COMUNICADO: Janssen Presents Long Term Phase 3 Efficacy and Safety Data of Sirukumab in Rheumatoid Arthritis Patients Who had an Ina

Publicado 14/06/2017 17:28:53CET

MADRID, June 14, 2017 /PRNewswire/ --

Sirukumab Phase 3 Data Presented at the Annual European Congress of Rheumatology

(EULAR) 2017 also Show Significant Improvement in Quality of Life Measures

Janssen-Cilag International NV (Janssen) today announced long-term results from SIRROUND-T*, a pivotal Phase 3 study that showed sirukumab improved the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) through 52 weeks of treatment in adult patients with an inadequate response and/or intolerance to anti-tumour necrosis factor (TNF)-alpha treatments.[1] This is a typically difficult-to-treat population, representative of clinical practice where up to 40% of RA patients do not respond to biologics.[2] This study and other data from the SIRROUND clinical programme will be presented in 11 abstracts accepted for presentation at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.  

Data from the SIRROUND-T* study showed that more than half of patients receiving either sirukumab 50 mg or 100 mg achieved at least a 20% improvement in the signs and symptoms of disease (ACR20) at week 52 (54.3% sirukumab 50 mg; 59.3% sirukumab 100 mg).[1] Patients receiving sirukumab also demonstrated clinically meaningful improvements from baseline through week 52 in quality of life measures, as demonstrated by the health assessment questionnaire disability index (HAQ-DI) and the short form-36 (SF-36) health survey, for patient-reported outcomes in both physical and emotional well-being.[1]

The incidences of adverse events (AEs) and serious AEs were comparable between sirukumab 50 mg (79.6% and 14.2%, respectively) and sirukumab 100 mg (81.3% and 13.2%, respectively).

"The long-term efficacy of sirukumab as shown in the SIRROUND-T study is encouraging considering the study includes a difficult-to-treat patient population. More than 60 percent of patients in the trial had previously received two or more biologics, including anti-TNFs and treatments with other mechanisms of action. This is representative of real world clinical practice," commented Professor Daniel Aletaha, Consultant Rheumatologist and Associate Professor at the Medical University of Vienna. "Rheumatoid arthritis can be a very heterogeneous disease and therefore additional therapeutic options, like sirukumab, are needed."

In a post-hoc analysis from four sirukumab Phase 3 studies** presented at the congress, investigators reported that treatment with sirukumab consistently increased levels of haemoglobin in adult patients with moderately to severely active RA, thus reducing by week 16 the proportion of patients with anaemia, which is common in rheumatoid arthritis.[3]

Two additional poster presentations evaluated improvements in Health-Related Quality of Life (HRQoL) compared with an age/gender matched normal population in patients with RA and an inadequate response to conventional disease-modifying anti-rheumatic drugs (DMARDS) and anti-TNFs (SIRROUND-D and SIRROUND-T Phase 3 studies, respectively). The post-hoc analyses found that treatment with sirukumab resulted in greater and clinically meaningful improvements in HRQoL at week 24 compared with patients receiving placebo (P<0.001), with similar results observed across sirukumab doses (50 mg every 4 weeks and 100 mg every 2 weeks).[4],[5]

An oral presentation of a post-hoc analysis (SIRROUND-D) highlighted the effect of sirukumab plus methotrexate on circulating biomarkers and demonstrated that in addition to inhibiting radiographic progression (bone destruction measured on x-ray images), treatment with sirukumab strongly inhibited biomarkers of bone and tissue destruction, and enhanced markers of bone formation.[6]

"The data presented at this year's congress support the profile of sirukumab in the treatment of moderately to severely active adult rheumatoid arthritis. While patient outcomes have improved in the last few decades with the advent of new RA treatments, there are still many patients whose disease is not effectively managed and continues to progress. We believe that sirukumab has the potential to offer an important new alternative treatment for patients," said Bogdana Coudsy MD, European Medical Affairs Director Immunology, Janssen EMEA.

*SIRROUND-T: Efficacy and Safety of Sirukumab in Patients with Active Rheumatoid Arthritis Despite Anti-TNF Therapy[1],[7]

The Phase 3 SIRROUND-T trial is a randomised, double-blind, placebo-controlled study that included 878 adult patients with an inadequate response and/or intolerance to anti-TNF-alpha therapy, more than 39% of whom had prior exposure to non-TNF-alpha biologic therapies. Patients were randomised evenly to receive sirukumab 50 mg every 4 weeks or sirukumab 100 mg every 2 weeks or placebo (patients on placebo were re-randomised at week 24 to receive sirukumab 50 mg every 4 weeks or 100 mg every 2 weeks). 54.3% of patients receiving sirukumab 50 mg every 4 weeks and 59.3% receiving sirukumab 100 mg every 2 weeks, achieved at least a 20% improvement in ACR response criteria at week 52. Patients receiving sirukumab achieved clinically meaningful improvements in patient-reported outcomes as measured by change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI): sirukumab 50 mg -0.36 (standard deviation, SD=0.57) and sirukumab 100 mg -0.43 (SD=0.57). Short form-36 (SF-36) summary scores were: sirukumab 50 mg: physical component summary (PCS)=5.69, mental component score (MCS)=4.65; sirukumab 100 mg PCS=5.80, MCS=4.85.

The most common AEs were injection-site reactions and alanine aminotransferase increases. Malignancies occurred in <3% of the sirukumab 50 mg and 100 mg treated population and major adverse cardiac events (MACE) occurred in <2% of the sirukumab 50 mg and 100 mg treated population.

**About the SIRROUND Clinical Programme 

The Phase 3 clinical programme in patients with active RA includes five studies investigating subcutaneously administered sirukumab 50 mg every 4 weeks and sirukumab 100 mg every two weeks in combination with conventional disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. The comprehensive development programme - the largest conducted for an anti-IL-6 biologic therapy - involves more than 3,100 patients encompassing the following five studies:

- SIRROUND-D study: patients who had an inadequate response to DMARDs. This study has completed. - SIRROUND-T study: patients who had an inadequate response or were intolerant to anti-TNF-alpha agents. This study has completed and data was published in The Lancet [http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(17)30401-4.pdf ] in February 2017. - SIRROUND-H study: patients with an inadequate response or who were intolerant to MTX or for whom MTX was inappropriate. This study has completed. - SIRROUND-M study: Japanese patients who had an inadequate response to MTX or sulfasalazine. This study has completed. - SIRROUND-LTE study: a long-term extension study for patients completing SIRROUND-D and SIRROUND-T. This study is estimated to complete in 2020.

Sirukumab is not being investigated for the treatment of anaemia.  

About Sirukumab 

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