Business Wire

Octapharma: New Consensus Recommendations on Treatment of Secondary Antibody Deficiency in Patients With Haematological Malignancies

Share

New expert consensus guidelines on the use of immunoglobulin replacement therapy (IgRT) in patients with haematological malignancy and secondary antibody deficiencies (SAD) were recently published in the European Journal of Haematology.

The publication, sponsored by Octapharma, marks the first pan-European consensus guidance on the use of IgRT in patients with hypogammaglobulinaemia secondary to haematological malignancies and aims to support harmonisation of clinical practice across Europe.

Octapharma has a longstanding commitment to improving the management of patients with secondary immunodeficiencies (SID) and in 2020 launched PRO-SID, a phase III clinical trial investigating primary infection prophylaxis with intravenous immunoglobulin (IVIg) in patients with chronic lymphocytic leukaemia (CLL). These efforts address the need for both robust clinical data and unified guidance on managing infection risk in patients with SID.

Absence of guidance leaves patients at risk

SAD is a common complication in patients with haematological malignancies such as CLL and multiple myeloma (MM). Up to 85% of CLL patients and up to 83% of patients with smouldering MM have low immunoglobulin levels, which leaves patients more susceptible to infections1,2. Infections are the likely cause of death in 22% of patients with MM and up to 50% of patients with CLL3,4. IgRT is effective at reducing the risk of infections in patients with haematological malignancies5.

In 2019, the EMA approved an expanded use of IVIg in patients with SID6. However, detailed European guidelines on the use of IgRT in patients with haematological malignancies and SAD were lacking. Differences in treatment approaches to reduce the infection burden remain significant across Europe, including different strategies for initiation, dosing and discontinuation of IgRT.

Stephen Jolles, lead author of the publication and Professor at the Immunodeficiency Centre for Wales in Cardiff, UK, commented: “Developing consensus guidelines for the use of IgRT in secondary antibody deficiency (SAD) aims to address a major need for treatment recommendations for patients with haematological malignancies and SAD. IgRT can reduce morbidity and mortality in a selected group of these patients and it is important that physicians have consistent guidance on defining this group and managing infection risk.”

A Task Force of eight experts in immunology and haemato-oncology developed statements on key aspects of IgRT, which were reviewed by a panel of 32 European experts. This Delphi consensus exercise developed clear recommendations for SAD due to haematological malignancies such as: measurement of IgG levels at the beginning of anti-cancer treatment; initiation of IgRT in patients who have received appropriate anti-infective therapy during or after a single severe infection or during recurrent or persistent infections when IgG levels are <4 g/l or if test immunization has failed; initiation of IgRT with a minimum IgG dose of 0.4 g/kg bodyweight every 3-4 weeks or stopping IgRT after at least 6 months without infections and concomitant evidence of immunological recovery. The 21 consensus statements emphasise the importance of IgRT for patients with SAD who experience severe, recurrent or persistent infections and provide guidance on initiation, dosing and discontinuation of IgRT, as well as measurement of IgG levels and the use of subcutaneous immunoglobulin (SCIg) therapy. The publication is available through open access at "Treating Secondary Antibody Deficiency in Patients with Haematological Malignancy: European Expert Consensus".

More information on SID in patients with haematological malignancies, including detailed information on the recent consensus guidelines, can be found at https://www.secondaryimmunodeficiency.com/

Patient recruitment continues for the PRO-SID study

Recruitment for the phase III PRO-SID study (NCT04502030) of IVIg in patients with CLL and SID is underway, in 22 sites across 7 countries. The PRO-SID study is investigating the efficacy and safety of IVIg (Panzyga®) as primary prophylaxis in patients with CLL and SID. Secondary prophylaxis with IVIg is an established approach to reduce the rate of infections in patients with haematological malignancies and SAD, but there is a need for robust data on IVIg as primary infection prophylaxis, i.e. before a major infection occurs7.

Commenting on Octapharma’s involvement in the field of SID, Olaf Walter, Board Member at Octapharma, said that: “Infections remain a serious concern for patients with haematological malignancies and SID, and at Octapharma we continue to strive for a better understanding of how to minimise the risk of such potentially life-threatening complications.”

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 is conducted at multiple sites across Europe (Italy, Poland, Denmark, Hungary, Germany and Russia) and the USA and plans to recruit at least 240 patients.

