Publications

Upadacitinib for the Treatment of Active Non-radiographic Axial Spondyloarthritis (SELECT-AXIS 2): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Lancet 2022 doi: 10.1016/S0140-6736(22)01212-0

Deodhar A,

Van den Bosch F,

Poddubnyy D,

Maksymowych WP,

van der Heijde D,

Kim TH,

Kishimoto M,

Blanco R,

Duan Y,

Li Y,

Pangan AL,

Wung P,

Song IH

Upadacitinib significantly improved the signs and symptoms of nr-axSpA compared with placebo at Week 14 in this investigation. Prior to this, upadacitinib had been shown to be effective in patients with AS. This study aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Efficacy and Safety of Upadacitinib for Active Ankylosing Spondylitis Refractory to Biological Therapy: A Double-blind, Randomised, Placebo-controlled Phase 3 Trial

Ann Rheum Dis 2022 doi:10.1136/annrheumdis-2022-222608

van der Heijde D,

Baralikos X,

Sieper J,

Deodhar A,

Inman RD,

Kameda H,

Zend X,

Si Y,

Bu X,

Pangan AL,

Wung P,

Song I

Van der Heijde et al., carried out a study to show whether upadacitinib offers an effective treatment option for bDMARD-naïve and bDMARD-IR patients with active AS. Their results indicated that upadacitinib 15 mg significantly improved the signs and symptoms of active AS. The treatment was well tolerated for 14 weeks in bDMARD-IR patients, consistent with results observed in the upadacitinib AS bDMARD-naïve study.

Keywords:

• JAK,
• Updacitinib,
• Efficacy,
• Safety,
• Phase 3

Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: Results from three Phase 3, multicentre, double-blind, randomised trials

Lancet 2022;399(10341):2113–28 doi: 10.1016/S0140-6736(22)00581-5

Danese S,

Vermeire S,

Zhou W,

Pangan AL,

Siffledeen J,

Greenbloom S,

Hébuterne X,

D'Haens G,

Nakase H,

Panés J,

Higgins PDR,

Juillerat P,

Lindsay JO,

Loftus EV Jr,

Sandborn WJ,

Reinisch W,

Chen MH,

Sanchez Gonzalez Y,

Huang B,

Xie W,

Liu J,

Weinreich MA,

Panaccione R

The results of two induction studies (UC1 and UC2) and a maintenance study (UC3) show upadacitinib superiority to placebo in treating ulcerative colitis (UC). Rates of clinical remission were significantly higher for all upadacitinib doses versus placebo in all three studies.

Keywords:

• Efficacy,
• GI,
• IL-6,
• Outcomes,
• Phase 3,
• Updacitinib

Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study

RMD Open. 2021;7(3):e001838

McInnes IB,

Kato K,

Magrey M,

Merola JF,

Kishimoto M,

Pacheco-Tena C,

Haaland D,

Chen L,

Duan Y,

Zueger P,

Liu J,

Lippe R,

Pangan AL,

Behrens F

Analysis of data over 56 weeks shows that efficacy responses are maintained with upadacitinib 15 mg and 30 mg.Following the publication of 12-week data from the Phase III, randomised double-blind, SELECT-PsA 1 study, earlier this year, McInnes, et al. now report the 56-week efficacy and safety data of upadacitinib 15 mg and 30 mg in patients with PsA and an inadequate response to non-biological therapyEfficacy responses and inhibition of radiographic progression were maintained with upadacitinib...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

Rheumatol Ther. 2021;8(2):903–919

Mease PJ,

Lertratanakul A,

Papp KA,

van den Bosch FE,

Tsuji S,

Dokoupilova E,

Keiserman MW,

Bu X,

Chen L,

McCaskill RM,

Zueger P,

McDearmon-Blondell EL,

Pangan AL,

Tillett W.

Fifty-six-week data suggest that upadacitinib could be a favourable long-term treatment option in patients with PsA who are refractory to biologic therapy.As the need for additional therapeutic agents that can effectively control disease activity continues, new data from a 56-week analysis of the oral reversible JAK1 inhibitor, upadacitinib, currently under investigation for the treatment of PsA, shows that efficacy of the drug is maintained over the duration of this study.Mease, et al. explored...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Safety,
• Efficacy

Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis

N Engl J Med. 2021;384(13):1227-1239.

McInnes IB,

Anderson JK,

Magrey M,

Merola JF,

Liu Y,

Kishimoto M,

Jeka S,

Pacheco- Tena C,

Wang X,

Chen L,

Zueger P,

Liu J,

Pangan AL,

Behrens F.

Upadacitinib efficacy proves to be greater than placebo, and non-inferior to adalimumab, in treating patients with psoriatic arthritis (PsA). Already approved for the treatment of rheumatoid arthritis, McInnes, et al. studied oral upadacitinib at a dose of 15 mg or 30 mg, alongside placebo or adalimumab, in this 24-week, Phase III trial, in over 1700 patients with PsA. At the primary endpoint (Week 12), ACR20 response was greater with upadacitinib than placebo, and non-inferior to adalimumab; wi...

Keywords:

• JAK,
• Updacitinib,
• Review

Upadacitinib Monotherapy Versus Methotrexate Monotherapy in Methotrexate-naïve Japanese Patients with Rheumatoid Arthritis: A Sub-analysis of The Phase 3 SELECT-EARLY study

Mod Rheumatol 2021;26:1–16.

Takeuchi T,

Rischmueller M,

Blanco R,

Xavier RM,

Ueki Y,

Atsumi T,

Chen S,

Friedman A,

Pangan AL,

Strand V,

van Vollenhoven RF

In this sub-analysis of the Phase 3 SELECT-EARLY study, UPA demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Along with a favourable efficacy observed with the Japan-specific 7.5 mg dose of UPA for all secondary endpoints. SELECT-EARLY was designed to study the safety and efficacy of UPA 15 and 30mg as monotherapy, but it also included a subset of 138 Japanese patients, 40% of whom were randomised to receive UPA 7.5mg. This was designed to meet the requirements o...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2

Annals of the rheumatic diseases. 2021 Mar 1;80(3):312-20.

Mease PJ,

Lertratanakul A,

Anderson JK,

Papp K,

Van den Bosch F,

Tsuji S,

Dokoupilova E,

Keiserman M,

Wang X,

Zhong S,

McCaskill RM,

Zueger P,

Pangan AL,

Tillett W

In this trial of patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD, upadacitinib 15 mg and 30 mg was more effective than placebo over 24 weeks in improving signs and symptoms of PsA. Despite the availability of bDMARDs in PsA, only a small proportion of patients achieve the recommended target of minimal disease activity; as such, additional treatment options are needed. Upadacitinib is under evaluation for PsA. This paper reports the 24-week data ...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Trial of UPA or Abatacept in Rheumatoid Arthritis

N Engl J Med 2020;383:1511–21 DOI: 10.1056/NEJMoa2008250

Rubbert‑Roth A,

Enejosa J,

Pangan AL,

Haraoui B,

Rischmueller M,

Khan N,

Zhang Y,

Martin N,

Xavier RM

In patients with refractory RA to bDMARDs, upadacitinib was found to be superior to abatacept in DAS28-CRP change from baseline and the achievement of remission at week 12.612 bDMARD-IR patients were randomised 1:1 to UPA 15 mg QD or ABA, each in combination with stable synthetic DMARDs. At Week 12, patients with <20% decrease in TJC and Swollen joint count (SJC) had background medication adjusted or added. All patients completing Week 24 were eligible to remain in an open-label, long-term exten...

Keywords:

• JAK,
• Updacitinib

Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Randomized, Double-blind, Active-comparator, Multi-center, Multi-country Trial

Arthritis Rheumatol 2020

van Vollenhoven R,

Takeuchi T,

Pangan AL,

Friedman A,

Mohamed MEF,

Chen S,

Rischmueller M,

Blanco R,

Xavier RM,

Strand V

Upadacitinib monotherapy demonstrated superior clinical, radiographic, and patient-reported outcomes versus methotrexate in methotrexate-naïve RA patients.This 48-week double-blind active comparator study investigated upadacitinib monotherapy in patients with early RA, who were either methotrexate-naïve, or who had very limited exposure. 947 patients were randomised to once-daily upadacitinib 15 or 30 mg, or weekly methotrexate. Unusually, there were two separate primary endpoints, selected for ...

Keywords:

• JAK,
• Updacitinib,
• Phase 3