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3. OP05 Primary efficacy and safety of mirikizumab in moderate to severe Crohn’s Disease: results of the treat-through VIVID 1 study

Author

Ferrante, M, primary, Danese, S, additional, Chen, M, additional, D'Haens, G, additional, Ghosh, S, additional, Hisamatsu, T, additional, Jairath, V, additional, Kierkus, J, additional, Peyrin-Biroulet, L, additional, Siegmund, B, additional, Bragg, S M, additional, Crandall, W, additional, Hunter Gibble, T, additional, Lin, Z, additional, Ugolini Lopes, M, additional, Morris, N, additional, Carlier, H, additional, and Sands, B, additional

Published
2024
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5. POS0301 STRUCTURAL OUTCOMES IN THE SACROILIAC JOINT AFTER IXEKIZUMAB TREATMENT FOR 16 WEEKS IN PATIENTS WITH ACTIVE NON‑RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS STRATIFIED BY GENDER, HLA-B27, AND BASELINE MRI INFLAMMATION

Author

Maksymowych, W. P., primary, Baraliakos, X., additional, Lambert, R. G., additional, Landewé, R. B. M., additional, Sandoval, D., additional, Carlier, H., additional, Lisse, J., additional, LI, X., additional, Hojnik, M., additional, and Østergaard, M., additional

Published
2022
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6. The ASAS-OMERACT core domain set for axial spondyloarthritis

Author

Navarro-Compán, V., primary, Boel, A., additional, Boonen, A., additional, Mease, P., additional, Landewé, R., additional, Kiltz, U., additional, Dougados, M., additional, Baraliakos, X., additional, Bautista-Molano, W., additional, Carlier, H., additional, Chiowchanwisawakit, P., additional, Dagfinrud, H., additional, de Peyrecave, N., additional, El-Zorkany, B., additional, Fallon, L., additional, Gaffney, K., additional, Garrido-Cumbrera, M., additional, Gensler, L.S., additional, Haroon, N., additional, Kwan, Y.H., additional, Machado, P.M., additional, Maksymowych, W.P., additional, Poddubnyy, D., additional, Protopopov, M., additional, Ramiro, S., additional, Shea, B., additional, Song, IH, additional, van Weely, S., additional, and van der Heijde, D., additional

Published
2021
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7. Poursuite ou arrêt du traitement par l’ixékizumab chez des patients atteints de spondyloarthrite axiale et ayant atteint la rémission : résultats d’une étude de retrait randomisé, contrôlée versus placebo

Author

Landewé, R., primary, Gensler, L., additional, Poddubnyy, D., additional, Rahman, P., additional, Hojnik, M., additional, Li, X., additional, Liu-Leage, S., additional, Adams, D., additional, Carlier, H., additional, Van den Bosch, F., additional, and Lukas, C., additional

Published
2021
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9. The ASAS-OMERACT core domain set for axial spondyloarthritis

Author

Universidad de Sevilla. Departamento de Geografía Física y Análisis Geográfico Regional, Universidad de Sevilla. HUM981: Health & Territory Research, Navarro Compán, Victoria, Boel, Anne, Boonen, Annelies, Mease, Philip, Landewé, Robert, Kiltz, Uta, Dougados, Maxime, Baraliakos, Xenofon, Bautista Molano, Wilson, Carlier, H., Chiowchanwisawakit, Praveena, Dagfinrud, Hanne, Peyrecave, Natasha de, El-Zorkany, Bassel, Fallon, Lara, Gaffney, K., Garrido Cumbrera, Marco, Gensler, Lianne, Haroon, Nigil, Kwan, Yu Heng, Machado, Pedro, Maksymowych, Walter P., Poddubnyy, Denis, Protopopov, Mikhail, Ramiro, Sofía, Shea, Beverly, Song, In-Ho, Weely, Salima van, Heijde, Désirée van der, Universidad de Sevilla. Departamento de Geografía Física y Análisis Geográfico Regional, Universidad de Sevilla. HUM981: Health & Territory Research, Navarro Compán, Victoria, Boel, Anne, Boonen, Annelies, Mease, Philip, Landewé, Robert, Kiltz, Uta, Dougados, Maxime, Baraliakos, Xenofon, Bautista Molano, Wilson, Carlier, H., Chiowchanwisawakit, Praveena, Dagfinrud, Hanne, Peyrecave, Natasha de, El-Zorkany, Bassel, Fallon, Lara, Gaffney, K., Garrido Cumbrera, Marco, Gensler, Lianne, Haroon, Nigil, Kwan, Yu Heng, Machado, Pedro, Maksymowych, Walter P., Poddubnyy, Denis, Protopopov, Mikhail, Ramiro, Sofía, Shea, Beverly, Song, In-Ho, Weely, Salima van, and Heijde, Désirée van der

Abstract

Background: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary. Objective: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA). Methods: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two settings are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies. Results: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials. Conclusion: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.

