Publications

Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis)

Rheumatol Ther 2023;11(1):177–189 doi 10.1007/s40744-023-00619-0

Curtis JR,

Emery P,

Downie B,

Zhong Y,

Liu J,

Han L,

Hawtin RE,

Burmester GR

This post hoc analysis by Curtis, et al. found that current and former smokers were more likely to switch from an anti-TNF bDMARD to a different bDMARD or JAK inhibitor in comparison to non-smokers. They also found that DAS28(CRP) ≤3.2 achievement was significantly higher after filgotinib therapy regardless of smoking status in MTX-IR, bDMARD-IR, and MTX-naïve patients.

Keywords:

• Adalimumab,
• Filgotinib,
• Phase 3,
• Efficacy

Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme

Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916

Fleischmann R,

Curtis JR,

Charles-Schoeman C,

Mysler E,

Yamaoka K,

Richez C,

Palac H,

Dilley D,

Liu J,

Strengholt S,

Burmester G

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Safety,
• Cardiovascular

Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease

N Engl J Med 2023; 388:1966–1980 doi: 10.1056/NEJMoa2212728

Loftus Jr. EV,

Panés J,

Lacerda AP,

Peyrin‑Biroulet L,

D’Haens G,

Panaccione G,

Reinisch W,

Louis E,

Chen M,

Nakase H,

Begun J,

Boland BS,

Phillips C,

Mohamed M-EF,

Liu J,

Geng Z,

Feng T,

Dubcenco E,

Colombel J-F

Upadacitinib was associated with higher percentages of remission and endoscopic response regardless of previous failure of biologic therapy. This paper reports the Phase 3 efficacy and safety results of upadacitinib in patients with moderate-to-severe Crohn’s disease.

Keywords:

• Efficacy,
• Safety,
• Updacitinib

Safety Profile of Upadacitinib over 15 000 Patient-years Across Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Atopic Dermatitis

RMD Open. 2023;9(1):e002735 doi: 10.1136/rmdopen-2022-002735

Burmester GR,

Cohen SB,

Winthrop KL,

Nash P,

Irvine AD,

Deodhar A,

Mysler E,

Tanaka Y,

Liu J,

Lacerda AP,

Palac H,

Shaw T,

Mease PJ,

Guttman-Yassky E

Integrated analysis of the safety profile of upadacitinib demonstrates that it was generally well-tolerated in RA, PsA, AS and AD, with no new safety risks identified, compared with previous reports.

Keywords:

• JAK,
• Updacitinib,
• Safety,
• Review

Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study

Rheumatol Ther. 2022 Oct 15:1–18 doi: 10.1007/s40744-022-00499-w

McInnes IB,

Kato K,

Magrey M,

Merola JF,

Kishimoto M,

Haaland D,

Chen L,

Duan Y,

Liu J,

Lippe R,

Wung P

Results from the long-term extension of SELECT-PsA 1 show efficacy responses similar or greater with upadacitinib, 15 or 30mg, versus adalimumab through 104 weeks.

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• LTE

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

Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

Rheumatol Ther. 2022 doi: 10.1007/s40744-021-00410-z

Burmester G,

Winthrop K,

Blanco R,

Nash P,

Goupille P,

Azevedo V,

Salvarani C,

Rubbert-Roth A,

Lesser E,

Lippe R,

Lertratanakul A,

Mccaskill RM,

Liu J,

Ruderman EM

Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA

Keywords:

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

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

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 in Rheumatoid Arthritis: A Benefit–Risk Assessment Across a Phase III Program

Drug Saf. 2021 Feb 2. DOI: 10.1007/s40264-020-01036-w

Conaghan PG,

Mysler E,

Tanaka Y,

Da Silva-Tillmann B,

Shaw T,

Liu J,

Ferguson R,

Enejosa JV,

Cohen S,

Nash P,

Rigby W,

Burmester G

Upadacitinib 15 mg has a favourable benefit–risk profile according to an assessment of data from the phase III SELECT clinical trial programme.In this review of data for the once-daily, oral JAK inhibitor, Conaghan PG, et al. provided insights into the benefit–risk profile of upadacitinib in approximately 4400 patients with RA. Based on pooled data from five pivotal studies, benefits and risks were assessed up to the time of regulatory submission, and additional long-term integrated safety revie...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Review