Systemic Lupus Erythematosus Analysis
Systemic Lupus Erythematosus Treatments
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease. It harms the skin, joints, kidneys, lungs, nervous system, and the serous membranes (Specchia et al, 2014, p.1). The symptoms in patients most commonly involve a mixture of skin conditions that affect one’s muscles, bones, and joints. Furthermore, SLE can have blood and blood serum symptoms. Women are more commonly affected than men, and the disease is diagnosed in patients aged 15 to 45 (Phung, 2011, p.118). SLE has no cure, but there are medicines and treatments that can help control it. Current medicines available to give to a person who has symptoms limited to one specific organ of the body. They include high doses …show more content…
of nonsteroidal anti-inflammatory drugs, which reduce inflammation and relieve fever and pain by blocking enzymes and proteins made by the body. Corticosteroids are used to provide relief for inflamed areas of the body, such as to lessen swelling redness, and even itching. Antimalarial agents can treat skin rashes and prevent lupus flares. Finally, immunosuppressant drugs prevent activity of the immune system. (Specchia et al, 2014, p. 2). These types of medicines are prescribed based on the individual patient’s severity of SLE.
In regards to treating SLE, short and medium-term outcomes have been made for patients. Prolonged corticosteroids and immunosuppressant drugs have been associated with iatrogenic morbidity such as a buildup of plaque around the artery wall and infections (Marthian et al, 2015, p. 836). However, in some SLE patients the disease is aggressive and unresponsive to these traditional treatments. Therefore, several new treatments in biotherapies are currently being developed. These new biotherapies aim to decrease negative side effects related to a specific treatment and improve long-term clinical outcomes
Also, T cells, B cells, and cytokines all have a role in SLE. T cells are lymphocytes produced or processed by the thymus gland and actively participating in the immune response. B cells, which is a lymphocyte not processed by the thymus gland, and is responsible for. producing antibodies. Cytokines are important in cell singing and promoting systemic inflammation (Phung, 2011, p. 118).
In the last 50 years, belimumab also known as benlysta is the first new drug for the treatment of SLE approved by Food and Drug Admission, on March 9, 2011. (Phung, 2011, p. 118). Belimumab is a B-lymphocyte stimulator. Therefore, B cells participate in regulating the immune system of SLE on multiple levels by serving as the forerunner of antibody secreting cells, helping inflammation, and regulating other immune cells (Specchia et al, 2014, p.2).
In Japan, a study of 16 healthy Japanese men was solely conducted to evaluate the safely of belimumab. Also, the open label, randomized single dose study wanted to evaluate body absorption, distribution, metabolism and excretion (Shida,et al, 2014, p. 97). The patients were assigned to receive a single dose of 200 K=mg of belimumab, either injected by a subcutaneous injection or an intravenous infusion.
The random groups were based on body weight, due to avoiding an excessive imbalance in body weight between subcutaneous injections and intravenous infusion groups. In the IV group, a liquid form of belimumab was given in normal saline at a constant rate over one hour. In the SC group injections of belimumab was given in the thigh for approximately 10 to 15 seconds.
To ensure the patients safety were evaluated not only during the treatment, but 70 days after. A wide range of factors were evaluated, such as their vital signs, electrocardiogram findings, blood, urine, rashes, and pain (Shida et al, 2014, p.98). Also, the evolution of plasma concentrations, diseases, infections, immune responses and any undesirable experiences due to the drug were evaluated. All 16 Japanese men completed the study. No deaths, reactions to injections, or serious adverse events to the drug were reported.
In the United States the approval of belimumab came from the FDA due to the positive results from two long-scaled clinical trials. All three trials were randomized, double-blind, placebo controlled trials. In the phase one clinical trial, measuring instruments and scales were used. The safety of Estrogens in Lupus Erythematosus Disease Activity Index used a score ranging from 0 to 105. Zero indicated the disease being inactive. National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) looked for new or worsening disease activity, or change in medicine. (Phung, 2011, p. 127) Clinical trial one was not to test the efficacy of belimumab, but rather the safely. Overall, there was no difference in disease activity.
The phase two clinical trial was also a randomized, doubled blind, a placebo controlled trial. To be eligible, patients had to be adults, 18 or older with active SLE. They had to be taking 5 to 40 mg/day of antimalarial, or immunosuppressive agents, 60 days prior to the trial (Phung, 2010, p. 127). During phase two, patients were assigned to a one, four, or ten mg/kg belimumab or placebo. The treatment was received through an IV for over two hours on days one ,14, and 28, then every 28 days for 52 weeks. In addition to the new treatment, patients were still to maintain their regular medicine or treatment plan. After 24 weeks and 54 weeks, it was reported there was no significant change in the SELENA_SLEDAI score.
However, improvements were seen in Global Assessment (GA) scores at 52 weeks.
Patients who had received the belimumab had a longer time before a flare occurred. This result may have suggested belimumab stabilized the disease. During the phase two trial, the study evaluated outcomes in a serum and a blood serum sub group. Within this subgroup at 52 weeks, patients in the belimumab had greater reductions in SELENA-SLEDAI score and improvements in PGA scores (Phung, 2011, p.127).
Phase three clinical trial was comparing two doses of belimumab in patients with SLE for 52 weeks. Before patients were allowed to be a part of the trial, they had to meet certain requirements. Patients had to have a base line SELLENA_SLEDAI score less than or equal to six. They also had to have care therapy for at 30 days prior to entering the study.
During phase three, patients were either assigned a one or ten mg/kg of belimumab or placebo in addition to their regular treatment plan. The drug was given through an IV at days Zero ,14, 28, and then every day 28 days through week 48. The final results were conducted at week 52. A four-point improvement was seen in SELENA_SLEDAI and mean changes in PGA (Phung, 2011, p. 129). The treatment was 72 weeks long. Overall, there was no organ flares or worsening
conditions.
As a result of the clinical trials, patients tolerated belimumab well, and no increase in infections were evaluated. Patients who have active SLE and are receiving standard therapy are approved a dosage of belimumab of 10 mg/kg at two week intervals for the first three weeks and at four week intervals. One can only receive the treatment through IV, over one hour. During the treatment, patients are to be monitored for severe, life threatening allergic reactions. (Phung, 201, p.129). Long-term studies still need to be performed; however, belimumab may be the break through drug to reduce disease activity and prevent lupus flares.
Although SLE is a chronic inflammatory autoimmune disease that is without a cure, in the last 50 years’ improvements to control the disease have been made. There are medicines and treatments now to control the disease. There have also been studies done in three clinical trials for belimumab, the first drug approved by the FDA. More countries are conducting studies with the B-lymphocyte stimulator. Hopefully, belimumab will be the answer to cure SLE.
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease. It harms the skin, joints, kidneys, lungs, nervous system, and the serous membranes (Specchia et al, 2014, p.1). The symptoms in patients most commonly involve a mixture of skin conditions that affect one’s muscles, bones, and joints. Furthermore, SLE can have blood and blood serum symptoms. Women are more commonly affected than men, and the disease is diagnosed in patients aged 15 to 45 (Phung, 2011, p.118). SLE has no cure, but there are medicines and treatments that can help control it. Current medicines available to give to a person who has symptoms limited to one specific organ of the body. They include high doses …show more content…
of nonsteroidal anti-inflammatory drugs, which reduce inflammation and relieve fever and pain by blocking enzymes and proteins made by the body. Corticosteroids are used to provide relief for inflamed areas of the body, such as to lessen swelling redness, and even itching. Antimalarial agents can treat skin rashes and prevent lupus flares. Finally, immunosuppressant drugs prevent activity of the immune system. (Specchia et al, 2014, p. 2). These types of medicines are prescribed based on the individual patient’s severity of SLE.
In regards to treating SLE, short and medium-term outcomes have been made for patients. Prolonged corticosteroids and immunosuppressant drugs have been associated with iatrogenic morbidity such as a buildup of plaque around the artery wall and infections (Marthian et al, 2015, p. 836). However, in some SLE patients the disease is aggressive and unresponsive to these traditional treatments. Therefore, several new treatments in biotherapies are currently being developed. These new biotherapies aim to decrease negative side effects related to a specific treatment and improve long-term clinical outcomes
Also, T cells, B cells, and cytokines all have a role in SLE. T cells are lymphocytes produced or processed by the thymus gland and actively participating in the immune response. B cells, which is a lymphocyte not processed by the thymus gland, and is responsible for. producing antibodies. Cytokines are important in cell singing and promoting systemic inflammation (Phung, 2011, p. 118).
In the last 50 years, belimumab also known as benlysta is the first new drug for the treatment of SLE approved by Food and Drug Admission, on March 9, 2011. (Phung, 2011, p. 118). Belimumab is a B-lymphocyte stimulator. Therefore, B cells participate in regulating the immune system of SLE on multiple levels by serving as the forerunner of antibody secreting cells, helping inflammation, and regulating other immune cells (Specchia et al, 2014, p.2).