Published
2021

11. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W)

Author

Dougados, M., Wei, J.C.C., Landewe, R., Sieper, J., Baraliakos, X., Bosch, F. van den, Maksymowych, W.P., Ermann, J., Walsh, J.A., Tomita, T., Deodhar, A., Heijde, D. van der, Li, X.Q., Zhao, F.Y., Bertram, C.C., Gallo, G., Carlier, H., Gensler, L.S., COAST-V Study Grp, COAST-W Study Grp, Clinical Immunology and Rheumatology, and AII - Inflammatory diseases

Subjects
0301 basic medicine, Male, Time Factors, DMARDs (biologic), Severity of Illness Index, DISEASE, RECOMMENDATIONS, HI, 0302 clinical medicine, Monoclonal, Medicine and Health Sciences, Immunology and Allergy, Axial spondyloarthritis, Humanized, education.field_of_study, Drug Substitution, ANKYLOSING-SPONDYLITIS, spondyloarthritis, Miscellaneous, Treatment Outcome, Antirheumatic Agents, Female, HEALTH INDEX, BURDEN, medicine.drug, Ankylosing spondylitis, medicine.medical_specialty, Immunology, Population, Antibodies, Monoclonal, Humanized, Placebo, General Biochemistry, Genetics and Molecular Biology, Antibodies, 03 medical and health sciences, Rheumatology, Double-Blind Method, Internal medicine, ankylosing spondylitis, Spondylarthritis, medicine, Adalimumab, Humans, In patient, education, ASAS, 030203 arthritis & rheumatology, business.industry, Biology and Life Sciences, medicine.disease, Clinical trial, Radiography, Ixekizumab, 030104 developmental biology, Tumor Necrosis Factor Inhibitors, business
Abstract

ObjectivesTo investigate the efficacy and safety of ixekizumab for up to 52 weeks in two phase 3 studies of patients with active radiographic axial spondyloarthritis (r-axSpA) who were biological disease-modifying antirheumatic drug (bDMARD)-naive (COAST-V) or tumour necrosis factor inhibitor (TNFi)-experienced (COAST-W).MethodsAdults with active r-axSpA were randomised 1:1:1:1 (n=341) to 80 mg ixekizumab every 2 (IXE Q2W) or 4 weeks (IXE Q4W), placebo (PBO) or 40 mg adalimumab Q2W (ADA) in COAST-V and 1:1:1 (n=316) to IXE Q2W, IXE Q4W or PBO in COAST-W. At week 16, patients receiving ixekizumab continued their assigned treatment; patients receiving PBO or ADA were rerandomised 1:1 to IXE Q2W or IXE Q4W (PBO/IXE, ADA/IXE) through week 52.ResultsIn COAST-V, Assessment of SpondyloArthritis international Society 40 (ASAS40) responses rates (intent-to-treat population, non-responder imputation) at weeks 16 and 52 were 48% and 53% (IXE Q4W); 52% and 51% (IXE Q2W); 36% and 51% (ADA/IXE); 19% and 47% (PBO/IXE). Corresponding ASAS40 response rates in COAST-W were 25% and 34% (IXE Q4W); 31% and 31% (IXE Q2W); 14% and 39% (PBO/IXE). Both ixekizumab regimens sustained improvements in disease activity, physical function, objective markers of inflammation, QoL, health status and overall function up to 52 weeks. Safety through 52 weeks of ixekizumab was consistent with safety through 16 weeks.ConclusionThe significant efficacy demonstrated with ixekizumab at week 16 was sustained for up to 52 weeks in bDMARD-naive and TNFi-experienced patients. bDMARD-naive patients initially treated with ADA demonstrated further numerical improvements after switching to ixekizumab. Safety findings were consistent with the known safety profile of ixekizumab.Trial registration numberNCT02696785/NCT02696798.

Published
2020

12. Efficacité et tolérance à 52 semaines de l’ixékizumab dans la spondyloarthrite axiale radiographique chez des patients en réponse inadéquate ou intolérants aux anti-TNF

Author

Dougados, M., primary, Sieper, J., additional, Baraliakos, X., additional, Van den Bosch, F., additional, Maksymowych, W., additional, Ermann, J., additional, Li, X., additional, Gallo, G., additional, Carlier, H., additional, Gensler, L., additional, and Lespessailles, E., additional

Published
2020
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13. Ixékizumab dans la spondyloarthrite axiale non-radiographique : résultats d’un essai de phase 3

Author

Deodhar, A., primary, Van Der Heijde, D., additional, Gensler, L., additional, Kim, T.H., additional, Maksymowych, W., additional, Ostergaard, M., additional, Poddubnyy, D., additional, Marzo-Ortega, H., additional, Bessette, L., additional, Tomita, T., additional, Gallo, G., additional, Adams, D.H., additional, Leung, A., additional, Zhao, F., additional, Hojnik, M., additional, Carlier, H., additional, Sieper, J., additional, and Dougados, M., additional

Published
2020
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14. Fifty two-week efficacy and safety results from SPIRIT-P1: A Phase 3 study of ixekizumab in patients with active psoriatic arthritis

Author

Mease, Philip, Okada, M, Kishimoto, M, Shuler, Catherine, Carlier, H, Lin, Chen-Yen, Mou, J, Moriarty, Susan, Lee, Chin, Gladman, Dafna, and Kurzawa, Monika

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Background: The efficacy and safety of ixekizumab were evaluated in patients with active PsA. Methods: Patients (N=417) were randomized to ixekizumab 80mg once every 4 (IXEQ4W) or 2 (IXEQ2W) weeks (160mg starting dose included), 40mg adalimumab, or placebo during the double-blind treatment period[for full text, please go to the a.m. URL], 45. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2017

23. Ckecklist voor een droomtuin

Author

Carlier, H. and Carlier, H.

Abstract

Wie de tuin wil veranderen of opnieuw wil aanleggen komt voor allerlei vragen te staan. Je kunt natuurlijk alles uit handen geven maar je kunt ook zien hoever je zelf komt. Daarvoor is een goede inventarisatie van dromen en praktische zaken handig. Hans Carlier geeft praktische tips en overwegingen. Als ontwerper nam hij graag zijn klanten aan de hand bij de ontwikkeling van een tuin. Daarmee blijft of wordt de tuin van henzelf.

Published
2013

24. Clinical and laboratory guidelines for the use of HIV-1 drug resistance testing as part of treatment management: recommendations for the European setting

Author

Miller, V Vandamme, AM Loveday, C Staszewski, S and Lundgren, J Youle, M Ait-Khaled, M Boucher, C and Brun-Vezinet, F Dedes, N Giaquinto, C Hertogs, K Houyez, F Perrin, L Pillay, D Schmit, JC Schuurman, R Lange, J Banhegyi, D Biondi, G Broekhuizen, A Bush-Donovan, C and Camacho, R Carlier, H Clavel, F Clotet, B Clumeck, N and Colebunders, R De Clerq, K De Jaegher, JJ De Schrijver, G De Smet, K Hall, W Harrigan, R Hatzakis, A and Hellmann, N Hoetelmans, R Holtzer, C Katlama, C Larder, D Loriaux, E McCreedy, B Mulcahy, F Opravil, M and Phillips, A Ruiz, N Shulse, E Sonnerborg, A Soriano, V and Steel, H Vella, S Williams, A EuroGuidelines Grp HIV Resistance

Abstract

Viral drug susceptibility is associated with virologic response to new treatments. Standardized drug resistance tests are now available, and data from some clinical trials suggest that the use of drug resistance testing may be associated with improved virologic outcome. However, drug resistance testing is complex in terms of performance, interpretation and clinical application. HIV-1 drug resistance testing is used across Europe in patient management, but not in a consistent manner. This is due to differences in the national approaches to treatment, treatment management and reimbursement, as well as availability of tests. National guidelines only exist in some countries. In addition, the laboratory quality assurance and quality control standards are not applied uniformly. The EuroGuidelines Group was established to formulate clinical as well as laboratory guidelines for the use of HIV-1 drug resistance testing that are specific for the European setting. The group is comprised of academic clinicians and virologists, scientist from the industry and representatives of the patient community. The panel of experts will review these guidelines and update them on a yearly basis as new scientific evidence becomes available. (C) 2001 Lippincott Williams & Wilkins.

