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Clinical Experience with Octagam® 10 %, a solvent detergent virus inactivated intravenous immunoglobulin:… Betschel, Stephen D; Warrington, Richard J; Schellenberg, Robert Jul 27, 2016

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Betschel et al.  Allergy Asthma Clin Immunol  (2016) 12:32 DOI 10.1186/s13223-016-0138-9REVIEWClinical Experience with Octagam® 10 %, a solvent detergent virus inactivated intravenous immunoglobulin: a Canadian retrospective review of utilizationStephen D. Betschel1* , Richard J. Warrington2 and Robert Schellenberg3Abstract In Canada, intravenous immune globulin (IVIg) products are licensed for six disease indications, however it has been demonstrated that patients with a number of other conditions also benefit from IVIg. Here we report the routine clini-cal use of Octagam® 10 % across three Canadian institutions. A total of 135 patients were treated with Octagam®, for conditions represented by five distinct indication groups. The results of this review indicate that Octagam® has been well adopted and is prescribed to Canadian patients similar to other IVIg products. In alignment with current prac-tices, 85 % of Octagam’s utilization was classified as appropriate based on Canadian IVIg guidelines.Keywords: Octagam®, IVIg, Indication© 2016 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.BackgroundHistory of IVIgThe first reported success of antibody therapy was in 1890, when von Behring and Kitasato described how serum extracted from an infected rabbit could protect a naïve rabbit from the effects of diphtheria toxin [1]. With the advent of large-scale fractionation, and access to blood banks through the American Red Cross, the first immunoglobulin products became available in the 1940s [2]. These products became routinely used by both subcutaneous and intramuscular route to prevent and treat infections [2]. Intramuscular administration of immune serum globulin was later described as a suc-cessful therapeutic approach to treat a patient who had a primary immune deficiency (PID) in 1952 [3], and quickly became standard practice for the treatment of patients with antibody deficiency syndromes [2]. With improvements in manufacturing and purification pro-cesses, several European companies began producing serum immunoglobulin suitable for intravenous admin-istration in the 1960s [2]. With fewer reported side effects and improved efficacy [4, 5], intravenous administration became the mainstay approach for serum immunoglobu-lin treatment. Today, commercially available intravenous human normal immunoglobulin (IVIg) products are pre-pared from pooled plasma from large groups of healthy blood donors [1], providing a diversity of antibodies. Since its use as a replacement therapy for PID patients, the clinical use of IVIg has expanded and has become an important treatment option in a wide spectrum of dis-eases. IVIg is used routinely in autoimmune and acute inflammatory conditions due to IVIg’s immune-modula-tory and anti-inflammatory properties.Current Canadian landscapeIn Canada, IVIg products are distributed by the Cana-dian Blood Services with the exception of Québec, where Héma Québec assumes this role. The products are dis-tributed to Canadian blood banks within hospitals, at which point they are dispensed to patients as physicians prescribe them. IVIg is currently used as replacement therapy in primary and secondary immunodeficiencies. IVIg is also used as an immunomodulatory therapy in Open AccessAllergy, Asthma & Clinical Immunology*Correspondence:  betschels@smh.ca 1 St Michael’s Hospital and the University of Toronto, 30 Bond St, Toronto, ON M5B 1W8, CanadaFull list of author information is available at the end of the articlePage 2 of 6Betschel et al. Allergy Asthma Clin Immunol  (2016) 12:32 a number of autoimmune diseases. Among the 8 IVIg products available in Canada, there are six different approved indications (replacement and immunomodu-latory), including primary and secondary immunodefi-ciencies (PID/SID)—each with several different primary pathologies, chronic B-cell lymphocytic leukemia (CLL), immune thrombocytopenic purpura (ITP), chronic demyelinating polyneuropathy (CIDP) and multifo-cal motor neuropathy (MMN) although it is used for a variety of other indications with a range of data to sup-port its use. Although no single product in Canada is indicated for all of these conditions, Canadian hospitals stock a variety of IVIg products that tend to be used interchangeably. Canada is the highest per-capita con-sumer of IVIg products worldwide, and the usage of IVIg in Canada has been steadily increasing over the last two decades [6]. To help ensure IVIg use is in keeping with an evidence-based approach to the practice of medicine, the National Advisory Committee on Blood and Blood Products (NAC) and Canadian Blood Services developed evidence-based practice guidelines on the use of IVIg for various conditions [7–12]. The objectives of these guide-lines were to examine the evidence for the use of IVIg in specific conditions and provide recommendations to physicians on the optimal utilization of IVIg therapy in various therapeutic