In Japan, a study of 16 healthy Japanese men was solely conducted to evaluate the safely of belimumab. Also, the open label, randomized single dose study wanted to evaluate body absorption, distribution, metabolism and excretion (Shida,et al, 2014, p. 97). The patients were assigned to receive a single dose of 200 K=mg of belimumab, either injected by a subcutaneous injection or an intravenous infusion.
The random groups were based on body weight, due to avoiding an excessive imbalance in body weight between subcutaneous injections and intravenous infusion groups. In the IV group, a liquid form of belimumab was given in normal saline at a constant rate over one hour. In the SC group injections of belimumab was given in the thigh for approximately 10 to 15 seconds.
To ensure the patients safety were evaluated not only during the treatment, but 70 days after. A wide range of factors were evaluated, such as their vital signs, electrocardiogram findings, blood, urine, rashes, and pain (Shida et al, 2014, p.98). Also, the evolution of plasma concentrations, diseases, infections, immune responses and any undesirable experiences due to the drug were evaluated. All 16 Japanese men completed the study. No deaths, reactions to injections, or serious adverse events to the drug were reported.
In the United States the approval of belimumab came from the FDA due to the positive results from two long-scaled clinical trials. All three trials were randomized, double-blind, placebo controlled trials. In the phase one clinical trial, measuring instruments and scales were used. The safety of Estrogens in Lupus Erythematosus Disease Activity Index used a score ranging from 0 to 105. Zero indicated the disease being inactive. National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) looked for new or worsening disease activity, or change in medicine. (Phung, 2011, p. 127) Clinical trial one was not to test the efficacy of belimumab, but rather the safely. Overall, there was no difference in disease activity.
The phase two clinical trial was also a randomized, doubled blind, a placebo controlled trial. To be eligible, patients had to be adults, 18 or older with active SLE. They had to be taking 5 to 40 mg/day of antimalarial, or immunosuppressive agents, 60 days prior to the trial (Phung, 2010, p. 127). During phase two, patients were assigned to a one, four, or ten mg/kg belimumab or placebo. The treatment was received through an IV for over two hours on days one ,14, and 28, then every 28 days for 52 weeks. In addition to the new treatment, patients were still to maintain their regular medicine or treatment plan. After 24 weeks and 54 weeks, it was reported there was no significant change in the SELENA_SLEDAI score.
However, improvements were seen in Global Assessment (GA) scores at 52 weeks.
Patients who had received the belimumab had a longer time before a flare occurred. This result may have suggested belimumab stabilized the disease. During the phase two trial, the study evaluated outcomes in a serum and a blood serum sub group. Within this subgroup at 52 weeks, patients in the belimumab had greater reductions in SELENA-SLEDAI score and improvements in PGA scores (Phung, 2011, p.127).
Phase three clinical trial was comparing two doses of belimumab in patients with SLE for 52 weeks. Before patients were allowed to be a part of the trial, they had to meet certain requirements. Patients had to have a base line SELLENA_SLEDAI score less than or equal to six. They also had to have care therapy for at 30 days prior to entering the study.
During phase three, patients were either assigned a one or ten mg/kg of belimumab or placebo in addition to their regular treatment plan. The drug was given through an IV at days Zero ,14, 28, and then every day 28 days through week 48. The final results were conducted at week 52. A four-point improvement was seen in SELENA_SLEDAI and mean changes in PGA (Phung, 2011, p. 129). The treatment was 72 weeks long. Overall, there was no organ flares or worsening
conditions.
As a result of the clinical trials, patients tolerated belimumab well, and no increase in infections were evaluated. Patients who have active SLE and are receiving standard therapy are approved a dosage of belimumab of 10 mg/kg at two week intervals for the first three weeks and at four week intervals. One can only receive the treatment through IV, over one hour. During the treatment, patients are to be monitored for severe, life threatening allergic reactions. (Phung, 201, p.129). Long-term studies still need to be performed; however, belimumab may be the break through drug to reduce disease activity and prevent lupus flares.
Although SLE is a chronic inflammatory autoimmune disease that is without a cure, in the last 50 years’ improvements to control the disease have been made. There are medicines and treatments now to control the disease. There have also been studies done in three clinical trials for belimumab, the first drug approved by the FDA. More countries are conducting studies with the B-lymphocyte stimulator. Hopefully, belimumab will be the answer to cure SLE.