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Octapharma Pharmazeutika Produktionsgesellschaft Mbh
Last update 01 Mar 2026
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CTIS2023-503507-29-00
Prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, efficacy and safety phase 3 study of an intravenous human plasma-derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks
EUCTR2019-001693-28-DE
Prospective, open-label, single arm, multicenter, pharmacokinetic, and safety study of a single dose intravenous human plasma-derived C1 Esterase Inhibitor (C1-INH) concentrate in patients with congenital C1-INH deficiency and hereditary angioedema
EUCTR2016-002649-41-BG
A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N (Kcentra), for the reversal of vitamin K antagonist induced anticoagulation in patients needing urgent surgery with significant bleeding risk.
100 Clinical Results associated with Octapharma Pharmazeutika Produktionsgesellschaft Mbh
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01 Oct 2025Rheumatology and Therapy
Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study
Article
Author: Dimachkie, Mazen M ; Moiseev, Sergey ; Schiopu, Elena ; Clodi, Elisabeth ; Schessl, Joachim ; Levine, Todd ; Vencovský, Jiri ; Aggarwal, Rohit ; Oddis, Chester V ; Charles-Schoeman, Christina ; Griger, Zoltan ; Bata-Csörgő, Zsuzsanna
INTRODUCTION:
Muscle and skin involvement are well defined in dermatomyositis but other symptoms contribute significantly to the disease burden and their treatment is not well characterized. This post hoc analysis of ProDERM assessed the effect of intravenous immunoglobulin (IVIg) treatment on other manifestations of dermatomyositis beyond muscular and cutaneous involvement.
METHODS:
ProDERM was a randomized, placebo-controlled study. For weeks 0-16, patients with dermatomyositis received 2.0 g/kg IVIg (Octagam, 10%) or placebo every 4 weeks. Eligible patients entered the open-label extension, where all received IVIg to week 40. Pulmonary, skeletal, constitutional, gastrointestinal, and cardiovascular disease activity was assessed using the myositis disease activity assessment tool, comprising a visual analog scale (VAS; 0-10 cm) and myositis intention-to-treat activity index.
RESULTS:
Of 95 patients enrolled, 47 received IVIg and 48 received placebo to week 16. At baseline, 37.9% of patients experienced pulmonary, 64.2% experienced skeletal, 76.8% experienced constitutional, 33.7% experienced gastrointestinal, and 15.8% experienced cardiovascular involvement (VAS > 0.5). Among these patients, for those on IVIg, the following mean VAS scores decreased from baseline to week 16: pulmonary (37.7%; P = 0.001), skeletal (52.6%; P < 0.001), constitutional (44.4%; P < 0.001), and gastrointestinal (49.2%; P = 0.005). No corresponding improvement was seen with placebo except for constitutional VAS. With IVIg, the proportions of patients with arthritis (36.2 to 17.8%; P = 0.01), arthralgia (68.1 to 0.0%; P < 0.001), and fatigue (68.1 to 3.3%; P = 0.008) decreased from baseline to week 16. In the combined cohort, the proportions of patients with dysphonia (20.0 to 8.1%; P = 0.04), arthralgia (66.3 to 39.8%; P < 0.001), weight loss (10.5 to 3.4%; P = 0.04), fatigue (75.8 to 50.0%; P < 0.001), and dysphagia (40.0 to 18.4%; P < 0.001) decreased from baseline to week 40.
CONCLUSION:
IVIg was effective in treating pulmonary, skeletal, constitutional, and gastrointestinal manifestations of dermatomyositis. We advocate exploring IVIg as treatment for dermatomyositis, beyond muscle and skin manifestations.
TRIAL REGISTRATION:
ClinicalTrials. gov identifier, NCT02728752.