areas.Differences between IVIg productsVarious product characteristics contribute to the toler-ability of the IVIg preparation including form (liquid versus lyophilized), type of stabilizer, product purity, osmolarity, concentration, IgG and IgA content, pH, osmolality, and sodium content [13, 14]. IVIg therapy is generally well tolerated [15–17], with most adverse events being mild, reversible infusion related events such as rigors, low-grade fever, headache, myalgia, back-ache, flushing, and nausea [17, 18]. The incidence of mild adverse events is reported to be between 5 and 15 % per infusion [19]. Although some IVIg products may have a lower incidence of drug-related adverse reactions than others, differences in reporting, and lack of compara-tive trial data makes this assertion difficult. Serious IVIg treatment-related adverse events are rarely reported, and are more common in patients with risk factors for poor prognosis [18, 19]. The safe and effective use of IVIg requires attention not only to product characteristics but also to administration issues and patient related risk-fac-tors. It is critical that patients receiving IVIg therapy are carefully evaluated and monitored so that treatment can be optimized.In terms of clinical efficacy, there are limited numbers of trials that directly compare two products head-to-head. The small number of studies that compared two IVIg products were primarily licensing studies and not studies designed to compare product efficacy [20–23]. Dhainaut et al. compared in vitro and in vivo biological and biochemical properties of five liquid IVIg prepara-tions. The authors concluded that the origin of plasma and the type of IVIg purification processes both con-tribute to obtain a pharmaceutical product with distinct biochemical and physiological properties, although all IVIg preparations were found to be efficacious in various patients groups [24]. A Canadian consensus statement also considered different IVIg products to have compa-rable clinical efficacy [11]. However, some patients may tolerate one product better than another [25, 26].Efficacy, tolerability and safety of Octagam®Octagam®, a liquid ready-to-use solvent deter-gent treated IVIg, is manufactured by Octapharma Pharmazeutika (Vienna, Austria). First approved in 1995 in Germany as a 5  % liquid human immunoglobulin preparation and in subsequent years the Octagam® 10 % formulation was available [27]. Octagam® has been in clinical use for over 20  years in 80 countries. Approved indications differ between IVIg formulations and coun-tries [13]. Globally, Octagam® 5 % and 10 % are indicated for the treatment of primary and secondary immunode-ficiencies, children with congenital AIDS and infection, Guillain–Barre Syndrome, Kawasaki Disease, allogenic bone marrow transplant, ITP and CIDP (5  % only) in the various global jurisdictions [13, 28]. Octagam® has been shown to be a safe and efficacious therapy, it is well tolerated and not associated with significant treatment-related adverse reactions.To date, one of the largest prospective studies on IVIg therapy evaluated the tolerability and safety of Octagam® [16]. Commencing in 1995, data were collected from 310 study sites over a 10-year period. This study included 6357 subjects with various PIDs, SIDs, and autoimmune diseases, who received 92,958 infusions. Adverse drug reactions were reported in 4.2 % of patients, which cor-responded to 0.35  % of all infusions [16]. Most of the adverse events recorded were mild (55.9  %) or moder-ate (34.3 %), and resolved quickly. The same study high-lighted that there was no detectable relationship between the frequency of adverse drug reactions and elevated infusion rates or high dosages [16]. A recent prospective observational study in 117 PID patients compared the incidence of infusion-related adverse reactions of differ-ent IVIg products [29]. Of a total of 1765 infusions, the overall incidence of infusion-related adverse reactions was only 2.15, 92  % of which were classified as mild or moderate in severity. This study found that there were significantly fewer infusion-related adverse reactions for patients treated with Octagam® (1.4  %) compared Page 3 of 6Betschel et al. Allergy Asthma Clin Immunol  (2016) 12:32 with another IVIg product (5.6  %) [29]. Of note, the incidence of adverse reactions reported in this study were surprisingly low, and this observation was thought to be attributed to infusion adjustments made for most patients prior to study start, an enrollment criteria that the patients be experienced (most patients had previous exposure to multiple brands that may have desensitized them), and inclusion of adverse reactions that occurred only during infusion. An additional limitation to the study was the manual regulation of infusion rates, due to the absence of infusion pumps [29].The safety and quality of Octagam® products is further ensured by the rigorous manufacturing process in which measures have been implemented to reduce the possi-ble content of procoagulant factors. Testing of the final product also involves a thrombin generation assay that is designed to detect increased thromboembolic potential. Finally, to ensure viral safety is