About Panzyga®

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 Kawasaki disease, chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) in Europe.

About Octapharma

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 9,000 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, and operates more than 160 plasma donation centres across Europe and the USA.

References

  1. Patel SY, Carbone J, Jolles S. The Expanding Field of Secondary Antibody Deficiency: Causes, Diagnosis, and Management. Frontiers in Immunology 2019; 10 (DOI: 10.3389/fimmu.2019.00033).
  2. Kyle RA, Remstein ED, Therneau TM, Dispenzieri A, Kurtin PJ, Hodnefield JM, Larson DR, Plevak MF, Jelinek DF, Fonseca R, Melton LJ, Rajkumar SV. Clinical course and prognosis of smoldering (asymptomatic) multiple myeloma. N Engl J Med 2007; 356:2582-90.
  3. Blimark C, Holmberg E, Mellqvist UH, Landgren O, Bjorkholm M, Hultcrantz M, Kjellander C, Turesson I, Kristinsson SY. Multiple myeloma and infections. Haematologica 2015; 100:107-13.
  4. Compagno N, Malipiero G, Cinetto F, Agostini C. Immunoglobulin replacement therapy in secondary hypogammaglobulinemia. Frontiers in Immunology 2014; 5:626.
  5. Benbrahim O, Viallard J-F, Choquet S, Royer B, Bauduer F, Decaux O, Crave J-C, Fardini Y, Clerson P, Lévy V. The use of octagam and gammanorm in immunodeficiency associated with hematological malignancies: a prospective study from 21 French hematology departments. Hematology 2019; 24:173-82.
  6. EMA. Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) 2019; https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-human-normal-immunoglobulin-intravenous-administration-ivig-rev-5_en.pdf
  7. Agostini C, et al. Prophylactic immunoglobulin therapy in secondary immune deficiency – an expert opinion. Expert Rev Clin Immunol 2016; 12:921-926.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Ivana Spotakova
Communications Manager
ivana.spotakova@octapharma.com
Tel.: +41793474607

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

SentinelOne Receives Highest Score for the Type C Use Case in the Gartner 2021 Critical Capabilities for Endpoint Protection Platforms14.5.2021 16:00:00 CEST | Press release

SentinelOne, the autonomous cybersecurity platform company, today announced that Gartner has positioned SentinelOne with the highest score in customer use case C in Gartner’s 2021 Critical Capabilities for Endpoint Protection Platforms report1. SentinelOne also received the highest score across all three Critical Capabilities use cases out of the 19 vendors included in the report. According to Gartner, “Type C organizations typically view technology as an expense or operational necessity and use it as a means to reduce costs.” Additionally, Gartner comments, “For EPP, these organizations focus on prevention, rather than on integrated detection and response capabilities and solutions that offer a complement of managed services.” “Recognition for this use case is a testament to SentinelOne’s ability to offer cost-effective and efficient solutions for enterprises of all types, including those who need to prioritize innovation and capabilities with budget and operational constraints,” said

Wipro Limited Appoints Tulsi Naidu to Its Board14.5.2021 14:22:00 CEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced the appointment of Ms. Tulsi Naidu, a widely respected business leader, to its Board of Directors for five years effective July 1, 2021, subject to the approval of shareholders. Tulsi Naidu will serve as an Independent Director on the Board and bring a wealth of experience to Wipro, having spent 25 years in the global financial services sector. Ms. Naidu is CEO Asia Pacific of Zurich Insurance Group (Zurich) and a member of Zurich’s Executive Committee. She joined Zurich in September 2016 and was named the CEO of the UK business in November 2016 where she implemented an extensive transformation program – reshaping the business, simplifying the structure, improving technical and digital capabilities, and positioning it for growth in its core markets. Before joining Zurich, Ms. Naidu spent 14 years at Prudential in various executiv

REPLY: The Board of Directors Approves the Quarterly Report Dated 31 March 202114.5.2021 12:49:00 CEST | Press release

