Publications

Post-Approval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States–Based Rheumatoid Arthritis Registry

ACR Open Rheumatol. 2021 Feb 11.

Kremer JM,

Bingham CO 3rd,

Cappelli LC,

Greenberg JD,

Madsen AM,

Geier J,

Rivas JL,

Onofrei AM,

Barr CJ,

Pappas DA,

Litman HJ,

Dandreo KJ,

Shapiro AB,

Connell CA,

Kavanaugh A

Analysis from the US Corrona RA registry has provided the longest-term real-world safety data for a JAK inhibitor to date. The analysis showed that the cohorts had similar adverse events, except for higher herpes zoster rates for tofacitinib initiators vs bDMARDs.Kremer JM, et al. analysed adult patients with RA newly initiating tofacitinib, or a bDMARD, to compare incidence rates of MACE, SIEs, HZ, malignancies and death. VTE data were also collected prospectively and assessed descriptively thr...

Keywords:

• JAK,
• Tildrakizumab,
• Real-World

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

Comparative effectiveness of first-line tumour necrosis factor inhibitor versus non-tumour necrosis factor inhibitor biologics and targeted synthetic agents in patients with rheumatoid arthritis: results from a large US registry study

Ann Rheum Dis 2021;80:96–102.

Pappas DA,

St John G,

Etzel CJ,

Fiore S,

Blachley T,

Kimura T,

Punekar R,

Emeanuru K,

Choi J,

Boklage S,

Kremer JM

RA treatment guidelines recommend a treat-to-target approach guided by disease stage and treatment history, yet the optimal sequence of different treatment modalities has not been established. Data from Corrona – were used to evaluate the comparative effectiveness of TNFi versus non-TNFi bDMARDs and tsDMARDs as first-line treatment following csDMARD failure. Results support RA guidelines recommending individualised care based on clinical judgement and consideration of patient preference.The stud...

Keywords:

• Real-World

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

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis

Annals of the Rheumatic Diseases 2020;79:760-770

Sepriano A,

Kerschbaumer A,

Smolen JS,

Van Der Heijde D,

Dougados M,

Van Vollenhoven R,

McInnes IB,

Bijlsma JW,

Burmester GR,

De Wit M,

Falzon L,

Landewé R

This SLR informed the 2019 EULAR taskforce updating recommendations for RA management. Overall, no new safety signals were reported. The known safety profile of bDMARDs was confirmed and extended to tsDMARDS. IL-6i associated lower intestinal perforation has been further confirmed, while VTE and PE concerns in JAKi treatment need further evaluation.Previous updates for the EULAR recommendations on RA pharmacological management were conducted in 2016. In this SLR safety of csDMARDs, tsDMARDs, and...

Keywords:

• Safety,
• EULAR

Drug retention of 7 biologics and tofacitinib in biologics-naïve and biologics-switched patients with rheumatoid arthritis: the ANSWER cohort study

Arthritis Res Ther 2020;22:142

Ebina K,

Hirano T,

Maeda Y,

Yamamoto W,

Hashimoto M,

Murata K,

Takeuchi T,

Shiba H,

Son Y,

Amuro H,

Onishi A,

Akashi K,

Hara R,

Katayama M,

Yamamoto K,

Kumanogoh A,

Hirao M

This paper is based upon a long-term cohort study, namely the ANSWER cohort, an observational multi-centre registry of RA patients in the Kansai district of Japan. Analyses demonstrate a difference in observed drug retention between bDMARDs-naïve and bDMARDs-switched patients. 7 bDMARD treatments were compared in patients with no prior exposure to biologics, with abatacept showing the greatest retention rate. In patients that had switched between these same bDMARDs or to tofacitinib throughout t...

Keywords:

• JAK,
• TNF,
• Tofacitinib,
• Real-World

Comparative effectiveness of antitumour necrosis factor agents, biologics with an alternative mode of action and tofacitinib in an observational cohort of patients with rheumatoid arthritis in Switzerland

RMD Open 2020;6:e001174 doi:10.1136/rmdopen-2020-001174

Finckh A,

Tellenbach C,

Herzog L,

Scherer A,

Moeller B,

Ciurea A,

von Muehlenen I,

Gabay C,

Kyburz D,

Brulhart L,

Müller R,

Hasler P,

Zufferey P

This nested cohort study found that, in Switzerland, there was a generally limited overall drug maintenance for b/tsDMARD options in RA. Using data from SCQM-RA – a prospective longitudinal registry, overall maintenance (drug survival) was calculated for TNFi, bDMARD-OMA or JAKi in patients with RA.After adjusting for potential confounding factors, there was a higher hazard of drug discontinuation with TNFi compared with tofacitinib; no significant difference was observed between non-TNF bDMARDs...

Keywords:

• JAK,
• Tofacitinib,
• Real-World,
• Efficacy

Baricitinib Exposure During Pregnancy in Rheumatoid Arthritis

Ther Adv Musculoskelet Dis. 2020;12:1759720X19899296

Costanzo G,

Firinu D,

Losa F,

Deidda M,

Barca MP,

Del Giacco S.

Broad and focused studies are required to have an insight of safety for small molecules, such as JAK inhibitors in the case of accidental exposure before or during pregnancy.This case study’s objective describes a case report of a 43-year-old woman affected by RA who became pregnant during BARI treatment. She has had two previous pregnancies at term without complications. After failure of bDMARDs due to loss of efficacy and adverse drug reactions, the patient was started on BARI when it became a...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Pregnancy / Fertility

EULAR Recommendations for the Management of Rheumatoid Arthritis – 2019 Update and Consensus Statement on JAKinibs

Ann Rheum Dis. 2020 Jan 22. pii: annrheumdis-2019-216655.

Smolen JS,

Landewé RBM,

Bijlsma JWJ,

Burmester GR,

Dougados M,

Kerschbaumer A,

McInnes IB,

Sepriano A,

et al.

The EULAR recommendations for the management of RA have become increasingly useful in providing rheumatologists, patients, payers and other stakeholders with the evidence-based guidance and views of experts on the optimal use and sequence of pharmaceutical therapies in patients with RA. Over the course of the last decade, the evolution of the treatment landscape has already required two updates. The release of the new addition updates the 2016 recommendations.An international task force consider...

Keywords:

• EULAR

Effects of Upadacitinib on Patient-Reported Outcomes: Results from SELECT-BEYOND, a Phase 3 Randomized Trial in Patients with Rheumatoid Arthritis and Inadequate Responses to Biologic Disease-Modifying Antirheumatic Drugs

Arthritis Res Ther . 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.

Strand V,

Schiff M,

Tunida N,

Friedman A,

Meerwein S,

Pangan A,

Ganguli A,

Fuldeore M,

Song Y,

Pope J

In SELECT-BEYOND, UPA demonstrated clinically meaningful improvements in patient reported outcomes compared to PBO in patients with RA who had an inadequate response to bDMARDs. In this post-hoc analysis of the SELECT-BEYOND study, the effect of UPA 15 or 30 mg on patient reported outcomes were assessed and compared to PBO.Eligible patients (498) with an inadequate response to bDMARDs were randomly assigned 1:1:1 to receive UPA 15 mg, UPA 30 mg or PBO. PROs collected at Wk1, Wk4, and Wk12 includ...

Keywords:

• JAK,
• Updacitinib,
• PRO / QoL,
• Phase 3