Medical Value of AbbVie Immunology Portfolio of Products

This site is intended for U.S. Healthcare Access Decision Makers only.

The AbbVie immunology portfolio consists of clinically
meaningful therapies for the treatment of immunologic disorders

Timely and long-term response
for meaningful outcomes

Achieving stringent efficacy endpoints
in difficult to treat populations

While anchored in favorable
benefit/risk profiles

SKYRIZI® (risankizumab-rzaa) Overview

Timely and Long-term Response for Meaningful Outcomes

Psoriasis (2019)

In the UltiMMa-1 & 2 trials, more patients (75% in both studies) achieved a PASI 90 after two doses of risankizumab at Week 16 compared to placebo (5 and 2%) (p<0.001) with separation from placebo as early as Week 4.1 Efficacy was sustained by 83% of patients maintaining a PASI 90 out to 256 weeks in an open-label extension trial.2

Psoriatic Arthritis (2022)

After 3 doses, more patients (57% v. 34%, p<0.001) receiving risankizumab achieved primary endpoint ACR20 versus placebo at Week 24, with separation from placebo as early as Week 4, and maintained ACR20 response rate through Week 52 (70% of patients) in an open-label extension.3,4

Crohn’s Disease (2022)

Risankizumab achieved the co-primary endpoint of clinical remission (CDAI <150) at Week 12 versus placebo in two parallel induction studies (ADVANCE 45% vs 25%, p<0.001 and MOTIVATE 42% vs 20%, p<0.001).5 Symptom relief was seen as early as Week 4 (ADVANCE 41% vs 25%, nominal p<0.001 and MOTIVATE 37% vs 21%, nominal p<0.01).6 Clinical remission was achieved versus placebo through Week 52 (FORTIFY 180 mg 61% vs 46%, p<0.05; 360 mg 57% vs 46% p<0.05).5

Stringent Efficacy Endpoints in Difficult to Treat Populations

Psoriasis (2019)

After 2 doses, more patients receiving risankizumab achieved a PASI90 score when compared to ustekinumab, secukinumab, or adalimumab in head to head trials, and 88% of patients who achieved PASI90, maintained efficacy at 1 year in an open-label extension.2

Psoriatic Arthritis (2022)

Greater proportion of patients treated with risankizumab compared to placebo achieved ACR20/50/70, MDA, and complete resolution of enthesitis and dactylitis at Week 24 that was maintained up to Week 100 in an open-label extension.3,7

Crohn’s Disease (2022)

More patients treated with risankizumab, across both induction and maintenance phases of the clinical trials (bio-naïve and bio-IR) achieved the co-primary endpoint of endoscopic response (decrease in SES-CD >50% from baseline) at Week 12 compared to placebo (ADVANCE 40% vs 12%, p<0.001 and MOTIVATE 29% vs 11%, p<0.001), as well as at Week 52 (FORTIFY 180 mg 50% vs 22%, p<0.05; 360 mg 48% vs 22%, p<0.05).5

OLE Limitation: There is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

Anchored in Favorable Benefit/Risk Profiles

26 CLINICAL TRIALS

Across 3 indications8,9*

>16,700 PYs

Of exposure to risankizumab8,9*

6,618 PATIENTS

Enrolled in global clinical trials across US-approved indications8,9*

8 YEARS

Clinical trials experience8,9*

Psoriasis (2019)

Rates of adverse events at Week 52 were similar to those observed at Week 16. In an integrated analysis of risankizumab including almost 3,200 patients with more than 9,900 PY of exposure from the psoriasis clinical trial program, the AEs of special interest were consistent with the previous studies of risankizumab of up to 52 weeks and were within the reference benchmark.2

Psoriatic Arthritis (2022)

Safety profile is generally consistent with PsO (19 clinical trials across dermatology; 2 in PsA and 17 in PsO) with the addition of hepatic events and hypersensitivity reactions.9

Crohn’s Disease (2022)

2% of risankizumab-treated patients in ADVANCE and 1% of risankizumab-treated patients in MOTIVATE discontinued therapy due to AEs; one episode of hepatoxicity during induction phase, one episode of MACE in risankizumab arm and placebo arm during maintenance phase.10

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*Safety data were evaluated for all patients receiving 2 doses or more of risankizumab from Phase 1-4 trials, including open-label extensions and dose-ranging studies.

