Octapharma is pleased to announce that the first site for the international PRO-SID (Primary Infection Prophylaxis with Panzyga® in Secondary Immunodeficiency in Chronic Lymphocytic Leukaemia) study was initiated in Milan, Italy, and patient recruitment is underway. Additional sites across Europe (Italy, Poland, Denmark, Hungary, Germany and Russia) and the USA are expected to begin recruitment soon. PRO-SID is the first randomised, placebo-controlled study to systematically evaluate the efficacy and safety of IVIG for primary prophylaxis for infection control in patients with chronic lymphocytic leukaemia (CLL).
Secondary immunodeficiency (SID) is a common complication in patients with haematological malignancies such as CLL. Up to 85% of CLL patients develop hypogammaglobulinemia during the course of the disease, either due to the underlying disease or as a side effect of their treatment.1 For example, in one study, 39% of CLL patients developed hypogammaglobulinaemia after treatment with a B-cell depleting therapy.2 Patients with hypogammaglobulinaemia are more likely to develop infections, which are not only a major cause of morbidity but also account for up to 60% of deaths in patients with CLL.3 The use of intravenous immunoglobulins (IVIG) is well established as secondary prophylaxis to reduce the rate of infections in patients with haematological malignancies. However, there are insufficient data from well-designed, randomised, controlled studies to recommend IVIG as primary prophylaxis, before occurrence of the first major infection.4 For more information on SID and haematological malignancies, please visit https://www.secondaryimmunodeficiency.com/.
The double-blind, randomised, placebo-controlled, prospective, multicentre phase III PRO-SID study (NCT04502030) was designed to assess the efficacy and safety of Panzyga®, a human immunoglobulin for intravenous administration, as primary prophylaxis in patients with CLL and SID. The study plans to recruit at least 240 adult patients with CLL and hypogammaglobulinaemia (IgG levels < 5 g/L) who are receiving antineoplastic treatment. The primary outcome is the occurrence of at least one major infection over 52 weeks in patients receiving Panzyga® compared with placebo. Both treatment groups will also receive standard of care infection prophylaxis. Secondary outcomes include the overall infection rate and the frequency and duration of prophylaxis with anti-infectives.
Wei Ding, M.B.B.S, PhD, Mayo Foundation for Medical Education and Research, member of the PRO-SID study steering committee, commented that: "Despite improved therapy options in CLL patients, infections are still one of the major causes of morbidity and mortality. Primary prophylaxis with IVIG before severe infections occur has the potential to reduce infection rates and the burden on patients and the healthcare system. There is a need for robust data on the efficacy and safety of this approach, and insights from the PRO-SID study may prove highly valuable for informing treatment decisions
Dr. Olaf Walter, Board Member at Octapharma, added: "There remains a significant need to reduce the burden of the disease in managing patients with haematological malignancies and secondary immunodeficiency. Initiation of the PRO-SID study represents a key milestone in Octapharma’s efforts to improve the care of patients with CLL."
About the PRO-SID study
The PRO-SID study (NCT04502030) is a prospective, double-blind, randomised, multi-centre, placebo-controlled, interventional, phase III study investigating the efficacy and safety of Panzyga® in patients with chronic lymphocytic leukaemia (CLL) and hypogammaglobulinaemia (IgG < 5 g/L) who are receiving antineoplastic treatment. The study will be conducted at multiple sites across Europe (Italy, Poland, Denmark, Hungary, Germany and Russia) and the USA and plans to recruit at least 240 patients.
Panzyga® is a 10% human normal immunoglobulin solution ready for intravenous administration. Panzyga® is approved for use in treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura in the USA, Europe and Canada. It is also approved for secondary immunodeficiencies and Guillain Barré syndrome in Europe and Canada and for CIDP in Europe.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum.
In addition, Octapharma operates more than 140 plasma donation centres across Europe and the USA.
1. Sanchez-Ramon S, et al. Challenges in the Role of Gammaglobulin Replacement Therapy and Vaccination Strategies for Hematological Malignancy. Front Immunol 2016; 7:317.
2. Casulo C, et al. Incidence of hypogammaglobulinemia in patients receiving rituximab and the use of intravenous immunoglobulin for recurrent infections. Clin Lymphoma Myeloma Leuk 2013; 13:106–111.
3. Tadmor T, et al. A review of the infection pathogenesis and prophylaxis recommendations in patients with chronic lymphocytic leukemia. Exp Rev Hematol 2018; 11:57–70.
4. Agostini C, et al. Prophylactic immunoglobulin therapy in secondary immune deficiency –an expert opinion. Expert Rev Clin Immunol 2016; 12:921–926.