Publications

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the Phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial

J Am Acad Dermatol 2017;76:418–31. doi: 10.1016/j.jaad.2016.11.042

Reich K,

Armstrong AW,

Foley P,

Song M,

Wasfi Y,

Randazzo B,

Li S,

Shen YK,

Gordon KB

Patients treated with guselkumab showed an improved and sustained clinical response compared to both adalimumab and placebo, without compromising safety profile. The Phase 3 VOYAGE 2 trial by Reich et al focused on treatment interruption and withdrawal, as well as treatment switching from adalimumab to guselkumab.

Keywords:

• Efficacy,
• Guselkumab,
• IL-23,
• Phase 3,
• Safety,
• Switching

fficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the Phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial

J Am Acad Dermatol 2017;76:405–17. doi: 10.1016/j.jaad.2016.11.041

Blauvelt A,

Papp KA,

Griffiths CE,

Randazzo B,

Wasfi Y,

Shen YK,

Li S,

Kimball AB

Guselkumab demonstrated superiority to adalimumab and placebo in treating PsO in this Phase 3 study. Improvements in IGA and PASI scores were observed as early as Week 16 and were maintained up to Week 48. Incidence of adverse events was similar across both treatment groups.

Keywords:

• Efficacy,
• Guselkumab,
• Phase 3,
• Safety,
• Skin

Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Strober B,

Coates LC,

Lebwohl MG,

Deodhar A,

Leibowitz E,

Rowland K,

Kollmeier AP,

Miller M,

Wang Y,

Li S,

Chakravarty SD,

Chan D,

Shawi M,

Yang YW,

Thaҫi D,

Rahman P.

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

Keywords:

• Guselkumab,
• Phase 2,
• Phase 3,
• Safety

Pain Reduction in Rheumatoid Arthritis Patients Who Use Opioids: A Post Hoc Analysis of Phase 3 Trials of Baricitinib

ACR Open Rheumatol. 2021. Epub ahead of print. doi: 10.1002/acr2.11380

Pope JE,

Lee YC,

Curtis JR,

Mo D,

Xie L,

Dickson CL,

Schlichting DE,

Cardoso A,

Simon LS,

Taylor PC

This post hoc analysis shows that pain reduction was similar between opioid users and nonusers with baricitinib 2 mg and 4 mg, but not adalimumab.Use of opioids to treat RA-related pain has increased, yet long-term use has been associated with reduced efficacy and safety concerns. In addition, the misuse of opioids has resulted in a public health crisis in the United States and highlights the need for safe, effective nonaddictive alternatives for pain management. As such, Pope, et al. assessed p...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• Pain

Efficacy of Baricitinib in Treating Rheumatoid Arthritis: Modulatory Effects on Fibrotic and Inflammatory Biomarkers in a Real-Life Setting

Int Immunopharmacol. 2020 Sep;86:106748.

Alessandro M,

Perillo F,

Refini R,

Bergantini L,

Bellisai F,

Selvi E,

Cameli P,

Manganelli S,

Conticini E,

Cantarini L,

Sestini P,

Frediani B,

Bargagli E

BARI demonstrated to be a safe immune modulator that reduces the concentrations biomarkers of lung fibrosis and inflammation in RA patients, including a subgroup with interstitial lung involvement. Professor Alessandro and colleagues analysed the effects of baricitinib in a population of RA and RA-ILD patients in a real-life setting, describing any changes in lung function parameters, serum inflammatory biomarkers and fibrotic biomarkers after 6 months of treatment. Fifteen patients were recruit...

Keywords:

• JAK,
• Baricitinib,
• Basic Science,
• Biomarkers

Efficacy and Pharmacodynamic Modeling of the BTK Inhibitor Evobrutinib in Autoimmune Disease Models

J Immunol 2019;202:2888–2906. DOI: 10.4049/jimmunol.1800583

Haselmayer P,

Camps M,

Liu-Bujalski L,

Nguyen N,

Morandi F,

Head J,

O’Mahony A,

Zimmerli SC,

Bruns L,

Bender AT,

Schroeder P,

Grenningloh

BTK is involved in both adaptive and innate immune responses and mediates signalling of several immune receptors of relevance to RA and SLE pathogenesis. Targeting BTK is a promising approach therefore for autoimmune disorders with aberrant B cell responses. Evobrutinib is a novel, highly specific, and irreversible BTK inhibitor. In vivo and animal models showed that evobrutinib modulated B cell and innate immune cell activation, was efficacious, and prevented joint damage. The potency of evobru...

Keywords:

• BTK,
• Evobrutinib,
• Preclinical

Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (SELECT-NEXT): a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial

Lancet 2018;391:2503–12

Burmester GR,

Kremer JM,

Van den Bosch F,

Kivitz A,

Bessette L,

Li Y,

Zhou Y,

Othman AA,

Pangan AL,

Camp HS

Patients with moderate-to-severe active RA had significant improvements in clinical signs and symptoms with upadacitinib (UPA) compared with placebo.In Phase 2 studies, UPA showed favourable efficacy when administered twice daily as an immediate-release formulation at doses of 6–12 mg in patients with active RA who had TNFi-IR.1,2 An extended-release formulation allowing once-daily (QD) administration was developed for Phase 3 studies. SELECT-NEXT was a double-blind, multicentre, Phase 3 study t...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Effects of Baricitinib on Radiographic Progression of Structural Joint Damage at 1 year in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Synthetic Disease-modifying Antirheumatic Drugs

RMD Open. 2018 May 8;4(1):e000662. DOI: 10.1136/rmdopen-2018-000662

van der Heijde D,

Dougados M,

Chen YC,

Greenwald M,

Drescher E,

Klar R,

Xie L,

de la Torre I,

Rooney TP,

Witt SL,

Schlichting DE,

de Bono S,

Emery P

Once daily baricitinib (BARI) inhibited radiographic progression of structural joint damage in patients with an inadequate response or intolerance to csDMARDs over 48 weeks.Current treatment goals aim to use DMARDs to inhibit structural joint damage and prevent long-term functional disability. In RA-BUILD¹, BARI was shown to significantly reduce radiographic joint damage progression in patients with active RA, with an intolerance or inadequate response to csDMARDs. Here, the authors report the l...

Keywords:

• JAK,
• Baricitinib,
• Phase 3,
• Radiographic

Long-term Radiographic and Patient-reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses

Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7

Strand V,

Kavanaugh A,

Kivitz AJ,

van der Heijde D,

Kwok K,

Akylbekova E,

Soonasra A,

Snyder M,

Connell C,

Bananis E,

Smolen JS

Tofacitinib (TOF) therapy reduced the progression of structural joint damage at 2 years, in patients of all disease states, compared with patients given methotrexate (MTX). Early intervention with DMARDs aim to prevent the development of future RA symptoms and inhibit the progression of structural damage to the joints. This post-hoc analysis uses data from two Phase 3 TOF studies, to examine the efficacy of early intervention with TOF on long-term radiographic outcomes and disease activity state...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL,
• Radiographic

Patient-Reported Outcomes in Newly Diagnosed Early Rheumatoid Arthritis Patients Treated to Target with a Tocilizumab- or Methotrexate-based Strategy

Rheumatology (Oxford) 2017 Dec 1;56(12):2179-2189 doi: 10.1093/rheumatology/kex319

Teitsma XM,

Jacobs JWG,

Welsing PMJ,

Pethö-Schramm A,

Borm MEA,

Hendriks L,

Denissen NHAM,

van Laar JM,

Lafeber FPJG,

Bijlsma JWJ

Patient-reported outcomes (PROs) vastly improved in the first 24 weeks post-initiation of tocilizumab (TCZ) therapies compared to methotrexate (MTX) monotherapy in the U-Act-Early trial.U-Act-Early was a two-year, treat-to-target study that compared the safety and efficacy of TCZ and MTX treatment strategies in DMARD-naïve patients with early RA. Sustained remission was classed as more effective in patients given TCZ monotherapy or combination therapy with MTX compared to MTX alone. TCZ therapie...