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Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis.

BACKGROUNDIn a phase 2 study, the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis. We sought to evaluate the efficacy and safety of secukinumab, an anti-interleukin-17A monoclonal antibody, in such patients. METHODSIn this double-blind, phase 3 study, 60... Full description

Journal Title: The New England journal of medicine October 2015, Vol.373(14), pp.1329-1339
Main Author: Mease, Philip J
Other Authors: Mcinnes, Iain B , Kirkham, Bruce , Kavanaugh, Arthur , Rahman, Proton , van Der Heijde, Désirée , Landewé, Robert , Nash, Peter , Pricop, Luminita , Yuan, Jiacheng , Richards, Hanno B , Mpofu, Shephard , Mease, Philip J
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: E-ISSN: 1533-4406 ; DOI: 1533-4406 ; DOI: 10.1056/NEJMoa1412679
Link: http://search.proquest.com/docview/1718909510/?pq-origsite=primo
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title: Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis.
format: Article
creator:
  • Mease, Philip J
  • Mcinnes, Iain B
  • Kirkham, Bruce
  • Kavanaugh, Arthur
  • Rahman, Proton
  • van Der Heijde, Désirée
  • Landewé, Robert
  • Nash, Peter
  • Pricop, Luminita
  • Yuan, Jiacheng
  • Richards, Hanno B
  • Mpofu, Shephard
  • Mease, Philip J
subjects:
  • Administration, Intravenous–Administration & Dosage
  • Adolescent–Adverse Effects
  • Adult–Complications
  • Aged–Drug Therapy
  • Antibodies, Monoclonal–Antagonists & Inhibitors
  • Arthritis, Psoriatic–Etiology
  • Double-Blind Method–Etiology
  • Drug Administration Schedule–Etiology
  • Female–Etiology
  • Humans–Etiology
  • Injections, Subcutaneous–Etiology
  • Interleukin-17–Etiology
  • Male–Etiology
  • Middle Aged–Etiology
  • Respiratory Tract Infections–Etiology
  • Severity of Illness Index–Etiology
  • Treatment Outcome–Etiology
  • Young Adult–Etiology
  • Abridged
  • Antibodies, Monoclonal
  • Interleukin-17
  • Secukinumab
ispartof: The New England journal of medicine, October 2015, Vol.373(14), pp.1329-1339
description: BACKGROUNDIn a phase 2 study, the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis. We sought to evaluate the efficacy and safety of secukinumab, an anti-interleukin-17A monoclonal antibody, in such patients. METHODSIn this double-blind, phase 3 study, 606 patients with psoriatic arthritis were randomly assigned in a 1:1:1 ratio to receive intravenous secukinumab (at a dose of 10 mg per kilogram) at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo. Patients in the placebo group were switched to subcutaneous secukinumab at a dose of 150 mg or 75 mg at week 16 or 24, depending on clinical response. The primary end point was the proportion of patients with an American College of Rheumatology 20 (ACR20) response at week 24, defined as a 20% improvement from baseline in the number of tender and swollen joints and at least three other important domains. RESULTSACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%) (P
language: eng
source:
identifier: E-ISSN: 1533-4406 ; DOI: 1533-4406 ; DOI: 10.1056/NEJMoa1412679
fulltext: fulltext
issn:
  • 15334406
  • 1533-4406
url: Link


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titleSecukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis.
