REAL-WORLD DATA FOR SELEXIPAG IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION: A SPHERE (SELEXIPAG: THE USERS DRUG REGISTRY) ANALYSIS
2020; Elsevier BV; Volume: 158; Issue: 4 Linguagem: Inglês
10.1016/j.chest.2020.08.1875
ISSN1931-3543
AutoresKelly Chin, Murali M. Chakinala, Anna R. Hemnes, Harrison W. Farber, Vallerie V. McLaughlin, Nick Kim, Carol Zhao, VEENA NARAYAN, Kristin B. Highland,
Tópico(s)Pulmonary Hypertension Research and Treatments
ResumoSESSION TITLE: Pulmonary Vascular Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: Connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) has a poor prognosis compared with other PAH etiologies. Selexipag, a selective oral IP prostacyclin receptor agonist, has shown benefit in patients (pts) with CTD-PAH in GRIPHON (NCT01106014). The ongoing US-based SPHERE registry provides real-world data for PAH pts on selexipag. METHODS: Pts enrolled in SPHERE (NCT03278002) are aged ≥18 years (yrs) with a documented selexipag titration regimen and are followed for up to 18 months (mos); data are collected from baseline (selexipag initiation) and quarterly to end of follow-up. Disease characteristics, treatment patterns and outcomes of CTD-PAH and idiopathic PAH (IPAH) for the first 500 pts in SPHERE were analyzed using descriptive statistics; survival rates were estimated using Kaplan-Meier method. RESULTS: This data cut (December 20, 2019; N=500) comprised 132 CTD-PAH (26.4%), 246 IPAH (49.2%) and 122 other (24.4%) pts. For the CTD-PAH population, median time from PAH diagnosis to selexipag initiation was 3.3 yrs; 31.1% were newly initiated (enrolled ≤60 days after starting selexipag). This was similar for all subgroups. Compared with IPAH, CTD-PAH pts were more likely to: be female (87.9% vs 72.4%), have a shorter 6-minute walk distance (286.2 meters vs 320 meters), have a higher NT-proBNP level (1185 ng/L vs 400 ng/L); and have interstitial lung disease (29.5% vs 6.1%), reflux (46.2% vs 26.8%) or immune system disorders (83.3% vs 19.1%). Most CTD-PAH pts (64.9%) were receiving dual therapy at selexipag initiation; median maintenance dose (1200µg) and time to maintenance dose (8.3 weeks) was similar to IPAH. In newly initiated pts, median selexipag treatment duration was 16.4 and 16.9 mos for CTD-PAH and IPAH, respectively. Discontinuation rates were 46.3% and 44.9% in CTD-PAH and IPAH, respectively: 19.5% and 14.5% were PAH worsening-related adverse events (AEs) and 17.1% and 20.3% were selexipag-related AEs, in CTD-PAH and IPAH, respectively. Median 18 mos survival rate was slightly lower although CI overlap in CTD-PAH (71.0% [95% CI 53.7%, 82.8%]) than IPAH (84.4% [95% CI 71.6%, 91.8%]). Per REVEAL 2.0 risk calculator, 19.7%, 26.5% and 17.4% of CTD-PAH pts had improved, stable and worsened risk at 18 mos vs baseline, vs 12.2%, 41.5% and 12.6% of IPAH pts, respectively (missing data: CTD-PAH 36.4%, IPAH 33.7%). CONCLUSIONS: In SPHERE, CTD-PAH disease and treatment characteristics were consistent with previously reported data. Compared to baseline, the majority of pts had either improved or stable risk status with treatment. Outcomes for CTD-PAH pts receiving selexipag in the real-world setting were broadly similar to those of IPAH. CTD-PAH and IPAH pts had similar discontinuation rates due to tolerability. CLINICAL IMPLICATIONS: SPHERE data informs real-world use of selexipag in clinical practice. DISCLOSURES: Speaker/Speaker's Bureau relationship with Bayer Please note: $1001 - $5000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Honoraria PI for clinical trial relationship with Bayer Please note: $5001 - $20000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Advisory Committee Member relationship with Bayer Please note: $1001 - $5000 Added 06/01/2020 by Murali Chakinala, source=Web Response, value=Honoraria Advisory Committee Member relationship with Actelion/Janssen Please note: $1001 - $5000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Honoraria PI for clinical trials relationship with Actelion/Janssen Please note: >$100000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support Please list any financial relationships relationship with Medtronic Please note: $20001 - $100000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support PI for clinical trial relationship with Reata Please note: $20001 - $100000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support PI for clinical trial relationship with Liquidia Please note: $5001 - $20000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with Phase Bio Please note: $1001 - $5000 Added 06/01/2020 by Murali Chakinala, source=Web Response, value=Consulting fee PI for clinical trial relationship with Phase Bio Please note: $20001 - $100000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support PI for clinical trial relationship with Complexa Please note: $20001 - $100000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support PI for clinical trials relationship with United Therapeutics Please note: $20001 - $100000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support PI for clinical trial relationship with Altavant Please note: $5001 - $20000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support Consultant relationship with Altavant Please note: $1001 - $5000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Consulting fee PI for clinical trial relationship with Acceleron Please note: $5001 - $20000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with Acceleron Please note: $1001 - $5000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Honoraria Advisory Committee Member relationship with Express Scripts Please note: $1001 - $5000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Honoraria Consultant relationship with Arena Please note: $1-$1000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Consulting fee PI for clinical trial relationship with Trio Health Analytics Please note: $1001 - $5000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with V-Wave Please note: $1-$1000 Added 05/31/2020 by Murali Chakinala, source=Web Response, value=Consulting fee Advisory relationship with TBD Please note: $1-$1000 Added 04/06/2020 by Kelly Chin, source=Web Response, value=Consulting fee Removed 04/08/2020 by Kelly Chin, source=Web Response Scientific Medical Advisor relationship with Actelion Pharmaceuticals US, Inc. Please note: $1-$1000 Added 04/08/2020 by Kelly Chin, source=Web Response, value=Consulting fee Steering committee member relationship with Actelion Pharmaceuticals US, Inc. Please note: $1-$1000 Added 04/08/2020 by Kelly Chin, source=Web Response, value=Grant/Research Support Consultant relationship with United Therapeutics Please note: $1-$1000 Added 04/08/2020 by Kelly Chin, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with Bayer Healthcare Please note: $1-$1000 Added 04/08/2020 by Kelly Chin, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with Ironwood Pharmaceuticals Please note: $1-$1000 Added 04/08/2020 by Kelly Chin, source=Web Response, value=Grant/Research Support Circulation associate editor relationship with American Heart Association Please note: $1-$1000 Added 04/08/2020 by Kelly Chin, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Actelion Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Actelion Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Bayer Please note: $5001 - $20000 by Harrison Farber, source=Web Response, value=Honoraria Advisory Committee Member relationship with Arena Please note: $5001 - $20000 by Harrison Farber, source=Web Response, value=Consulting fee Removed 04/28/2020 by Harrison Farber, source=Web Response Advisory Committee Member relationship with United Therapeutics Please note: $5001 - $20000 by Harrison Farber, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Bellerophon Please note: $1-$1000 by Harrison Farber, source=Web Response, value=Consulting fee Removed 04/28/2020 by Harrison Farber, source=Web Response Advisory Committee Member relationship with Boehringer-Ingelheim Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Consulting fee Consultant relationship with Bristol-Myers Squibb Please note: $1001 - $5000 by Harrison Farber, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Acceleron Please note: $1001 - $5000 Added 04/28/2020 by Harrison Farber, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Altavant Please note: $1001 - $5000 Added 04/28/2020 by Harrison Farber, source=Web Response, value=Consulting fee Advisory Committee Member relationship with bayer Please note: $1001 - $5000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Complexa Please note: $1-$1000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Advisory Committee Member relationship with United Therapeutics Please note: $1001 - $5000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Advisory Committee Member relationship with actelion Please note: $1001 - $5000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with PHPreMedicine Please note: $1-$1000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Ownership interest Speaker/Speaker's Bureau relationship with United Therapeutics Please note: $20001 - $100000 Added 06/01/2020 by Kristin Highland, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with actelion Please note: $20001 - $100000 Added 06/01/2020 by Kristin Highland, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with bayer healthcare Please note: $5001 - $20000 Added 06/01/2020 by Kristin Highland, source=Web Response, value=Honoraria Consultant relationship with Actelion Please note: $5001 - $20000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Consulting fee Consultant relationship with Bayer Please note: $5001 - $20000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Actelion Please note: $1001 - $5000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Bayer Please note: $1001 - $5000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Honoraria Scientific Medical Advisor relationship with Gossamer Bio Please note: $5001 - $20000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Grant/Research Support Scientific Medical Advisor relationship with Sonivie Please note: $5001 - $20000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Grant/Research Support Scientific Medical Advisor relationship with United Therapeutics Please note: $1001 - $5000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with United Therapeutics Please note: $1001 - $5000 Added 05/20/2020 by Nick Kim, source=Web Response, value=Consulting fee Removed 05/20/2020 by Nick Kim, source=Web Response Consultant relationship with Acceleron Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Consulting fee Research Investigator relationship with Acceleron Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Grant/Research Support Consultant relationship with Actelion Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Consulting fee Research Investigator relationship with Actelioni Please note: $5001 - $20000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Grant/Research Support Consultant relationship with Bayer Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Consulting fee Research Investigator relationship with Bayer Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Grant/Research Support Consultant relationship with Caremark Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Consulting fee Consultant relationship with CiVi Biopharma Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Consulting fee Research Investigator relationship with Reata Pharm. Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Grant/Research Support Research Investigator relationship with SonoVie Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Grant/Research Support Consultant relationship with United Therapeutics Please note: $1001 - $5000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Consulting fee Research Investigator relationship with United Therapeutics Please note: $5001 - $20000 Added 02/26/2020 by Vallerie McLaughlin, source=Web Response, value=Grant/Research Support Employee relationship with Actelion Please note: >$100000 Added 06/11/2020 by Veena Narayan, source=Web Response, value=Salary No relevant relationships by Carol Zhao, source=Web Response
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