Publications

View and download slide summaries of the latest original articles focusing on therapies in immune-mediated inflammatory diseases including rheumatology, dermatology, and gastroenterology. All materials produced by the team are subsequently reviewed and approved by individual Steering Committee members.

August 2025

Safety profile of upadacitinib: Descriptive analysis in over 27,000 patient‑years across rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, and inflammatory bowel disease

Adv Ther 2025 Doi: 10.1007/s12325-025-03328-y Epub ahead of print

Levy G,

Palac H,

Ford S,

This descriptive analysis indicates a long-term safety profile of UPA consistent with previous reports, further supporting long-term treatment of chronic diseases with UPA. Burmester at al. characterized the safety profile of UPA across multiple approved indications and offer insights into its long-term use to help inform clinical decision-making.

Keywords:

June 2025

Long-term efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis: an interim analysis of the phase 3 U-ACTIVATE long-term extension study

Lancet Gastroenterol Hepatol 2025;10:507–19 doi: 10.1016/S2468-1253(25)00017-2

Yao X,

Geng Z,

Palac H,

Sharma D,

Suravaram S,

Schreiber S

This interim analysis by Panaccione et al. supports the positive long–term risk–benefit profile for UPA 15mg and 30mg among patients with moderately to severely active UC. U–ACTIVATE is a Phase 3 LTE study evaluating the long-term safety and efficacy of UPA in patients with moderately to severely active UC who enrolled in the preceding induction and maintenance studies. Panaccione et al. reported the interim results from the U-ACTIVATE study after approximately 3 years of total treatment, showing that the risk–benefit profile of UPA in patients with moderately to severely active UC is favourable.

Keywords:

July 2024

Pregnancy outcomes in patients treated with upadacitinib: Analysis of data from clinical trials and postmarketing reports

Drug Saf 2024 doi: 10.1007/s40264-024-01454-0 Epub ahead of print

Levy G,

Ali M,

Palac H,

Long M,

This study by Mahadevan, et al. evaluated pregnancy outcomes in patients exposed to upadacitinib during pregnancy. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases not receiving upadacitinib. The data were limited for in utero exposure to upadacitinib, so definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes.

Keywords:

December 2023

MACE and VTE across Upadacitinib Clinical Trial Programmes in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

RMD Open 2023; 9(4):e003392 doi 10.1136/rmdopen-2023-003392

Choy E,

Nash P,

Lippe R,

Khan N,

Shmagel AK,

Palac H,

Suboticki J,

Curtis JR

Rates of MACE and VTE events in patients with RA or PsA treated are consistent across 15 mg and 30 mg doses of upadacitinib, and comparable with active comparators adalimumab and MTX. Several risk factors were also identified for MACE and VTE events in patients with RA.

Keywords:

June 2023

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

Palac H,

Liu J,

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:

March 2023

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

Nash P,

Liu J,

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.