Psoriatic arthritis therapy: NSAIDs and traditional
Ann Rheum Dis
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Psoriatic arthritis therapy: NSAIDs and traditional DMARDsP Nash, D O Clegg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ann Rheum Dis 2005;64(Suppl II):ii74–ii77. doi: 10.1136/ard.2004.030783
Non-steroidal anti-inflammatory drugs (NSAIDs) and tradi-
effect on rash (assessed by Psoriasis Area and Severity Index
tional disease modifying antirheumatic drugs (DMARDs) are
(PASI) score) or on the erythrocyte sedimentation rate (ESR)to suggest disease modification.7 Worsening of skin disease
widely used in the treatment of psoriatic arthritis (PsA), but
with initiation of NSAID therapy has been observed for both
this is based more upon clinical experience than adequate
non-specific and cyclo-oxygenase-2 specific NSAIDs8–10 with
evidence from clinical trials. This report summarises the
shunting of arachidonic acid metabolites down the leuko-
results from available trials highlighting evidence of efficacy
triene pathway postulated as the mechanism, although other
and deficiencies with respect to effect on joints and to a lesser
controlled studies suggest this is not a major clinical issue.7
degree cutaneous disease. The available published data on
No unusual toxicity associated with the use of NSAIDs in PsA
efficacy of NSAIDs, glucocorticoids, antimalarials, sulfasa-
lazine, gold, methotrexate, azathioprine, and ciclosporin aredetailed, as well as new data on leflunomide and other novel
agents. The conclusions of this review are that evidence
Periodic intra-articular injection of corticosteroid can be of
supports marginal efficacy of sulfasalazine and perhaps gold
particular value in the management of patients with
in the treatment of peripheral psoriatic arthropathy, and
oligoarticular disease or those with controlled polyarticular
methotrexate and ciclosporin are effective for treating the
disease but one or two persistently actively inflamed joints.
skin disease although evidence for improvement of the
Two failed injections are a requirement for eligibility for
arthropathy is empirical at best. New trials with standardised
antitumour necrosis factor (anit-TNF) therapy in recently
and validated outcome measures are required to better
devised guidelines.11 In general, systemic glucocorticoids
assess efficacy. Evaluating newer agents, against and in
should be used judiciously because of the risk of provoking
combination with traditional DMARDS, may further clarify
a pustular flare in the skin disease on withdrawal.12
the latter’s role in the future management of this condition.
CONVENTIONAL DISEASE MODIFYINGANTIRHEUMATIC DRUGSSulfasalazine
rash and joint disease, treat peripheral and axial manifes-
tides led to its use in PsA. Efficacy was initially observed in
tations including dactylitis and enthesitis. Erosive joint
pilot studies and a number of controlled trials, with most
damage as well as the impact on quality of life from PsA have
documenting a modest degree of clinical benefit. Typical of
been shown to be comparable with that in patients with
three early controlled trials13 involving relatively small
rheumatoid arthritis (RA).1 2 Therefore, both symptomatic
numbers of patients was a 24 week double blind, placebo
therapy and aggressive treatment aimed at disease modifica-
controlled study of 30 patients using a dose of 2 g/day.
