Retrospective chart review of Acthar Gel use in patients with uveitis

A real-world, medical-record evaluation of Acthar Gel therapy1

  • Acthar Gel was evaluated in a US-based, retrospective review of medical records among a sample of ophthalmologists who treated patients with Acthar Gel for uveitis
  • The utilization pattern of Acthar Gel was assessed over a 12-month period
91 patients circle

Patient population

91 patients with uveitis who received Acthar Gel during the past 12 months (completed or receiving Acthar Gel at data collection)

40-80 U circle

Initial Acthar Gel dose

40 to 80 units subcutaneously once or twice weekly (initial dose received by the majority [77%] of patients)

Study design: A total of 21 eligible ophthalmologists or their designated staff abstracted data from patient medical records using a pretested electronic data collection instrument and responded to survey questions. A nationally representative sample of physicians and patients were randomly selected from Acthar Gel database prescribers and the American Medical Association Physician Masterfile. To be included, patients had to have a diagnosis of uveitis and have received treatment with Acthar Gel in the past 12 months and have either completed Acthar Gel treatment or were receiving Acthar Gel treatment at the time of data collection. Complete medical records had to be available. The chart review excluded patients with infectious eye inflammation, ophthalmic neoplasm, recent ophthalmic or orbital surgery (within 6 months prior to diagnosis), or recent trauma to the eye (within 60 days prior to diagnosis).1

Baseline patient and disease characteristics (N=91)1

Age
Mean (SD) 41 years (14 years)
Range 11–78 years
Uveitis diagnosis
Mean time from diagnosis 3.98 years
Mean acute episodes in the past 3.5
Uveitis anatomic presentation, n (%)
Anterior 38 (42%)
Intermediate 19 (21%)
Posterior 19 (21%)
Diffuse uveitis/panuveitis 15 (16%)
Medication history, n (%)
Mean number of medications prior to Acthar Gel 2.5
Prior prednisone 71 (78%)
Prior prednisone ≥10 mg per day for ≥6 months 50 (70%)*
Comorbidities, n (%)
Patients with 1 or more comorbidities typically associated with uveitis 63 (69%)

SD=standard deviation.

*Among 71 patients with documented prednisone treatment.

Baseline visual impairment level, n (%)1

Visual impairment level One eye Both eyes
Mild or none (better than 20/70) 10 (27%) 11 (20%)
Moderate (worse than 20/70 and better than 20/200) 18 (49%) 30 (56%)
Severe (worse than 20/200 and better than 20/400) 9 (24%) 12 (22%)
Undetermined/unspecified 0 1 (2%)

No patients were considered blind according to World Health Organization and ICD-10 criteria.

Uveitis symptoms and severity before initiation of Acthar Gel (N=91)1

Sign and symptom n (%) Mild Moderate Severe
Blurred vision 81 (89%) 10 52 19
Light sensitivity 41 (45%) 9 22 10
Floaters 40 (44%) 12 25 3
Visual loss/acuity 40 (44%) 5 24 11
Eye pain 34 (37%) 9 20 5
Eye redness 30 (33%) 6 22 2
Sign and symptom n (%)
Blurred vision 81 (89%)
Light sensitivity 41 (45%)
Floaters 40 (44%)
Visual loss/acuity 40 (44%)
Eye pain 34 (37%)
Eye redness 30 (33%)
Sign and symptom Mild
Blurred vision 10
Light sensitivity 9
Floaters 12
Visual loss/acuity 5
Eye pain 9
Eye redness 6
Sign and symptom Moderate
Blurred vision 52
Light sensitivity 22
Floaters 25
Visual loss/acuity 24
Eye pain 20
Eye redness 22
Sign and symptom Severe
Blurred vision 19
Light sensitivity 10
Floaters 3
Visual loss/acuity 11
Eye pain 5
Eye redness 2

Available options included all those shown in the table. Respondents could select all options that apply; sum exceeds 100%.

 

Study limitations1

  • Retrospective data collection may be incomplete
  • Outcomes may be influenced by therapies not documented in the charts
  • Patient outcomes and safety were not quantified
  • Physician assessment of patient outcomes may be subjective
  • Most patients were on multiple therapies; the clinical outcomes may not be solely attributable to Acthar Gel

Seeing a difference in the real world

Physicians reported improved patient status* in 84% of patients after Acthar Gel therapy1

Percentages are based on total number of patients (N=91)

Improved patient status chart

Improved patient status*

Patient status remained the same: 16% (n=15)

Improvements in vision

Improvements in eye pain

Improvements in vitreous haze

Reduction of background medication use

Improvements in vitreous flare

Improvements in macular edema (as measured by OCT)

Improved patient status chart
Improved patient status chart
  • Not all 91 patients applied to each category at baseline
  • Individual patients may have experienced more than one area of improvement

OCT=optimal coherence tomography.

*Based on physicians' responses to the following two prompts:

  • "What is the patient’s current status?"
  • "Please select the outcomes that have improved as a result of treatment with Acthar Gel."

Reduction in concomitant medication use both during and after Acthar Gel treatment (N=91)1

Reduction in concomitant medication use chart Reduction in concomitant medication use chart
  • Prior to Acthar Gel initiation, all 91 patients were receiving concomitant medications for uveitis
  • Concomitant medications used by ≥20% of patients in the 3 months prior to Acthar Gel initiation included: steroid eye drops, oral steroids, intraocular steroids, and nonsteroid eye drops
  • The number of patients treated with concomitant medications decreased during Acthar Gel treatment and during the 3 months following Acthar Gel therapy

Clinical outcomes may not be solely attributable to Acthar Gel.

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INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar
  • Acthar is contraindicated where congenital infections are suspected in infants

INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar
  • Acthar is contraindicated where congenital infections are suspected in infants
  • Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins

Warnings and Precautions

  • The adverse effects of Acthar are related primarily to its steroidogenic effects
  • Acthar may increase susceptibility to new infection or reactivation of latent infections
  • Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment
  • Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
  • Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored
  • Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
  • Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding
  • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravated
  • Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
  • Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms
  • Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity
  • There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
  • Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
  • Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy
  • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain
  • Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information.