Unmet Needs
Unmet needs 2016: systemic lupus erythematosus
November 3, 2016

Five years after approval by the FDA and EMA, IV Benlysta remains the only drug licensed for the treatment of systemic lupus erythematosus (SLE) in almost 60 years, highlighting the difficulty in successfully bringing to market agents to treat this multifactorial disease. Despite the high level of unmet need in SLE, IV Benlysta has seen slow uptake, especially in some European markets, owing to a combination of factors including high price, modest efficacy, low response rate, and slow onset of action. Thus, the   level   of   unmet   need   in   SLE   remains   high, and   significant   clinical   and   commercial opportunities persist for therapies that can provide superior efficacy in reducing disease activity, help to decrease use of corticosteroids, and improve quality of life of patients with SLE. https://decisionresourcesgroup.com/report/141094-biopharma-systemic-lupus-erythematosus-moderate-to-severe/ 

The unmet need in rheumatology: reports from the Targeted Therapies meeting 2016


The primary and secondary unmet scientific needs within systemic lupus erythematosus with regard to translational science, clinical science and therapeutic trials, and clinical care.

Translational science: Primary Unmet Need:

  • Better understanding of the role of T and B lymphocytes (and subsets), the epigenetic modification of various cell types (in connection with environmental factors), and metabolic perturbations in the pathophysiology of disease.
  • Further development of longitudinal, clinically well-characterized cohorts (immunologically, genetically, and metabolically) with appropriate imaging, tissue and fluid samples; improved data-sharing among investigators.

Translational science: Secondary Unmet Needs:

  • The development of biomarkers to identify “pre-disease” (high risk individuals) and very early disease.
  • Better understanding of the natural history of disease flares.

Clinical science and therapeutic trials: Primary Unmet Need:

  • Further refinement of clinical response measures/index.
  • Standardization of a definition of disease remission.
  • Clinical trials that incorporate IFN signature and emphasize responder analyses.
  • Large pragmatic trials of existing and emerging therapies.
  • Small proof of mechanism trials for emerging therapies.

Clinical science and therapeutic trials: Secondary Unmet Needs:

  • Improved identification and targeting of the innate immune response.
  • Improved identification and use of biomarkers within clinical practice and trials.
  • Broaden membership of groups designing trials.

Clinical care: Primary Unmet Need:

  • Better characterize patient concerns (vs. provider concerns).
  • Optimization of steroid-sparing approaches to treatment including the development of toxicity scoring systems, the development of sustained release or organ-targeted steroid preparations, and consideration of different “phases” of steroid use.
  • Improved understanding of targeting specific therapies to specific disease clinical manifestations.

Clinical care: Secondary Unmet Needs:

  • Identification of socioeconomic factors that contribute to long-standing disease.
  • Establish patient support groups & guides/advocates, to improve adherence to medical regimen.
  • Better understand cognitive dysfunction associated with disease and the development of a usable instrument to quantify in clinical practice.

Merck KGaA (MKGAF.PK), Darmstadt, Germany, Presents Phase II Data On The Safety And Efficacy Of Atacicept At The 2016 ACR/ARHP Annual Meeting


  • Results from phase II investigations of atacicept in systemic lupus erythematosus (Abstract Numbers: 12L and 764)

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that clinical data on atacicept, an investigational drug for systemic lupus erythematosus, are scheduled to be presented in poster sessions at the 2016 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting taking place from November 11-16, 2016, in Washington, DC, U.S.

“There is a significant unmet medical need in systemic lupus erythematosus, with limited treatment options currently available for this debilitating disease,” said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck KGaA, Darmstadt, Germany. “The safety and efficacy data that will be presented at ACR/ARHP indicate that atacicept may play an important role as a potential new therapeutic option for patients with lupus. Our goal is to continue to advance innovation across our immunology pipeline that could make a meaningful difference for people living with lupus and other autoimmune diseases.”