creatorMease, Philip J ; Mcinnes, Iain B ; Kirkham, Bruce ; Kavanaugh, Arthur ; Rahman, Proton ; van Der Heijde, Désirée ; Landewé, Robert ; Nash, Peter ; Pricop, Luminita ; Yuan, Jiacheng ; Richards, Hanno B ; Mpofu, Shephard ; Mease, Philip J
contributorCaeiro, Francisco (correspondence author) ; Soriano, Enrique (record owner) ; Baravalle, Marcos ; Ceitlin, Raul ; Rillo, Oscar ; Carrio, Judith ; Hall, Stephen ; Nash, Peter ; Van Den Bosch, Filip ; de Vlam, Kurt ; Geusens, Piet ; Pinheiro, Marcelo ; Zerbini, Cristiano ; Keiserman, Mauro ; Papp, Kim ; Lessard, Clode ; Tremblay, Jean-Luc ; Rahman, Proton ; Mustafa, Majed ; Thorne, J Carter ; Langevitz, Pnina ; Reitblat, Tatiana ; Rosner, Itzhak ; Elkayam, Ori ; Frediani, Bruno ; Foti, Rosario ; Cantini, Fabrizio ; Adami, Silvano ; Navarra, Sandra ; Perez, Emmanuel ; Lanzon, Allan ; Baes, Rosario ; Lucero, Auxencio ; Gulay-Carvajal, Carjen ; Li-Yu, Julie ; Tan, Perry ; Javier, Juan ; Chirieac, Rodica ; Ionescu, Ruxandra Maria ; Rednic, Simona ; Nasonov, Evgeny ; Stanislav, Marina ; Raskina, Tatiana ; Ershova, Olga ; Izmozherova, Nadezda ; Lesnyak, Olga ; Zotkin, Evgenii ; Yoon, Kam Hon ; Lim, Anita ; Leung, Ying Ying Katy ; Asavatanabodee, Paijit ; Suwannalai, Parawee ; Nanagara, Ratanavadee ; Louthrenoo, Worawit ; Strapkova, Maria ; Tahir, Hasan ; Mc Innes, Iain ; Sheeran, Thomas ; Helliwell, Philip ; Kirkham, Bruce ; Shimbova, Krasimira ; Stoilov, Rumen ; Mihaylova, Mariyana ; Dokoupilova, Eva ; Vitek, Petr ; Galatikova, Dagmar ; Janecka, Izabella ; Supronik, Jerzy ; Sieper, Joachim ; Kurthen, Reiner ; Dahmen, Georg ; Demary, Winfried ; Nuesslein, Hubert ; Degtyareva, Elizaveta ; Maus, Olga ; Kekow, Joern ; Rubbert-Roth, Andrea ; Rech, Juergen ; Schuch, Florian ; Wassenberg, Siegfried ; Martz, Rene ; Spieler, Wolfgang ; Braun, Juergen ; Halpert, Elias ; Moreta, Elvia ; Box, Jane ; Legerton, Clarence ; Flint, Kathleen ; Starr, John ; Jajoo, Ramina ; Caldron, Paul ; Tesser, John ; Frankel, Ellen ; El-Kadi, Hisham ; Petrone, Dianne ; Reimold, Andreas ; Singhal, Atul ; Sunkureddi, Prashanth ; Wellborne, Frank ; Budd, John ; Codding, Christine ; Kohen, Michael ; Kivitz, Alan ; Chindalore, Vishala ; Mease, Philip ; Aelion, Jacob ; Lee, Eric ; Valente, Robert ; Gottlieb, Alice ; Gottlieb, Alice ; Gottlieb, Alice
ispartofThe New England journal of medicine, October 2015, Vol.373(14), pp.1329-1339
identifier
subjectAdministration, Intravenous–Administration & Dosage ; Adolescent–Adverse Effects ; Adult–Complications ; Aged–Drug Therapy ; Antibodies, Monoclonal–Antagonists & Inhibitors ; Arthritis, Psoriatic–Etiology ; Double-Blind Method–Etiology ; Drug Administration Schedule–Etiology ; Female–Etiology ; Humans–Etiology ; Injections, Subcutaneous–Etiology ; Interleukin-17–Etiology ; Male–Etiology ; Middle Aged–Etiology ; Respiratory Tract Infections–Etiology ; Severity of Illness Index–Etiology ; Treatment Outcome–Etiology ; Young Adult–Etiology ; Abridged ; Antibodies, Monoclonal ; Interleukin-17 ; Secukinumab
descriptionBACKGROUNDIn a phase 2 study, the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis. We sought to evaluate the efficacy and safety of secukinumab, an anti-interleukin-17A monoclonal antibody, in such patients. METHODSIn this double-blind, phase 3 study, 606 patients with psoriatic arthritis were randomly assigned in a 1:1:1 ratio to receive intravenous secukinumab (at a dose of 10 mg per kilogram) at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo. Patients in the placebo group were switched to subcutaneous secukinumab at a dose of 150 mg or 75 mg at week 16 or 