01 Jul 2025EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
PredicDiff™: a computational tool for the prediction of PERLs concentrations based on extractables data
Article
Author: Heider, Nicole ; Sobańtka, Alicja
PredicDiff™, a computational modeling tool that allows fitting diffusion curves to process equipment related leachables (PERLs) is presented. Based on the measurement of extractables (analytical data), Fick's second law of diffusion, and a Trust Region Rebounds based fitting algorithm (optimize.curve_fit from Scipy), the Python-based model fits a diffusion curve to each extractable/PERL thus allowing the determination of the PERL amount after any arbitrary contact time and temperature for example, the actual production conditions. In addition, PredicDiff™ delivers the system's diffusion- and partition coefficients and the equilibrium concentration. Three case studies are presented: 1) interpolation of ε-caprolactam from a polysulfone disconnector from 24 h to 2 h, 2) adjustment of the diffusion of ε-caprolactam from a polysulfone disconnector from 40 °C to 21 °C, and 3) extrapolation of 2,4-Di-tert-butylphenol from an ultra-low-density polyethylene (ULDPE) bag from 70 to 90 days. In addition, the usability of PredicDiff™ for inter- or extrapolation of an unidentified extractable from a silicone tubing is shown. In the first case, after a contact time of 2 h, the concentration and hence, also patient exposure to ε-caprolactam is reduced by 70 % in comparison to the extractable value after 24 h. In the second case, further adjustment based on contact temperature (21 °C vs. 40 °C) gives a total reduction of 87 %. In the third case, the concentration and therefore, also patient exposure to 2,4-Di-tert-butylphenol increases by 2.6 % if storage is prolonged from 70 days to 90 days. PredicDiff™ has no limitations on the types of extractables (including those whose identities are not elucidated) or concentration ranges. Based on the remodeling of diffusion curves from literature and the calculation of extractables amounts from studies (analytical data), it is shown that PredicDiff™ provides reliable results within an acceptable range of uncertainty. Inter- and extrapolated PERLs can support the extractables and leachables (E&L) risk management by quickly calculating a more realistic concentration and ultimately, patient exposure.
01 Jun 2025RHEUMATOLOGY
Predictors of response to intravenous immunoglobulin in patients with dermatomyositis: the ProDERM study
Article
Author: Dimachkie, Mazen M ; Schiopu, Elena ; Moiseev, Sergey ; Clodi, Elisabeth ; Charles-Schoeman, Christina ; Levine, Todd ; Schessl, Joachim ; Vencovský, Jiri ; Oddis, Chester V ; Aggarwal, Rohit ; Bata-Csörgő, Zsuzsanna ; Griger, Zoltan
Abstract:
Objectives:
The phase 3 ProDERM study demonstrated intravenous immunoglobulin (IVIg) was safe and effective in patients with dermatomyositis (DM). This analysis assessed clinical and serological predictors of IVIg response in DM patients from ProDERM.
Methods:
ProDERM was a prospective, randomized, placebo-controlled study of DM patients. For weeks 0–16, patients received 2.0 g/kg IVIg (Octagam, 10%) or placebo every 4 weeks. Eligible patients entered the open-label extension phase, where all received IVIg to week 40. Univariate and multivariate analyses examined associations between baseline variables and total improvement score (TIS), including myositis disease activity assessment tool (MDAAT; assessing different organ involvement), and myositis-specific and myositis-associated autoantibodies.
Results:
Ninety-five patients were enrolled. Univariate analyses found no significant association between TIS at week 16 or 40 and age; sex; ethnicity; disease duration/activity; cutaneous, skeletal, gastrointestinal or muscle disease activity; or previous failed or concomitant medications. Multivariate analysis found patients with higher MDAAT cutaneous scores had a better chance of at least minimal TIS improvement. Higher MDAAT pulmonary scores were associated with a lower, but still considerable, chance of improvement. Patients with TIF1-γ antibodies had a better TIS response; however, after controlling for cutaneous disease activity, there was no significant association between antibody classification (including anti-TIF1-γ) and efficacy outcome.
Conclusion:
IVIg was effective in treating DM patients regardless of demographic features and autoantibody status (for most autoantibodies). Patients with higher cutaneous disease activity and/or anti-TIF1-γ responded best to IVIg, while pulmonary disease activity predicted a lower, but still effective, IVIg response, warranting further investigation.
Trial registration:
ClinicalTrials.gov, http://clinicaltrials.gov, NCT02728752.
100 Deals associated with Octapharma Pharmazeutika Produktionsgesellschaft Mbh
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100 Translational Medicine associated with Octapharma Pharmazeutika Produktionsgesellschaft Mbh
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