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SEVERE GOUT REFRACTORY TO CONVENTIONAL THERAPY

By Clinical Content Hub

S: A 56-year-old man presents for management of podagra.

O: Imaging of the right foot shows radiolucency of the metaphysis of the first
metatarsal, suggestive of gout.

A: The patient is started on allopurinol. Over the course of 3 visits in 6
months, his serum urate levels partially decrease, but his symptoms progress to
the point where he experiences weekly flares.

P: Treatment is reviewed with the patient, and he is switched to pegloticase
with methotrexate. He is cautioned to refrain from alcohol and triggering foods.
He is scheduled to return in 1 month for monitoring.



Introduction

Many factors may contribute to hyperuricemia, which is often associated with the
presence of conditions such as hypertension, congestive heart failure, diabetes,
kidney disease, and obesity, as well as a family history of gout. Treatments for
these conditions (eg, thiazide diuretics, often prescribed for mild
hypertension) are also associated with increases in serum urate levels, which
can cause gout. These cases of gout may be particularly resistant to
conventional therapies and require strategies designed to lower serum urate
levels, such as uricase agents.1,2

Case Scenario

Tom is a 56-year-old White man who works as a supervisor in a tool-making
factory. He spends much of his day on his feet and frequently goes out after
work for drinks with his peers. His wife works as a hospital nurse, often on a
later shift, which leaves him alone in the evenings. He and his wife have no
children at home.

Tom is overweight, and he eats at diners and sports bars 3 to 4 times per week.
He usually orders cheeseburgers or fried seafood with fries. He has 2 to 3 beers
with dinner, followed by a few more drinks at home. Outside of work, he leads a
sedentary lifestyle, generally sitting in front of the television until he falls
asleep.

Presentation

Tom is referred to you by his primary care physician for a history of podagra,
although he is in no acute distress at the time of your examination.

Personal and Family History

Tom reveals a history of hypertension, chronic kidney disease stage 2, coronary
artery disease (status: post-stent placement), and metabolic syndrome.

Tom describes recurring episodes, which occur several times per year, of pain
and swelling in his great toe; the frequency of these episodes has recently
increased from every few years to every few months. Both he and his wife have
noticed that these episodes are associated with eating shellfish and commonly
occur during football season, when he typically consumes more alcohol.

His family history is notable for the presence of obesity in both parents and 2
siblings. He also has an uncle with gout.

Prior Medications

Tom has been treated for 20 years for hypertension. He is currently taking a
thiazide diuretic, an angiotensin-converting enzyme (ACE) inhibitor, and a beta
blocker. He also takes low-dose aspirin.

Clinical Examination

On examination, Tom appears to be in no acute distress. General examination is
largely unremarkable except for the presence of generalized obesity and mild
hypertension.

Examination of his joints and extremities reveals bilateral hallux valgus with
slight fluctuance of the first metatarsal phalangeal joint of the right foot,
without warmth or redness.

Imaging Studies

Imaging obtained of Tom’s feet shows radiolucency of the metaphysis of the first
metatarsal on the right foot, suggestive of gouty erosions and slight soft
tissue haziness.

Laboratory Findings

Tom’s serum urate level is 9.5 mg/dL, his glomerular filtration rate is 45
mL/min, and his creatinine level is 1.6 mg/dL. His laboratory findings are
otherwise normal.

Diagnosis

Tom is diagnosed with gouty arthritis and hyperuricemia.

Treatment

Tom is started on 100 mg allopurinol, with plans to increase his dosage by 100
mg each month in an effort to achieve a target serum urate level of 6 mg/dL or
lower. Tom is concurrently started on colchicine 6 mg every other day.

Follow-Up Visit: 4 Months Later

Tom reports intermittent adherence to allopurinol 200 mg/day. He has experienced
recurrent episodes of gout, which initially worsened when he began taking
allopurinol. Clinical examination reveals fullness in the right knee, along with
limited effusion and a bulge sign; it also shows warmth over the left midfoot.
Laboratory assessment reveals a serum urate level of 8 mg/dL.

You instruct Tom to increase his allopurinol dosage to 300 mg/day, maintain
colchicine at 6 mg every other day, and return for a follow-up visit in 3
months.

Acute Relapse: 1 Month Later

You receive a call from Tom, who reports now-weekly occurring flares of gout. He
has also noticed the development of 2 new nodules: near his elbow and on the
dorsum of his right foot, near his great toe. He reports that he has continued
to use allopurinol, typically 200 to 300 mg/day.

Follow-Up Visit: 1 Week Later

You see Tom in the clinic 1 week later, and laboratory assessment indicates that
his serum urate level has increased to 8.5 mg/dL. He has several swollen joints,
as well as nodules over his foot with characteristic skin translucency and an
underlying whitish discoloration, suggestive of gouty tophi.

You discuss various therapeutic options with him, including a change in his
xanthine oxidase inhibitor treatment or the addition of a uricosuric agent. You
mutually elect to initiate pegloticase in combination with methotrexate to
prevent immunogenicity.

You caution him about the need to abstain from alcohol, and you plan to initiate
the pegloticase regimen when you have confirmed that his glucose-6-phosphate
dehydrogenase (G6PD) level is normal. You recommend that he return for another
follow-up visit in 1 month.

Discussion of Uricase Treatment

Many agents have been approved for the treatment of gout, which is achieved
through a combination approach. Early flares of gout should be treated with any
monotherapy or combination of colchicine, nonsteroidal anti-inflammatory drugs
(NSAIDs), and oral or intra-articular steroids to reduce inflammation and pain
around the joints. An interleukin (IL)-1 blocker should be considered for
patients with repeated flares, as well as patients in whom side effects or
comorbid conditions contraindicate first-line therapies.3

Because gout is a chronic condition, the treatment of repeated flares includes
the addition of urate-lowering therapies (ULTs) such as allopurinol, the
preferred first-line therapy, to alleviate acute symptoms and prevent future
attacks via reduced production of serum urate.3,4 Febuxostat is a second-line
ULT because of concerns regarding its potential greater cardiovascular toxicity.
Patients are also counseled to avoid foods that are high in purine (eg, seafood,
red meat, and organ meats), which contribute to serum urate accumulation; they
are also counseled to substantially reduce their consumption of beer and hard
alcohol.4

Despite lifestyle modifications and the use of conventional ULTs, nearly 2% of
patients with gout continue to experience flares and their serum urate levels
remain elevated.5 Desired serum urate levels are <6 mg/dL (360 µmol/L) for all
patients and <5 mg/dL (300 µmol/L) for patients with visible tophi.3 For
patients with severe refractory gout (particularly patients with tophaceous
disease), pegloticase is an alternative therapy.3,5

Pegloticase has shown efficacy in the rapid resolution of tophi and can
significantly reduce serum urate levels; compared with other types of ULTs,
pegloticase functions through a unique mechanism that involves the enzymatic
degradation of serum urate.5 Common drug-related immunogenicity and
anti-pegloticase antibody challenges can be managed by coadministration of
medications such as methotrexate or mycophenolate mofetil, thereby extending the
duration of pegloticase efficacy.6,7

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Acknowledgments

Kenneth G. Saag, MD, MSc, is the division director of Clinical Immunology and
Rheumatology and director of the Comprehensive Arthritis, Musculoskeletal, Bone,
and Autoimmunity Center at the University of Alabama at Birmingham. Dr Saag is
also the founding director of the UAB Center of Research Translation in Gout and
Hyperuricemia.

References

1. Kuwabara M. Hyperuricemia, cardiovascular disease, and hypertension. Pulse
(Basel). 2016;3(3-4):242-252. doi:10.1159/000443769

2. McAdams DeMarco MA, Maynard JW, Baer AN, et al. Diuretic use, increased serum
urate levels, and risk of incident gout in a population-based study of adults
with hypertension: the Atherosclerosis Risk in Communities cohort study.
Arthritis Rheum. 2012;64(1):121-129. doi:10.1002/art.33315

3. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based
recommendations for the management of gout. Ann Rheum Dis. 2017;76(1):29-42.
doi:10.1136/annrheumdis-2016-209707.

4. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of
Rheumatology guideline for the management of gout. Arthritis Care Res (Hoboken).
2020;72(6):744-760. doi:10.1002/acr.24180

5. Schlesinger N, Lipsky PE. Pegloticase treatment of chronic refractory gout:
update on efficacy and safety. Semin Arthritis Rheum. 2020;50(3S):S31-S38.
doi:10.1016/j.semarthrit.2020.04.011

6. Botson JK, Saag K, Peterson J, et al. A randomized, placebo-controlled study
of methotrexate to increase response rates in patients with uncontrolled gout
receiving pegloticase: primary efficacy and safety findings. Arthritis
Rheumatol. 2023;75(2):293-304. doi:10.1002/art.42335

7. Khanna PP, Khanna D, Cutter G, et al. Reducing immunogenicity of pegloticase
with concomitant use of mycophenolate mofetil in patients with refractory gout:
a phase II, randomized, double-blind, placebo-controlled trial. Arthritis
Rheumatol. 2021;73(8):1523-1532. doi:10.1002/art.41731

Posted by Haymarket’s Clinical Content Hub. The editorial staff of Rheumatology
Advisor had no role in this content’s preparation.

Reviewed March 2023

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