New Race Goals

I've been feeling antsy. Despite taking up two new sports--golf and tennis--I feel as if something is missing from my life. It took me a while to come to terms with the fact that I was missing running. I had literally stopped running since the Goofy Challenge in January, touting the need to start running for fun rather than to be race-ready, to regain my core passion for the sport. The sad thing was that I was not running for fun as I thought I would; I would not consider running 5K once or twice within four months a commitment to running for pleasure.

I am now seeing a sports nutritionist to get my eating on track for racing in the Scotiabank Half Marathon in September of this year. My goal is to surpass my last personal best by 11 minutes. Today is day three on my nutritional plan; so far, so good.

Health Canada approves Simponi for AS

Health Canada approves new medication for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

(Posted April 29, 2009)

Centocor Ortho Biotech Inc. and Schering-Plough Corporation recently announced that Health Canada has granted approval of Simponi (TM) (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).   With this approval in Canada, Simponi, in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms in adult patients with moderately to severely active RA; reducing signs and symptoms in adult patients with moderately to severely active PsA, alone or in combination with MTX; and reducing signs and symptoms in adult patients with active AS who have had an inadequate response to conventional therapies. According to a company release, this medication is the first biologic therapy to be approved concurrently in three distinct rheumatologic diseases. Schering-Plough anticipates that the medication will become available in Canada in the second half of 2009.   "This first approval marks a major milestone in the clinical development program for Simponi," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc. "More importantly, the approval of Simponi expands the therapeutic options for physicians and offers patients an effective new medication that can be self-administered once monthly."   "This is the first approval for Simponi, one of the five stars in our late-stage pipeline," said Thomas P. Koestler, Ph.D., executive vice president, Schering-Plough Corporation and president, Schering-Plough Research Institute. "Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients. Simponi expands our leading immunology franchise in meeting the needs of the rheumatology community."   Centocor Ortho Biotech Inc. developed and discovered Simponi and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights in Canada and other countries (except for a few) outside the United States. The approval of this medication in Canada is based on data from five pivotal clinical trials: GO-BEFORE, GO-FORWARD, GO-AFTER, GO-REVEAL and GO-RAISE. Each trial found the medication to be effective in reducing the signs and symptoms of RA, PsA and AS.   Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. The first once-monthly subcutaneous anti-TNF-alpha therapy, this medication is available either through the Simponi SmartJect auto injector or a prefilled syringe. It's also being studied as an intravenous infusion therapy for the treatment of rheumatoid arthritis. (Source: PR Newswire - Centocor and Schering-Plough)

Goofy

The Goofy Challenge is just around the corner. Just a few more days before I jet-set to sunny Florida to fulfill my dream goal of running in this particular group of races. I plan on running nice and easy for both the half and full marathons, primarily because I have succumbed to a terrible virus that has left me with severe laryngitis, mild fevers, night sweats, and frequent uncontrollable dry coughing fits. Not very sexy at all. As a result, I can focus on enjoying the scenery, the spectators' cheers of support, the live bands, and the experience of all that is Walt Disney World.

First day on Humira

My package of Humira arrived on December 22nd, perfectly timed with my return from hitting the sloped in Mont Tremblant, Quebec. A Registered Nurse from VON was expected to arrive on Christmas Eve to show me how to administer the medication properly, and to answer any questions I had. I prepared my list of questions in anticipation and waited with bated breath.

I was not impressed with the nurse's skills, I'm afraid. I never told her that we were members of the same registered body, and I almost wished I had: the basic skill of proper hand hygiene was sorely lacking. Despite the nurse telling me that I should wash my hands before injecting myself, she failed to do so and then proceeded to manipulate the area on my abdomen that I had carefully swabbed with alcohol. I swabbed a second time the now-contaminated site, and she once again manipulated the area and then quickly injected me the with medication. I was warned by the pharmacy that the formula was very acidic and burned, but I was not prepared for the intensity with which it stung. Reflexively, I tensed my muscles tightly; the pain was unwavering. The nurse told me, as I watched drops of medicated fluid spill down my stomach (I counted the hundreds of dollars being wasted with every dribble), that my abdominal muscles were creating resistance and pushing the needle out of my body. I was not sure if that was the true cause for the wastage of my precious medication, or if she was not as competent as her professional title implied. I am sorry to be so harsh, but if you been there listening to her...watching her...you would have been shaking your head and wondering if she had ever given a subcutaneous injection before. When I asked her about the side effects, she told me to read the pamphlet that came with the drug; which is all well and good given my nursing background, but she did not know of my clinical expertise and should have explained the side effects instead of directing me to small-printed clinical-trial jargon. She also directed me to do searches on the internet. Geez...why didn't I think of that (sarcasm dripping down the screen so thick you can barely read my blog anymore).

On a more positive note, Progress contact me to find out if the nurse had shown up to provide the instruction and to learn of my experience. I was not brutally honest about my experience with respect to providing all of the details, but I did share my disappointment with the lack of hand washing. Progress committed to following up with VON to have another nurse come on January 6th to provide my second dose and answer any outstanding questions. At this point, I am extremely impressed with the comprehensive case management of Progress; it has certainly eased any anxieties I had starting a new biologic.

Seven days hitting Whistler Blackcomb

It was time, finally, to hit the slopes: eleven days of ripping up powder in Whistler and Mont Tremblant. On December 7th, I ventured out to Whistler, British Columbia for seven days with four close friends. We arrived in Vancouver before 10am and drove the scenic Sea-to-Sky Highway to the Whistler Blackcomb resort. I spotted at least ten spectacular bald eagles resting on tree tops and soaring the bluebird sky as we made our way through Squamish.

Little did we know, but we would be present for the grand opening of the Peak to Peak Gondola that spans the 4.4km distance between the peaks of Whistler and Blackcomb mountains. The Guinness Book of World Records, along with hoards of media, descended on Whistler Village during the week prior to the Gondola's opening on December 12th--mainly because over three world records had been broken by this impressive engineering masterpiece.

I boarded on Blackcomb for two days and hit Whistler for three this week. Unfortunately, tearing up the snow for six hours every day took a toll on my lower back. I started flaring on my second night with terrible night sweats, stiffness, and back pain. I tried to suck it up and stick it out, but the stiffness worsened each day after that. By Thursday December 11th, I could barely stand up after strapping myself on my board. I had a noticeable difficult time walking...lifting each leg to propel me forward was met with significant stiffness and pain (the SI joint being the pivot point). Extra-strength Motrin took the edge off the pain a bit, but my mobility became progressively hindered. Needless to say, it's impossible for me to bend forward (friends help me don my socks and shoes/boots), and most mobilization requires some creative movements if I don't have friends nearby to assist. After five straight days of exploring the terrain on both mountains, I decided to give my body a break during my last two days here and enjoy the activities the Village offered: shopping, restaurants, apres, soaking in the hot-tub with friends and beer, and night life fun. I wanted to allow my body time to recover before leaving for Mont Tremblant on December 18th. With all of the snow Tremblant has experienced so far, I anticipated taking in some hardcore powder during my four day stay there.

The weather has been a bit wonky this week, with spring-like conditions at the base of the mountains, and a light foundation at the peak, resulting in the limited access to trails and runs on both summits and forcing every level of alpinist to share the track. There was a frustrating disorganized convergence of people from novice toddlers to professional racers. Everyone became either a target or an obstacle to avoid; I even overheard the mountain guides and safety patrol comment on the chaos. I was guilty of taking out a few people, and suffered the forceful impacts of others' uncontrolled speed. We relished the light dusting of snow on the peak on Tuesday and delighted on Friday when we awoke to the first snow gracing the Village (which meant that the peaks would have enough snow to conceal the icy 57cm snowbase for the morning crowd). Today was -25 degrees Celsius at the peak (with 57km/hr winds) and -12 degrees in the valley. The winds howled through the Village too. I was still struggling to mobilize my legs which forced me to walk slower than normal and endure the bone-chilling temperature. I was glad I was not on the peaks today. Instead, I spent the day shopping for snow-sport clothing, and the evening celebrating friendships over internationally-acclaimed fine dining at Araxi Restaurant and Lounge.

I'm LOVING the apres!!!

Humira Welcome Package Arrives

In Canada, support services are provided by the Progress Program for Canadian patients with Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis, Ankylosing Spondylitis, or Crohn's taking Humira. They have nurses available around the clock to answer any questions, as well as cost reimbursement specialist to assist patients in optimizing reimbursement of Humira.

My Humira Starter Kit arrived today by FedEx from my Support Specialist at the Progress Program. Inside was a 2-compartment bag containing a journal, Humira Treatment Guide, 5 Steps card, an information booklet, a magnetic compliance device, a Medical Alert card, a Progress magnet, a DVD, Welcome card, demo auto-injector pen, a cooler bag, a reusable ice pack, and a Sharps disposable container.

I am now awaiting their pharmacy to deliver the medication to my home, and a home-care nurse to visit and walk me through using Humira. I have been reading about others' experience switching to Humira from Enbrel. The pattern has been that Enbrel initially relieves the disabling symptoms, but the relief wears off. Noticeable improvement occurs for most after switching to Humira. This is not to say that the same thing won't happen with Humira, or any other biologic; perhaps the beneficial effects are time limited. Unfortunately, we are the guinea pigs for long-term studies on this group of medications.

Still waiting

Well, I'm still waiting for the Humira to arrive. A community agency representative contacted me today to confirm that my private health benefits will cover 90% of the cost of the medication. She indicated Humira costs approximately $1600 each month (that's only two injections), so any reprieve from the full expense is a blessing.

I found a Canadian health advisory for Humira that I thought may interest readers:

HEALTH CANADA ADVISORY

January 13, 2006

Health Canada has issued new warnings concerning the use of Humira(adalimumab). To read the full Health Canada Advisory, visit Health Canada's web site at: http://www.hc-sc.gc.ca.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately. The needle cover on the pre-filled syringe contains dry natural rubber. Before you start injections, tell your doctor if you have an allergy to rubber or latex.

Blood disorders: Rarely, people taking this medication have become deficient in certain types of blood cells. If you notice signs of infection (such as fever, shaking or chills, fast heartbeat, or quick breathing) or bleeding (such as easy bruising, blood in the stools, black tarry stools, or vomiting blood or material that looks like coffee grounds), seek immediate medical attention.

Cancer: Compared to the general population, people taking adalimumab have a slightly greater risk of developing a cancer of the immune system (known as lymphoma). However, the risk is still small. In general, people with severe rheumatoid arthritis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take adalimumab. If you experience any of the following or other unusual symptoms, contact your doctor immediately:

• chills
• decreased appetite
• fever
• night sweats
• one or more enlarged lymph node
• unusual fatigue
• weight loss

Signs and symptoms of lymphoma can vary depending on the extent of the disease and the parts of the body involved (e.g., chest, abdomen or bowel).

Heart failure: Adalimumab may cause congestive heart failure (CHF) or worsen existing CHF. People with CHF should be monitored closely by their doctors. Symptoms to watch out for include swelling of the feet and ankles and shortness of breath. If you notice these symptoms, contact your doctor immediately.

Infections: This medication, or other TNF blockers, can increase the risk of developing infections such as tuberculosis and those caused by bacteria and fungi. If you notice signs of an infection such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible. Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections, including fungal infections. This medication should not be used in combination with anakinra, as this can increase the risk of severe infections.

Immune system disorders: Some people who take this medication have developed lupus-like syndrome, an autoimmune disease (a condition where the body is attacked by its own immune system). Symptoms of lupus-like syndrome include chest pain, joint pain, difficulty breathing, and a skin rash (usually on the cheeks and arms) that is sensitive to the sun. If you develop these symptoms, contact your doctor as soon as possible.

Liver problems: Very rarely, people taking adalimumab may experience liver problems. Symptoms of liver problems include:

• abdominal pain
• dark urine
• fatigue
• loss of appetite
• yellow eyes or skin

If you notice these symptoms, contact your doctor immediately. People infected with hepatitis B (an infection that can damage the liver) may have a relapse of their condition while taking this medication. If you are at risk for hepatitis B, your doctor may want to test you for this infection before starting treatment with adalimumab, and will follow your condition closely while you are taking the medication. If you notice symptoms of a liver problem (see above), contact your doctor immediately.

Nervous system diseases: Rare cases of disorders that affect the nervous system have been reported by people taking adalimumab or other TNF blockers. If you are experiencing numbness and tingling, vision problems, weakness in your legs, and dizziness, contact your doctor immediately.

Pregnancy: This medication is not recommended for use during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks.

Breast-feeding: It is not known if adalimumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication has not been established for children.