For adult patients with active psoriatic arthritis (PsA)
US-MULT-230356
US-MULT-230356
For adult patients with active psoriatic arthritis (PsA)
ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,2
ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs
Extrapolated analysisa
aFor subjects who were randomized to HUMIRA and did not have a mTSS at Week 48, mTSS was imputed by linear extrapolation using the baseline and Week 24 scores. The mTSS, which included distal interphalangeal joints, was used by the readers blinded to treatment group to assess the radiographs.1,3
bP<0.001 HUMIRA at Week 48 vs placebo at Week 24
EOW=every other week; mTSS=modified total Sharp score; OLE=open-label extension; RCT=randomized controlled trial
EOW=every other week; mTSS=modified total Sharp score
As with any long-term OLE, there are several limitations with the OLE portion of this study. For example, there is the potential for enrichment of the long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue.
285 patients from the ADEPT trial enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.6
ACR=American College of Rheumatology; OLE=open-label extension; RCT=randomized controlled trial
P<0.001
LOCF analysisa
aLast observation carried forward (LOCF) analysis of intent-to-treat (ITT) population.
The MCID (minimum clinically important difference) for HAQ-DI is defined as a ≥0.3-point decrease from baseline in clinical trials.6,b
bHealth Assessment Questionnaire Disability Index (HAQ-DI) at baseline: HUMIRA=1.0; placebo=1.0.
ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score
*PASI was assessed only for patients with psoriatic skin involvement of at least 3% body surface area at baseline.
EOW=every other week; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; RCT=randomized controlled trial
Adverse reaction rates observed in clinical trials may not predict the rates observed in a broader patient population in clinical practice.
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA.
Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death, including active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.
*Non-infectious (NI) intermediate, posterior, or panuveitis
ADEPT study design intro: Double-blind trial of adult patients with active PsA who had an inadequate response to NSAIDs. 313 patients were randomized to receive HUMIRA 40 mg EOW (n=151) or placebo (n=162). The co-primary endpoints were ACR20 response rate at Week 12 and change from baseline mTSS at Week 48 vs placebo at Week 24.1,3 285 patients from the RCT enrolled in the OLE at Week 24. All patients received HUMIRA 40 mg EOW.4
ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open-label extension
Psoriatic Arthritis (PsA): HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
SERIOUS INFECTIONS
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
CONGESTIVE HEART FAILURE
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
Please see Full Prescribing Information.
US-HUM-210183
References:
Patient characteristics1,2
Primary endpoints1,2
Select ranked secondary endpoints2
Select additional endpoints4
ACR=American College of Rheumatology; BSA=body surface area; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; HAQ DI=Health Assessment Questionnaire Disability Index; mTSS=modified total Sharp score; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; RCT=randomized controlled trial; SF-36=Short Form 36
Patient characteristics at baseline in ADEPT2
| SELECT BASELINE CHARACTERISTICS | HUMIRA Group (n=151) |
Placebo Group (n=162) |
| Demographics | ||
| Mean age (years) | 48.6 | 49.2 |
| Male | 56.3% | 54.9% |
| Disease duration (years) | ||
| PsA | 9.8 | 9.2 |
| Psa | 17.2 | 17.1 |
| History (% patients) | ||
| RF (-) | 89.4 | 90.1 |
| Taking MTX at baseline | 51 | 50 |
| Inflammatory signs & symptoms | ||
| CRP (normal <0.287) | 1.4 | 1.4 |
| Tender joint count (0-78 joints) | 23.9 | 25.8 |
| Swollen joint count (0-76 joints) | 14.3 | 14.3 |
| Radiographic measuresb | ||
| Joint erosion score | 11.2 | 9.2 |
| Joint space narrowing score | 11.4 | 10.0 |
| mTSS | 22.7 | 19.1 |
an=161 for placebo
bn=150 for HUMIRA; n=161 for placebo
CRP=C-reactive protein; mTSS=modified total Sharp score; MTX=methotrexate; Ps=plaque psoriasis; PsA=psoriatic arthritis; RF=rheumatoid factor
US-HUM-210672
US-HUM-210672
HUMIRA has >90% preferred national commercial and Medicare Part D formulary coverage under the pharmacy benefit as of January 20231*
*Preferred means HUMIRA is on a preferred tier or otherwise has preferred status on the plan’s formulary.
Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
Questions about access for your patients?
Learn more about how to help your patients access HUMIRA
1. Data on file, AbbVie Inc., January 2023.
US-HUM-220513
