This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

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)



Mean (SD) a
  XELJANZ 5 mg

Twice Daily


Mean (SD) a
  XELJANZ 5 mg

Twice Daily

Mean Difference

from Placebo b

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)



Mean (SD) a
  XELJANZ 5 mg

Twice Daily


Mean (SD) a
  XELJANZ 5 mg

Twice Daily

Mean Difference

from MTX b

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.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs