JointHealth™ express   July 30, 2014

Call for patient input on IV form of certolizumab pegol (Cimzia®) for ankylosing spondylitis

Do you have ankylosing spondylitis or care for someone who does? We need your valuable input.

The Common Drug Review (CDR) is currently welcoming patients and their caregivers to provide input on the manufacturer’s submission for the intravenous (IV) form of certolizumab pegol (Cimzia®) for the treatment of ankylosing spondylitis (AS). Certolizumab pegol has a Health Canada indication for use in combination with methotrexate for reducing signs and symptoms, inducing major clinical response, and reducing the progression of joint damage as assessed by x-ray, in adult patients with moderately to severely active rheumatoid arthritis (RA). It may be used alone for reducing signs and symptoms in patients with moderately to severely active RA who do not tolerate methotrexate.

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 drug formulary 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). Because patient input is vitally important to government decision-making about medications, we would like to gather your views and share them with the CDR.

These are the questions they are asking:
  1. What are the ankylosing spondylitis related symptoms and problems that impact the patients' day-to-day life and quality of life? For example: what aspects of ankylosing spondylitis are more important to control, how does ankylosing spondylitis affect day-to-day life, and are there any activities that the patient is not able to do as a result of ankylosing spondylitis?
  2. How well are patients managing their ankylosing spondylitis with currently available treatments? Examples of the types of information to be included in the answer are:
    • What therapy are patients using for ankylosing spondylitis?
    • How effective is current therapy in controlling the common aspects of ankylosing spondylitis?
    • 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 ankylosing spondylitis?
    • 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 certolizumab pegol for the treatment of ankylosing spondylitis, what are the expectations for the medication?
    • Is it expected that the lives of patients will be improved by certolizumab pegol, and how?
    • Is there a particular gap or unmet patient need in current therapy that certolizumab pegol will help alleviate?
    • Would patients be willing to experience serious adverse effects with certolizumab pegol if they experienced other benefits from the medication?
    • How much improvement in the condition would be considered adequate? What other benefits might certolizumab pegol have, for example, fewer hospital visits or less time off work?
  5. What experiences have patients had to date with certolizumab pegol as part of a clinical trial or through a manufacturer's compassionate supply?
    • What positive and negative effects does certolizumab pegol have on the condition?
    • Which symptoms does certolizumab pegol manage better than the existing therapy and which ones does it manage less effectively?
    • Does certolizumab pegol cause adverse effects?
    • Which adverse effects are acceptable and which ones are not?
    • Is certolizumab pegol easier to use?
    • How is certolizumab pegol expected to change a patient's long-term health and wellbeing?
If you live with ankylosing spondylitis or care for someone with the disease, please send us your input by Friday, August 15, 2014, so that we may submit a report by the August 28 deadline. Your input will be anonymous.

Please contact us at to provide your input or arrange for a phone interview at 604-974-1366.