The incidence of arthropathy adverse events in efalizumab-treated patients is low and similar to placebo and does not increase with long-term treatment: pooled analysis of data from Phase III clinical trials of efalizumab
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作者:
Carlo Pincelli
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机构:University of Modena and Reggio Emilia,Department of Medicine, Institute of Dermatology
Carlo Pincelli
Eric Henninger
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机构:University of Modena and Reggio Emilia,Department of Medicine, Institute of Dermatology
Eric Henninger
Florence Casset-Semanaz
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机构:University of Modena and Reggio Emilia,Department of Medicine, Institute of Dermatology
Florence Casset-Semanaz
机构:
[1] University of Modena and Reggio Emilia,Department of Medicine, Institute of Dermatology
[2] Serono International S.A. ,undefined
来源:
Archives of Dermatological Research
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2007年
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298卷
A large-scale, pooled analysis of safety data from five Phase III clinical trials (including open-label extensions of two of these studies) and two Phase III open-label clinical trials of efalizumab was conducted to explore whether arthropathy adverse events (AEs) were associated with efalizumab treatment in patients with moderate-to-severe chronic plaque psoriasis. Data from patients who received subcutaneous injections of efalizumab or placebo were stratified for analysis into phases according to the nature and duration of treatment. These included: the ‘first treatment’ phase (0–12-week data from patients who received either efalizumab, 1 mg/kg once weekly, or placebo in the five placebo-controlled studies); the ‘extended treatment’ phase (13–24-week data from seven trials for all efalizumab-treated patients); and the ‘long-term treatment’ phase (data from efalizumab-treated patients who received treatment for up to 36 months in two long-term trials). Descriptive statistics were performed and the incidence of arthropathy AEs per patient-year was calculated using 95% confidence intervals (CIs). During the first treatment phase, a similar proportion of patients had an arthropathy AE in the efalizumab group (3.3%; 58/1740 patients) compared with the placebo group (3.5%; 34/979 patients); the incidence of arthropathy AEs per patient-year was 0.15 in the efalizumab group (95% CI 0.11–0.19) and 0.16 in the placebo group (95% CI 0.11–0.22). Analysis of first treatment phase data from one study (n = 793) showed that the incidence of psoriatic arthropathy per patient-year was lower in efalizumab-treated patients (0.10; 95% CI 0.05–0.18) than in those given placebo (0.17; 95% CI 0.08–0.30). During the extended treatment phase, the incidence of arthropathy remained low (0.17; 95% CI 0.14–0.22). Data from two long-term studies showed that there was no increase in the incidence of arthropathy AEs over time in patients treated with efalizumab for up to 36 months. Patients who had an arthropathy AE during treatment with efalizumab appeared to be more likely to have a history of arthropathy prior to treatment. Efalizumab does not appear to increase the risk of arthropathy AEs compared with placebo.
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Royal Free Hosp, Dept Haematol, London NW3 2QG, England
UCL, Dept Haematol, London NW3 2PF, EnglandRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Hughes, Derralynn A.
Gonzalez, Derlis E.
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IPHIC, Asuncion, ParaguayRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Gonzalez, Derlis E.
Lukina, Elena A.
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Minist Publ Hlth Russia, Hematol Res Ctr, Dept Orphan Dis, Moscow, RussiaRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Lukina, Elena A.
Mehta, Atul
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Royal Free Hosp, Dept Haematol, London NW3 2QG, England
UCL, Dept Haematol, London NW3 2PF, EnglandRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Mehta, Atul
Kabra, Madhulika
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All India Inst Med Sci, Dept Pediat, New Delhi, IndiaRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Kabra, Madhulika
Elstein, Deborah
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Hebrew Univ Jerusalem, Hadassah Med Sch, Shaare Zedek Med Ctr, Gaucher Clin, IL-91010 Jerusalem, IsraelRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Elstein, Deborah
Kisinovsky, Isaac
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Your Hlth SA, Dept Hematol, Buenos Aires, DF, ArgentinaRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Kisinovsky, Isaac
Giraldo, Pilar
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CIBERER, Med Metab Hereditaria, Zaragoza, Spain
Hosp Univ Miguel Servet, Grp Estudio Enfermedades Hematol & Metab, Zaragoza, SpainRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Giraldo, Pilar
Bavdekar, Ashish
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King Edward Mem Hosp Res Ctr, Dept Pediat Gastroenterol, Pune, Maharashtra, IndiaRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Bavdekar, Ashish
Hangartner, Thomas N.
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Wright State Univ, Dept Biomed Ind & Human Factors Engn, Dayton, OH 45435 USARoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Hangartner, Thomas N.
Wang, Nan
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Shire, Biostat & Stat Programming Dept, Lexington, MA USARoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Wang, Nan
Crombez, Eric
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Shire, Rare Dis Unit, Lexington, MA USARoyal Free Hosp, Dept Haematol, London NW3 2QG, England
Crombez, Eric
Zimran, Ari
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Hebrew Univ Jerusalem, Hadassah Med Sch, Shaare Zedek Med Ctr, Gaucher Clin, IL-91010 Jerusalem, IsraelRoyal Free Hosp, Dept Haematol, London NW3 2QG, England
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Univ Lisbon, Inst Med Mol, Fac Med, Lisbon, Portugal
CNS, Torres Vedras, PortugalUniv Lisbon, Inst Med Mol, Fac Med, Lisbon, Portugal
Ferreira, J. J.
Lees, A.
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UCL, Reta Lila Weston Inst, London, EnglandUniv Lisbon, Inst Med Mol, Fac Med, Lisbon, Portugal
Lees, A.
Rocha, J. -F.
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BIAL Portela & Ca SA, Dept Res & Dev, S Mamede Do Coronado, PortugalUniv Lisbon, Inst Med Mol, Fac Med, Lisbon, Portugal
Rocha, J. -F.
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Poewe, W.
Rascol, O.
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Univ Toulouse 3, Univ Hosp Toulouse, Dept Clin Pharmacol & Neurosci, NS Pk FCRIN Network,INSERM,Clin Invest Ctr CIC143, Toulouse, FranceUniv Lisbon, Inst Med Mol, Fac Med, Lisbon, Portugal
Rascol, O.
Soares-da-Silva, P.
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BIAL Portela & Ca SA, Dept Res & Dev, S Mamede Do Coronado, Portugal
Univ Porto, Dept Pharmacol & Therapeut, Fac Med, Porto, Portugal
Univ Porto, MedInUP, Ctr Drug Discovery & Innovat Med, Porto, PortugalUniv Lisbon, Inst Med Mol, Fac Med, Lisbon, Portugal
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Univ Utah, Sch Med, Salt Lake City, UT 84108 USAUniv Utah, Sch Med, Salt Lake City, UT 84108 USA
Brinton, Eliot A.
Kashyap, Moti L.
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Atherosclerosis Res Ctr, Dept Vet Affairs Healthcare Syst, Long Beach, CA USA
Univ Calif Irvine, Dept Med, Irvine, CA 92717 USAUniv Utah, Sch Med, Salt Lake City, UT 84108 USA
Kashyap, Moti L.
Vo, Anthony N.
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Atherosclerosis Res Ctr, Dept Vet Affairs Healthcare Syst, Long Beach, CA USA
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Vo, Anthony N.
Thakkar, Roopal B.
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Abbott, Abbott Pk, IL USAUniv Utah, Sch Med, Salt Lake City, UT 84108 USA
Thakkar, Roopal B.
Jiang, Ping
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Abbott, Abbott Pk, IL USAUniv Utah, Sch Med, Salt Lake City, UT 84108 USA
Jiang, Ping
Padley, Robert J.
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Abbott, Abbott Pk, IL USAUniv Utah, Sch Med, Salt Lake City, UT 84108 USA
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Janssen Sci Affairs LLC, Field Based Med Affairs, Titusville, NJ USA
Janssen Sci Affairs LLC, Titusville, NJ USA
Univ S Alabama, Coll Med, 2450 Old Shell Rd,Ste A, Mobile, AL 36607 USAJanssen Sci Affairs LLC, Field Based Med Affairs, Titusville, NJ USA
Williamson, David J.
Gogate, Jagadish R.
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Janssen Res & Dev LLC, Stat & Decis Sci, Titusville, NJ USAJanssen Sci Affairs LLC, Field Based Med Affairs, Titusville, NJ USA
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Manera, Lewis S.
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Preskorn, Sheldon H.
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Univ Kansas, Dept Psychiat & Behav Sci, Sch Med, Wichita, KS USAJanssen Sci Affairs LLC, Field Based Med Affairs, Titusville, NJ USA
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Winokur, Andrew
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UConn Hlth, Dept Psychiat, Farmington, CT USAJanssen Sci Affairs LLC, Field Based Med Affairs, Titusville, NJ USA
Winokur, Andrew
Starr, Lynn
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