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Are Your Psoriatic Arthritis Patients Achieving These Treatment Goals?

Addressing 4 Treatment Goals for Psoriatic Arthritis

This post was sponsored by AbbVie Inc.

 

 

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Could HUMIRA (adalimumab) meet your PsA patients' treatment goals?

 

Reduction in signs and symptoms, radiographic inhibition, skin clearance, and improving physical function are considered 4 important goals for the treatment of active PsA.

HUMIRA, an anti-TNF monoclonal antibody, is a therapy option that addresses these goals.1 The results from the ADEPT trial established HUMIRA as an effective agent for treating both articular and cutaneous manifestations of PsA. In the trial, HUMIRA significantly reduced signs and symptoms, inhibited radiographic progression, achieved clearer skin, and improved physical function in patients with active PsA compared with placebo.2 See the details of the results below.
 

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.

 

Safety Considerations1
Serious Infections: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

 

Malignancies: 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.

 

Other Serious Adverse Reactions: Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.   

 

Please see additional Important Safety Information below.

 

A more in-depth look at HUMIRA’s efficacy across 4 important parameters:

 

Rapid and sustained improvement in PsA signs and symptoms: The co-primary endpoint, ACR20 at Week 12, was achieved by nearly 6 out of 10 HUMIRA-treated patients (58%) compared to 14% of placebo-treated patients.2,a In some patients on HUMIRA, clinical responses were seen as early as 2 weeks, after only one dose.2,b And improvement was sustained at 2 years in a majority of patients (57%) who remained in the open-label extension (OLE).3

 

OLE Limitations

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.
 
aThe analysis is of the intent-to-treat population, using nonresponder imputation (NRI) methodology. Patients who had missing data or received rescue therapy were counted as nonresponders.2
bWeek 2 data was an other efficacy variable; endpoint was not controlled for multiplicity; treatment differences in these data cannot be regarded as statistically significant.
cLast observation carried forward (LOCF) analysis based on the duration of exposure to HUMIRA (including those patients originally randomly assigned to placebo).3
 
 
Significant results were also seen in PsA patients across all 7 ACR components—including pain and inflammation—at Week 24.1
 
Data Limitations: Change from baseline in individual ACR components at Week 2 was an other efficacy variable; endpoint was not controlled for multiplicity; treatment differences in these data cannot be regarded as statistically significant.
 
aFor HUMIRA, n at Week 2 are the following: TJC, SJC, PGA, HAQ-DI, CRP n=149; Pain n=148; PhGA n=146.
bP<0.001 for Week 24 HUMIRA vs placebo comparisons based on median changes.
cScale 0–78.
dScale 0–76.
eVisual analog scale: 0=best, 100=worst.
fHealth Assessment Questionnaire Disability Index (HAQ-DI); 0=best, 3=worst. Measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
gC-reactive protein (CRP) normal range: 0–0.287 mg/dL.

 

Significant results in radiographic inhibition: 9 out of 10 patients (91%) on HUMIRA at Week 24, compared to 7 out of 10 patients (71%) on placebo, had no radiographic progression (defined as change in mTSS≤0.5).5 The mean change in mTSS from baseline was -0.2 for patients on HUMIRA at Week 48 vs 0.9 on placebo at Week 24, which was a co-primary endpoint.1

 

*mTSS scores at baseline: HUMIRA=22.7; placebo=19.1.

 

Noticeably clearer skin: HUMIRA provided noticeably clearer skin in PsA. In the study, skin clearance was assessed in patients with ≥3% psoriasis body surface area at baseline. At 24 weeks, a majority of HUMIRA patients—nearly 6 out of 10 (59%)—saw PASI75 skin clearance compared to only 1% on placebo.1 More than 4 out of 10 PsA patients (42%) achieved PASI90 clearance,1 and 29.7% of patients had PASI100 skin clearance on HUMIRA.6

 

aPASI was assessed only for patients with psoriatic skin involvement of at least 3% body surface area at baseline. 

 

Data Limitations
PASI100 data was a post-hoc analysis which was not powered to demonstrate a statistically significant difference in treatment effect. No statistical inferences can be made due to the exploratory nature of the analysis.

 

Physical function improvement: Physical function, as measured by HAQ-DI, improved significantly among patients on HUMIRA—at Week 24, they saw 49% mean decrease from baseline in HAQ-DI score vs 3% on placebo.1

 

aHealth Assessment Questionnaire Disability Index (HAQ-DI) at baseline: HUMIRA=1.0; placebo=1.0.2

AdvertisementView study design, baseline characteristics, and more data from ADEPT

 

Consider how your patients may be able to keep doing what they enjoy if you can help them by halting further joint damage, reducing their signs and symptoms, and improving their ability to do daily tasks.

 

ADEPT Study Design Intro
The ADEPT randomized, double-blind trial assessed HUMIRA 40 mg EOW vs placebo in adult patients with active PsA who had an inadequate response to NSAIDs.2  Co-primary endpoints: ACR20 response rate at Week 12 and mean change from baseline mTSS at Week 48 vs placebo at Week 24.1,2

 

ADEPT OLE Study Design Intro
At Week 24, 285 patients from the ADEPT trial enrolled in the OLE. All patients received HUMIRA 40 mg EOW.5

 

ADEPT Study Safety Profile

 

aAdverse events experienced by ≥5% of patients in either study arm.

 

Most common adverse reactions1:

  • The most common adverse reactions in HUMIRA clinical trials (incidence >10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the ADEPT study for HUMIRA may not reflect the rates observed in clinical practice. 

 

 

IMPORTANT SAFETY INFORMATION1
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:
  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

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.

  • Do not start HUMIRA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.
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.
  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
  • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.
HYPERSENSITIVITY
  • Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
  • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.
NEUROLOGIC REACTIONS
  • TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.
HEMATOLOGIC REACTIONS
  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.
AUTOIMMUNITY
  • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
  • Patients on HUMIRA should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.
ADVERSE REACTIONS
  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

 

INDICATION1
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.

 

Please see full AdvertisementPrescribing Information.

 

ACR=American College of Rheumatology; EOW=every other week; mTSS=modified total Sharp score; NOS=not otherwise specified; NSAID=nonsteroidal anti-inflammatory drug; PASl=Psoriasis Area and Severity Index; TNF=tumor necrosis factor.

 

 

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Mease PJ, Gladman DD, Ritchlin CT, et al; for the Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(10):3279-3289. 3. Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68(5):702-709. 4. Data on File ABVRRTI69469. 5. Gladman DD, Mease PJ, Ritchlin, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial. Arthritis Rheum. 2007:56(2):476-488. 6. Data on File ABVRRTI64750.

 

 

 

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