Rituximab is a monoclonal antibody. It is currently used alone or in combination to treat certain types of non-Hodgkin lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia and blood vessel disorders. The immunotherapy is also being tested as a potential treatment for scleroderma-associated pulmonary arterial hypertension. Rituximab works by lowering the number of certain B-cells to decrease the pain, swelling and inflammation in these conditions.1
Scleroderma treatment represents a significant clinical challenge due to the disease’s complex development, which includes fibrotic and vascular alterations mediated by immune T- and B-cells. A previous study and clinical trials suggest that rituximab may have a possible therapeutic role in scleroderma, demonstrated by the specific activity of rituximab on B-cells, and a good safety profile. This may explain rituximab’s beneficial effects on some scleroderma symptoms; namely, improvements in the skin and joints and, possibly, in lung fibrosis.2
A Phase 2 study on rituximab as a potential treatment of scleroderma-associated pulmonary arterial hypertension is currently recruiting participants (NCT01086540) at sites across the U.S. The double-blind and placebo-controlled study aims to determine if rituximab has a marked beneficial effect on clinical progression of scleroderma, with minimal toxicity, in people with pulmonary arterial hypertension associated to scleroderma (SSc-PAH). Its primary outcome is change in pulmonary vascular resistance measured by right heart catheterization.
Some of the common side effects that people experience when taking rituximab are diarrhea, flushing, indigestion, light-headedness, mild fever and chills, muscle or joint pain, muscle spasms, nausea, night sweats, sneezing, throat irritation, sleeping disorders, vomiting and weakness.1 Rituximab can cause severe infusion reactions, meaning that if any of the following reactions occur while receiving rituximab, or within 24 hours after receiving it, your doctor must be must be notified immediately: blurred vision, chest pain, cough, dizziness, drowsiness, fainting, fast or irregular heartbeat, headache, hives, itching, numbness in an arm or leg, shortness of breath, swelling (lips, tongue, throat, face), trouble breathing, weakness or wheezing.1
SSc-PAH is a serious, life-threatening manifestation of scleroderma, that is characterized by scarring and atrophy of the skin, joints, tendons, skeletal muscles, and internal organs, and by immunological irregularities. There is currently no cure for SSc-PAH, and treatment is limited to PAH-specific drugs that induce dilation of blood vessels.
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