RINVOQ® (upadacitinib) Overview

Timely and Long-term Response for Meaningful Outcomes

Rheumatoid Arthritis (2019)

In the SELECT-BEYOND trial (bDMARD-IR population), more patients treated with upadacitinib 15 mg + csDMARDs vs placebo + csDMARDs (65% vs 28%) achieved the primary endpoint ACR20 at Week 12, with separation from placebo as early as Week 1, with 31% of patients maintaining a state of clinical remission at Week 260 in an open-label extension.11-14

Psoriatic Arthritis (2021)

More patients who were biologic-inadequate responders treated with upadacitinib 15 mg vs placebo (57% vs 24%) achieved the primary endpoint ACR20 at Week 12, with separation from placebo as early as Week 2, and with joint (ACR20) and skin (PASI) efficacy being maintained out to Week 56.15,16

Ankylosing Spondylitis (2022)

For the primary endpoint ASAS40, 40.8% of patients treated with upadacitinib 15 mg achieved ASAS40 vs 15.8% of patients receiving placebo at Week 12, with separation between upadacitinib 15 mg and placebo at 4 weeks, and efficacy maintained to out to Week 52 in an open-label extension.17,18

Non-radiographic Axial spondylarthritis (2022)

For bio-IR patients with nr-axSpA, 46.3% of those treated with upadacitinib 15 mg achieved ASAS40 vs 22.9% of patients receiving placebo at Week 12. There was separation between upadacitinib 15 mg and placebo at Week 2, and efficacy was maintained to out to Week 52.19-20

Atopic Dermatitis (2022)

Patients treated with upadacitinib 15 mg and 30 mg achieved both the primary endpoints of vIGA-AD (43.5% and 57.0%) and percentage of patients achieving EASI 75 (64.7% and 76.3%) vs placebo (vIGA-AD 6.6%; EASI 75 14.8%) at Week 16. Reduction in itch (WP NRS ≥4) was observed within 3 days after first dose of upadacitinib 15 mg and 30 mg, and itch and EASI-75 response were maintained out to Week 52.21

Ulcerative Colitis (2022)

The primary endpoint of clinical remission was achieved by upadacitnib 45 mg vs placebo at Week 8 (U-ACHIEVE 26% vs 5%, p<0.001 and U-ACCOMPLISH 33% vs 4%, p<0.001) and separation from placebo using clinical response (partial modified MAYO Score) was observed as early as Week 2 (U-ACHIEVE 60.1% vs 27.3%, p<0.001 and U-ACCOMPLISH 63.3% vs 25.9%, p<0.001).11,22,23 Clinical remission was maintained through Week 52.11

Crohn’s Disease (2023)

Achieved the co-primary endpoint of clinical remission (CDAI <150) at Week 12 vs placebo in two parallel induction studies (U-EXCEL 46% vs 23%, p<0.001 and U-EXCEED 36% vs 18%, p<0.001).11 Clinical remission (CDAI <150) was maintained vs placebo through Week 52 (U-ENDURE 30 mg 55% vs 14%, p<0.002; 15 mg 42% vs 14%, p<0.001).11 A greater proportion of patients treated with upadacitnib 45 mg QD achieved clinical response (CR-100) at Week 2 vs placebo (37% vs 24%, p<0.01) and Week 12 vs placebo (64% vs 40%) in U-EXCEL and at Week 2 vs placebo (37% vs 14%, p<0.0001) and Week 12 vs placebo (54% vs 31%, p<0.001) in U-EXCEED.24

Stringent Efficacy Endpoints in Difficult to Treat Populations

Rheumatoid Arthritis (2019)

A higher percentage of patients treated with upadacitinib 15 mg + csDMARDs vs placebo + csDMARDs in a bDMARD-IR population achieved remission and low disease activity, at Week 12 and out to Week 260 of the open-label extension.11-14,25,26

Psoriatic Arthritis (2021)