Systemic Lupus Erythematosus Drugs Market 2016: Global Industry Insights, Statistics, Market shares and Forecasts to 2022


Latest industry research report on Systemic lupus erythematosus (SLE) is the chronic, autoimmune disorder which involves multiple organ-systems such as heart, kidney, skin, joints, blood, lungs and, in most severe cases, brain. In this disease, the human immune system becomes hyperactive and attacks the normal, healthy tissues of the body. Women from the Asian, Afro-Caribbean and Hispanic descent are chiefly affected by this disease. According to National Institute of Arthritis and Musculoskeletal and Skin Diseases, the prominence of this disease is majorly in the African-American and Asian populations. During the past few years, the global SLE drugs market has witnessed a paradigm shift from generic and off label drugs to standard innovator drugs with better delivery options.

Formerly, the market was equipped with various drugs administered through conventional routes such as oral, intravenous and topical formulations. However, the recent launch of sub-cutaneous formulation of existing drug namely, Benlysta has addressed the unmet need for better and efficient innovator drugs with convenient mode of delivery. Hence in future, the global Systemic Lupus Erythematosus Drugs market would grow prominently due to factors such as rising incidences of SLE, increasing R&D investment on SLE drugs, and rising ageing population. Factors restraining the market growth are increasing drugs prices and presence of stringent regulatory environment.

Presently, North America occupies major of the market followed by Asia Pacific and Europe region. The key strategies adopted by major players of this market include product launches, collaborations and mergers & acquisitions over last three years. Recently, Lupus Research and Pfizer have formed Novel Research Collaborations with the Leading Academic-Medical Centers. This alliance for Lupus Research (ALR) and the Pfizer’s Centers for the Therapeutic Innovation (CTI) would promote the research activities in the field of systemic lupus erythematosus.

Furthermore, the EMD Serono, biopharmaceutical division of the Merck KGaA, and the Pfizer would jointly fund collaboration, for receiving the real-time access towards the data on lupus erythematosus of the Broad Institute for the analysis. These collaborations would enable endorsement of the novel therapeutics approaches in the treatment of systemic lupus erythematosus. 

Exagen Diagnostics to Present Six Scientific Posters at 2016 ACR/ARHP Annual Meeting


Exagen Diagnostics to feature six poster presentations on AVISE® testing at the American College of Rheumatology’s (ACR) annual meeting being held Nov. 11-16, 2016 in Washington, D.C. The AVISE family of tests includes AVISE CTD featuring patented biomarkers called cell-bound complement activation products (CB-CAPS) along with a proprietary index, all of which combines to offer enhanced detection for certain autoimmune rheumatic diseases including systemic lupus erythematosus (SLE). Attendees are invited to visit the Exagen booth #313 to learn more about the benefits of AVISE testing, including a new enhanced result report and the novel AVISE Touch specimen collection method. Abstracts can be seen online at the ACR website http://acrabstracts.org/meetings/2016-acrarhp-annual-meeting/. Titles, presentation dates and abstract numbers for the six featured posters are listed below.

Sunday, November 13, 2016:

Abstract Title: Complement C4d Split Products on Erythrocytes Are Associated with Composite Measure of Disease Activity in Systemic Lupus Erythematosus Subjects Receiving Methotrexate and Hydroxychloroquine. Presenter: Michelle Petri, MD. Abstract #751

Abstract Title: Differing Contribution of Methotrexate Polyglutamation to Infliximab and Adalimumab Exposure as Compared to Etanercept. Presenter: Thierry Dervieux, PhD. Abstract #601

Tuesday, November 15, 2016:

Abstract Title: Cell-Bound Complement Activation Products in Multi-Analyte Assay with Algorithm Aid the Diagnosis of Systemic Lupus Erythematosus. Presenter: James Mossell, MD. Abstract #2800

Abstract Title: Prospective Validation of a Panel of Autoantibodies in Combination with C4d-Bound Complement Activation Products for the Differential Diagnosis of Systemic Lupus Erythematosus. Presenter: Daniel Wallace, MD. Abstract #2797

Abstract Title: Multi-Center Validation of Platelet Bound C4d, a Biomarker for Systemic Lupus Erythematosus. Presenter: Richard Furie, MD. Abstract #2798

Abstract Title: Cell-bound Complement Activation Products Correlate with Disease Activity in Childhood-onset Systemic Lupus Erythematosus. Presenter: Hui-Yuen, MD. Abstract #2421

Current and emerging treatment options in the management of lupus