24, depending on clinical response. The primary end point was the proportion of patients with an American College of Rheumatology 20 (ACR20) response at week 24, defined as a 20% improvement from baseline in the number of tender and swollen joints and at least three other important domains. RESULTSACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%) (P<0.001 for both comparisons with placebo). Secondary end points, including the ACR50 response and joint structural damage, were significantly better in the secukinumab groups than in the placebo group. Improvements were sustained through 52 weeks. Infections, including candida, were more common in the secukinumab groups. Throughout the study (mean secukinumab exposure, 438.5 days; mean placebo exposure, 128.5 days), four patients in the secukinumab groups had a stroke (0.6 per 100 patient-years; 95% confidence interval [CI], 0.2 to 1.5), and two had a myocardial infarction (0.3 per 100 patient-years; 95% CI, 0.0 to 1.0), as compared with no patients in the placebo group. CONCLUSIONSSecukinumab was more effective than placebo in patients with psoriatic arthritis, which validates interleukin-17A as a therapeutic target. Infections were more common in the secukinumab groups than in the placebo group. The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT01392326.).
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0Mease, Philip J
1Mcinnes, Iain B
2Kirkham, Bruce
3Kavanaugh, Arthur
4Rahman, Proton
5van Der Heijde, Désirée
6Landewé, Robert
7Nash, Peter
8Pricop, Luminita
9Yuan, Jiacheng
10Richards, Hanno B
11Mpofu, Shephard
titleSecukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis.
descriptionBACKGROUNDIn a phase 2 study, the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis. We sought to evaluate the efficacy and safety of secukinumab, an anti-interleukin-17A monoclonal antibody, in such patients. METHODSIn this double-blind, phase 3 study, 606 patients with psoriatic arthritis were randomly assigned in a 1:1:1 ratio to receive intravenous secukinumab (at a dose of 10 mg per kilogram) at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo. Patients in the placebo group were switched to subcutaneous secukinumab at a dose of 150 mg or 75 mg at week 16 or 24, depending on clinical response. The primary end point was the proportion of patients with an American College of Rheumatology 20 (ACR20) response at week 24, defined as a 20% improvement from baseline in the number of tender and swollen joints and at least three other important domains. RESULTSACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%) (P<0.001 for both comparisons with placebo). Secondary end points, including the ACR50 response and joint structural damage, were significantly better in the secukinumab groups than in the placebo group. Improvements were sustained through 52 weeks. Infections, including candida, were more common in the secukinumab groups. Throughout the study (mean secukinumab exposure, 438.5 days; mean placebo exposure, 128.5 days), four patients in the secukinumab groups had a stroke (0.6 per 100 patient-years; 95% confidence interval [CI], 0.2 to 1.5), and two had a myocardial infarction (0.3 per 100 patient-years; 95% CI, 0.0 to 1.0), as compared with no patients in the placebo group. CONCLUSIONSSecukinumab was more effective than placebo in patients with psoriatic arthritis, which validates interleukin-17A as a therapeutic target. Infections were more common in the secukinumab groups than in the placebo group. The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT01392326.).
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0Administration, Intravenous–Administration & Dosage
1Adolescent–Adverse Effects
2Adult–Complications
3Aged–Drug Therapy
4Antibodies, Monoclonal–Antagonists & Inhibitors
5Arthritis, Psoriatic–Etiology
6Double-Blind Method–Etiology
7Drug Administration Schedule–Etiology
8Female–Etiology
9Humans–Etiology
10Injections, Subcutaneous–Etiology
11Interleukin-17–Etiology
12Male–Etiology
13Middle Aged–Etiology
14Respiratory Tract Infections–Etiology
15Severity of Illness Index–Etiology
16Treatment Outcome–Etiology
17Young Adult–Etiology
18Abridged
19Antibodies, Monoclonal
20Interleukin-17
21Secukinumab
22NCT01392326
23ClinicalTrials.gov
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0Caeiro, Francisco
1Soriano, Enrique
2Baravalle, Marcos
3Ceitlin, Raul
4Rillo, Oscar
5Carrio, Judith
6Hall, Stephen
7Nash, Peter
8Van Den Bosch, Filip
9de Vlam, Kurt
10Geusens, Piet
11Pinheiro, Marcelo
12Zerbini, Cristiano
13Keiserman, Mauro
14Papp, Kim
15Lessard, Clode
16Tremblay, Jean-Luc
17Rahman, Proton
18Mustafa, Majed
19Thorne, J Carter
20Langevitz, Pnina
21Reitblat, Tatiana
22Rosner, Itzhak
23Elkayam, Ori
24Frediani, Bruno
25Foti, Rosario
26Cantini, Fabrizio
27Adami, Silvano
28Navarra, Sandra
29Perez, Emmanuel
30Lanzon, Allan
31Baes, Rosario
32Lucero, Auxencio
33Gulay-Carvajal, Carjen
34Li-Yu, Julie
35Tan, Perry
36Javier, Juan
37Chirieac, Rodica
38Ionescu, Ruxandra Maria
39Rednic, Simona
40Nasonov, Evgeny
41Stanislav, Marina
42Raskina, Tatiana
43Ershova, Olga
44Izmozherova, Nadezda
45Lesnyak, Olga
46Zotkin, Evgenii
47Yoon, Kam Hon
48Lim, Anita
49Leung, Ying Ying Katy
50Asavatanabodee, Paijit
51Suwannalai, Parawee
52Nanagara, Ratanavadee
53Louthrenoo, Worawit
54Strapkova, Maria
55Tahir, Hasan
56Mc Innes, Iain
57Sheeran, Thomas
58Helliwell, Philip
59Kirkham, Bruce
60Shimbova, Krasimira
61Stoilov, Rumen
62Mihaylova, Mariyana
63Dokoupilova, Eva
64Vitek, Petr
65Galatikova, Dagmar
66Janecka, Izabella
67Supronik, Jerzy
68Sieper, Joachim
69Kurthen, Reiner
70Dahmen, Georg
71Demary, Winfried
72Nuesslein, Hubert
73Degtyareva, Elizaveta
74Maus, Olga
75Kekow, Joern
76Rubbert-Roth, Andrea
77Rech, Juergen
78Schuch, Florian
79Wassenberg, Siegfried
80Martz, Rene
81Spieler, Wolfgang
82Braun, Juergen
83Halpert, Elias
84Moreta, Elvia
85Box, Jane
86Legerton, Clarence
87Flint, Kathleen
88Starr, John
89Jajoo, Ramina
90Caldron, Paul
91Tesser, John
92Frankel, Ellen
93El-Kadi, Hisham
94Petrone, Dianne
95Reimold, Andreas
96Singhal, Atul
97Sunkureddi, Prashanth
98Wellborne, Frank
99Budd, John
100...
startdate20151001
enddate20151001
citationpf 1329 pt 1339 vol 373 issue 14
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titleSecukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis.
authorMease, Philip J ; Mcinnes, Iain B ; Kirkham, Bruce ; Kavanaugh, Arthur ; Rahman, Proton ; van Der Heijde, Désirée ; Landewé, Robert ; Nash, Peter ; Pricop, Luminita ; Yuan, Jiacheng ; Richards, Hanno B ; Mpofu, Shephard ; Mease, Philip J
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0Administration, Intravenous–Administration & Dosage
1Adolescent–Adverse Effects
2Adult–Complications
3Aged–Drug Therapy
4Antibodies, Monoclonal–Antagonists & Inhibitors
5Arthritis, Psoriatic–Etiology
6Double-Blind Method–Etiology
7Drug Administration Schedule–Etiology
8Female–Etiology
9Humans–Etiology
10Injections, Subcutaneous–Etiology
11Interleukin-17–Etiology
12Male–Etiology
13Middle Aged–Etiology
14Respiratory Tract Infections–Etiology
15Severity of Illness Index–Etiology
16Treatment Outcome–Etiology
17Young Adult–Etiology
18Abridged
19Antibodies, Monoclonal
20Interleukin-17
21Secukinumab
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2ProQuest Natural Science Collection
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8Health Research Premium Collection (Alumni edition)
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0Mease, Philip J
1Mcinnes, Iain B
2Kirkham, Bruce
3Kavanaugh, Arthur
4Rahman, Proton
5van Der Heijde, Désirée
6Landewé, Robert
7Nash, Peter
8Pricop, Luminita
9Yuan, Jiacheng
10Richards, Hanno B
11Mpofu, Shephard
12Caeiro, Francisco
13Soriano, Enrique
14Baravalle, Marcos
15Ceitlin, Raul
16Rillo, Oscar
17Carrio, Judith
18Hall, Stephen
19Van Den Bosch, Filip
20de Vlam, Kurt
21Geusens, Piet
22Pinheiro, Marcelo
23Zerbini, Cristiano
24Keiserman, Mauro
25Papp, Kim
26Lessard, Clode
27Tremblay, Jean-Luc
28Mustafa, Majed
29Thorne, J Carter
30Langevitz, Pnina
31Reitblat, Tatiana
32Rosner, Itzhak
33Elkayam, Ori
34Frediani, Bruno
35Foti, Rosario
36Cantini, Fabrizio
37Adami, Silvano
38Navarra, Sandra
39Perez, Emmanuel
40Lanzon, Allan
41Baes, Rosario
42Lucero, Auxencio
43Gulay-Carvajal, Carjen
44Li-Yu, Julie
45Tan, Perry
46Javier, Juan
47Chirieac, Rodica
48Ionescu, Ruxandra Maria
49Rednic, Simona
50Nasonov, Evgeny
51Stanislav, Marina
52Raskina, Tatiana
53Ershova, Olga
54Izmozherova, Nadezda
55Lesnyak, Olga
56Zotkin, Evgenii
57Yoon, Kam Hon
58Lim, Anita
59Leung, Ying Ying Katy
60Asavatanabodee, Paijit
61Suwannalai, Parawee
62Nanagara, Ratanavadee
63Louthrenoo, Worawit
64Strapkova, Maria
65Tahir, Hasan
66Mc Innes, Iain
67Sheeran, Thomas
68Helliwell, Philip
69Shimbova, Krasimira
70Stoilov, Rumen
71Mihaylova, Mariyana
72Dokoupilova, Eva
73Vitek, Petr
74Galatikova, Dagmar
75Janecka, Izabella
76Supronik, Jerzy
77Sieper, Joachim
78Kurthen, Reiner
79Dahmen, Georg
80Demary, Winfried
81Nuesslein, Hubert
82Degtyareva, Elizaveta
83Maus, Olga
84Kekow, Joern
85Rubbert-Roth, Andrea
86Rech, Juergen
87Schuch, Florian
88Wassenberg, Siegfried
89Martz, Rene
90Spieler, Wolfgang
91Braun, Juergen
92Halpert, Elias
93Moreta, Elvia
94Box, Jane
95Legerton, Clarence
96Flint, Kathleen
97Starr, John
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99Caldron, Paul
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9de Vlam, Kurt
10Geusens, Piet
11Pinheiro, Marcelo
12Zerbini, Cristiano
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14Papp, Kim
15Lessard, Clode
16Tremblay, Jean-Luc
17Rahman, Proton
18Mustafa, Majed
19Thorne, J Carter
20Langevitz, Pnina
21Reitblat, Tatiana
22Rosner, Itzhak
23Elkayam, Ori
24Frediani, Bruno
25Foti, Rosario
26Cantini, Fabrizio
27Adami, Silvano
28Navarra, Sandra
29Perez, Emmanuel
30Lanzon, Allan
31Baes, Rosario
32Lucero, Auxencio
33Gulay-Carvajal, Carjen
34Li-Yu, Julie
35Tan, Perry
36Javier, Juan
37Chirieac, Rodica
38Ionescu, Ruxandra Maria
39Rednic, Simona
40Nasonov, Evgeny
41Stanislav, Marina
42Raskina, Tatiana
43Ershova, Olga
44Izmozherova, Nadezda
45Lesnyak, Olga
46Zotkin, Evgenii
47Yoon, Kam Hon
48Lim, Anita
49Leung, Ying Ying Katy
50Asavatanabodee, Paijit
51Suwannalai, Parawee
52Nanagara, Ratanavadee
53Louthrenoo, Worawit
54Strapkova, Maria
55Tahir, Hasan
56Mc Innes, Iain
57Sheeran, Thomas
58Helliwell, Philip
59Kirkham, Bruce
60Shimbova, Krasimira
61Stoilov, Rumen
62Mihaylova, Mariyana
63Dokoupilova, Eva
64Vitek, Petr
65Galatikova, Dagmar
66Janecka, Izabella
67Supronik, Jerzy
68Sieper, Joachim
69Kurthen, Reiner
70Dahmen, Georg
71Demary, Winfried
72Nuesslein, Hubert
73Degtyareva, Elizaveta
74Maus, Olga
75Kekow, Joern
76Rubbert-Roth, Andrea
77Rech, Juergen
78Schuch, Florian
79Wassenberg, Siegfried
80Martz, Rene
81Spieler, Wolfgang
82Braun, Juergen
83Halpert, Elias
84Moreta, Elvia
85Box, Jane
86Legerton, Clarence
87Flint, Kathleen
88Starr, John
89Jajoo, Ramina
90Caldron, Paul
91Tesser, John
92Frankel, Ellen
93El-Kadi, Hisham
94Petrone, Dianne
95Reimold, Andreas
96Singhal, Atul
97Sunkureddi, Prashanth
98Wellborne, Frank
99Budd, John
100...
atitleSecukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis.
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genrearticle
ristypeJOUR
abstractBACKGROUNDIn a phase 2 study, the inhibition of the interleukin-17A receptor improved signs and symptoms of psoriatic arthritis. We sought to evaluate the efficacy and safety of secukinumab, an anti-interleukin-17A monoclonal antibody, in such patients. METHODSIn this double-blind, phase 3 study, 606 patients with psoriatic arthritis were randomly assigned in a 1:1:1 ratio to receive intravenous secukinumab (at a dose of 10 mg per kilogram) at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo. Patients in the placebo group were switched to subcutaneous secukinumab at a dose of 150 mg or 75 mg at week 16 or 24, depending on clinical response. The primary end point was the proportion of patients with an American College of Rheumatology 20 (ACR20) response at week 24, defined as a 20% improvement from baseline in the number of tender and swollen joints and at least three other important domains. RESULTSACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%) (P<0.001 for both comparisons with placebo). Secondary end points, including the ACR50 response and joint structural damage, were significantly better in the secukinumab groups than in the placebo group. Improvements were sustained through 52 weeks. Infections, including candida, were more common in the secukinumab groups. Throughout the study (mean secukinumab exposure, 438.5 days; mean placebo exposure, 128.5 days), four patients in the secukinumab groups had a stroke (0.6 per 100 patient-years; 95% confidence interval [CI], 0.2 to 1.5), and two had a myocardial infarction (0.3 per 100 patient-years; 95% CI, 0.0 to 1.0), as compared with no patients in the placebo group. CONCLUSIONSSecukinumab was more effective than placebo in patients with psoriatic arthritis, which validates interleukin-17A as a therapeutic target. Infections were more common in the secukinumab groups than in the placebo group. The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT01392326.).
doi10.1056/NEJMoa1412679
urlhttp://search.proquest.com/docview/1718909510/
issn00284793
date2015-10-01