In a bDMARD-IR population, more patients treated with upadacitinib 15 mg compared to placebo achieved a state of minimal disease activity at Week 24 (25% vs 3%) and PASI 75/90/100 compared to placebo at Week 16 (52% vs 16%, 35% vs 8%, and 25% vs 6%, respectively) that were maintained through Week 56.15,16

Ankylosing Spondylitis AND nr-axSpA (2022)

More patients with ankylosing spondylitis and nr-axSpA being treated with upadacitinib 15 mg compared to placebo achieved the stringent primary endpoint of ASAS40 and a state of low disease activity at Week 14.17-20

Atopic Dermatitis (2022)

More patients taking upadacitinib 15 mg or 30 mg achieved 90% skin improvement (EASI 90) compared to placebo at Week 16.21

Ulcerative Colitis (2022)

Upadacitinib demonstrated statistically significant improvements vs placebo in all prespecified primary and secondary clinical, endoscopic, and histologic endpoints for induction and maintenance in 3 trials of patients with moderately to severely active ulcerative colitis.27

Crohn’s Disease (2023)

Achieved the co-primary endpoint of endoscopic response (decrease in SES-CD >50% from baseline) at Week 12 compared to placebo (U-EXCEL 46% vs 13%, p<0.001 and U-EXCEED 34% vs 3%, p<0.001) as well as at Week 52 (U-ENDURE 30 mg 41% vs 7%, p<0.001; 15 mg 28% vs 7%, p<0.001).11 More patients, across both induction and maintenance phases of the clinical trials (bio-naïve and bio-IR) achieved endoscopic remission at Weeks 12 vs placebo (20% vs 3%) in the pooled induction trials (U-EXCEL and U-EXCEED) and Week 52 vs placebo in U-ENDURE (30 mg 30% vs 3%, 15 mg 14% vs 3%).28

OLE Limitation: There is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

Anchored in Favorable Benefit/Risk Profiles

25 CLINICAL TRIALS

Across 7 indications29

>33,200 PYs

Of exposure to upadacitinib 15 mg, 30 mg, and 45 mg29

>12,500 PATIENTS

Enrolled in global clinical trials across US-approved indications, including 12+ years of age in AD29

10+ YEARS

Clinical trials experience29

Across Rheumatology Indications

Incidence of VTE, MACE, and malignancies is observed to be comparable for upadacitinib across trials.30

Atopic Dermatitis (2022)

Overall, the safety profile observed in patients with AD treated with upadacitnib was similar to the safety profile in patients with RA, and adverse reaction profile in the pediatric population was similar to adults. Other specific adverse reactions that were reported in patients with AD included eczema herpeticum/Kaposi’s varicelliform eruption.31

Ulcerative Colitis (2022)

In the ulcerative colitis pivotal trials program, 1 VTE was seen in the induction phase in placebo and no MACE or malignancies were reported. During the maintenance phase (52 weeks), 4 VTEs were seen in the upadacitinib arm and 1 VTE was seen in placebo, 1 MACE occurred in both placebo and upadacitinib arm, and 3 malignancies (excluding NMSC) were seen in upadacitinib arm and 1 in placebo. Overall, the safety profile observed in patients with UC treated with upadacitinib was generally similar to the safety profile in patients with RA and AD.27

CROHN’S DISEASE (2023)

Overall, the safety profile observed in patients with CD treated with upadacitinib was consistent to the safety profile for other indications. There were no reported VTEs, MACEs, or malignancies seen during the induction phase (12 weeks) and maintenance phase (52 weeks) in both the placebo and treatment arms. During the maintenance phase, there was 1 case of malignancy in the upadacitinib 15mg treatment arm, and 2 cases in the 30mg treatment arm.11,32,33

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Risankizumab-rzaa Indications and Important Safety Considerations

INDICATIONS

Risankizumab is indicated for the treatment of:

  • Moderate to severe plaque psoriasis (Ps) in adults who are candidates for systemic therapy or phototherapy.
  • Active psoriatic arthritis (PsA) in adults.
  • Moderately to severely active Crohn’s disease (CD) in adults.

