Sunday, November 09, 2008
In Memory of Valor
I haven't posted the past few days as I just didn't have the desire. Valor passed at 2:30 p.m. yesterday. He passing was peaceful. His head was in my lap and my voice was the last thing he heard, my face the last he saw. The vet stated that he agreed with our decision and it was time. It made it no more painful for us, but we know that ending Valor's suffering was the right thing to do. I cried myself to sleep last night, holding onto one of Valor's toys. I woke with it wrapped in my arms this morning. Fortunately, we had an early morning flight and, as we overslept, there was no time to think about anything else but making the plane. It wasn't until we were in the air that Valor was mentioned. The healing process is going to take some time.
Wednesday, November 05, 2008
Valor Update
Well, Mark heard from the vet about Valor's lab result. Kidney failure it is. The good news is that the shot Valor received from the vet yesterday to calm his tummy seems to have helped him. He kept down the small amount of mashed chicken, rice and green beans he had for dinner last night. His water consumption is still down, but Mark noticed the water level in his water bowl was a little lower this morning. Now, it's decision time. Valor is almost 10 and we have seen a big change in the last month, not to mention the five months before that. Do I selfishly hold on to him as long as I can, and he suffers. Or do I make a decision and help Valor go chase those butterflies in heaven sooner than I want him to? My head has already made the "rational" decision, but my heart is having a tough time.
Energy update
In spite of the emotional stress with Valor right now, I am pleased to say I'm seeing improvement (FINALLY) with the MS. As you know this summer was one long exacerbation that wouldn't ease up. As a result I had all kinds of new challenges. Optic Neuritis was a new experience and a wheelchair became my friend. What a summer! Being the scrapper that I am, I refused to just sit in a wheelchair and feel sorry for myself. (WAY to counterproductive). I tried to walk everyday. Even if all I could walk was from the chair and take two step to the recliner. Now, I'm probably spending half the day on my feet and half the day in the chair. It depends on my energy level and how strong my leg feels. This past week my energy level has really boosted up. In fact I felt so good on Saturday I did too much and as a result was down Sunday with zero energy. I hope to get to the point where soon I will only use the chair for energy conservation. Meaning if I'm out and about to shop etc. My right eye is a bit better, but still has some to go. Other MSers have told me that after their bouts with optic neuritis it took some of them a year before their eyes were "back to normal", so I have to be patient with that. At least I don't have a large black area in my vision anymore. My hands are still hit and miss. My fine motor skills with my hands can vary from day to day. So that may be something that just "Is the way it is". (You know I wrote that just for you Mom :0)~ So, it seems my body IS rebounding from the exacerbation. Thank God. A reminder to never give up. No matter how tough things are, or how bad they seem. Give the challenges to God, then give him time to work.
Tuesday, November 04, 2008
Valor
Been a heck of a few days. My dog, Valor, who is almost 10 has been sick. I've noticed a decline in the past few months and now he's sick. Each feeding is a gamble it seems. His ability to keep food down is hit and miss. We're now mashing green beans for him, soaking his kibble until it's mush and mixing it with rice. Feeding him about 2 tablespoons at a feeding to try and help his stomach keep it down. More worrisome is the fact he has almost completely stopped drinking and he's had some swelling in his rear legs. Today he's going back to the vet for the third time in 2 weeks. I pray I don't have to make a difficult decision. I was always hoping that when his time came he would go quietly in his sleep, chasing a butterfly to the heavens. Not looking at me with sad brown eyes, as if he's telling me "It's almost time". It's amazing how much our "pets" come to mean to us. For some, they will say, "he's just a dog" and don't understand the emotional attachment. Some, will understand completely as their "pets" are just as much family to them as Valor is to my husband and I. Valor of course, is so much more. Our friends know his history and how Valor and I became a "team" and I can't imagine my life without my "partner". I'll keep everyone posted on the blog. Please say some prayers for Valor. I pray for more time. I pray the vet can come up with a "magic pill" to give us more time, and if he can't I pray that God gives me the strength to do what's best for Valor and not what's easiest for me.
Saturday, November 01, 2008
Investigators Recruiting Participants with MS for Studies of Alemtuzumab
Here are the reports regarding the Phase 2 trial of Alemtuzumab.
