Our other therapy areas

    • {%buzitemName%}
        {%buzbrandMenuItems%}
    • {%bitemName%} {%barrowSpan%}
        {%bsubBrandMenuItems%}
    • {%sbitemName%} {%sbarrowSpan%}
        {%sbproductMenuItems%}
    • {%pitemKeyName%} {%pitemBadges%} {%parrowSpan%}
      {%pselfProduct%}
    • {%mNavitemName%}
      • {%lScountries%}
    • {%allMenuItem%}
      • {%cSlanguages%}

      • This website is for Israeli Healthcare Professionals only.

      Rinvoq upadacitinib logo
      רקע שחור עילי

      BROADLY STUDIES & CONSISTENT

      SAFETY PROFILE logo

      RINVOQ's safety profile has been established in 9 clinical trials in RA, PsA and AS1,3

      The safety profile of RINVOQ 15 mg has been established across multiple patient populations with up to 4.5 years of maximum exposure and over 7,000 PYs of exposure in RA3

      RINVOQ 15 mg has demonstrated a consistent safety profile across RA, PsA and AS2

      רקע שחור תחתי

      The efficacy and safety profile of RINVOQ has been established through the

      Select Clinical Trial Programs

      in RA, PsA and AS indications¹,²,³

      Clinical trials program
      Clinical trials program
      Clinical trials program

      *RINVOQ is a JAK inhibitor approved by the European Commission for the treatment of adult patients with moderate to severe active RA who have responded inadequately to, or who are intolerant to one or more DMARDs; for the treatment of active PsA in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active AS in adult patients who have responded inadequately to conventional therapy.1 †Includes 6 RA Phase 3 trials (SELECT-EARLY, SELECT-MONOTHERAPY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND, and SELECT-CHOICE). Includes 2 PsA Phase 3 trials (SELECT-PsA 1 and SELECT-PsA 2). Includes 1 Phase 2/3 trial (SELECT-AXIS J). 2‡Includes 7,023.8 patient-years in RA trials, 1,247.2 patient-years in PsA trials, and 291.1 patient-years in an AS trial.2

      רקע צהוב

      TEAEs observed with RINVOQ 15 mg in

      3 Separate Data Sets

      in RA, PsA and AS2-4

      Treatment-emergent adverse events*RA Integrated analysisa
      of Phase 3 program AEs3
      Events/100 PYs (95% CI)†      		PsA Integrated analysisb
      of Phase 3 program AEs4
      Events/100 PYs (95% CI)‡      		AS Phase 2/3 studyc AEs2
      Events/100 PYs§
      RINVOQ 15 mg QD pooled
      (n=3,209; PY=7,023.8)
      (Up to ~4.5 years max; ~2.6 years median)II      		RINVOQ 15 mg QD pooled
      n=907; PY=1,247.2)
      (Up to ~3 years max; ~1.3 years median)II      		RINVOQ 15 mg QD pooled
      (n=182; PYs=291.1)
      (Up to ~2.3 years max; ~1.7 years median)II
      Any adverse event230.7 (227.2, 234.3)263.9 (254.9, 272.9)237.7 (220.0, 256.1)
      Serious adverse event13.0 (12.2, 13.9)10.3 (8.6, 12.1)6.2 (3.7, 9.8)
      Any adverse event leading to discontinuation 5.6 (5.0, 6.1)6.7 (5.2, 8.1)5.5 (3.1, 8.9)
      Deaths0.4 (0.3, 0.6)0.2 (-0.1, 0.4)0
      INFECTIONS   
           Serious infection 3.3 (2.9, 3.7)2.3 (1.5, 3.2)0
           Herpes zoster3.3 (2.9, 3.8)3.8 (2.8, 4.9)1.7 (0.6, 4.0)
           Opportunistic infection (excluding tuberculosis,
           herpes zoster, and oral candidiasis)      		0.3 (0.2, 0.4)0.4 (0.0, 0.8)0.7 (0.1, 2.5)
           Active tuberculosis <0.1 (0.0, 0.2)00
      Hepatic disorder 11.7 (10.9, 12.5)13.5 (11.5, 15.6)8.2 (5.3, 12.3)
      Anemia3.4 (3.0, 3.9)2.2 (1.4, 3.1)1.7 (0.6, 4.0)
      Neutropenia 2.3 (2.0, 2.7)1.8 (1.0, 2.5)2.7 (1.2, 5.4)
      Elevated CPK4.9 (4.4, 5.4)9.1 (7.4, 10.7)10.3 (7.0, 14.7)
      GI perforation (adjudicated) <0.1 (0.0, 0.2)<0.1 (-0.1, 0.2)0
      ADVERSE EVENTS OF SPECIAL INTEREST   
           Malignancy
           (excluding nonmelanoma skin cancer)       		0.8 (0.6, 1.1)0.7 (0.3, 1.2)0.3 (0.0, 1.9)
           Nonmelanoma skin cancer0.3 (0.2, 0.4)0.8 (0.3, 1.3) 
           MACE# (adjudicated) 0.4 (0.3, 0.6)0.3 (0.0, 0.6)0
           VTE** (adjudicated)0.5 (0.3, 0.6)0.3 (0.0, 0.6)0

      Regardless of patient population or treatment group, ≥86% of patients had at least 1 CV risk factor at baseline (i.e., history of hypertension, diabetes mellitus, tobacco use, elevated LDL-C, Lowered HDL-C).2

       

       

       

       

      aSELECT-EARLY,
      SELECT-COMPARE,
      SELECT-MONOTHERAPY,
      SELECT-NEXT,
      SELECT-BEYOND, and
      SELECT-CHOICE.

      bSELECT-PsA 1 and
      SELECT-PsA 2.

      cSELECT-AXIS 1.

      Regardless of patient population or treatment group, ≥86% of patients had at least 1 CV risk factor at baseline (i.e., history of hypertension, diabetes mellitus, tobacco use, elevated LDL-C, Lowered HDL-C).2

      aSELECT-EARLY,
      SELECT-COMPARE,
      SELECT-MONOTHERAPY,
      SELECT-NEXT,
      SELECT-BEYOND, and
      SELECT-CHOICE.

      bSELECT-PsA 1 and
      SELECT-PsA 2.

      cSELECT-AXIS 1.

      The most commonly reported adverse reactions were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, alanine transaminase (ALT) increased, bronchitis, nausea, neutropenia, cough, aspartate transaminase (AST) increased, and hypercholesterolaemia. The most common serious adverse reactions were serious infections.1

      Psoriatic arthritis: A higher rate of serious infections (2.6 events per 100 patient-years and 1.3 events per 100 patient-years, respectively) and hepatic transaminase elevations (ALT elevations Grade 3 and higher rates 1.4% and 0.4%, respectively) was observed in patients treated with RONVOQ in combination with MTX therapy compared to patients treated with monotherapy.1

      עיצוב פס צהוב

      Rinvoq Prescribing Information

      For full information please see Rinvoq prescribing information Full prescribing information can be received from Abbvie Biopharmaceuticals Ltd. Israel at 4 Hacharash Street, Hod Hasharon 4524075. Tel: 09-7909600, Fax: 09-790960

      1. RINVOQ Prescribing Information, March 2023.

      2. Burmester GR, Cohen SB, Winthrop K, et al. Long-term safety profile of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. Poster presented at: American College of Rheumatology (ACR) Convergence, November 5-9, 2021.

      3. Cohen SB, van Vollenhoven R, Curtis JR, et al. Integrated safety profile of upadacitinib with up to 4.5 years of exposure in patients with rheumatoid arthritis. Poster presented at: The European Congress of Rheumatology, 2-5 June 2021, E-Congress.

      4. Burmester GR, Winthrop K, Blanco R, et al. Safety profile of upadacitinib up to 3 years in psoriatic arthritis: an integrated analysis of two pivotal phase 3 trials. Rheumatol Ther. 2021;1-19. doi:10.1007/s40744-021-00410-z. Online ahead of print.

       

      ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.