Published
2001

50. Quality of Life in Patients Treated with First-Line Antiretroviral Therapy Containing Nevirapine And/Or Efavirenz

Author

van Leth, Frank, Conway, Brian, Laplumé, Hector, Martin, Des, Fisher, Martin, Jelaska, Ante, Wit, Ferdinand W, Lange, Joep MA, Laplumé, H, Lasala, MB, Losso, MH, Bogdanowicz, E, Lattes, R, Krolewiecki, A, Zala, C, Orcese, C, Terlizzi, S, Duran, A, Ebensrteijn, J, Bloch, M, Russell, O, Russell, DB, Roth, NR, Eu, B, Austin, D, Gowers, A, Quan, D, Demonty, J, Peleman, R, Vandercam, B, Vogelaers, D, van der Gucht, B, van Wanzeele, F, Moutschen, MM, Badaro, R, Grinsztejn, B, Schechter, M, Uip, D, Netto, EN, Coelho, SS, Badaró, F, Pilotto, JH, Schubach, A, Barros, ML, Leite, OHM, Kiffer, CRV, Wunsch, CT, Nunes, D, Catalani, A, de Cassia Alves, Lira R, Dossin, TJ, D'Alló de Oliveira, MT, Martini, S, Conway, B, de Wet, JJ, Montaner, JSG, Murphy, C, Woodfall, B, Sestak, P, Phillips, P, Montessori, V, Harris, M, Tesiorowski, A, Willoughby, B, Voigt, R, Farley, J, Reynolds, R, Devlaming, S, Livrozet, JM, Rozenbaum, W, Sereni, D, Valantin, MA, Lascoux, C, Milpied, B, Brunet, C, Billaud, E, Huart, A, Reliquet, V, Charonnat, MF, Sicot, M, Esnault, JL, Slama, L, Staszewski, S, Bickel, M, Lazanas, MK, Stavrianeas, N, Mangafas, N, Zagoreos, I, Kourkounti, S, Paparizos, V, Botsi, Ch, Clarke, S, Brannigan, E, Boyle, N, Chiriani, A, Leoncini, F, Montella, F, Francesco, L, Ambu, S, Farese, A, Gargiulo, M, Di Sora, F, Lavria, F, Folgori, F, Beniowski, M, Boron Kaczmarska, A, Halota, W, Prokopowicz, D, Bander, DB, Leszuzyszyn-Pynka, MLP, Wnuk, AW, Bakowska, E, Pulik, P, Flisiak, R, Wiercinska-Drapalo, A, Mularska, E, Witor, A, Antunes, F, Sarmento, RSE, Doroana, M, Horta, AA, Vasconcelos, O, Andrews, SM, Huisamen, CB, Johnson, D, Martin, O, Bekker, L-G, Maartens, G, Wilson, D, Visagie, CJ, David, NJ, Rattley, M, Nettleship, E, Martin, DJ, Keyser, V, Moraites, TM, Moorhouse, MA, Pitt, JA, Orrell, CJ, Bester, C, Parboosing, R, Moodley, P, Gathiram, V, Woolf, D, Bernasconi, E, Magenta, L, Cardiello, P, Kroon, E, Ungsedhapand, C, Fisher, M, Wilkins, EGL, Stockwell, E, Day, J, Daintith, RS, Perry, N, Timaeus, C, Intosh-Roffet, J Mc, Powell, A, Youle, M, Tyrer, M, Madge, S, Drinkwater, A, Cuthbertson, Z, Carroll, A, Becker, S, Katner, H, Rimland, D, Saag, MS, Thompson, M, Witt, M, Aguilar, MM, LaVoy, A, Illeman, M, Guerrero, M, Gatell, J, Belsey, E, Hirschel, B, Potarca, A, Cronenberg, M, Kreekel, L, Meester, R, Khodabaks, J, Botma, H-J, Esrhir, N, Farida, I, Feenstra, M, Jansen, K, Klotz, A, Mulder, M, Ruiter, G, Bass, CB, Pluymers, E, de Vlegelaer, E, Leeneman (VCL), R, Carlier, H, van Steenberge, E, and Hall, D

Abstract

Objective To assess whether differences in safety profiles between nevirapine (NVP) and efavirenz (EFV), as observed in the 2NN study, translated into differences in ‘health related quality of life’ (HRQoL).Design A sub-study of the 2NN study, with antiretro-viral-naive patients randomly allocated to NVP (once or twice daily), EFV or NVP+EFV, in addition to stavudine and lamivudine.Methods Comparing differences in changes of HRQoL over 48 weeks as measured with the Medical Outcomes Study HIV Health Survey (MOS-HIV) questionnaire, using analysis of variance.Results The 2NN study enrolled 1216 patients. No validated questionnaires were available for 244 patients, and 55 patients had no HRQoL data at all, leaving 917 patients eligible for this sub-study. A total of 471 (51%) had HRQoL measurements both at baseline and week 48. The majority (69%) of patients without HRQoL measurements did, however, complete the study. The change in the physical health score (PHS) was 3.9 for NVP, 3.4 for EFV and 2.4 for NVP+EFV (P=0.712). For the mental health score (MHS) these values were 6.1, 7.0 and 3.9, respectively (P=0.098). A baseline plasma HIV-1 RNA concentration (pVL) =100 000 copies/ml and a decline in pVL (per log10) were independently associated with an increase of PHS. An increase of MHS was only associated with pVL decline. Patients experiencing an adverse event during follow-up had a comparable change in PHS but a significantly smaller change in MHS, compared with those without an adverse event.Conclusions First-line ART containing NVP and/or EFV leads to an improvement in HRQoL. The gain in HRQoL was similar for NVP and EFV, but slightly lower for the combination of these drugs.

Published
2004
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