Today, the Board of Directors of Reply S.p.A. [MTA, STAR: REY] approved the results as at 31 March 2021. Since the beginning of the year, the Group has recorded a consolidated turnover amounting to €352.4 million, an increase of 11.2% compared to the corresponding data for 2020. All indicators are positive for the period. In the first quarter of 2021 the consolidated EBITDA was €59.6 million compared to €47.6 million in 2020, equal to 16.9% of the turnover. EBIT, from January to March, was €47.9 million (€38.0 million in 2020), and is equal to 13.6% of the turnover. The profit before tax, from January to March 2021, was €47.6 million (€33.9 million in 2020), equal to 13.5% of the turnover. The net financial position of the Group on 31 March 2021 is also positive by 227.9 million. The net financial position on 31 December 2020 was positive for €158.7 million. “"The first quarter of 2021 - stated Mario Rizzante, Reply's Chairman - was very positive, both in terms of revenue and margin gr

PMC Biogenix Announces Price Increase on Armoslip® and Kemamide® Fatty Amides14.5.2021 11:00:00 CEST | Press release

PMC Biogenix Inc. announces that effective June 1, 2021 or as contracts permit, prices for Armoslip and Kemamide brand primary and secondary fatty amides and bisamides will increase by $1.00 to $3.00 per kilo for all orders, globally; adjusted for currency fluctuations. This increase is necessary to counterbalance the unprecedented and rapid rate of raw material and logistical cost increases and to continue providing the world class service expected by our global customer base. Customers with questions should contact their local sales manager. About PMC PMC Group is a growth oriented, diversified, global chemicals and plastics company dedicated to innovative solutions to everyday needs in a broad range of end markets including plastics, consumer products, electronics, paints, packaging, personal care, food, automotive and pharmaceuticals. The Company was built on a sustainable model of growth through innovation while promoting social good. PMC operates from a global manufacturing, inno

Mavenir Wins Award for Multi-G Open RAN Small Cell Solutions14.5.2021 09:00:00 CEST | Press release

Mavenir, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, is pleased to announce that it has won the Small Cell Forum Judges’ Choice award for its role in transforming mobile networks through its Multi-G Open RAN small cell solutions and its Mobile Network Operator (MNO) Open RAN neutral host integration. Multi-G Open RAN small cell solutions: Adding 2G/3G across a single unified RAN to support Multi-G radio access in 2020, Mavenir extended its Open Radio Access Network (Open RAN) capabilities across 2G, 3G, 4G and 5G to offer MNOs and enterprises a complete end-to-end, software-centric network proposition, spanning small cell radios to converged packet core to digital enablement solutions. This enables the move towards one network, rather than managing cost and complexity of several different networks. With a seamless, multi radio access technology (Multi-RAT) single RAN solution,

Swimlane and Elastic Partner to Deliver an Extensible Framework for Security Operations Teams13.5.2021 22:30:00 CEST | Press release

Swimlane, provider of the industry's leading security automation platform, and Elastic (NYSE: ESTC), the company behind Elasticsearch and the Elastic Stack, today announced a strategic partnership to help global security teams break down silos in their security processes, and provide a force multiplier to security operations teams that are perpetually overwhelmed. This partnership will enhance existing product integrations and jointly develop new capabilities to help security teams be more efficient and effective in protecting their organizations. The combined power of scale and automation Key integrations will enable even highly distributed security operations teams to significantly reduce friction associated with context-gathering tasks and threat containment — providing critical time savings that help analysts triage alerts quickly while minimizing damage from threats. Swimlane and Elastic plan further enhancements to the product experience through: An extensible framework that exte

IFF Achieves Key 2020 Sustainability Goals13.5.2021 22:15:00 CEST | Press release

IFF (NYSE:IFF) today announced the achievement of key 2020 sustainability goals that were set at the launch of the Company’s sustainability program in 2010. During that time, IFF met and surpassed its original intensity-based targets for three environmental goals, resulting in a reduction in its greenhouse gas (GHG) emissions, water withdrawal and hazardous waste generation per metric ton of production by -42.6%, -67.1% and -41% below 2010 levels, respectively. IFF has also achieved its 2020 goal to have 100% of the palm oil used in its products be certified according to the Roundtable on Sustainable Palm Oil (RSPO) Mass Balance Supply Chain Model. These and other milestones are captured in its latest Sustainability Report, “For a Better World,” which is published today. The title references the Company’s purpose – Applying science and creativity for a better world – a clear and bold aspiration that inspires everyone at IFF to push past traditional boundaries and to be a force for a be

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom