Lupus erythematodes – Update 2016

Zusammenfassung

Mittlerweile sind fünf Jahre vergangen, seit der Anti-BAFF-Antikörper Belimumab als erstes Biologikum für den SLE zugelassen wurde, aber kein weiteres SLE-Medikament ist auch nur annähernd zulassungsreif. Zu den neuen oralen Antikoagulanzien liegen noch keine Studiendaten zum Einsatz beim Anti-Phospholipid-Syndrom (APS) vor. Zu Mycophenolat-Mofetil (MMF) gibt es trotz eindeutiger Datenlage für die Therapie der Lupus-Nephritis noch keine Entscheidung des Gemeinsamen Bundesausschusses (GBA) hinsichtlich der Kostenübernahme. Mehrere der aktuell laufenden Therapiestudien haben aber das Potenzial, in absehbarer Zeit zu wichtigen Fortschritten zu führen. Zumindest existieren mittlerweile brauchbare Werkzeuge, um das Therapieansprechen bei SLE-Studien zu erfassen. Zudem gibt es groß angelegte Projekte zu konkreten Zielen für das SLE-Management und zu hoffentlich wieder einheitlichen SLE-Klassifikationskriterien.

Abstract

Meanwhile, five years have passed since the approval of the anti-BAFF antibody belimumab as a first biological for SLE, but no further SLE drug candidate is even close to approval. There are still no clinical trial data available for the use of new oral anticoagulants in antiphospholipid syndrome. In spite of convincing evidence for the use of mycophenolate mofetil (MMF) in lupus nephritis, the German “Gemeinsame Bundesausschuss” (GBA) has not yet decided on its reimbursement. However, several of the ongoing clinical trials have potential to lead to important advances in SLE treatment in the future. At least, we have validated tools for detecting therapeutic effects in SLE treatment trials. In addition, there are large projects ongoing to develop defined treatment goals for the management of SLE as well as new classification criteria, which hopefully will be generally accepted.

Schlüsselwörter

Systemischer Lupus erythematodes (SLE) - Lupusnephritis - Klassifikationskriterien - treat-to-target - Anti-Interferon

Keywords

Systemischer Lupus erythematodes (SLE) - lupus nephritis - classification criteria - treat-to-target - anti- interferon

• Literatur

• 1 Petri M, Orbai AM, Alarcon GS et al. Derivation and validation of systemic lupus international collaborating clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum 2012; 64: 2677-2686
• 2 Aringer M, Dorner T, Leuchten N et al. Toward new criteria for systemic lupus erythematosus-a standpoint. Lupus 2016; 25: 805-811
• 3 van Vollenhoven RF, Mosca M, Bertsias G et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis 2014; 73: 958-967
• 4 Franklyn K, Lau CS, Navarra SV et al. Definition and initial validation of a Lupus Low Disease Activity State (LLDAS). Ann Rheum Dis 2015; 75: 1615-1621
• 5 van Vollenhoven RF, Aranow C, Bertsias G et al. Remission in SLE: Consensus findings from a large international panel on definitions of remission in SLE (DORIS). Ann Rheum Dis 2015; 74: 103
• 6 Furie R, Wang L, Drappa J et al. Systemic lupus erythematosus (SLE) responder index [SRI(4)] response is associated with global benefit in patients with moderate to severe SLE. Ann Rheum Dis 2016; 75: 70
• 7 Dall'Era M, Cisternas MG, Smilek DE et al. Predictors of long-term renal outcome in lupus nephritis trials: lessons learned from the Euro-Lupus Nephritis cohort. Arthritis Rheumatol 2015; 67: 1305-1313
• 8 Khamashta M, Merrill JT, Werth VP et al. Sifalimumab, an anti-interferon-alpha monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis 2016;
• 9 Furie R, Merrill JT, Werth VP et al. Anifrolumab, an anti-interferon alpha receptor monoclonal antibody, in moderate to severe systemic lupus eyrthematosus (SLE). Arthritis Rheumatol 2015 67. (Suppl. 10) Im Internet: http://acrabstracts.org/abstract/anifrolumab-an-anti-interferon-alpha-receptor-monoclonal-antibody-in-moderate-to-severe-systemic-lupus-erythematosus-sle/ Letzter Zugriff: 12.09.2016
• 10 Isenberg DA, Petri M, Kalunian K et al. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis 2016; 75: 323-331
• 11 Merrill JT, van Vollenhoven RF, Buyon JP et al. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis 2016; 75: 332-340
• 12 Yusof MYMd, Shaw D, Rawstron A et al. Validation of highly sensitive flow cytometry as a biomarker for rituximab in SLE: a rationale for more intensive treatment to improve clinical ouctomes. Ann Rheum Dis 2016; 75: 296
• 13 Alexander T, Sarfert R, Klotsche J et al. The proteasome inhibitior bortezomib depletes plasma cells and ameliorates clinical manifestations of refractory systemic lupus erythematosus. Ann Rheum Dis 2015; 74: 1474-1478
• 14 von Spee-Mayer C, Siegert E, Abdirama D et al. Low-dose interleukin-2 selectively corrects regulatory T cell defects in patients with systemic lupus erythematosus. Ann Rheum Dis 2016; 75: 1407-1415
• 15 Humrich JY, von Spee-Mayer C, Siegert E et al. Rapid induction of clinical remission by low-dose interleukin-2 in a patient with refractory SLE. Ann Rheum Dis 2015; 74: 791-792