SCQM Study Design | Xeljanz® (tofacitinib citrate)

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XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

65 years of age and older;
patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

SCQM-RA Study Design

Real World Evidence for Rheumatoid Arthritis

Study Population

Baseline Characteristics

Study Endpoints

Study Limitations

StudyObjective

The SCQM-RA Registry aimed to compare the drug maintenance and real-world effectiveness of three alternative treatment options for RA: XELJANZ (tofacitiinib citrate), TNFi, and bDMARD-OMA. It was also studied whether the effectiveness of these treatments was modiifed by concomitant csDMARD therapy.

Observational cohort study nested within the Swiss RA registry (SCQM-RA) to¹:

Compare the drug maintenance and real-world effectiveness of three alternative treatment options for RA – XELJANZ, TNFi, bDMARD /other modes of action (abatacept or anti-IL-6 agents)
Examine whether the effectiveness of these treatments is modified by concomitant csDMARD therapy

The majority of patients in the SCQM study received tofacitinib 5 mg BID¹.XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK².

StudyPopulation

Included patients with RA initiating a new therapy with XELJANZ, TNFi or bDMARD/OMA between August 2013 and September 2019¹:

4,023 treatment courses were initiated during the study period in 2,600 patients: 806 treatment courses for XELJANZ, 1,862 for TNFi and 1,355 for bDMARD/OMA¹

For XELJANZ, 96% of patients received XELJANZ ≤5 mg BID; a small minority (3.4%) received XELJANZ >5 mg BID¹

Baseline Characteristics

Differences in disease and treatment characteristics existed between groups
TNF is tended to be used more often as a first or second b/tsDMARD, resulting, on average, in younger patients with shorter disease duration

Characteristic	XELJANZ	TNFi	OMA	P-value
Mean age, years	59	54	58	<0.001
Mean duration of RA, years	12	9	11	<0.001
Mean CDAI	21	19	21	0.10
Mean DAS28	3.7	3.60	3.7	0.057

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StudyEndpoints

Primary Outcomes

Overall drug maintenance (period between treatment, initiation and discontinuation)

Secondary Outcomes

Low disease activity (LDA) response rates based on CDAI at 12 months

StudyLimitations

Missing data and incomplete follow-up
Effectiveness analysis was limited by a reduced proportion of patients having an available CDAI around 1 year, and despite use of a mixed-effects model, response rates at 1 year should be interpreted with caution
Confounding by unmeasured factors, as with observational studies, may have affected study results

Explore More

SCQM Registry Outcomes

Read next page to learn more about the SCQM-RA registry outcomes.

XELJANZ in action

If you are new to XELJANZ, then this short video contains useful information on it's mode of action.

bDMARD=biologic disease-modifying anti-rheumatic drug; CDAI=Clinical Disease Activity Index; csDMARD=conventional synthetic disease‑modifying anti-rheumatic drug; MTX=methotrexate; OMA=other modes of action; TNFi=tumour necrosis factor inhibitor; tsDMARD=targeted synthetic disease-modifying anti-rheumatic drug.

References

1. Finckh A, et al. RMD Open. 2020;6(1):e001174.
2. XELJANZ (tofacitinib citrate) Summary of Product Characteristics

XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

PP-XEL-GBR-4819. Dec 2023

Real-World Evidence: SCQM-RA

Study Design Study Outcomes

Explore more Real-World Evidence in RA

STAR-RA SCQM-RA CorEvitas

RA Insights - Using Real-World Evidence (RWE) on JAK inhibitors for shared decision making

In this video, Dr Ai Lyn Tan and Dr Sarah Mackie highlight the recent real-world evidence on shared decision making, treatment persistence and second-line treatment strategies in the context of Rheumatoid Arthritis (RA) with Janus Kinase inhibitors.

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