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Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis.

Abstract Background Interleukin-23 is thought to be critical to the pathogenesis of psoriasis. We compared risankizumab (BI 655066), a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit and thus prevents interleukin-23 signaling, and ustekinumab, an interleukin-12 and interleukin-23 inhibitor, in patients with moderate-to-severe plaque psoriasis. Methods We randomly assigned a total of 166 patients to receive subcutaneous injections of risankizumab (a single 18-mg dose at week 0 or 90-mg or 180-mg doses at weeks 0, 4, and 16) or ustekinumab (45 or 90 mg, according to body weight, at weeks 0, 4, and 16). The primary end point was a 90% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at week 12. Results At week 12, the percentage of patients with a 90% or greater reduction in the PASI score was 77% (64 of 83 patients) for risankizumab (90-mg and 180-mg groups, pooled), as compared with 40% (16 of 40 patients) for ustekinumab (P<0.001); the percentage of patients with a 100% reduction in the PASI score was 45% in the pooled 90-mg and 180-mg risankizumab groups, as compared with 18% in the ustekinumab group. Efficacy was generally maintained up to 20 weeks after the final dose of 90 or 180 mg of risankizumab. In the 18-mg and 90-mg risankizumab groups and the ustekinumab group, 5 patients (12%), 6 patients (15%), and 3 patients (8%), respectively, had serious adverse events, including two basal-cell carcinomas and one major cardiovascular adverse event; there were no serious adverse events in the 180-mg risankizumab group. Conclusions In this phase 2 trial, selective blockade of interleukin-23 with risankizumab was associated with clinical responses superior to those associated with ustekinumab. This trial was not large enough or of long enough duration to draw conclusions about safety. (Funded by Boehringer Ingelheim; ClinicalTrials.gov number, NCT02054481 ).
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title the new england journal of medicine
Publication Year Start




PMID- 28423301
OWN - NLM
STAT- In-Process
DA  - 20170419
LR  - 20170419
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 376
IP  - 16
DP  - 2017 Apr 20
TI  - Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis.
PG  - 1551-1560
LID - 10.1056/NEJMoa1607017 [doi]
AB  - Background Interleukin-23 is thought to be critical to the pathogenesis of
      psoriasis. We compared risankizumab (BI 655066), a humanized IgG1 monoclonal
      antibody that inhibits interleukin-23 by specifically targeting the p19 subunit
      and thus prevents interleukin-23 signaling, and ustekinumab, an interleukin-12
      and interleukin-23 inhibitor, in patients with moderate-to-severe plaque
      psoriasis. Methods We randomly assigned a total of 166 patients to receive
      subcutaneous injections of risankizumab (a single 18-mg dose at week 0 or 90-mg
      or 180-mg doses at weeks 0, 4, and 16) or ustekinumab (45 or 90 mg, according to 
      body weight, at weeks 0, 4, and 16). The primary end point was a 90% or greater
      reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at 
      week 12. Results At week 12, the percentage of patients with a 90% or greater
      reduction in the PASI score was 77% (64 of 83 patients) for risankizumab (90-mg
      and 180-mg groups, pooled), as compared with 40% (16 of 40 patients) for
      ustekinumab (P&lt;0.001); the percentage of patients with a 100% reduction in the
      PASI score was 45% in the pooled 90-mg and 180-mg risankizumab groups, as
      compared with 18% in the ustekinumab group. Efficacy was generally maintained up 
      to 20 weeks after the final dose of 90 or 180 mg of risankizumab. In the 18-mg
      and 90-mg risankizumab groups and the ustekinumab group, 5 patients (12%), 6
      patients (15%), and 3 patients (8%), respectively, had serious adverse events,
      including two basal-cell carcinomas and one major cardiovascular adverse event;
      there were no serious adverse events in the 180-mg risankizumab group.
      Conclusions In this phase 2 trial, selective blockade of interleukin-23 with
      risankizumab was associated with clinical responses superior to those associated 
      with ustekinumab. This trial was not large enough or of long enough duration to
      draw conclusions about safety. (Funded by Boehringer Ingelheim;
      ClinicalTrials.gov number, NCT02054481 ).
FAU - Papp, Kim A
AU  - Papp KA
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Blauvelt, Andrew
AU  - Blauvelt A
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Bukhalo, Michael
AU  - Bukhalo M
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Gooderham, Melinda
AU  - Gooderham M
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Krueger, James
AU  - Krueger J
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Lacour, Jean-Philippe
AU  - Lacour JP
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Menter, Alan
AU  - Menter A
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Philipp, Sandra
AU  - Philipp S
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Sofen, Howard
AU  - Sofen H
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Tyring, Stephen
AU  - Tyring S
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Berner, Beate R
AU  - Berner BR
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Visvanathan, Sudha
AU  - Visvanathan S
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Pamulapati, Chandrasena
AU  - Pamulapati C
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Bennett, Nathan
AU  - Bennett N
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Flack, Mary
AU  - Flack M
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Scholl, Paul
AU  - Scholl P
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
FAU - Padula, Steven J
AU  - Padula SJ
AD  - From K. Papp Clinical Research and Probity Medical Research, Waterloo, ON
      (K.A.P.), School of Medicine, Queen's University, Kingston, ON (M.G.), and Centre
      for Dermatology and Probity Medical Research, Peterborough, ON (M.G.) - all in
      Canada; Oregon Medical Research Center, Portland (A.B.); Altman Dermatology
      Associates, Arlington Heights, IL (M.B.); Rockefeller University, New York
      (J.K.); Hopital de l'Archet, University of Nice-Sophia Antipolis, Nice, France
      (J.-P.L.); Baylor Research Institute, Dallas (A.M.); Charite Universitatsmedizin 
      Berlin, Berlin (S.P.), Boehringer Ingelheim Pharma, Biberach (B.R.B.), and
      Boehringer Ingelheim Pharma, Ingelheim, (S.J.P.) - all in Germany; University of 
      Texas Health Science Center, Houston (S.T.); University of California, Los
      Angeles, School of Medicine, Los Angeles (H.S.); and Boehringer Ingelheim
      Pharmaceuticals, Ridgefield, CT (S.V., C.P., N.B., M.F., P.S.).
LA  - eng
SI  - ClinicalTrials.gov/NCT02054481
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
EDAT- 2017/04/20 06:00
MHDA- 2017/04/20 06:00
CRDT- 2017/04/20 06:00
AID - 10.1056/NEJMoa1607017 [doi]
PST - ppublish
SO  - N Engl J Med. 2017 Apr 20;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.

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