Ravulizumab (ALXN1210; Alexion Pharmaceuticals, Inc) is a new C5 inhibitor that achieves immediate, complete, and sustained inhibition of complement-mediated hemolysis with an extended dosing interval.14 It exhibits high-affinity binding to C5 and inhibits C5a and C5b formation, thereby preventing immune activation and hemolysis.15,16 Ravulizumab was designed via targeted substitution of 4 amino acids in the complementary binding and neonatal Fc regions of the eculizumab backbone, resulting in augmented endosomal dissociation of C5 and efficient recycling of ravulizumab to the vascular compartment via the neonatal Fc receptor pathway.17 Accordingly, the terminal half-life of ravulizumab is ∼4 times longer than that of eculizumab.14 A >99% reduction in free C5 has been observed as early as the end of the first intravenous infusion of ravulizumab15 ; in phase 1b/2 studies in patients with PNH, ravulizumab elicited immediate and sustained suppression of complement-mediated hemolysis (mean lactate dehydrogenase [LDH] range at baseline, 1027-2142 U/L; mean range at primary end point, 228-306 U/L) throughout dosing intervals up to every 12 weeks.18 In these studies, intravenous ravulizumab dosing that achieved a higher trough exposure was associated with a greater proportion of patients reaching plasma LDH levels within the normal or near-normal range with a lack of breakthrough hemolysis, relative to low trough exposures.18 Subsequent exposure-response analyses informed the weight-based dosing regimen being evaluated in 2 complementary phase 3 studies in PNH patients who are either naive to or receiving stable eculizumab therapy.19 The objective of the current study was to assess the noninferiority of ravulizumab vs eculizumab in adult PNH patients naive to complement inhibitor therapy. are employees and stockholders of Alexion Pharmaceuticals, Inc. H.S. The proportion of patients with stabilized hemoglobin was 68.0% (85 of 125) with ravulizumab vs 64.5% (78 of 121) with eculizumab (difference, 2.9% [95% CI, −8.80, 14.64; Pinf < .0001]). Contribution: J.W.L. Patients in both treatment groups reported improvements from baseline in clinical manifestations of PNH (Table 3). Ravulizumab achieved complete terminal complement inhibition (defined as serum free C5 <0.5 μg/mL) by the end of the first infusion, which was sustained throughout the 183-day treatment period in all patients. Secondary end points were percent change from baseline in LDH, change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score, proportion of patients with breakthrough hemolysis, stabilized hemoglobin, and change in serum free C5. Three patients experienced MAVEs, 2 in the ravulizumab group and 1 in the eculizumab group. 2020 Dec 10;11:599417. doi: 10.3389/fimmu.2020.599417. Patients with lactate dehydrogenase (LDH) ≥1.5 times the upper limit of normal and at least 1 PNH symptom were randomized 1:1 to receive ravulizumab or eculizumab for 183 days (N = 246). The authors thank the investigators of ALXN1210-PNH-301, who are listed in supplemental Appendix Section 1. The protocol was approved by the institutional review board or independent ethics committee at each participating center, and the study was conducted in accordance with the Declaration of Helsinki and the Council for International Organizations of Medical Sciences International Ethical Guidelines. The intravenous ravulizumab group received a loading dose (2400 mg for patients weighing ≥40 to <60 kg, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter. Similarly, a higher percentage of patients in the ravulizumab group experienced a ≥3-point improvement in FACIT-Fatigue score (61.6%) vs the eculizumab group (58.7%; difference [95% CI], 2.2 [−9.9, 14.3]). One patient, who was taking concomitant oral contraceptive medication, experienced an event of lower leg deep vein thrombosis. Ravulizumab: a complementary option for PNH. BL, baseline (the last nonmissing assessment value before first dose of study drug). has received honoraria and research support (to St. Louis Hospital) from Alexion Pharmaceuticals, Inc. V. Pessoa and S.G. have received research support from Alexion Pharmaceuticals, Inc. W.F. V. Ptushkin has received honoraria from Alexion Pharmaceuticals, Inc. Pharmacodynamic analyses were performed on all patients who received ≥1 dose of study drug and had evaluable pharmacodynamic data. Ravulizumab (ALXN1210), a new complement C5 inhibitor, provides immediate, complete, and sustained C5 inhibition. No cases of meningococcal infections, Aspergillus infections, or sepsis were reported. Serious AEs in the ravulizumab group included: anemia, aplastic anemia, neutropenia, thrombocytopenia, left ventricular failure, myocardial ischemia, pyrexia, leptospirosis, systemic infection, laceration, uterine leiomyoma, renal colic, and deep vein thrombosis (n = 1 patient each). are employees and stockholders of Alexion Pharmaceuticals, Inc. H.S. For FACIT-Fatigue, Diff (95% CI) is based on estimated differences in change from baseline with 95% CI. Blood. Safety analyses were performed on the safety set, defined as all patients who received ≥ 1 dose of study drug. Ravulizumab every 8 weeks is noninferior to eculizumab every 2 weeks across all efficacy end points in C5 inhibitor–naive PNH patients. The safety and tolerability of ravulizumab and eculizumab were similar; no meningococcal infections occurred. The percentage of patients with a ≥3-point improvement in FACIT-Fatigue score was similar between the ravulizumab and eculizumab groups (37.1% vs 33.7%). Key secondary end points included percentage change from baseline to day 183 in LDH and change from baseline to day 183 in quality of life, as assessed via the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue scale, version 420,21 ; the proportion of patients with breakthrough hemolysis, defined as ≥1 new or worsening sign or symptom of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia [hemoglobin <10 g/dL], MAVEs including thrombosis, dysphagia, or erectile dysfunction) in the presence of LDH ≥2× ULN after prior reduction of LDH to <1.5× ULN on treatment, and proportion of patients with stabilized hemoglobin, defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline in the absence of transfusion. 2020 Mar;20(3):227-237. doi: 10.1080/14712598.2020.1725468. The authors thank Rodrigo Pavani and Masayo Ogawa of Alexion Pharmaceuticals, Inc, for their contribution to the implementation of the study. One patient from the Republic of Korea had a heterozygous missense mutation (c.2654G>A in exon 21) of the C5 gene that confers low response to eculizumab27 and, as expected, did not experience a clinical response to ravulizumab. The study consisted of a 4-week screening period and a 26-week randomized treatment period to evaluate the efficacy and safety of ravulizumab vs eculizumab, followed by an extension period of up to 2 years, during which all patients receive ravulizumab (supplemental Appendix Section 3; supplemental Figure 1, available on the Blood Web site). The most frequently reported AE was headache (36.0% and 33.1% in the ravulizumab and eculizumab groups, respectively). ORs and 95% CIs for the coprimary end point of LDH normalization were analyzed using a generalized estimating equation approach with first-order autoregressive correlation structure. Patients assigned to eculizumab received induction doses of 600 mg on days 1, 8, 15, and 22, followed by maintenance dosing of 900 mg on day 29 and every 2 weeks thereafter per the approved PNH dosing regimen.4,5. All patients gave written informed consent. The coprimary end points were: (1) transfusion avoidance (TA), defined as the proportion of patients who remain transfusion-free and do not require a transfusion per protocol-specified guidelines through day 183; and (2) hemolysis as measured by LDH normalization (ULN, 246 U/L) from days 29 through 183. Treatment of Rare Inflammatory Kidney Diseases: Drugs Targeting the Terminal Complement Pathway. Serious AEs in the eculizumab group included: pyrexia (n = 2 patients), ileus, neutropenic colitis, limb abscess, cellulitis, infection, pneumonia, viral upper respiratory tract infection, adenocarcinoma of colon, lung adenocarcinoma, and paroxysmal nocturnal hemoglobinuria (n = 1 patient each). Mean (95% CI) free C5 concentrations in the ravulizumab and eculizumab groups over time. Additional secondary end points included time to first occurrence of LDH normalization, total number of packed red blood cell units transfused, change in clinical manifestations of PNH, change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 Scale (EORTC QLQ-C30), version 3.0,22 proportion of patients experiencing MAVEs (including thrombosis), and change in free C5 concentrations. A complete list of ALXN1210-PNH-301 study investigators appears in the supplemental appendix. Ravulizumab was found to be non-inferior to eculizumab for both coprimary endpoints . 