achieved—the manufac-turing process involves two validated inactivation steps: a S/D method aimed at lipid enveloped virus inactivation, and a pH 4 treatment that reduces anti-complementary activation and aggregation of the IgG polymers. The S/D method is regarded by the World Hemophilia Federation as the “gold standard” in lipid enveloped virus inactiva-tion [30]. This two-stage viral inactivation process has an excellent safety record [31], which is documented in the Octagam® pharmacoviligence data (Octapharma, data on file).Canadian experience—Octagam® 10 %As of April 2013, Octagam® 10  % became available to Canadian physicians and patients. Following approval in Germany in 1995, an open observations study was initi-ated to evaluate the tolerably and long-term safety profile of Octagam® 5 % in routine clinical use in a wide variety of patients and diseases [16]. As the 10 % formulation is essentially similar to the less concentrated Octagam® 5 %, it was expected to be equally efficacious, safe and well tolerated. We present here the results of the first Cana-dian retrospective file review that evaluated the routine clinical use of Octagam® across three Canadian institu-tions: St. Paul’s Hospital in Vancouver British Columbia, St. Michael’s Hospital in Toronto Ontario, and St. Boni-face Hospital in Winnipeg Manitoba.MethodsData was collected over a 1-year period in an anonymous manner from IVIG request forms which were collected by the Blood Banks at St. Paul’s Hospital in Vancou-ver British Columbia, St. Michael’s Hospital in Toronto Ontario, and St. Boniface Hospital in Winnipeg Mani-toba. The information included; the indications, the pre-scribing physicians’ specialty, and the number of patients treated for a given indication. A separate analysis was performed to determine the appropriateness of IVIg use based on various published Canadian Consensus Guide-lines for IVIg utilization [7–10].ResultsOver a 1-year period, a total of 135 patients were treated with Octagam® spanning 28 different indications (refer to Table  1). Similar to other IVIg products, Octagam® was prescribed to patients with diseases spanning several indication groups: immunology, hematology, neurology, rheumatology, and infectious disease. The proportion of patients that received Octagam® by indication is pre-sented in Fig.  1. Octagam® was most often prescribed to patients with diseases included in the immunology indication (PID, SID, acute antibody mediated rejection, desensitization for kidney transplantation, and secondary immune deficiency due to malignancy). Notably, 36/58 patients from this group were treated for PID. This was not surprising as two of the institutions involved have a dedicated immunology (immune deficiency) clinic. A large proportion of patients were also treated with Oct-agam® for hematology indications, where 36/38 of these patients were diagnosed with ITP. A smaller proportion of patients treated were diagnosed with a neurological condition (23 patients, or 17 %)—however this included 11 different disease categories. A small proportion of patients were also treated for rheumatology and infec-tion disease indications. A total of 5 patients (3.7 %) were not categorized by indication group, and this included patients treated for a pneumonia query tuberculosis, treatment post coronary artery bypass graft surgery, sep-tic shock, and a dental/gum problem.DiscussionGlobally, IVIg has been used in the treatment of approxi-mately 100 different disease states and conditions. How-ever, there is a paucity of compelling scientific evidence supporting many of these uses. Both the NAC and Ontario Regional Blood Coordinating Network (ORB-CoN) monitor and evaluate IVIg utilization and related indications and these organizations provide useful guid-ance to practitioners regarding the appropriate use of IVIg [7, 8, 11, 12, 32].ORBCoN recently published an audit of the routine clinical use of IVIg products across Ontario in 2012 [32]. The audit included 2246 patients over a 3-month period with diseases spanning 120 different indications. The patients were treated with one of the five IVIg products that were licensed in Canada at the time, and the labeled versus unlabeled utilization was examined. Labeled indi-cations referred to those that were approved for use by Health Canada for at least one of the IVIg products. Page 4 of 6Betschel et al. Allergy Asthma Clin Immunol  (2016) 12:32 Using published clinical data, and Canadian IVIg guide-lines [1, 7–10, 12, 18, 32] they summarized the off-label utilization (indications not approved by Health Canada) as either off-label and potentially indicated, or off-label and not indicated. Interestingly, their audit found that 55 % of utilization was for labeled indications. Approxi-mately 33 % of IVIg utilization in Ontario is for unlabeled but potentially clinically appropriate conditions or dis-eases. This category includes disease states and condi-tions for which there are supporting data but that have not been evaluated by Health Canada. Examples of unlabeled but potentially appropriate uses for IVIg in Ontario include myasthenia gravis, juvenile dermato-myositis, pemphigus vulgaris and Guillain–Barre Syn-drome. Lastly, 