JointHealth™ express   July 25, 2013

Do you have ulcerative colitis or care for someone who does? We want your valuable input.

The Common Drug Review (CDR) is currently welcoming patients and their caregivers to provide input on the manufacturer’s submission for golimumab (Simponi®) for the treatment of ulcerative colitis. Earlier this year, the U.S. Food and Drug Administration (FDA) approved golimumab for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients. The symptoms of ulcerative colitis have a strong association with seronegative spondyloarthropathies which include diseases such as psoriatic arthritis and ankylosing spondylitis.

The CDR is part of the Canadian Agency for Drugs and Technologies in Health (CADTH). The CDR conducts objective, rigorous reviews of the clinical and cost effectiveness of drugs, and provides formulary listing recommendations to the publicly funded drug plans in Canada (except Quebec).

To help them make their recommendations, the CDR accepts input from patient groups, like Arthritis Consumer Experts (ACE). We would like to gather your views and share them with the CDR.

These are the questions they are asking:
  1. What are the ulcerative colitis related symptoms and problems that impact the patients' day-to-day life and quality of life?
    • For example: what aspects of ulcerative colitis are more important to control, how does ulcerative colitis affect day-to-day life, and are there any activities that the patient is not able to do as a result of ulcerative colitis?
  2. How well are patients managing their ulcerative colitis with currently available treatments? Examples of the types of information to be included in the answer are:
    • What therapy are patients using for ulcerative colitis?
    • How effective is current therapy in controlling the common aspects of ulcerative colitis?
    • Are there adverse effects that are more difficult to tolerate than others?
    • Are there hardships in accessing current therapy?
    • Are there needs, experienced by some or many patients, which are not being met by current therapy?
    • What are these needs?
  3. What challenges do caregivers face in caring for patients with ulcerative colitis?
    • How do treatments impact on the caregivers' daily routine or lifestyle?
    • Are there challenges in dealing with adverse effects related to current therapy?
  4. Based on no experience with golimumab, what are the expectations for the medication?
    • Is it expected that the lives of patients will be improved by golimumab, and how?
    • Is there a particular gap or unmet patient need in current therapy that golimumab will help alleviate?
    • Would patients be willing to experience serious adverse effects with golimumab if they experienced other benefits from the medication?
    • How much improvement in the condition would be considered adequate? What other benefits might golimumab have, for example, fewer hospital visits or less time off work?
  5. What experiences have patients had to date with golimumab as part of a clinical trial or through a manufacturer's compassionate supply?
    • What positive and negative effects does golimumab have on the condition?
    • Which symptoms does golimumab manage better than the existing therapy and which ones does it manage less effectively?
    • Does golimumab cause adverse effects?
    • Which adverse effects are acceptable and which ones are not?
    • Is golimumab easier to use?
    • How is golimumab expected to change a patient's long-term health and well-being?
If you live with ulcerative colitis or care for someone with the disease, please send us your input by Wednesday, July 31, 2013, so that we may submit a report by the August 2 deadline. Your input will be anonymous, unless you expressly state that you wish to have your name or that of the person in your care included in the submission.

Please contact us at to provide your input or arrange for a phone interview.