Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial

Iain B. McInnes, Arthur Kavanaugh, Alice B. Gottlieb, Lluís Puig, Proton Rahman, Christopher Ritchlin, Carrie Brodmerkel, Shu Li, Yuhua Wang, Alan M. Mendelsohn, Mittie K. Doyle, Jacob Aelion, Gaspar Akovbyan, Daina Andersone, Audrey Bakulev, Vida Basijokiene, Andre Beaulieu, Charles Birbara, Erin Boh, Marc BourcierJurgen Braun, Jan Brzezicki, Russell Buchanan, John Budd, Loreta Bukauskiene, Michael Burnette, Juan Canete Crespillo, Wayne Carey, Chandra Chattapadhyay, Dariusz Chudzik, Robert Cooper, Edit Drescher, Anna Dudek, Jan Dutz, Hisham El-Kadi, Ludwig Erlacher, Scott A. Fretzin, Juan A. Garcia Meijide, Emmanuel George, Nigel Gilchrist, Geoffrey Gladstein, Peter Gow, Winfried Graninger, Robert M. Griffin, Lyn Guenther, Wayne Gulliver, Stephen Hall, Dale G. Halter, Kathryn Hobbs, Elana Ilivanova, Pentti Jarvinen, Slawomir Jeka, Peter Jones, Majed Khraishi, Muza Kokhan, Attila Kovacs, Laszlo Kovacs, Alexey Kubanov, Rod Kunynetz, Richard Langley, Susan Lee, Craig L. Leonardi, Clode Lessard, Virginija Lietuvininkiene, Paul Lizzul, Alan Martin, Alexey Maslyanskiy, Robert T. Matheson, Helene Mikazane, Frederick T. Murphy, Peter Nash, Eugeny Nasonov, Frederico Navarro Sarabia, Alexander Orlov-Morozov, Leena Paimela, William Palmer, Kim Papp, Margarita Pileckyte, G. Poór, Yves Poulin, Ruben Queiro Silva, Ronald Rapoport, Audrey Rebrov, Maria Rell-Bakalarska, Phoebe Rich, Maureen Rischmueller, Bernadette Rojkovich, Cheryl Rosen, Les Rosoph, Clemens Scheinecker, Rudolph Schopf, Michael Sebastian, Stuart Seigel, Saeed Shaikh, Tom Sheeran, William J. Shergy, Valery Shirinsky, Evan L. Siegel, Howard Sofen, Wolfram Sterry, Jerzy Supronik, Zoltan Szabo, Ferenc Szanyo, Hasan Tahir, Jerry Tan, William Taylor, Vadim Temnikov, Diamant Thaci, Darryl Toth, I. Újfalussy, Heikki Valleala, Ronald Vender, Norman Wasel, Martin Willans, Jurgen Wollenhaupt, Omid Zamani, Ellen Zanetakis, Elena Zonova, David Zoschke, Anna Zubrzycka-Sienkiewicz

Research output: Contribution to journalArticle

429 Citations (Scopus)

Abstract

Background Many patients with psoriasis develop psoriatic arthritis, a chronic inflammatory disease that afflicts peripheral synovial, axial, and entheseal structures. The fully human monoclonal antibody ustekinumab is an efficacious treatment for moderate-to-severe plaque psoriasis. We did a randomised, placebo-controlled, phase 3 trial to assess the safety and efficacy of ustekinumab in patients with active psoriatic arthritis. Methods In this phase 3, multicentre, double-blind, placebo-controlled trial at 104 sites in Europe, North America, and Asia-Pacific, adults with active psoriatic arthritis (≥5 tender and ≥5 swollen joints, C-reactive protein ≥3·0 mg/L) were randomly assigned (1:1:1, by dynamic central randomisation based on an algorithm implemented by an interactive voice-web response system) to 45 mg ustekinumab, 90 mg ustekinumab, or placebo at week 0, week 4, and every 12 weeks thereafter. At week 16, patients with less than 5% improvement in both tender and swollen joint counts entered masked early-escape and were given 45 mg ustekinumab (if in the placebo group) or 90 mg ustekinumab (if in the 45 mg group). At week 24, all remaining patients in the placebo group received ustekinumab 45 mg, which they continued at week 28 and every 12 weeks thereafter. Our primary endpoint was 20% or greater improvement in American College of Rheumatology (ACR20) criteria at week 24. This trial is registered with ClinicalTrials.gov (NCT01009086) and EudraCT (2009-012264-14). Findings Between Nov 30, 2009, and March 30, 2011, 615 patients were randomly assigned-206 to placebo, 205 to 45 mg ustekinumab, and 204 to 90 mg ustekinumab. More ustekinumab-treated (87 of 205 [42·4%] in the 45 mg group and 101 of 204 [49·5%] in the 90 mg group) than placebo-treated (47 of 206 [22·8%]) patients achieved ACR20 at week 24 (p

