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Actelion (SIX: ATLN) has announced that following the recent FDA approval and positive CHMP opinion for macitentan (Opsumit®) in pulmonary arterial hypertension (PAH), further positive data on the efficacy of macitentan from the SERAPHIN study were presented at CHEST 2013 in Chicago, USA (26-31 October 2013).
Professor GĂ©rald Simonneau of HĂ´pital Universitaire de BicĂŞtre, Le Kremlin-BicĂŞtre, France gave an oral presentation of data from a subgroup analysis of SERAPHIN revealing that treatment-naĂŻve patients receiving macitentan 10mg had significantly improved long-term outcomes, irrespective of the time from diagnosis to treatment initiation.
Macitentan 10mg reduced the risk of morbidity/mortality by 60% in 'incident' patients compared to placebo (hazard ratio 0.40, 95% CL 0.20-0.73), in 'prevalent' patients, macitentan 10mg reduced the risk of morbidity/mortality by 53% (hazard ratio 0.47, 95% CL 0.24-0.91). The risk reductions for the secondary endpoint of death due to PAH or hospitalization for PAH (DHPAH) were 77% (hazard ratio 0.23, 95% CL 0.09-0.57) and 62% (hazard ratio 0.38, 95% CL 0.16-0.92) for incident and prevalent patients treated with macitentan 10mg versus placebo, respectively.
Incident cases are those that were diagnosed shortly before entering the study (median time post diagnosis to study inclusion of 50 days). Prevalent cases are those whose disease was diagnosed more than 6 months prior entering in the study (median time from diagnosis to study inclusion 834 days). In SERAPHIN, the incident patient group had a worse prognosis than the prevalent group however, despite this, both groups receiving macitentan saw a significant improvement in the risk of morbidity/mortality events.
The most common adverse reactions (more frequent than placebo by 3% or more) observed in patients treated with Opsumit were anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.
Professor Simonneau commented, "These data are important as they demonstrate that macitentan is an effective first-line therapy for both newly diagnosed patients and those who have waited longer before starting treatment. Despite having a poorer prognosis, incident patients benefit as much as prevalent patients when treated with macitentan in SERAPHIN. This is very encouraging news for all of our treatment-naĂŻve patients and supports earlier diagnosis and treatment for improved outcomes in PAH today."
CHEST 2013 also saw additional SERAPHIN data from an oral presentation by Professor RogĂ©rio Souza of the University of SĂŁo Paulo, SĂŁo Paulo, Brazil entitled 'Association between WHO functional class and long-term prognosis in patients with pulmonary arterial hypertension: Data from SERAPHIN, a randomized controlled study of macitentan'. Professor Souza's presentation demonstrated that worsening functional class is related to worse long-term clinical outcomes, while improving functional class is associated with better long-term clinical outcomes. He noted that this underlines the importance of maintaining or improving functional class where possible to improve the prognosis for PAH patients.
Further SERAPHIN data will also be presented at the meeting in a poster presentation by Dr Richard Channick of Massachusetts General Hospital, Boston, USA entitled 'Do parameters of cardiac function predict long-term outcomes in patients with pulmonary arterial hypertension? Data from SERAPHIN, a randomized controlled study of macitentan.'
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented, "Following on from the recent US FDA approval and positive CHMP opinion these data from the long-term SERAPHIN study reinforces that Opsumit 10 mg can delay disease progression in PAH patients over the long-term. With this data, specific to incident and prevalent patients, we are truly seeing the benefits to the PAH community of undertaking the largest and longest trial ever in PAH, and in focusing on the most clinically relevant endpoints of morbidity and mortality."
Article adapted by Medical News Today from original press release. Source:
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Ltd, Actelion. "Further positive Opsumit (macitentan) data in pulmonary arterial hypertension presented at CHEST 2013." Medical News Today. MediLexicon, Intl., 31 Oct. 2013. Web.
13 Dec. 2013. <http://www.medicalnewstoday.com/releases/268131>
Ltd, A. (2013, October 31). "Further positive Opsumit (macitentan) data in pulmonary arterial hypertension presented at CHEST 2013." Medical News Today. Retrieved from
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