2020 Oct;112(4):466-476. doi: 10.1007/s12185-020-02934-6. Between 11% and 27% of eculizumab-treated patients experience breakthrough hemolysis,9-11 which may lead to a return of the symptoms and complications of PNH.6 In this study, 5 ravulizumab-treated patients experienced breakthrough hemolysis compared with 13 patients treated with eculizumab (P < .06) at the approved dose; higher doses than the approved dose of eculizumab were not permitted in this study. The adjusted prevalence of LDH normalization was 53.6% for the ravulizumab group and 49.4% for the eculizumab group; the adjusted OR for comparison of ravulizumab vs eculizumab was 1.19 (95% CI, 0.80, 1.77; Pinf < .0001). Even though previous clinical trials have shown that ravulizumab seems to be slightly more potent than eculizumab at standard dosing, no significant differences in LDH normalization, transfusion … Proportions of patients with breakthrough hemolysis were 4.0% (5 of 125 patients had 1 event each) in the ravulizumab group vs 10.7% (13 of 121 patients had a total of 15 events) in the eculizumab group (difference, −6.7% [95% CI, −14.21, 0.18]; Pinf < .0001). ‡P < .06 for the lower bound of the 95% CI. Coprimary efficacy end points were proportion of patients remaining transfusion-free and LDH normalization. Coprimary efficacy end points were proportion of patients remaining transfusion-free and LDH normalization. Ravulizumab and eculizumab were well tolerated in this study. View side-by-side comparisons of medication uses, ratings, cost, side effects and interactions. Portions of this work were presented at the 23rd Congress of the European Hematology Association, Stockholm, Sweden, 14-17 June 2018. FOIA n = 118 patients with evaluable data in the eculizumab group. There were no discontinuations of ravulizumab and 2 discontinuations of eculizumab during the randomized treatment period, 1 due to a physician’s decision and 1 patient withdrew consent. eCollection 2020. Other secondary efficacy outcomes at day 183. n = 119 patients were included in the analysis of clinical manifestations of PNH. The study enrolled patients ≥18 years of age with documented diagnosis of PNH, confirmed by high-sensitivity flow cytometry of red and white blood cells with granulocyte or monocyte clone size of at least 5%, and LDH level ≥1.5× ULN at screening. Ravulizumab … For the overall population, in 99.9% of iterations of the probabilistic sensitivity analysis, total costs were lower and health benefit (number of QALYs) was greater for ravulizumab than for eculizumab; therefore, the cost-effectiveness acceptability curve of ravulizumab vs eculizumab … Ishiyama K, Nakao S, Usuki K, Yonemura Y, Ikezoe T, Uchiyama M, Mori Y, Fukuda T, Okada M, Fujiwara SI, Noji H, Rottinghaus S, Aguzzi R, Yokosawa J, Nishimura JI, Kanakura Y, Okamoto S. Int J Hematol. Efficacy analyses were performed on the full analysis set, which included all patients who received ≥ 1 dose of ravulizumab or eculizumab and had ≥ 1 efficacy assessment after the first infusion. Data regarding packed red blood cell transfusions, incidence of MAVEs, and clinical manifestations of PNH are summarized in Table 3. Ravulizumab (Alexion Pharmaceuticals, Inc.), a humanized monoclonal antibody that blocks terminal complement activation at C5, was engineered from eculizumab, resulting in a molecule that targets … © 2019 by The American Society of Hematology. Additional details are available in supplemental Appendix Section 2. 