Original languageEnglish
Pages (from-to)780-789
Number of pages10
JournalThe Lancet
Volume382
Issue number9894
DOIs
Publication statusPublished - 2013

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Psoriatic Arthritis
Placebos
Safety
Psoriasis
Joints
Northern Asia
Ustekinumab
Random Allocation
North America
C-Reactive Protein
Chronic Disease
Monoclonal Antibodies

ASJC Scopus subject areas

  • Medicine(all)

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Efficacy and safety of ustekinumab in patients with active psoriatic arthritis : 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. / McInnes, Iain B.; Kavanaugh, Arthur; Gottlieb, Alice B.; Puig, Lluís; Rahman, Proton; Ritchlin, Christopher; Brodmerkel, Carrie; Li, Shu; Wang, Yuhua; Mendelsohn, Alan M.; Doyle, Mittie K.; Aelion, Jacob; Akovbyan, Gaspar; Andersone, Daina; Bakulev, Audrey; Basijokiene, Vida; Beaulieu, Andre; Birbara, Charles; Boh, Erin; Bourcier, Marc; Braun, Jurgen; Brzezicki, Jan; Buchanan, Russell; Budd, John; Bukauskiene, Loreta; Burnette, Michael; Crespillo, Juan Canete; Carey, Wayne; Chattapadhyay, Chandra; Chudzik, Dariusz; Cooper, Robert; Drescher, Edit; Dudek, Anna; Dutz, Jan; El-Kadi, Hisham; Erlacher, Ludwig; Fretzin, Scott A.; Garcia Meijide, Juan A.; George, Emmanuel; Gilchrist, Nigel; Gladstein, Geoffrey; Gow, Peter; Graninger, Winfried; Griffin, Robert M.; Guenther, Lyn; Gulliver, Wayne; Hall, Stephen; Halter, Dale G.; Hobbs, Kathryn; Ilivanova, Elana; Jarvinen, Pentti; Jeka, Slawomir; Jones, Peter; Khraishi, Majed; Kokhan, Muza; Kovacs, Attila; Kovacs, Laszlo; Kubanov, Alexey; Kunynetz, Rod; Langley, Richard; Lee, Susan; Leonardi, Craig L.; Lessard, Clode; Lietuvininkiene, Virginija; Lizzul, Paul; Martin, Alan; Maslyanskiy, Alexey; Matheson, Robert T.; Mikazane, Helene; Murphy, Frederick T.; Nash, Peter; Nasonov, Eugeny; Sarabia, Frederico Navarro; Orlov-Morozov, Alexander; Paimela, Leena; Palmer, William; Papp, Kim; Pileckyte, Margarita; Poór, G.; Poulin, Yves; Silva, Ruben Queiro; Rapoport, Ronald; Rebrov, Audrey; Rell-Bakalarska, Maria; Rich, Phoebe; Rischmueller, Maureen; Rojkovich, Bernadette; Rosen, Cheryl; Rosoph, Les; Scheinecker, Clemens; Schopf, Rudolph; Sebastian, Michael; Seigel, Stuart; Shaikh, Saeed; Sheeran, Tom; Shergy, William J.; Shirinsky, Valery; Siegel, Evan L.; Sofen, Howard; Sterry, Wolfram; Supronik, Jerzy; Szabo, Zoltan; Szanyo, Ferenc; Tahir, Hasan; Tan, Jerry; Taylor, William; Temnikov, Vadim; Thaci, Diamant; Toth, Darryl; Újfalussy, I.; Valleala, Heikki; Vender, Ronald; Wasel, Norman; Willans, Martin; Wollenhaupt, Jurgen; Zamani, Omid; Zanetakis, Ellen; Zonova, Elena; Zoschke, David; Zubrzycka-Sienkiewicz, Anna.

