Psoriatic Arthritis (PsA)

Brown AN—Open Access Rheumatology, 2016

Acthar Gel was evaluated in patients with PsA who had previously been on ≥1 therapies and were experiencing ongoing disease activity1

Acthar Gel study design icon
Study Design
Acthar Gel study results icon
Results

STUDY OBJECTIVE 

A retrospective case series of 9 patients with refractory PsA1

  • Refractory PsA was defined as failure to achieve disease remission with previous treatment
  • Patients had previously failed 1 or more therapies and were experiencing ongoing disease activity prior to treatment with Acthar Gel
  • Six patients were evaluated using Routine Assessment of Patient Index Data 3 (RAPID3)*
  • Acthar Gel was initiated to help manage active disease or as a bridge therapy to manage symptoms during transition to new treatment
  • Acthar Gel was initiated at 80 U subcutaneously (SC) twice weekly and titrated based on patient response

*The RAPID3 score is the sum of 3 patient self-reported scores on the Multidimensional Health Assessment Questionnaire (MDHAQ). Pain, physical function, and patient global assessment are rated by the patient on a 0-10 visual analogue scale (VAS).2 The score does not include physician assessment of tender or swollen joint count, peripheral joint symptoms, skin symptoms, dactylitis, enthesitis, nail symptoms, or spine symptoms typically associated with PsA. The final score is calculated by the treating healthcare professional and recorded on a 0-30 scale: 1-3=near remission; 4-6=low severity; 7-12=moderate severity; and 13-30=high severity.2-4

Study Limitations

Results are based on a retrospective case series of 9 patients and may not be fully representative of outcomes in the overall patient population. Some patients were on other therapies. The clinical outcomes may not be solely attributable to Acthar Gel.

The majority of patients experienced improvement with Acthar Gel

  • Of 9 patients with joint disease, 8 experienced improvement that continued during treatment; 1 experienced short-term improvement
  • Of 8 patients with active skin disease, 6 experienced lasting improvement that continued during treatment; 2 experienced short-term improvement

Case Summaries1

Review results for individual patients in the series.

Patient Previous treatments Disease at baseline Treatment
with Acthar Gel		 RAPID3 disease
activity measures
Case 1:
88-year-old female

Golimumab +
Etanercept

Infliximab
Adalimumab
  • Active joint disease
    characterized by
    widespread
    arthralgias and joint
    tenderness, ankle
    swelling, elbow and
    thumb pain, and
    morning stiffness
  • Active skin disease
    with plaques present
    at hairline
  • Acthar Gel initiated at 80 U SC twice weekly
  • Titrated to 20 U
    3 times weekly at
    12 weeks
  • Experienced
    improvement in skin
    and joint symptoms
  • Maintained Acthar Gel 20 U 3 times weekly for 80 weeks
 Baseline: 20.7
After 4 weeks: 14.3
Disease duration:
20+ yrs
Case 2:
46-year-old male

Adalimumab
Certolizumab
  • Tender proximal
    interphalangeal
    (PIP) joints and
    psoriatic plaques
    over waistline and
    gluteal fold
  • Acthar Gel initiated at 80 U SC twice
    weekly
  • Titrated to 40 U SC
    twice weekly at ~12
    weeks and then to
    20 U SC 3 times
    weekly
  • Experienced
    improvement in
    skin and joint symptoms
  • Discontinued at 6
    months due to
    weight gain and
    worsening of
    preexisting
    hypertension
 Baseline: 7.5
After ~12 weeks: 6.2
Disease duration:
1.5 yrs
Case 3:
51-year-old female

Certolizumab
Adalimumab
Infliximab
  • Inflammation in
    fingers, joint pain,
    and skin disease
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced
    improvement in skin
    and joint symptoms
  • Patient experienced
    elevated blood
    pressure and
    weight gain at 8 weeks, but
    continued Acthar Gel for 4 weeks
  • Discontinued at 12 weeks due to elevated blood pressure and weight gain
 Baseline: 9.7
After 8 weeks: 3.0
Disease duration:
5 yrs
Case 4:
55-year-old female

Etanercept
Golimumab
Infliximab
Adalimumab
Methotrexate
  • Pain in feet, hands,
    and knees
  • ESR: 49 mm/hr
  • CRP: 1.95 mg/dL
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced improvement in joint symptoms
  • ESR at 4 weeks: 16 mm/hr
  • CRP at 4 weeks: 0.94 mg/dL
  • Discontinued due to an unrelated illness
 Baseline: 19.3
After 8 weeks: 3.0
Disease duration:
7.5 yrs
Case 5:
58-year-old male