Alemtuzumab Results Published: Reduced MS Relapses and Accumulation of Disability in Phase 2 Trial. Treatment with alemtuzumab (Genzyme Corporation) reduced the accumulation of disability and the frequency of relapses in people with early relapsing-remitting MS, compared to Rebif® (interferon beta-1a, EMD Serono, Inc. and Pfizer, Inc.). Those taking alemtuzumab had a 74% reduction in the risk of MS relapse compared with those on Rebif, and a 71% reduction in the risk for sustained accumulation of disability. Those on alemtuzumab, an immune-suppressing monoclonal antibody, experienced adverse events more frequently, including immune thrombocytopenic purpura (a serious bleeding disorder), thyroid adverse events, and infections. The results, originally reported at medical meetings, have now been published (New England Journal of Medicine 2008 359;17: 30-45), and two Phase 3 trials are currently recruiting participants with relapsing-remitting MS.
Background and Details
Alemtuzumab is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) that is currently approved by the U.S. Food and Drug Administration as a single agent for treatment of patients with B-cell chronic lymphocytic leukemia. Its ability to target immune cells has led investigators to test its potential as a treatment for relapsing-remitting MS.
Drs. D. Alastair Compston, Alasdair J. Coles (University of Cambridge, UK) and colleagues have now published results of phase 2 clinical trial that compared high and low doses of alemtuzumab (given by IV infusion over three to five days once a year) with Rebif, a standard MS therapy, in 334 people with early relapsing-remitting MS who had never taken any other disease-modifying therapies. The primary outcomes were the time to sustained accumulation of disability and the rate of relapse.
Those in the alemtuzumab groups were slated to receive two to three cycles of the annual infusion. However, dosing was temporarily suspended due to the occurrence of immune thrombocytopenic purpura (ITP), a rare condition in which low blood platelet counts can lead to abnormal bleeding. After the first cases of ITP occurred, one of which was fatal, Genzyme implemented a patient safety monitoring program which includes patient and physician education and regular contacts with patients. A total of six alemtuzumab-associated ITP cases were identified and, when necessary, promptly treated.
Most of those on alemtuzumab received their second infusion cycle (207 out of 223 total), but fewer went on to receive a third cycle (46 out of 223). The results reported in this publication follow the participants out to 36 months of the study.
Results
The results were nearly the same for the two doses of alemtuzumab, so the data for patients receiving this drug were pooled for the comparison with Rebif. After thirty-six months, those taking alemtuzumab experienced significant reductions in the risk of MS relapse compared with those taking Rebif (74% reduction, with an annualized relapse rate of 0.36 for Rebif versus 0.10 for alemtuzumab) as well as significant reductions in the risk for progression of disability compared with those taking Rebif (71% reduction). Among secondary outcomes that were measured, significantly more of those on alemtuzumab remained relapse-free at 36 months (52% for Rebif and 80% for alemtuzumab). In addition, the mean disability score (EDSS) for those on alemtuzumab improved slightly (by 0.39 point) while the mean score of those on Rebif declined slightly (by 0.38 point).
Among other side effects reported in the Phase 2 study, patients who received alemtuzumab were more likely to develop thyroid disease and mild to moderate infections (i.e., infections requiring no specific medical intervention or requiring only oral medication). Thyroid problems are reported to have been easily detected and treated. Patients who received Rebif experienced injection site reactions, fatigue, flu-like illness, headache and abnormal liver function tests.
Mary Ann Holm, MSW
Manager, Clinical Services
National Multiple Sclerosis Society
Southern California Chapter
2440 S. Sepulveda Blvd., Suite 115
Los Angeles, CA 90064
Tel +310 479-4456 x121
If you would like more information, or pehaps be interested in participating the the phase 3 trail go to this link for more information: http://www.nationalmssociety.org/research/research-news/news-detail/index.aspx?nid=231
Alemtuzumab Results Published: Reduced MS Relapses and Accumulation of Disability in Phase 2 Trial. Treatment with alemtuzumab (Genzyme Corporation) reduced the accumulation of disability and the frequency of relapses in people with early relapsing-remitting MS, compared to Rebif® (interferon beta-1a, EMD Serono, Inc. and Pfizer, Inc.). Those taking alemtuzumab had a 74% reduction in the risk of MS relapse compared with those on Rebif, and a 71% reduction in the risk for sustained accumulation of disability. Those on alemtuzumab, an immune-suppressing monoclonal antibody, experienced adverse events more frequently, including immune thrombocytopenic purpura (a serious bleeding disorder), thyroid adverse events, and infections. The results, originally reported at medical meetings, have now been published (New England Journal of Medicine 2008 359;17: 30-45), and two Phase 3 trials are currently recruiting participants with relapsing-remitting MS.