2020 Dec 4;2020(1):312-318. doi: 10.1182/hematology.2020000171. n = 65 male patients in the ravulizumab group and n = 68 male patients in the eculizumab group. Hematology Am Soc Hematol Educ Program. Expert opinion: In phase 3 trials, ravulizumab has been shown to be as safe and efficacious as eculizumab, to be associated numerically with lower rates of breakthrough hemolysis (p for non-inferiority <0.0004), and to be preferred over eculizumab by most patients. In 191 patients completing 183 days of treatment, ravulizumab was noninferior to eculizumab (P inf < .0006 for all end points), including percentage change in LDH (difference, 9.21% [95% confidence … *Red triangle indicates the noninferiority margin. A safety review committee performed safety monitoring, and an independent data monitoring committee was in place to monitor meningococcal infections. Epub 2020 Aug 31. Qualified academic investigators may request participant-level, deidentified clinical data and supporting documents (statistical analysis plan and protocol) pertaining to this study. All analyses were performed using SAS (SAS Institute Inc, Cary, NC), version 9.4, or higher or other validated statistical software. In conclusion, ravulizumab given every 8 weeks achieved noninferiority compared with eculizumab given every 2 weeks for all efficacy end points, with a similar safety profile. Prescribed for Myasthenia Gravis, Neuromyelitis Optica, Hemolytic Uremic Syndrome, Paroxysmal Nocturnal Hemoglobinuria. Eculizumab Remove Eculizumab from your drug comparison Soliris … 4 53.6% (95%CI 45.9–61.2%) in the ravulizumab … declares no competing financial interests. 8600 Rockville Pike To assess the strength of evidence of the study results, post hoc P values were calculated for testing of noninferiority (Pinf) relative to the prespecified noninferiority margins. From a patient and health care perspective, a fourfold longer dosing interval of ravulizumab vs eculizumab may reduce treatment burden and health care resource utilization and … Ravulizumab is a newly approved treatment for paroxysmal nocturnal hemoglobinuria that may reduce breakthrough hemolysis risk, thus improving health-related quality of life and … This trial was registered at www.clinicaltrials.gov as #NCT02946463. 2019 Feb 7;133(6):503-504. doi: 10.1182/blood-2018-12-891499. Free C5 levels <0.5 µg/mL are associated with complete inhibition of C5 activity. This phase 3, open-label study assessed the noninferiority of ravulizumab to eculizumab in complement inhibitor–naive adults with paroxysmal nocturnal hemoglobinuria (PNH). Cells. Hemoglobin levels were evaluated before randomization and within 5 days before study drug initiation; patients were transfused, if necessary, to reach the protocol-specified hemoglobin level. Patients were stratified into 6 groups based on transfusion history (0, 1-14, or >14 units of packed red blood cells in the 1 year before the first dose of study drug) and LDH screening level (1.5 to <3 times the upper limit of normal [ULN] or ≥3× ULN). Immunogenicity was low with 1 treatment-emergent antidrug antibody–positive sample in each treatment arm. The ALXN1210-PNH-301 study (NCT02946463, EudraCT 2016-002025-11, CHAMPION-301), sponsored by Alexion Pharmaceuticals, Inc, is a phase 3, multicenter, randomized, active-controlled, open-label study conducted in 123 centers in 25 countries. The new results come from an open-label, multicenter trial, presented here at the European Hematology Association (EHA) 2018 Congress. Ravulizumab was noninferior to eculizumab on the 4 key secondary end points (Figure 1B; Table 2), with all point estimates consistently favoring ravulizumab. See this image and copyright information in PMC. Adverse events (AEs) were documented and immunogenicity, reflected by development of antidrug antibodies, was also monitored. In the pivotal phase‐3 trial of ravulizumab vs. eculizumab in treatment‐naïve PNH patients, the weighted average of proportions of LDH normalization (LDH < 246 U/L) from day 29 to 183 was the co‐primary endpoint of the study. Pre-discontinuation treatment contributed the largest proportion of total costs for ravulizumab (94.8% and 88.0%) and eculizumab (94.8% and 87.8%) in adults and children, respectively. From a patient and health care perspective, a fourfold longer dosing interval of ravulizumab vs eculizumab may reduce treatment burden and health care resource utilization and may expand access to patients who are unable to comply with the every-2-week dosing of eculizumab. Accessibility Ravulizumab was noninferior to eculizumab for both coprimary and all key secondary end points (Pinf < .0001): transfusion avoidance (73.6% vs 66.1%; difference of 6.8% [95% confidence interval (CI), -4.66, 18.14]), LDH normalization (53.6% vs 49.4%; odds ratio, 1.19 [0.80, 1.77]), percent reduction in LDH (-76.8% vs -76.0%; difference [95% CI], -0.83% [-5.21, 3.56]), change in FACIT-Fatigue score (7.07 vs 6.40; difference [95% CI], 0.67 [-1.21, 2.55]), breakthrough hemolysis (4.0% vs 10.7%; difference [95% CI], -6.7% [-14.21, 0.18]), and stabilized hemoglobin (68.0% vs 64.5%; difference [95% CI], 2.9 [-8.80, 14.64]). Jong Wook Lee, Flore Sicre de Fontbrune, Lily Wong Lee Lee, Viviani Pessoa, Sandra Gualandro, Wolfgang Füreder, Vadim Ptushkin, Scott T. Rottinghaus, Lori Volles, Lori Shafner, Rasha Aguzzi, Rajendra Pradhan, Hubert Schrezenmeier, Anita Hill; Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study. 2021 Jan 13;10(1):148. doi: 10.3390/cells10010148. The other patient had history of lower leg pain and edema and was taking an oral anticoagulant, which was discontinued after initiation of study drug. Ninety-two of 125 patients (73.6%) receiving ravulizumab and 80 of 121 patients (66.1%) receiving eculizumab avoided transfusion, with a between-group difference of 6.8% (95% CI, −4.66, 18.14; Pinf < .0001). Ravulizumab was noninferior to eculizumab for both coprimary and all key secondary end points (P inf < .0001): transfusion avoidance (73.6% vs 66.1%; difference of 6.8% [95% confidence interval (CI), … Ravulizumab, a new long-acting C5 inhibitor, recently received FDA approval for the treatment of aHUS. Half-life of eculizumab is 11.25-17.25 days. doi: https://doi.org/10.1182/blood-2018-09-876136. The coprimary end point TA was evaluated as the proportion of patients achieving the end point, computed as a weighted combination of differences between the treatment groups within the 2 randomization stratifications, using Mantel-Haenszel tests. Improvements in EORTC QLQ-C30 global health status/quality of life assessment scores were also similar in the ravulizumab and eculizumab treatment groups (supplemental Appendix Section 4; supplemental Table 1). Because noninferiority was achieved for all 4 key secondary end points, hierarchal superiority testing was performed for breakthrough hemolysis, with a resulting P < .06. For the LDH normalization (LDH-N) end point, adjusted prevalence within each treatment is displayed. has received honoraria and research support (to St. Louis Hospital) from Alexion Pharmaceuticals, Inc. V. Pessoa and S.G. have received research support from Alexion Pharmaceuticals, Inc. W.F. Patients with lactate dehydrogenase (LDH) ≥1.5 times the upper limit of normal and at least 1 PNH symptom were randomized 1:1 to receive ravulizumab or eculizumab for 183 days (N = 246). Indeed, presence of ≥1 reported PNH-related symptom in addition to hemolysis confers particularly high risk of thrombosis-related complications.12,25 Complement inhibition mitigates these poor outcomes26 through the inhibition of intravascular hemolysis, stabilization of hemoglobin levels, and reduced need for transfusions. Ravulizumab (ALXN1210), a new complement C5 inhibitor, provides immediate, complete, and sustained C5 inhibition. Noninferiority of ravulizumab was based on the coprimary end points and defined as: (1) the lower bound of the 95% confidence interval (CI) for the difference in TA rate between ravulizumab and eculizumab being greater than −20%, and (2) lower bound of the 95% CI for the odds ratio (OR) of ravulizumab vs eculizumab for LDH normalization being greater than an OR of 0.39. has received honoraria and research support (all to University of Ulm) from Alexion Pharmaceuticals, Inc. A.H. has received honoraria and consulting fees from Alexion Pharmaceuticals, Inc. L.W.L.L. Therefore, and solely to indicate this fact, this article is hereby marked “advertisement” in accordance with 18 USC section 1734. Epub 2018 Dec 3. Patients with PNH who had not previously been treated with complement inhibitors were randomly assigned to treatment with ravulizumab (n = 125) or eculizumab (n = 121) for 26 weeks.Mean patient age was 44.8 years in the ravulizumab group and 46.2 years in the eculizumab group, and the m… Please enable it to take advantage of the complete set of features! Complement as a Therapeutic Target in Systemic Autoimmune Diseases. has received honoraria, consulting fees, and research support (to Seoul St. Mary’s Hospital) from Alexion Pharmaceuticals, Inc. F.S.d.F. Additional details are available in supplemental Appendix Section 2. One patient in the eculizumab arm