Adalimumab
Certolizumab
  • Widespread
    arthralgia and neck
    pain
  • Active skin disease,
    with widespread
    psoriatic plaques on
    face, ears, elbows,
    and knees
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced improvement in joint symptoms
  • Improvements in skin symptoms not as significant
  • Acthar Gel used as bridge therapy to apremilast and discontinued after 12 weeks
 Baseline: 8.3
After 12 weeks: 6.0
Disease duration:
8 yrs
Case 6:
66-year-old female

Methotrexate
Adalimumab
Ustekinumab
  • Joint disease in
    hands, with swollen
    PIP joints
  • Severe skin flares
    over palms of hands
    and soles of feet,
    with pustular lesions;
    cracked, bleeding,
    and painful skin on
    palms and soles
  • ESR: 61 mm/hr
  • CRP: 1.3 mg/dL
  • Acthar Gel initiated at 80 U SC twice weekly
  • Titrated to 40 U SC twice weekly after 12 weeks and then to 20 U SC twice weekly at 24 weeks
  • Experienced improvement in skin and joint symptoms
  • ESR at 24 weeks: 45 mm/hr
  • CRP at 24 weeks: 0.6 mg/dL
  • Discontinued at 30 weeks due to worsening of preexisting hyperglycemia
 Not recorded
Disease duration:
5 yrs
Case 7:
37-year-old male

Adalimumab
  • Monoarthritis in left
    knee
  • Active skin disease,
    with skin lesions
    over penis, soles of feet, and right ear,
    as well as a small
    effusion
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced improvement in skin and joint symptoms
  • Skin symptoms improved initially, but relapsed over time
  • Discontinued at 12 weeks due to lack of skin improvement
 Baseline: 4.0
After 3 months: 2.8
Disease duration:
2 yrs
Case 8:
69-year-old female

Adalimumab
Methotrexate
Certolizumab
monotherapy
  • Active joint disease,
    with pain in hip and
    left shoulder
  • Psoriatic plaques
    over lower left
    extremities,
    abdomen, back, and
    posterior ears
  • Added Acthar Gel 80 U SC twice weekly to certolizumab 400 mg every 2 weeks
  • Experienced improvement in skin and joint symptoms
  • Acthar Gel discontinued at 12 weeks and certolizumab monotherapy maintained
 Not recorded
Disease duration:
7 yrs
Case 9:
48-year-old female

Adalimumab
Certolizumab
  • Experiencing
    morning stiffness for
    2 hours
  • Active skin disease,
    with psoriatic
    plaques posterior to
    the ear, over left
    elbow, and over
    lower extremities
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced initial improvement in skin and joint symptoms
  • After 12 weeks, experienced temporary joint improvements and had no significant improvements in skin disease
  • Discontinued at 12 weeks
 Not recorded
Disease duration:
19 yrs

CRP=C-reactive protein; ESR=erythrocyte sedimentation rate; PIP=proximal interphalangeal.

Case Summaries1

Review results for individual patients in the series.

Case 1: 88-year-old female

Disease duration: 20+ yrs

Previous treatments
Golimumab +
Etanercept
Infliximab
Adalimumab
Disease at baseline
  • Active joint disease characterized by widespread arthralgias and joint tenderness, ankle swelling, elbow and thumb pain, and morning stiffness
  • Active skin disease with plaques present at hairline
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Titrated to 20 U 3 times weekly at 12 weeks
  • Experienced improvement in skin and joint symptoms
  • Maintained Acthar Gel 20 U 3 times weekly for 80 weeks
RAPID3 disease activity measures
Baseline: 20.7
After 4 weeks: 14.3

Case 2: 46-year-old male

Disease duration: 1.5 yrs

Previous treatments
Adalimumab
Certolizumab
Disease at baseline
  • Tender PIP joints and psoriatic plaques over waistline and gluteal fold
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Titrated to 40 U SC twice weekly at ~12 weeks and then to 20 U SC 3 times weekly
  • Experienced improvement in skin and joint symptoms
  • Discontinued at 6 months due to weight gain and worsening of preexisting hypertension
RAPID3 disease activity measures
Baseline: 7.5
After ~12 weeks: 6.2

PIP=proximal interphalangeal.

Case 3: 51-year-old female

Disease duration: 5 yrs

Previous treatments
Certolizumab
Adalimumab
Infliximab
Disease at baseline
  • Inflammation in fingers, joint pain, and skin disease
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced improvement in skin and joint symptoms
  • Patient experienced elevated blood pressure and weight gain at 8 weeks, but continued Acthar Gel for 4 weeks
  • Discontinued at 12 weeks due to elevated blood pressure and weight gain
RAPID3 disease activity measures
Baseline: 9.7
After 8 weeks: 3.0

Case 4: 55-year-old female

Disease duration: 7.5 yrs

Previous treatments
Etanercept
Golimumab
Infliximab
Adalimumab
Methotrexate
Disease at baseline
  • Pain in feet, hands, and knees
  • ESR: 49 mm/hr
  • CRP: 1.95 mg/dL
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced improvement in joint symptoms
  • ESR at 4 weeks: 16 mm/hr
  • CRP at 4 weeks: 0.94 mg/dL
  • Discontinued due to an unrelated illness
RAPID3 disease activity measures
Baseline: 19.3
After 8 weeks: 3.0

CRP=C-reactive protein;
ESR=erythrocyte sedimentation rate. 

Case 5: 58-year-old male

Disease duration: 8 yrs

Previous treatments
Adalimumab
Certolizumab
Disease at baseline
  • Widespread arthralgia and neck pain
  • Active skin disease, with widespread psoriatic plaques on face, ears, elbows, and knees
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced improvement in joint symptoms
  • Improvements in skin symptoms not as significant
  • Acthar Gel used as bridge therapy to apremilast and discontinued after 12 weeks
RAPID3 disease activity measures
Baseline: 8.3
After 12 weeks: 6.0

Case 6: 66-year-old female

Disease duration: 5 yrs

Previous treatments
Methotrexate
Adalimumab
Ustekinumab
Disease at baseline
  • Joint disease in hands, with swollen PIP joints
  • Severe skin flares over palms of hands and soles of feet, with pustular lesions; cracked, bleeding, and painful skin on palms and soles
  • ESR: 61 mm/hr
  • CRP: 1.3 mg/dL
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Titrated to 40 U SC twice weekly after 12 weeks and then to 20 U SC twice weekly at 24 weeks
  • Experienced improvement in skin and joint symptoms
  • ESR at 24 weeks: 45 mm/hr
  • CRP at 24 weeks: 0.6 mg/dL
  • Discontinued at 30 weeks due to worsening of preexisting hyperglycemia
RAPID3 disease activity measures
Not recorded

CRP=C-reactive protein;
ESR=erythrocyte sedimentation rate;
PIP=proximal interphalangeal.

Case 7: 37-year-old male

Disease duration: 2 yrs

Previous treatments
Adalimumab
Disease at baseline
  • Monoarthritis in left knee
  • Active skin disease, with skin lesions over penis, soles of feet, and right ear, as well as a small effusion
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced improvement in skin and joint symptoms
  • Skin symptoms improved initially, but relapsed over time
  • Discontinued at 12 weeks due to lack of skin improvement
RAPID3 disease activity measures
Baseline: 4.0
After 3 months: 2.8

Case 8: 69-year-old female

Disease duration: 7 yrs

Previous treatments
Adalimumab
Methotrexate
Certolizumab
monotherapy
Disease at baseline
  • Active joint disease, with pain in hip and left shoulder
  • Psoriatic plaques over lower left extremities, abdomen, back, and posterior ears
Treatment with Acthar Gel
  • Added Acthar Gel 80 U SC twice weekly to certolizumab 400 mg every 2 weeks
  • Experienced improvement in skin and joint symptoms
  • Acthar Gel discontinued at 12 weeks and certolizumab monotherapy maintained
RAPID3 disease activity measures
Not recorded

Case 9: 48-year-old female

Disease duration: 19 yrs

Previous treatments
Adalimumab
Certolizumab
Disease at baseline
  • Experiencing morning stiffness for 2 hours
  • Active skin disease, with psoriatic plaques posterior to the ear, over left elbow, and over lower extremities
Treatment with Acthar Gel
  • Acthar Gel initiated at 80 U SC twice weekly
  • Experienced initial improvement in skin and joint symptoms
  • After 12 weeks, experienced temporary joint improvements and had no significant improvements in skin disease
  • Discontinued at 12 weekst
RAPID3 disease activity measures
Not recorded

Safety Findings

  • Three patients discontinued due to worsening of preexisting conditions or other adverse events, including hypertension (n=2), hyperglycemia (n=1), and weight gain (n=2)
  • No other adverse events were reported during treatment with Acthar Gel

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