Background and Details
Alemtuzumab is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) that is currently approved by the U.S. Food and Drug Administration as a single agent for treatment of patients with B-cell chronic lymphocytic leukemia. Its ability to target immune cells has led investigators to test its potential as a treatment for relapsing-remitting MS.
Drs. D. Alastair Compston, Alasdair J. Coles (University of Cambridge, UK) and colleagues have now published results of phase 2 clinical trial that compared high and low doses of alemtuzumab (given by IV infusion over three to five days once a year) with Rebif, a standard MS therapy, in 334 people with early relapsing-remitting MS who had never taken any other disease-modifying therapies. The primary outcomes were the time to sustained accumulation of disability and the rate of relapse.
Those in the alemtuzumab groups were slated to receive two to three cycles of the annual infusion. However, dosing was temporarily suspended due to the occurrence of immune thrombocytopenic purpura (ITP), a rare condition in which low blood platelet counts can lead to abnormal bleeding. After the first cases of ITP occurred, one of which was fatal, Genzyme implemented a patient safety monitoring program which includes patient and physician education and regular contacts with patients. A total of six alemtuzumab-associated ITP cases were identified and, when necessary, promptly treated.
Most of those on alemtuzumab received their second infusion cycle (207 out of 223 total), but fewer went on to receive a third cycle (46 out of 223). The results reported in this publication follow the participants out to 36 months of the study.
Results
The results were nearly the same for the two doses of alemtuzumab, so the data for patients receiving this drug were pooled for the comparison with Rebif. After thirty-six months, those taking alemtuzumab experienced significant reductions in the risk of MS relapse compared with those taking Rebif (74% reduction, with an annualized relapse rate of 0.36 for Rebif versus 0.10 for alemtuzumab) as well as significant reductions in the risk for progression of disability compared with those taking Rebif (71% reduction). Among secondary outcomes that were measured, significantly more of those on alemtuzumab remained relapse-free at 36 months (52% for Rebif and 80% for alemtuzumab). In addition, the mean disability score (EDSS) for those on alemtuzumab improved slightly (by 0.39 point) while the mean score of those on Rebif declined slightly (by 0.38 point).
Among other side effects reported in the Phase 2 study, patients who received alemtuzumab were more likely to develop thyroid disease and mild to moderate infections (i.e., infections requiring no specific medical intervention or requiring only oral medication). Thyroid problems are reported to have been easily detected and treated. Patients who received Rebif experienced injection site reactions, fatigue, flu-like illness, headache and abnormal liver function tests.
Mary Ann Holm, MSW
Manager, Clinical Services
National Multiple Sclerosis Society
Southern California Chapter
2440 S. Sepulveda Blvd., Suite 115
Los Angeles, CA 90064
Tel +310 479-4456 x121
If you would like more information, or pehaps be interested in participating the the phase 3 trail go to this link for more information: http://www.nationalmssociety.org/research/research-news/news-detail/index.aspx?nid=231
Halloween Wrap-up
Halloween was great at my house. My husband and I sat on the porch and passed candy out to all the kids. We had OVER 100 fairies, witches, pirates and other assorted characters stop by. (We had 130 candy bars, gave ONE to each little ghoul and had only 3 left. We actually went inside with kids still out as we didn't want a group of kids come up and not have enough candy for the group. We know next year to have 200 bars)! An amazing number, especially since it was RAINING! Of course, the little one's are always my favorite. They are just too cute. We had several that could barely walk, holding mom or dads hand when they came up. Of course, it made me miss my grand kids even more as they are too far away for me to see their costumes. However, I have to say my favorite of the evening was a teeny one in a skunk costume who darted by the house. Too excited to even stop for candy. We laughed quite a bit over that one. With the rain it was a bit on the cool side, not to mention WET! That sure didn't stop the fun though. I hope everyone enjoyed their Halloween as much as we did our!
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