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EFFICACY AND SAFETY OF SCIG FOR CIDP TREATMENT

Marinos Dalakas, MD, Neurology, discusses the results of a study using SCIG for treating CIDP.

GAMUNEX-C is not indicated for subcutaneous administration in the treatment of CIDP.

Transcript

EFFICACY AND SAFETY OF SCIG FOR CIDP TREATMENT

 

Marinos Dalakas, MD, Neurology, discusses the results of a study using SCIG for treating CIDP.

Interviewer: Doctor, you wrote an article in the Lancet Neurology about an IG product for chronic inflammatory demyelinating polyneuropathy or CIDP, could you tell us a little bit about the study?

Dr. Dalakas: Yes, this was an editorial I wrote regarding this study. This was an important study because it was the first study with the subcutaneous immunoglobulin involving the largest number of patients ever enrolled into a controlled study. The study had three arms, one-third of patients were randomized to placebo, another third were randomized to a lower dose of subcutaneous immunoglobulin and the other third to high dose of subcutaneous immunoglobulin. The duration of the study was 24 weeks and then it had an extension period for another 24 weeks. And it did show that the patients on subcutaneous immunoglobulin, had less number of relapses compared to the placebo.

Interviewer: Okay, in the study 19% of the patients receiving high dose SCIG and 33% receiving low dose SCIG relapsed. What should be considered when you look at relapse rates in SCIG and how does that affect patients switching from IVIG to SCIG?

Dr. Dalakas: This is an important point because the patients before have been stable using the intravenous immunoglobulin. And now the patients were switched to subcutaneous immunoglobulin and relapsed.

Interviewer: Okay, the patients in the study who were given IVIG rescue therapy, a few of these patients did not return to baseline. When it comes to using rescue therapy, what should a physician consider? Why do some of these patients not return to baseline?

Dr. Dalakas: Yeah, that's an interesting question and we really don't know exactly the answer, but I have speculated in my article that the patients probably did not go back to the baseline because they have been off the immunoglobulin for quite some time.

Interviewer: Okay. In the study, several patients dropped out due to reasons unrelated to relapse, could you elaborate on why that might be?

Dr. Dalakas: Well, probably several reasons, to do the subcutaneous immunoglobulin you have to inject yourself in several areas around on the skin particularly the abdomen or the thighs and it is done subcutaneously. It takes about an hour or two to do it in parallel sides.

Interviewer: The study authors mentioned frustration with pumps as possible causes, do you think that could be the case?

Dr. Dalakas: Yes, I think, it's one of the reasons, because it's really sort of the process to take the pump. And to take the needles, the tubes to insert the needles. And then sometimes there's a leak of the fluids outside.

Interviewer: Okay, now how may cost figure into SCIG consideration for patients?

Dr. Dalakas: Yes, this is an interesting question. Theoretically, you will suspect that the subcutaneous should be less expensive than the intravenous and the reason is, it requires less nursing care, you do it, you administer the product by yourself, but it turns out not to be the case because the subcutaneous product has its own expenses--it's an expense of the pump, of the tubing, training, so these are additional expenses. But on top of that, the amount of immunoglobulin used for subcutaneous is higher than the IVIG so the cost comes essentially a little higher. I don't know the numbers but, it is not less expensive.

Interviewer: And one final question for you. Overall, how do you hope that this study will influence the prescribing habits of neurologists?

Dr. Dalakas: Well, it is-- We have a choice that patients have a choice and we as therapists have a choice, so, as I mentioned in high-risk patients, I have a solution here, that I didn't have before.

gives us a better freedom in treating the disease.

Interviewer: Okay. Thank you so much, Dr. Dalakas.

Dr. Dalakas: All right.

Interviewer: It was a pleasure.

Dr. Dalakas: Pleasure, thank you.

Transcript

EFFICACY AND SAFETY OF SCIG FOR CIDP TREATMENT

 

Marinos Dalakas, MD, Neurology, discusses the results of a study using SCIG for treating CIDP.

Interviewer: Doctor, you wrote an article in the Lancet Neurology about an IG product for chronic inflammatory demyelinating polyneuropathy or CIDP, could you tell us a little bit about the study?