died of lung cancer (unrelated to treatment) during the extension phase of the study. Results from multinational phase 3 studies of ravulizumab (ALXN1210) versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria: subgroup analysis of Japanese patients. Mean LDH levels decreased and normalized rapidly after initiation of study drug, and LDH normalization was sustained through the 26-week treatment period. This outcome is clinically relevant for patients with PNH, some of whom do not achieve complete disease control with the current standard of care, labeled-dose eculizumab (900 mg every 2 weeks as maintenance).9-11 Therefore, the results of this study demonstrating a trend favoring ravulizumab for all 6 end points are most likely driven by the sustained inhibition of C5 associated with ravulizumab. Of 285 patients screened for eligibility, 246 (all of whom received meningococcal vaccination) were randomized to ravulizumab (n = 125) or eculizumab (n = 121); 244 patients completed the 26-week treatment period (ravulizumab, n = 125; eculizumab, n = 119; supplemental Appendix Section 3; supplemental Figure 2). declares no competing financial interests. Bethesda, MD 20894, Copyright 2019 Feb 7;133(6):540-549. doi: 10.1182/blood-2018-09-876805. The online version of this article contains a data supplement. Within 3 months of screening, ≥1 of the following PNH-related signs or symptoms must have been present: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (ie, hemoglobin level <10 g/dL), or history of MAVEs (including thrombosis), dysphagia, erectile dysfunction, or history of packed red blood cell transfusion because of PNH. BTH decreased in the eculizumab–ravulizumab arm; no events were associated with free C5 ⩾0.5 μg/mL while receiving ravulizumab. Coprimary and key secondary efficacy outcomes at day 183. None of these events was associated with inadequate terminal complement inhibition (free C5 levels ≥0.5 μg/mL). Antibody titers were low (≤1) and not neutralizing, with no apparent effects on pharmacokinetics/pharmacodynamics or safety. Unable to load your collection due to an error, Unable to load your delegates due to an error. A Position Paper From the SAAWP of the EBMT. S.T.R., L.V., L.S., R.A., and R.P. Patients within each of the 6 groups were randomly assigned in a 1:1 ratio to receive ravulizumab or eculizumab (supplemental Appendix Section 3; supplemental Figure 1). Serious infections observed in patients treated with ravulizumab included leptospirosis and systemic infection (causative agents not identified); serious infections observed in patients treated with eculizumab included limb abscess, cellulitis, infection, pneumonia, and viral upper respiratory tract infection (causative agents not identified). Ravulizumab met the prespecified noninferiority threshold with 73.6% of study participants avoiding transfusion whereas 66.1% of those receiving eculizumab avoided transfusion. Prevention and treatment information (HHS). S.T.R., L.V., L.S., R.A., and R.P. The planned sample size of ∼214 evaluable patients would provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab at a 1-sided α level of 0.025, a 10% dropout rate, and a noninferiority margin of −20% for the difference in TA rate (minimum of 193 patients required). The less-frequent, every-eight-week dosing with ravulizumab appeared to be associated with better quality of life, compared with eculizumab: A higher proportion of ravulizumab-treated … *Red triangle indicates the noninferiority margin. The lower bound of the 95% CI was greater than the protocol-specified noninferiority margin of 0.39. The key secondary end points were tested in a hierarchical manner if noninferiority was declared for the coprimary end points. The safety and tolerability of ravulizumab and eculizumab were similar; no meningococcal infections occurred. This trial was registered at www.clinicaltrials.gov as #NCT02946463. Ultomiris ravulizumab Remove Ultomiris from your drug comparison. The humanized monoclonal antibody eculizumab (Soliris ®) is a complement inhibitor indicated for use in anti-acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis (gMG) … Baseline was defined as the last available assessment before first study drug infusion for all other parameters.
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