New Phase 3 MITIGATE Open-Label Extension Data Support the Long-Term Safety Profile and Sustained Results of UPLIZNA
®
in IgG4-RD
Real-World Evidence Supports TAVNEOS
®
Efficacy and Safety Profile with Reduced Steroid Use in ANCA-Associated Vasculitis
THOUSAND OAKS, Calif., June 3, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across rare autoimmune and inflammatory diseases at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, taking place from June 3-6 in London.
New data from the Phase 3 MITIGATE trial of UPLIZNA® (inebilizumab) provide insights into the biology of immunoglobulin G4-related disease (IgG4-RD),1 while additional analyses support its long-term safety profile and sustained results in IgG4-RD.2 Additionally, new real-world evidence on TAVNEOS® (avacopan) further support its established efficacy and safety profile with reduced steroid use in people living with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.3
"Patients living with rare autoimmune diseases still face significant unmet medical needs despite advances in treatment, with conditions often being difficult to diagnose and challenging to manage," said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. "The data we're presenting at EULAR deepen our understanding of disease biology and demonstrate the strength of our portfolio of options for patients with these conditions, reflecting our commitment to advancing the science and delivering meaningful progress for patients."
Key presentations include:
Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period (OLP) of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST
IgG4-RD is a chronic and debilitating condition, marked by recurrent, unpredictable flares that can potentially impact multiple organs.4,5 New Phase 3 MITIGATE data further support the longer-term clinical profile of UPLIZNA.
Key findings include:
In the first year of the OLP, these data demonstrated sustained results and disease control with continued UPLIZNA treatment in patients with IgG4-RD.
No patients (0%) who received UPLIZNA in the randomized controlled period (RCP) and continued with UPLIZNA in the OLP (N=56) experienced a flare, and 71.4% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2
5.9% of patients who received placebo in the RCP and transitioned to UPLIZNA in the OLP (N=51) experienced a flare, and 41.2% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2
Safety results were consistent with the established safety profile of UPLIZNA. The most common adverse events in the OLP were COVID-19, upper respiratory tract infection, cough and influenza.2
Across the combined RCP and OLP period, median total UPLIZNA treatment exposure was 2.2 years among participants who received ≥1 dose of inebilizumab.2
"For clinicians, a sustained reduction in flares and timely intervention are central to improving long-term outcomes," said John Stone, M.D., M.P.H., principal investigator and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital. "The new MITIGATE data reinforce the long-term safety and efficacy profile of UPLIZNA while advancing our understanding of how IgG4-RD progresses over time. These findings may help clinicians identify opportunities for earlier intervention and reduce avoidable flares."
Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the Phase 3 MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST
The first-of-its-kind natural history analysis reinforced the chronic and unpredictable nature of IgG4-RD, underscoring widespread and diverse multi-organ involvement and the need for earlier intervention and more comprehensive monitoring and risk stratification.
Key findings include:
Dynamic patterns of organ involvement over time, including the emergence of new organ manifestations and biological signals that may precede disease flares.1
CD19+ B cells were the first biomarker to rise ahead of a flare, followed by increases in total IgG and IgG subsets within the 30-day window preceding a flare.1
An additional exploratory combined analysis (Abstract #POS0089) of clinical trial RCP and OLP data in MITIGATE (N=119) showed how long-term use of UPLIZNA resulted in mostly mild immunoglobulin (Ig) reduction, with no significant association between these Ig reductions and occurrence of infections or serious infections. The incidence of infections and serious infections did not increase with each additional year of UPLIZNA treatment.
Real-World Evidence Supports TAVNEOS Efficacy, Safety and Reduced Steroid Use
The AQUARIUS analyses (Abstracts #POS01356 and #POS08673), conducted at Massachusetts General Hospital and Northwestern University, evaluated the largest U.S. real-world cohort to date of patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) treated with TAVNEOS (n=159). The findings provide new insights into clinical outcomes in patients with ANCA-associated vasculitis and are consistent with the established clinical efficacy and safety profile of TAVNEOS in patients with severe active GPA or MPA.3,6
"Real-world experience with TAVNEOS across two large healthcare systems demonstrates that many patients can achieve meaningful disease control with reduced reliance on glucocorticoids when considering prior standard-of-care glucocorticoid regimens," said Naomi Patel, M.D., rheumatologist at Massachusetts General Hospital and study investigator. "Because prolonged steroid use carries significant risks for patients, these findings are encouraging and also suggest that shorter steroid tapers (e.g., < 2 months) may reduce overall glucocorticoid exposure without compromising effectiveness outcomes."
Key findings include:
Results highlighted variability in glucocorticoids (GCs) tapering strategies in real world practice and showed that many patients were able to taper to very low or no doses of GCs quickly.3
Observations underscored the complexity of managing ANCA-associated vasculitis and pointed to opportunities to further optimize treatment approaches to reduce steroid exposure while maintaining disease control.3,6
The safety profile observed in this real-world setting was consistent with the established safety profile in patients with severe active GPA or MPA.3,6 Among patients who experienced hepatic adverse events, all hepatic abnormalities were resolved.
"People living with ANCA-associated vasculitis often have limited treatment options and may rely heavily on steroids for disease control," said Joyce Kullman, executive director, Vasculitis Foundation. "Given the challenges associated with long-term steroid use, these new data reinforce that TAVNEOS can help patients achieve disease control with reduced steroid use. For the vasculitis community, this may represent a step toward reducing treatment burden over time."
For more information on the full list of Amgen abstracts and presentation times, see below.
All Amgen-sponsored abstracts being presented at EULAR:
UPLIZNA
®
(inebilizumab)
Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST
Immunogenicity and Impact of Anti-drug Antibodies on the Efficacy and Pharmacokinetics of Inebilizumab In MITIGATE, a Phase 3 Trial in IgG4-Related Disease
Abstract #POS0432, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST
Atypical IgG4-Related Disease: Re-Examining the Entry Criteria of the
2019 ACR/EULAR Classification Criteria
Abstract #POS0439, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST
Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST
Serum IgG4 Elevation in IgG4-Related Disease: A Marker of Disease Phenotype and Organ Involvement
Abstract #OP056, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 5:10–5:20 p.m. BST
Long-term Inebilizumab Treatment Results in Mild Immunoglobulin Reduction but No Increase in Infection Risk
Abstract #POS0089, Basic and Clinical Poster Tours: From Treatment to Outcome in Other Diseases (Poster Tour Presentation), Thursday, June 4 from 9:30–9:36 a.m. BST
TAVNEOS (avacopan)
Reliability and Content Validity of a Definition of Severe Active Granulomatosis with Polyangiitis and Microscopic Polyangiitis
Abstract #POS0627, Poster View I (Poster View Presentation), Wednesday, 3 June at 4:20 p.m. BST
Clinical Outcomes by Glucocorticoid Duration in Individuals with Granulomatosis with Polyangiitis and Microscopic Polyangiitis Treated with Avacopan in a Real-World Setting in Two Large Healthcare Systems
Abstract #POS0867, Poster View IV (Poster View Presentation), Thursday, 4 June at 4:00 p.m. BST
One Year Real-World Effectiveness and Safety with Avacopan in Granulomatosis with Polyangiitis and Microscopic Polyangiitis in Two Large Healthcare Systems
Abstract #POS0135, Clinical Poster Tours: New frontiers in Small Vessel Vasculitis and Behcet's (Poster View Presentation), Thursday, 4 June from 1:36-1:42 p.m. BST
KRYSTEXXA (pegloticase)
Association of Pegloticase-Induced Remission with Patient-Reported Quality of Life Outcomes in the MIRROR Randomized Controlled Trial
Abstract #POS0841, Poster View IV (Poster View Presentation), Wednesday, June 3 at 3:30 p.m. BST
Reduction of Gout Flares with Pegloticase in Patients with or without Tophi at Baseline: A Post Hoc Analysis of the MIRROR Trial
Abstract #POS0421, Poster View I (Poster View Presentation), Thursday, June 4 at 4:00 p.m. BST
Differences in Gout Management and Outcomes in Patients Referred From Primary Care to Rheumatology
Abstract #POS0843, Poster View IV (Poster View Presentation), Thursday, June 4 at 4:00 p.m. BST
Baseline Predictors of Gout Remission During Intensive Urate-Lowering with Pegloticase: Post Hoc Analysis of the MIRROR Randomized Trial
Abstract #POS0169, Basic and Clinical Poster Tours: Advances in Gout and Crystal Disease (Poster Tour Presentation), Thursday, June 4 from 4:48–4:54 p.m. BST
A Phase 4, Randomized, Double-blind Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous Pegloticase Administered Every 4 Weeks vs Every 2 Weeks with Weekly Methotrexate
Abstract #OP0294, Basic and Clinical Abstract Session: Beyond Hyperuricemia - New Insights into Gout Detection (Oral Abstract Presentation), Friday, June 5 from 9:05–9:15 a.m. BST
OTEZLA (apremilast)
Efficacy of Apremilast in Early Oligoarticular Psoriatic Arthritis by Baseline Active Joint Count: A Post Hoc Analysis of the FOREMOST Study
Abstract #POS0490, Poster View I (Poster View Presentation), Wednesday, 3 June from 3:30-4:50 p.m. BST
Partner-Led Abstracts
The Sjögren's Tool for Assessing Response (STAR) Demonstrates its Ability to Accurately Detect Treatment Efficacy in 15 Recent RCTs in Sjögren's Disease
Abstract #OP0125, Clinical Abstract Sessions: Positive Clinical Trials - A New Era in Sjögren's Disease (Oral Abstract Presentation), Wednesday, 3 June from 4:40-4:50 p.m. BST
A
bout UPLIZNA
®
(inebilizumab)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects in IgG4-RD is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.7
About TAVNEOS
®
(avacopan)
TAVNEOS is an orally administered small molecule indicated as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis (GPA/MPA). It is a selective complement 5a receptor (C5aR) antagonist that targets inflammation by blocking the activity of C5a, a key driver of neutrophil activation. By inhibiting C5aR, TAVNEOS helps reduce inflammation while preserving other complement system functions. The precise mechanism by which TAVNEOS exerts its therapeutic effects in ANCA-associated vasculitis has not been fully established.8
UPLIZNA
®
(inebilizumab-cdon)
U.S.
INDICATIONS
UPLIZNA® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).
UPLIZNA U.S. IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
UPLIZNA® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis.
WARNINGS AND PRECAUTIONS
Infusion Reactions: Infusion reactions, including anaphylaxis, can occur. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods (RCPs) of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.
Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection, influenza, and pneumonia. In the gMG RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection and nasopharyngitis. Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed with B-cell-depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., HBsAg+), consult liver disease experts before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Tuberculosis
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.
Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy
In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B cells in these exposed infants may increase the risks from live or live-attenuated vaccines. Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.
Reductions in
Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
Fetal Risk: Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell-depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose.
ADVERSE REACTIONS
The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo): urinary tract infection and arthralgia in NMOSD; urinary tract infection and lymphopenia in IgG4-RD; headache and infusion-related reactions in gMG.
Please see UPLIZNA
®
full Prescribing Information
TAVNEOS (avacopan) U.S. INDICATION
TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
TAVNEOS U.S. IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported. These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter. If a patient receiving treatment with TAVNEOS presents with an elevation in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] to >3 times the upper limit of normal, evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the upper limit of normal (ULN), or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or alkaline phosphatase ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected. TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.
Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common.
ADVERSE REACTIONS
The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.
DRUG INTERACTIONS
Avoid co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS. Co‑administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS.
TAVNEOS is available as a 10 mg capsule.
Please see
Full Prescribing Information
and
Medication Guide
for TAVNEOS.
To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting or calling 1-800-332-1088.
About Amgen
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References
Stone J, et al. Oral Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #OP052.
Stone J, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0440.
Patel, N, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0867.
Stone JH, Zen Y, Deshpande V. IgG4-related disease. N Engl J Med. 2012;366(6):539-551.
Perugino CA, Stone JH. IgG4-related disease: an update on pathophysiology and implications for clinical care. Nat Rev Rheumatol. 2020;16(12):702-714.
Patel, N, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0135.
UPLIZNA (inebilizumab) Summary of Product Characteristics (SmPC). Available at Uplizna, INN-inebilizumab. Last accessed May 2026.
TAVNEOS (avacopan) Summary of Product Characteristics (SmPC). Available at Tavneos, INN-avacopan. Last accessed May 2026.
KRYSTEXXA (pegloticase) Summary of Product Characteristics (SmPC). Available at Krystexxa, INN-pegloticase. Last accessed May 2026.
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