11  % of IVIg utilization was for off-label and not indicated. Examples of uses of IVIg in Ontario that are not considered fully supported by data but that are approved include kidney transplant, and hematopoi-etic stem cell transplant. For a comprehensive review of IVIg utilization and approved uses please consult ORB-CoN 2012 Final Audit Report on IVIg [32].In other words, 88 % of the utilization was considered to be appropriate. Applying the same criteria set forth in the ORBCoN audit and the Canadian IVIg guide-lines, each of the indications identified in this study were similarly classified. Utilization of Octagam® by three Canadian hospitals was found to be 65, 21, and 14  % Table 1 Patients treated with Octagam® 10 % across three Canadian institutions with corresponding indication group, and diseaseIndication group Disease Number of patients Total number of patientsImmunology Primary immune deficiency 36 58Secondary immune deficiency 10Acute antibody mediated rejection 6Desensitization for kidney transplantation 4Secondary immune deficiency due to malignancy 2Hematology Idiopathic thrombocytopenic purpura 36 38Hemophagocytic lymphohistiocytosis 1Pancytopenia/general weakness 1Neurology Guillain-Barré syndrome 7 23Myasthenia Gravis 3Chronic inflammatory demyelinating polyneuropathy 3Stiff person syndrome 2Acute disseminated encephalomyelitis 2Multifocal motor neuropathy 1Acute sensimotor polyneuropathy 1Amyotrophic lateral sclerosis 1Opsoclonus-myoclonus 1Presumed neurosarcoidosis 1Limbic encephalitis 1Rheumatology Dermatomyositis 6 7Juvenile dermatomyositis 1Infectious disease Group A streptococcus fasciitis 2 4Staphylococcal toxic shock 1Cellulitis 1Miscellaneous Pneumonia query tuberculosis, post coronary artery bypass graft surgery, septic shock, dental/gum problem5 5Fig. 1 Percentage of patients treated with Octagam® 10 % by indica-tion categoryPage 5 of 6Betschel et al. Allergy Asthma Clin Immunol  (2016) 12:32 for labeled (Health Canada has approved the indication for at least one IVIg product), off-label and potentially indicated, and off-label and not-indicated, respectively (Fig.  2). In other words, 86  % of the Octagam® utiliza-tion was considered to be appropriate. These results sug-gest that Octagam® is utilized in Canada like other IVIg products.ConclusionAccording to the 2012 ORBCoN audit, the clinical spe-cialties that most often prescribed IVIg were neurol-ogy, immunology and hematology, similar to the routine clinical use of Octagam® [32]. There have been several initiatives in Canada that have been aimed at ensuring that IVIg utilization remains appropriate and in align-ment with an evidenced-based approach to the prac-tice of medicine. This retrospective review reported the routine clinical use and Canadian experience with Octagam® in three hospitals over a 1-year period. Oct-agam® was prescribed to patients across several disease indication groups including immunology, hematology, neurology, rheumatology and infection disease. When considering the Canadian IVIg guidelines, 116 of the 135 cases where Octagam® was utilized were deemed to be appropriate [7–12, 32]. When compared to data from the 2012 ORBCoN Audit report of IVIg utiliza-tion across Ontario, this review demonstrated that Octagam® utilization is similar to other IVIg products. Furthermore, these results suggest that Octagam® has been integrated into the system and is prescribed in Canada like other IVIg products. This is not surpris-ing since generally IVIg products have been utilized in a way that would suggest they have similar clinical effi-cacy and are interchangeable.AbbreviationsIVIg: intravenous immunoglobulin; PID: primary immune deficiency; SID: secondary immune deficiency; HIV: human immunodeficiency syndrome; ITP: idiopathic thrombocytopenic purpura; MMN: multifocal motor neuropa-thy; CLL: chronic B cell lymphocytic leukemia; CIDP: chronic inflammatory demyelinating polyneuropathy; NAC: National Advisory Committee on Blood and Blood Products; S/D: solvent/detergent; ORBCoN: Ontario Regional Blood Coordinating Network.Authors’ contributionsAll authors contributed equally to the manuscript and played and equal role it its study design. All authors read and approved the final manuscript.Author details1 St Michael’s Hospital and the University of Toronto, 30 Bond St, Toronto, ON M5B 1W8, Canada. 2 Head, Section of Allergy & Immunology, Department of Internal Medicine, University of Manitoba, Winnipeg Health Science Center, GC319 820 Sherbrook St, Winnipeg, MB R3A 1R9, Canada. 3 St Paul’s Hospital and the University of British Columbia, 1081 Burrard St, Vancouver, BC V6C 1Y6, Canada. AcknowledgementsWe would like to acknowledge the supportive care provided to the patients at the three participating hospitals. We would also like to acknowledge the support from Lidia Cosentino and Julia Pomoransky.Competing interestsDr. Betschel has served as a medical advisor for Octapharm.Received: 24 April 2016   Accepted: 6 July 2016References 1. Hartung HP. Advances in the understanding of the mechanism of action of IVIg. J Neurol. 2008;255(Suppl 3):3–6. doi:10.1007/s00415-008-3002-0. 2. Eibl MM. 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