Abbott Announces First Long-term Patient-reported Health Outcomes Data For Investigational Use Of HUMIRA® (Adalimumab) In Patients With Active Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
AxSpA can be a debilitating disease most often seen in younger individuals in their most productive time of life, and can go unrecognized for years. AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, primarily presents with chronic back pain and stiffness, and can be accompanied by the presence of arthritis, inflammation in the eye and/or gastrointestinal tract. People with nr-axSpA can have similar signs and symptoms as AS – including inflammation that can lead to chronic pain and loss of function – but do not have X-ray evidence of structural damage.
"Patient-reported outcomes data focusing on physical function and health-related quality of life help measure the impact treatment has on patients in their day-to-day life," said John R. Medich, Ph.D., divisional vice president, Immunology Clinical Development, Global Pharmaceutical Research and Development, Abbott. "Because there are currently so few treatment options available to help patients with non-radiographic axSpA, Abbott remains committed to exploring ways HUMIRA can help improve the care and outlook for this patient population."
In the open-label extension, both the investigator and patient knew that patients were receiving HUMIRA. Additionally, open-label extension data may be enriched as patients who remain in the study long-term tend to do better than those who drop out. Physical function and SF-36 PCS were two of nine secondary endpoints evaluated in the double-blind portion of the study, all of which were statistically significant for HUMIRA versus placebo.
Additional results from the double-blind period showed that nr-axSpA patients taking HUMIRA experienced a statistically significantly greater improvement in HAQ-S as compared to placebo (-0.3 versus -0.1 respectively; P=0.025.) at week 12, as well as a statistically significantly greater improvement in SF-36 PCS (5.5 versus 2.0, respectively; p<0.001) at week 12. Patients were then entered into an open-label period, in which all participants (n=179) could receive HUMIRA, and were asked to again complete the health assessment questionnaires at week 52.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV