start represents a clinically meaningful outcome for patients,” said Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business.

XELJANZ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). XELJANZ may be used as a single agent or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine is not recommended. The recommended dose is 5 mg twice-daily (BID).

The U.S. Prescribing Information contains a boxed warning for serious infections and malignancies. Patients treated with XELJANZ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as MTX or corticosteroids. Lymphoma and other malignancies have been observed in patients treated with XELJANZ.

The updated U.S. label now includes the radiographic response data from ORAL Scan (Study IV) at 6 months and ORAL Start (Study VI) at 6 and 12 months (see detailed study descriptions below the table). These studies evaluated the effect of XELJANZ on the progression of structural joint damage as measured by mean change from baseline in van der Heijde modified Total Sharp Score (mTSS) and its components, erosion score and joint space narrowing (JSN) score. The proportion of patients with no radiographic progression (mTSS change from baseline less than or equal to 0) was also assessed.

Radiographic Changes at Months 6 and 12
   

Study IV (ORAL Scan)
    Placebo

 

N=139

Mean (SD) a
  XELJANZ 5 mg

Twice Daily

N=277

Mean (SD) a
  XELJANZ 5 mg

Twice Daily

Mean Difference

from Placebo b

(CI)
mTSS(c)      
Baseline 33 (42) 31 (48) -
Month 6   0.5 (2.0)   0.1 (1.7)   -0.3 (-0.7, 0.0)
   

Study VI (ORAL Start)
    MTX

 

N=166

Mean (SD) a
  XELJANZ 5 mg

Twice Daily

N=346

Mean (SD) a
  XELJANZ 5 mg

Twice Daily

Mean Difference

from MTX b

(CI)
mTSS(c)
Baseline 17 (29) 20 (40) -
Month 6 0.8 (2.7) 0.2 (2.3) -0.7 (-1.0, -0.3)
Month 12   1.3 (3.7)   0.4 (3.0)   -0.9 (-1.4, -0.4)

aSD = Standard Deviation bDifference between least squares means XELJANZ minus placebo or MTX (95% CI = 95% confidence interval) CMonth 6 and Month 12 data are mean change from baseline.

In the placebo plus MTX group in ORAL Scan (Study IV), 74 percent of patients experienced no radiographic progression at Month 6 compared to 84 percent of patients treated with XELJANZ 5 mg BID plus MTX.

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