In: The Lancet, Vol. 382, No. 9894, 2013, p. 780-789.

Research output: Contribution to journalArticle

McInnes, IB, Kavanaugh, A, Gottlieb, AB, Puig, L, Rahman, P, Ritchlin, C, Brodmerkel, C, Li, S, Wang, Y, Mendelsohn, AM, Doyle, MK, Aelion, J, Akovbyan, G, Andersone, D, Bakulev, A, Basijokiene, V, Beaulieu, A, Birbara, C, Boh, E, Bourcier, M, Braun, J, Brzezicki, J, Buchanan, R, Budd, J, Bukauskiene, L, Burnette, M, Crespillo, JC, Carey, W, Chattapadhyay, C, Chudzik, D, Cooper, R, Drescher, E, Dudek, A, Dutz, J, El-Kadi, H, Erlacher, L, Fretzin, SA, Garcia Meijide, JA, George, E, Gilchrist, N, Gladstein, G, Gow, P, Graninger, W, Griffin, RM, Guenther, L, Gulliver, W, Hall, S, Halter, DG, Hobbs, K, Ilivanova, E, Jarvinen, P, Jeka, S, Jones, P, Khraishi, M, Kokhan, M, Kovacs, A, Kovacs, L, Kubanov, A, Kunynetz, R, Langley, R, Lee, S, Leonardi, CL, Lessard, C, Lietuvininkiene, V, Lizzul, P, Martin, A, Maslyanskiy, A, Matheson, RT, Mikazane, H, Murphy, FT, Nash, P, Nasonov, E, Sarabia, FN, Orlov-Morozov, A, Paimela, L, Palmer, W, Papp, K, Pileckyte, M, Poór, G, Poulin, Y, Silva, RQ, Rapoport, R, Rebrov, A, Rell-Bakalarska, M, Rich, P, Rischmueller, M, Rojkovich, B, Rosen, C, Rosoph, L, Scheinecker, C, Schopf, R, Sebastian, M, Seigel, S, Shaikh, S, Sheeran, T, Shergy, WJ, Shirinsky, V, Siegel, EL, Sofen, H, Sterry, W, Supronik, J, Szabo, Z, Szanyo, F, Tahir, H, Tan, J, Taylor, W, Temnikov, V, Thaci, D, Toth, D, Újfalussy, I, Valleala, H, Vender, R, Wasel, N, Willans, M, Wollenhaupt, J, Zamani, O, Zanetakis, E, Zonova, E, Zoschke, D & Zubrzycka-Sienkiewicz, A 2013, 'Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial', The Lancet, vol. 382, no. 9894, pp. 780-789. https://doi.org/10.1016/S0140-6736(13)60594-2
McInnes, Iain B. ; Kavanaugh, Arthur ; Gottlieb, Alice B. ; Puig, Lluís ; Rahman, Proton ; Ritchlin, Christopher ; Brodmerkel, Carrie ; Li, Shu ; Wang, Yuhua ; Mendelsohn, Alan M. ; Doyle, Mittie K. ; Aelion, Jacob ; Akovbyan, Gaspar ; Andersone, Daina ; Bakulev, Audrey ; Basijokiene, Vida ; Beaulieu, Andre ; Birbara, Charles ; Boh, Erin ; Bourcier, Marc ; Braun, Jurgen ; Brzezicki, Jan ; Buchanan, Russell ; Budd, John ; Bukauskiene, Loreta ; Burnette, Michael ; Crespillo, Juan Canete ; Carey, Wayne ; Chattapadhyay, Chandra ; Chudzik, Dariusz ; Cooper, Robert ; Drescher, Edit ; Dudek, Anna ; Dutz, Jan ; El-Kadi, Hisham ; Erlacher, Ludwig ; Fretzin, Scott A. ; Garcia Meijide, Juan A. ; George, Emmanuel ; Gilchrist, Nigel ; Gladstein, Geoffrey ; Gow, Peter ; Graninger, Winfried ; Griffin, Robert M. ; Guenther, Lyn ; Gulliver, Wayne ; Hall, Stephen ; Halter, Dale G. ; Hobbs, Kathryn ; Ilivanova, Elana ; Jarvinen, Pentti ; Jeka, Slawomir ; Jones, Peter ; Khraishi, Majed ; Kokhan, Muza ; Kovacs, Attila ; Kovacs, Laszlo ; Kubanov, Alexey ; Kunynetz, Rod ; Langley, Richard ; Lee, Susan ; Leonardi, Craig L. ; Lessard, Clode ; Lietuvininkiene, Virginija ; Lizzul, Paul ; Martin, Alan ; Maslyanskiy, Alexey ; Matheson, Robert T. ; Mikazane, Helene ; Murphy, Frederick T. ; Nash, Peter ; Nasonov, Eugeny ; Sarabia, Frederico Navarro ; Orlov-Morozov, Alexander ; Paimela, Leena ; Palmer, William ; Papp, Kim ; Pileckyte, Margarita ; Poór, G. ; Poulin, Yves ; Silva, Ruben Queiro ; Rapoport, Ronald ; Rebrov, Audrey ; Rell-Bakalarska, Maria ; Rich, Phoebe ; Rischmueller, Maureen ; Rojkovich, Bernadette ; Rosen, Cheryl ; Rosoph, Les ; Scheinecker, Clemens ; Schopf, Rudolph ; Sebastian, Michael ; Seigel, Stuart ; Shaikh, Saeed ; Sheeran, Tom ; Shergy, William J. ; Shirinsky, Valery ; Siegel, Evan L. ; Sofen, Howard ; Sterry, Wolfram ; Supronik, Jerzy ; Szabo, Zoltan ; Szanyo, Ferenc ; Tahir, Hasan ; Tan, Jerry ; Taylor, William ; Temnikov, Vadim ; Thaci, Diamant ; Toth, Darryl ; Újfalussy, I. ; Valleala, Heikki ; Vender, Ronald ; Wasel, Norman ; Willans, Martin ; Wollenhaupt, Jurgen ; Zamani, Omid ; Zanetakis, Ellen ; Zonova, Elena ; Zoschke, David ; Zubrzycka-Sienkiewicz, Anna. / Efficacy and safety of ustekinumab in patients with active psoriatic arthritis : 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. In: The Lancet. 2013 ; Vol. 382, No. 9894. pp. 780-789.
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title = "Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial",
abstract = "Background Many patients with psoriasis develop psoriatic arthritis, a chronic inflammatory disease that afflicts peripheral synovial, axial, and entheseal structures. The fully human monoclonal antibody ustekinumab is an efficacious treatment for moderate-to-severe plaque psoriasis. We did a randomised, placebo-controlled, phase 3 trial to assess the safety and efficacy of ustekinumab in patients with active psoriatic arthritis. Methods In this phase 3, multicentre, double-blind, placebo-controlled trial at 104 sites in Europe, North America, and Asia-Pacific, adults with active psoriatic arthritis (≥5 tender and ≥5 swollen joints, C-reactive protein ≥3·0 mg/L) were randomly assigned (1:1:1, by dynamic central randomisation based on an algorithm implemented by an interactive voice-web response system) to 45 mg ustekinumab, 90 mg ustekinumab, or placebo at week 0, week 4, and every 12 weeks thereafter. At week 16, patients with less than 5{\%} improvement in both tender and swollen joint counts entered masked early-escape and were given 45 mg ustekinumab (if in the placebo group) or 90 mg ustekinumab (if in the 45 mg group). At week 24, all remaining patients in the placebo group received ustekinumab 45 mg, which they continued at week 28 and every 12 weeks thereafter. Our primary endpoint was 20{\%} or greater improvement in American College of Rheumatology (ACR20) criteria at week 24. This trial is registered with ClinicalTrials.gov (NCT01009086) and EudraCT (2009-012264-14). Findings Between Nov 30, 2009, and March 30, 2011, 615 patients were randomly assigned-206 to placebo, 205 to 45 mg ustekinumab, and 204 to 90 mg ustekinumab. More ustekinumab-treated (87 of 205 [42·4{\%}] in the 45 mg group and 101 of 204 [49·5{\%}] in the 90 mg group) than placebo-treated (47 of 206 [22·8{\%}]) patients achieved ACR20 at week 24 (p",
author = "McInnes, {Iain B.} and Arthur Kavanaugh and Gottlieb, {Alice B.} and Llu{\'i}s Puig and Proton Rahman and Christopher Ritchlin and Carrie Brodmerkel and Shu Li and Yuhua Wang and Mendelsohn, {Alan M.} and Doyle, {Mittie K.} and Jacob Aelion and Gaspar Akovbyan and Daina Andersone and Audrey Bakulev and Vida Basijokiene and Andre Beaulieu and Charles Birbara and Erin Boh and Marc Bourcier and Jurgen Braun and Jan Brzezicki and Russell Buchanan and John Budd and Loreta Bukauskiene and Michael Burnette and Crespillo, {Juan Canete} and Wayne Carey and Chandra Chattapadhyay and Dariusz Chudzik and Robert Cooper and Edit Drescher and Anna Dudek and Jan Dutz and Hisham El-Kadi and Ludwig Erlacher and Fretzin, {Scott A.} and {Garcia Meijide}, {Juan A.} and Emmanuel George and Nigel Gilchrist and Geoffrey Gladstein and Peter Gow and Winfried Graninger and Griffin, {Robert M.} and Lyn Guenther and Wayne Gulliver and Stephen Hall and Halter, {Dale G.} and Kathryn Hobbs and Elana Ilivanova and Pentti Jarvinen and Slawomir Jeka and Peter Jones and Majed Khraishi and Muza Kokhan and Attila Kovacs and Laszlo Kovacs and Alexey Kubanov and Rod Kunynetz and Richard Langley and Susan Lee and Leonardi, {Craig L.} and Clode Lessard and Virginija Lietuvininkiene and Paul Lizzul and Alan Martin and Alexey Maslyanskiy and Matheson, {Robert T.} and Helene Mikazane and Murphy, {Frederick T.} and Peter Nash and Eugeny Nasonov and Sarabia, {Frederico Navarro} and Alexander Orlov-Morozov and Leena Paimela and William Palmer and Kim Papp and Margarita Pileckyte and G. Po{\'o}r and Yves Poulin and Silva, {Ruben Queiro} and Ronald Rapoport and Audrey Rebrov and Maria Rell-Bakalarska and Phoebe Rich and Maureen Rischmueller and Bernadette Rojkovich and Cheryl Rosen and Les Rosoph and Clemens Scheinecker and Rudolph Schopf and Michael Sebastian and Stuart Seigel and Saeed Shaikh and Tom Sheeran and Shergy, {William J.} and Valery Shirinsky and Siegel, {Evan L.} and Howard Sofen and Wolfram Sterry and Jerzy Supronik and Zoltan Szabo and Ferenc Szanyo and Hasan Tahir and Jerry Tan and William Taylor and Vadim Temnikov and Diamant Thaci and Darryl Toth and I. {\'U}jfalussy and Heikki Valleala and Ronald Vender and Norman Wasel and Martin Willans and Jurgen Wollenhaupt and Omid Zamani and Ellen Zanetakis and Elena Zonova and David Zoschke and Anna Zubrzycka-Sienkiewicz",
year = "2013",
doi = "10.1016/S0140-6736(13)60594-2",
language = "English",
volume = "382",
pages = "780--789",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "9894",

}

TY - JOUR

T1 - Efficacy and safety of ustekinumab in patients with active psoriatic arthritis

T2 - 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial

AU - McInnes, Iain B.

AU - Kavanaugh, Arthur

AU - Gottlieb, Alice B.

AU - Puig, Lluís

AU - Rahman, Proton

AU - Ritchlin, Christopher

AU - Brodmerkel, Carrie

AU - Li, Shu

AU - Wang, Yuhua

AU - Mendelsohn, Alan M.

AU - Doyle, Mittie K.

AU - Aelion, Jacob

AU - Akovbyan, Gaspar

AU - Andersone, Daina

AU - Bakulev, Audrey

AU - Basijokiene, Vida

AU - Beaulieu, Andre

AU - Birbara, Charles

AU - Boh, Erin

AU - Bourcier, Marc

AU - Braun, Jurgen

AU - Brzezicki, Jan

AU - Buchanan, Russell

AU - Budd, John

AU - Bukauskiene, Loreta

AU - Burnette, Michael

AU - Crespillo, Juan Canete

AU - Carey, Wayne

AU - Chattapadhyay, Chandra

AU - Chudzik, Dariusz

AU - Cooper, Robert

AU - Drescher, Edit

AU - Dudek, Anna

AU - Dutz, Jan

AU - El-Kadi, Hisham

AU - Erlacher, Ludwig

AU - Fretzin, Scott A.

AU - Garcia Meijide, Juan A.

AU - George, Emmanuel

AU - Gilchrist, Nigel

AU - Gladstein, Geoffrey

AU - Gow, Peter

AU - Graninger, Winfried

AU - Griffin, Robert M.

AU - Guenther, Lyn

AU - Gulliver, Wayne

AU - Hall, Stephen

AU - Halter, Dale G.

AU - Hobbs, Kathryn

AU - Ilivanova, Elana

AU - Jarvinen, Pentti

AU - Jeka, Slawomir

AU - Jones, Peter

AU - Khraishi, Majed

AU - Kokhan, Muza

AU - Kovacs, Attila

AU - Kovacs, Laszlo

AU - Kubanov, Alexey

AU - Kunynetz, Rod

AU - Langley, Richard

AU - Lee, Susan

AU - Leonardi, Craig L.

AU - Lessard, Clode

AU - Lietuvininkiene, Virginija

AU - Lizzul, Paul

AU - Martin, Alan

AU - Maslyanskiy, Alexey

AU - Matheson, Robert T.

AU - Mikazane, Helene

AU - Murphy, Frederick T.

AU - Nash, Peter

AU - Nasonov, Eugeny

AU - Sarabia, Frederico Navarro

AU - Orlov-Morozov, Alexander

AU - Paimela, Leena

AU - Palmer, William

AU - Papp, Kim

AU - Pileckyte, Margarita

AU - Poór, G.

AU - Poulin, Yves

AU - Silva, Ruben Queiro

AU - Rapoport, Ronald

AU - Rebrov, Audrey

AU - Rell-Bakalarska, Maria

AU - Rich, Phoebe

AU - Rischmueller, Maureen

AU - Rojkovich, Bernadette

AU - Rosen, Cheryl

AU - Rosoph, Les

AU - Scheinecker, Clemens

AU - Schopf, Rudolph

AU - Sebastian, Michael

AU - Seigel, Stuart

AU - Shaikh, Saeed

AU - Sheeran, Tom

AU - Shergy, William J.

AU - Shirinsky, Valery

AU - Siegel, Evan L.

AU - Sofen, Howard

AU - Sterry, Wolfram

AU - Supronik, Jerzy

AU - Szabo, Zoltan

AU - Szanyo, Ferenc

AU - Tahir, Hasan

AU - Tan, Jerry

AU - Taylor, William

AU - Temnikov, Vadim

AU - Thaci, Diamant

AU - Toth, Darryl

AU - Újfalussy, I.

AU - Valleala, Heikki

AU - Vender, Ronald

AU - Wasel, Norman

AU - Willans, Martin

AU - Wollenhaupt, Jurgen

AU - Zamani, Omid

AU - Zanetakis, Ellen

AU - Zonova, Elena

AU - Zoschke, David

AU - Zubrzycka-Sienkiewicz, Anna

PY - 2013

Y1 - 2013

N2 - Background Many patients with psoriasis develop psoriatic arthritis, a chronic inflammatory disease that afflicts peripheral synovial, axial, and entheseal structures. The fully human monoclonal antibody ustekinumab is an efficacious treatment for moderate-to-severe plaque psoriasis. We did a randomised, placebo-controlled, phase 3 trial to assess the safety and efficacy of ustekinumab in patients with active psoriatic arthritis. Methods In this phase 3, multicentre, double-blind, placebo-controlled trial at 104 sites in Europe, North America, and Asia-Pacific, adults with active psoriatic arthritis (≥5 tender and ≥5 swollen joints, C-reactive protein ≥3·0 mg/L) were randomly assigned (1:1:1, by dynamic central randomisation based on an algorithm implemented by an interactive voice-web response system) to 45 mg ustekinumab, 90 mg ustekinumab, or placebo at week 0, week 4, and every 12 weeks thereafter. At week 16, patients with less than 5% improvement in both tender and swollen joint counts entered masked early-escape and were given 45 mg ustekinumab (if in the placebo group) or 90 mg ustekinumab (if in the 45 mg group). At week 24, all remaining patients in the placebo group received ustekinumab 45 mg, which they continued at week 28 and every 12 weeks thereafter. Our primary endpoint was 20% or greater improvement in American College of Rheumatology (ACR20) criteria at week 24. This trial is registered with ClinicalTrials.gov (NCT01009086) and EudraCT (2009-012264-14). Findings Between Nov 30, 2009, and March 30, 2011, 615 patients were randomly assigned-206 to placebo, 205 to 45 mg ustekinumab, and 204 to 90 mg ustekinumab. More ustekinumab-treated (87 of 205 [42·4%] in the 45 mg group and 101 of 204 [49·5%] in the 90 mg group) than placebo-treated (47 of 206 [22·8%]) patients achieved ACR20 at week 24 (p

AB - Background Many patients with psoriasis develop psoriatic arthritis, a chronic inflammatory disease that afflicts peripheral synovial, axial, and entheseal structures. The fully human monoclonal antibody ustekinumab is an efficacious treatment for moderate-to-severe plaque psoriasis. We did a randomised, placebo-controlled, phase 3 trial to assess the safety and efficacy of ustekinumab in patients with active psoriatic arthritis. Methods In this phase 3, multicentre, double-blind, placebo-controlled trial at 104 sites in Europe, North America, and Asia-Pacific, adults with active psoriatic arthritis (≥5 tender and ≥5 swollen joints, C-reactive protein ≥3·0 mg/L) were randomly assigned (1:1:1, by dynamic central randomisation based on an algorithm implemented by an interactive voice-web response system) to 45 mg ustekinumab, 90 mg ustekinumab, or placebo at week 0, week 4, and every 12 weeks thereafter. At week 16, patients with less than 5% improvement in both tender and swollen joint counts entered masked early-escape and were given 45 mg ustekinumab (if in the placebo group) or 90 mg ustekinumab (if in the 45 mg group). At week 24, all remaining patients in the placebo group received ustekinumab 45 mg, which they continued at week 28 and every 12 weeks thereafter. Our primary endpoint was 20% or greater improvement in American College of Rheumatology (ACR20) criteria at week 24. This trial is registered with ClinicalTrials.gov (NCT01009086) and EudraCT (2009-012264-14). Findings Between Nov 30, 2009, and March 30, 2011, 615 patients were randomly assigned-206 to placebo, 205 to 45 mg ustekinumab, and 204 to 90 mg ustekinumab. More ustekinumab-treated (87 of 205 [42·4%] in the 45 mg group and 101 of 204 [49·5%] in the 90 mg group) than placebo-treated (47 of 206 [22·8%]) patients achieved ACR20 at week 24 (p

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