IMPORTANT SAFETY CONSIDERATIONS

Risankizumab is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, may occur. If a serious hypersensitivity reaction occurs, discontinue risankizumab and initiate appropriate therapy immediately. Risankizumab may increase the risk of infections. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, discontinue risankizumab until the infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with risankizumab. Drug-induced liver injury/hepatotoxicity during induction treatment of CD has been reported. Monitor liver enzymes and bilirubin at baseline and during induction (12 weeks). Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Avoid use of live vaccines in patients treated with risankizumab. The most common adverse reactions (≥1%) reported during treatment for Ps and PsA are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. The most common adverse reactions (>3%) reported during treatment for CD are upper respiratory infections, headache, and arthralgia during induction dosing and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection during maintenance dosing.

Review risankizumab-rzaa full Prescribing Information for additional information, visit www.rxabbvie.com or contact AbbVie Medical Information at 1-800-633-9110.

Upadacitinib Indications, Important Safety Considerations, and Boxed Warning

INDICATIONS

Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of:

  • Adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
  • Adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers.
  • Adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.
  • Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
    • Limitations of Use for RA, PsA, AS and nr-axSpA: Upadacitinib is not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
  • Adults and pediatric patients 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
    • Limitations of Use for AD: Upadacitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
  • Adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers.
  • Adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers.
    • Limitations of Use for UC and CD: Upadacitinib is not recommended for use in combination with other JAK inhibitors, biological therapies for UC or CD, respectively, or with potent immunosuppressants such as azathioprine and cyclosporine.

IMPORTANT SAFETY CONSIDERATIONS AND BOXED WARNING

Serious Infections: Patients treated with upadacitinib are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include tuberculosis (TB), invasive fungal, bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Test for latent TB before and during therapy; treat latent TB prior to use. Consider the risks and benefits prior to initiating therapy in patients with chronic or recurrent infection. If a serious infection develops, interrupt upadacitinib until the infection is controlled.

Mortality: In a postmarketing safety study in RA patients ≥ 50 years of age with at least one cardiovascular (CV) risk factor comparing another JAK inhibitor to TNF blockers, a higher rate of all-cause mortality, including sudden CV death, was observed with the JAK inhibitor.

Malignancies: Malignancies have been observed in upadacitinib treated patients. In RA patients treated with another JAK inhibitor, a higher rate of lymphomas and lung cancers was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with upadacitinib, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer [NMSC]), patients who develop a malignancy when on treatment, and patients who are current or past smokers. NMSCs have been reported in patients treated with upadacitinib. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Advise patients to limit sunlight exposure by wearing protective clothing and using sunscreen.

Major Adverse Cardiovascular Events (MACE): In RA patients who were ≥ 50 years of age with at least one CV risk factor treated with another JAK inhibitor, a higher rate of MACE (CV death, myocardial infarction, and stroke) was observed compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with upadacitinib. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. Discontinue upadacitinib in patients that have experienced a myocardial infarction or stroke.

Thrombosis: Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with JAK inhibitors, including upadacitinib. Many of these adverse events were serious and some resulted in death. In RA patients who were ≥ 50 years of age with at least one CV risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid upadacitinib in patients at risk. Patients with symptoms of thrombosis should discontinue upadacitinib and be promptly evaluated.

Hypersensitivity Reactions: Upadacitinib is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients. Serious hypersensitivity reactions such as anaphylaxis and angioedema were reported in patients receiving upadacitinib in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue upadacitinib and institute appropriate therapy.

Other Serious Adverse Reactions: Patients treated with upadacitinib also may be at risk for other serious adverse reactions, including gastrointestinal perforations, neutropenia, lymphopenia, anemia, lipid elevations, liver enzyme elevations, and embryo-fetal toxicity. If upadacitinib exposure occurs during pregnancy, please report the pregnancy to the surveillance program by calling 1-800-633-9110.

Vaccinations: Avoid use of live vaccines during, or immediately prior to, upadacitinib therapy. Prior to initiating upadacitinib, it is recommended that patients be brought up to date with all immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, in agreement with current immunization guidelines.

Medication Residue in Stool: Reports of medication residue in stool or ostomy output have occurred in patients taking upadacitinib. Most reports described patients with shortened gastrointestinal transit times. Instruct patients to contact their healthcare provider if medication residue is observed repeatedly.

Common Adverse Reactions in RA, PsA, AS and nr-axSpA: The most common adverse reactions (≥1%) were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache.

Common Adverse Reactions in AD: The most common adverse reactions (≥1%) are upper respiratory tract infections, acne, herpes simplex, headache, increased blood creatine phosphokinase, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.

Common Adverse Reactions in UC: The most common adverse reactions (≥5%) reported are upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, elevated liver enzymes, and rash.

Common Adverse Reactions in CD: The most common adverse reactions (≥5%) reported are upper respiratory tract infections, anemia, pyrexia, acne, herpes zoster, and headache.

Review upadacitinib full Prescribing Information for additional information, visit www.rxabbvie.com or contact AbbVie Medical Information at 1-800-633-9110.

ACR20/50/70=20%/50%/70% improvement in American College of Rheumatology score; AE= adverse events; bDMARD=biologic disease-modifying antirheumatic drug; bio=biologic; CDAI=Crohn’s Disease Activity Index; EASI 75=75% improvement on the EASI score; IR=inadequate response; LDA=low disease activity; MACE=major adverse cardiovascular event; MDA=minimal disease activity; NMSC=nonmelanoma skin cancer; PASI=Psoriasis area and severity index; PY=patient-year; RZB=risankizumab-rzaa; SES-CD=Simple Endoscopic Score in Crohn’s disease; UPA=upadacitinib; vIGA-AD=Validated Investigator Global Assessment scale for atopic dermatitis; VTE=venous thromboembolism.

References: 1. Gordon KB et al. Lancet. 2018;392:650-661. 2. Papp KA et al. AAD 2022. Poster 332270. 3. Östör A et al. Ann Rheum Dis. 2022;81(3):351-358. 4. Kristensen LE et al. EADV Virtual Congress 2021. Poster D1T01.4A. 5. SKYRIZI (risankizumab-rzaa) [package insert]. North Chicago, IL: AbbVie, Inc.; 2022. 6. Schreiber S et al. ECCO Virtual Congress 2021. #OP26. 7. Kristensen LE et al. EADV Virtual Congress 2022. Poster 3480. 8. Data on file, AbbVie Inc. ABVRRTI74689. 9. Data on file, AbbVie Inc. ABVRRTI73682. 10. D’Haens G et al. Lancet. 2022;399:2015-2030. 11. RINVOQ (upadacitinib) [package insert]. North Chicago, IL: AbbVie, Inc. 2022. 12. Genovese MC et al. Lancet. 2018;391(10139):2513-2524. 13. Data on file, AbbVie Inc. ABVRRTI72945. 14. Data on file, AbbVie Inc. ABVRRTI74946. 15. Mease PJ et al. Ann Rheum Dis. 2021;80(3):312-320. 16. Mease PJ et al. Rheumatol Ther. 2021;8:903-919. 17. van der Heijde D et al. Ann Rheum Dis. 2022;81(11):1515-1523. 18. Data on file, AbbVie Inc. ABVRRTI74951. 19. Deodhar A et al. Lancet. 2022;400(10349):369-379. 20. Data on File, AbbVie Inc. ABVRRTI74952. 21. Blauvelt et al. AAD VMX 2021. Poster 28032. 22. Danese S et al. ECCO Virtual Congress 2021. #OP24.23. Vermeire S et al. ECCO Virtual Congress 2021. #OP23. 24. Data on file, AbbVie Inc. ABVRRTI75381. 25. Fleischmann R et al. ACR Convergence 2022. Poster 0294. 26. Data on file, AbbVie Inc. ABVRRTI74946. 27. Danese S et al. Lancet. 2022;399:2113-2128. 28. Data on file, AbbVie Inc. ABVRRTI75991. 29. Data on file, AbbVie Inc. ABVRRTI74922. 30. Burmester GR et al. RMD Open. 2023;9(1): doi:10.1136/rmdopen-2022-002735 31. Guttman-Yassky E et al. J Allergy Clin Immunol. 2023;151(1):172-181. 32. Data on file. AbbVie, Inc. ABVRRTI75361. 33. Panes J et al. Oral Presentation #44 at ACG 2022.