Dr. Dalakas: Yes, this was an editorial I wrote regarding this study. This was an important study because it was the first study with the subcutaneous immunoglobulin involving the largest number of patients ever enrolled into a controlled study. The study had three arms, one-third of patients were randomized to placebo, another third were randomized to a lower dose of subcutaneous immunoglobulin and the other third to high dose of subcutaneous immunoglobulin. The duration of the study was 24 weeks and then it had an extension period for another 24 weeks. And it did show that the patients on subcutaneous immunoglobulin, had less number of relapses compared to the placebo.

Interviewer: Okay, in the study 19% of the patients receiving high dose SCIG and 33% receiving low dose SCIG relapsed. What should be considered when you look at relapse rates in SCIG and how does that affect patients switching from IVIG to SCIG?

Dr. Dalakas: This is an important point because the patients before have been stable using the intravenous immunoglobulin. And now the patients were switched to subcutaneous immunoglobulin and relapsed.

Interviewer: Okay, the patients in the study who were given IVIG rescue therapy, a few of these patients did not return to baseline. When it comes to using rescue therapy, what should a physician consider? Why do some of these patients not return to baseline?

Dr. Dalakas: Yeah, that's an interesting question and we really don't know exactly the answer, but I have speculated in my article that the patients probably did not go back to the baseline because they have been off the immunoglobulin for quite some time.

Interviewer: Okay. In the study, several patients dropped out due to reasons unrelated to relapse, could you elaborate on why that might be?

Dr. Dalakas: Well, probably several reasons, to do the subcutaneous immunoglobulin you have to inject yourself in several areas around on the skin particularly the abdomen or the thighs and it is done subcutaneously. It takes about an hour or two to do it in parallel sides.

Interviewer: The study authors mentioned frustration with pumps as possible causes, do you think that could be the case?

Dr. Dalakas: Yes, I think, it's one of the reasons, because it's really sort of the process to take the pump. And to take the needles, the tubes to insert the needles. And then sometimes there's a leak of the fluids outside.

Interviewer: Okay, now how may cost figure into SCIG consideration for patients?

Dr. Dalakas: Yes, this is an interesting question. Theoretically, you will suspect that the subcutaneous should be less expensive than the intravenous and the reason is, it requires less nursing care, you do it, you administer the product by yourself, but it turns out not to be the case because the subcutaneous product has its own expenses--it's an expense of the pump, of the tubing, training, so these are additional expenses. But on top of that, the amount of immunoglobulin used for subcutaneous is higher than the IVIG so the cost comes essentially a little higher. I don't know the numbers but, it is not less expensive.

Interviewer: And one final question for you. Overall, how do you hope that this study will influence the prescribing habits of neurologists?

Dr. Dalakas: Well, it is-- We have a choice that patients have a choice and we as therapists have a choice, so, as I mentioned in high-risk patients, I have a solution here, that I didn't have before.

gives us a better freedom in treating the disease.

Interviewer: Okay. Thank you so much, Dr. Dalakas.

Dr. Dalakas: All right.

Interviewer: It was a pleasure.

Dr. Dalakas: Pleasure, thank you.


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GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIG products containing sucrose. GAMUNEX-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.

GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Severe hypersensitivity reactions may occur with IVIG products, including GAMUNEX-C. In case of hypersensitivity, discontinue GAMUNEX-C infusion immediately and institute appropriate treatment.

Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C.

There have been reports of aseptic meningitis, hemolytic anemia, and noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) in patients administered with IVIG, including GAMUNEX-C.

The high-dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation.

Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter.

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis.

If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation.

If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient's serum.

After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.

In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia (in CIDP); cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis with intravenous use (in PIDD) and local infusion-site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia with subcutaneous use (in PIDD); and headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia (in ITP).

The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Please see accompanying full Prescribing Information for GAMUNEX-C.

Terms to know

IG, immune globulin; CIDP, chronic inflammatory demyelinating polyneuropathy; PIDD, primary immunodeficiency disease; ITP, idiopathic thrombocytopenic purpura; sub Q, subcutaneous; IV, intravenous; ICE, 10% caprylate-chromatography purified immune globulin intravenous (IGIV-C) CIDP efficacy.

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