At a Glance

‘JYSELECA Journeys’ by Film JYSELECA


Episode 1 - Finding Balance

JYSELECA - A JAK1 preferential inhibitor for
moderate to severe RA with a balance of:1-9

Sustained efficacy2-8

In Phase 3 trials, JYSELECA demonstrated:

  • ACR20 response as early as Week 2 in 37% of patients (n=475) vs. 15% of patients in the MTX + placebo group (n=475; p<0.001)
  • ACR70 response in 44% of patients by Week 52 (n=475)
  • DAS28-CRP <2.6 remission achieved in 54% of patients at Week 52 (n=475)2
  • Zero radiographic progression* at Week 52 in 88% of patients (n=475)6

Acceptable tolerability1,2,9

In Phase 2 and 3 trials, JYSELECA demonstrated:

  • Similar observed rates of serious infections and Herpes Zoster compared to adalimumab2
  • Consistently low rates of JAK inhibitor-associated adverse events up to 52 weeks:1,9†

• low rates of serious infection1†
• low rates of Herpes Zoster1†
• low rates of VTE9†

Common adverse events (≥1/100 to <1/10) include: nausea, upper respiratory tract infection, urinary tract infection, dizziness, lymphopenia.1
*Defined as change from baseline in modified Total Sharp Score ≤0.6 
†Based on AE rates observed as ‘Uncommon’ (<1% and >0.1%) or of lower frequency in the JYSELECA clinical trials.1,9

Over 8,000 patient-years of clinical experience with JYSELECA

across our clinical trial programme9

A total of 3,691 patients with RA received JYSELECA across two Phase 2 studies (DARWIN 1 and DARWIN 2), three Phase 3 studies (FINCH 1, FINCH 2 and FINCH 3), and two long-term extension studies (DARWIN 3 and FINCH 4), representing 8,085 patient-years of exposure.9

One tablet, once daily1

200 mg once daily1
Taken with MTX or as monotherapy1
100 mg dose available and recommended for:
  • patients with moderate or severe renal impairment (creatinine clearance 15 to <60 mL/min)1
  • as a starting dose for patients aged ≥75 years1

For JYSELECA dosage particulars, and considerations for initiation and monitoring, please consult the SPC.

JYSELECA is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).1 JYSELECA may be used as monotherapy or in combination with methotrexate (MTX).1

References: 1. JYSELECA SPC. Available at: www.medicines.org.uk / www.medicines.ie. Last accessed: November 2022. 2. Combe B, et al. Ann Rheum Dis 2021;doi:10.1136/annrheumdis-2020-219214. 3. Genovese MC, et al. JAMA 2019;322(4):315–325. 4. Westhovens R, et al. Ann Rheum Dis 2021;doi:10.1136/annrheumdis-2020-219213. 5. Kavanaugh A et al. J Rheumatol 2021;48:1230–8. 6. Data on file - Gilead Sciences Ltd - INF-UK-20-04. 7. Combe B, et al. Arthritis Rheumatol 2021;73(suppl 10). https://acrabstracts.org/abstract/clinical-outcomes-up-to-week-48-of-filgotinib-treatment-in-an-ongoing-long-term-extension-trial-of-ra-patients-with-inadequate-response-to-mtx-initially-treated-with-filgotinib-or-adalimumab-during-th/. Last accessed: November 2022. 8. Buch MH, et al. Arthritis Rheumatol 2021;73 (suppl 10). https://acrabstracts.org/abstract/clinical-outcomes-up-to-week-48-of-ongoing-filgotinib-ra-long-term-extension-trial-of-biologic-dmard-inadequate-responders-initially-on-filgotinib-or-placebo-in-a-phase-3-trial/. Last accessed: November 2022.  9. Winthrop K, et al. Arthritis Rheumatol 2021;73(suppl 10). Available at: https://acrabstracts.org/abstract/integrated-safety-analysis-update-for-filgotinib-in-patients-with-moderately-to-severely-active-rheumatoid-arthritis-receiving-treatment-over-a-median-of-2-2-years/ Last accessed: November 2022. 

UK-RA-JY-202203-00017  | Date of preparation December 2022