tion/amelioration should be the goal of effective medical
Significant improvement was observed in morning stiffness,
management of PsA. Traditional disease modifying antirheu-
number of painful joints, articular index, clinical score, and
matic drug (DMARD) therapy, as detailed below with these
pain score, with the favourable response more pronounced in
aims in mind, has been poorly studied. As will be shown,
the polyarticular group.14 A clinical response was observed as
there are few adequate well designed controlled randomised
early as four weeks in one study15 and was associated with a
trials, and those that have been performed have shown
reduction in ESR in another.16 Three further trials involving
disappointing efficacy. Consistently high placebo response
considerably larger numbers of patients reached similar
rates are seen in PsA trials, adding to the difficulty of
conclusions with significant improvement noted primarily
interpreting the results of uncontrolled trials when making
in patient reported measures. A study of 91 patients treated
management decisions for this condition. Difficulties in
with a dose of 3 g/day over 24 weeks revealed significant
defining clear disease subgroups and the possible maldis-
improvement in patient global assessment,17 and a study of
tribution of the subtypes of arthritis between the placebo and
120 patients treated for a similar period demonstrated
treatment arms further complicate the extrapolation of
significant improvement only in reduction of pain.18 The
results to specific disease subsets. Novel biological therapies
largest and longest of the controlled trials evaluated 221
for PsA and the development of more reliable outcome
patients treated with sulfasalazine 2 g/day over a 36 week
measures to assess responders’ symptomatic, functional, and
course. This study demonstrated efficacy of sulfasalazine
radiological endpoints are described elsewhere in this
determined by a predefined response criterion that included
improvement in tender and swollen joint counts and patientand physician global assessments. Interestingly, although the
responder definition was met statistically, the only individual
Non-steroidal anti-inflammatory drugs (NSAIDs) are com-monly used as initial therapy, prescribed for both peripheral
Abbreviations: DMARD, disease modifying antirheumatic drug; ESR,
and axial disease. However, controlled studies assessing
erythrocyte sedimentation rate; NSAID, non-steroidal anti-inflammatory
efficacy are limited; they confirm superiority to placebo on
drug; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis;
tender/swollen joint counts, and pain scores, but show no
measure within the definition that achieved statistical
study of parenteral gold.29 Neither significant flare nor
significance was the patient global assessment.19 The action
improvement in cutaneous psoriasis with oral or parenteral
of sulfasalazine appears to be confined to peripheral arthritis
gold has been observed. When comparisons are made
with no evidence of benefit in axial disease20 and only rare
retrospectively30 as well as prospectively31 between metho-
reports of either cutaneous improvement or exacerbation.
trexate and gold therapy, patients with PsA treated withmethotrexate are nine times more likely to respond and five
times less likely to discontinue therapy than patients treated
The efficacy of methotrexate in PsA was first demonstrated in
with gold—with mean treatment survival of 16 months with
1964 in a double blind, placebo controlled study of 21
methotrexate compared with six months with gold.
patients who had active skin disease and peripheralarthritis.21 Parenteral methotrexate (1–3 mg/kg divided in
three doses at 10 day intervals) was compared with placebo
Leflunomide is a selective pyrimidine synthesis inhibitor that
with an observation period of approximately three months.
targets activated T cells lacking a salvage pathway.32 A small,
Significant improvement was seen in joint tenderness and
pilot, open label study of six patients with psoriatic
range of motion, extent of skin involvement, and ESR. After
polyarthritis showed a significant decrease in the C-reactive
completion of therapy, however, most patients experienced a
protein (CRP) level as well as in the tender and swollen joint
recurrence of skin and joint disease within one to four
count, although not in the extent of psoriasis, after three
months. Adverse effects were common but did not require
months of therapy.33 Another study of 12 patients with
cessation of therapy. A randomised, double blind, placebo
polyarticular PsA who had failed at least one DMARD
controlled trial comparing oral low dose pulse methotrexate
confirmed the clinical efficacy of leflunomide in the eight
(7.5 mg or 15 mg/week) with placebo over 12 weeks did
patients available for follow up, over two years of follow up.34
show better patient tolerance; however, efficacy of this
Psoriatic rash improved in two thirds of the patients. These
regimen was not established, as the only response measure
promising results led to a randomised double blind, placebo
to attain statistical significance was the physician assessment
controlled study in 188 patients with active PsA (.3 tender
of arthritis activity.22 The study results were blunted because
and swollen joints) and active rash (.3% body surface area).
one arm was lower than currently used dose of methotrexate,
More than half of the patients had been inadequately
and because fewer patients were recruited than called for by
controlled by prior DMARD therapy including methotrexate.
the power calculations.22 In a retrospective report of 40
After six months, 59% (56/95) of patients treated with
patients over 12 years of treatment with a mean methotrex-
leflunomide met the primary efficacy endpoint (psoriatic
ate dose of 11.2 mg/week, 38 patients had an excellent or
arthritis response criteria; PsARC), compared with 30% (27/
good articular response, 36 had cutaneous resolution, and
91) of patients treated with placebo; 24% of the former
only two patients withdrew because of toxicity (leucopenia
(compared with 0% of the latter) had significant PASI score
and stomatitis).23 In seven patients who underwent 11 liver
improvements. Treatment was relatively well tolerated with
biopsies during the study, one patient was found to have
adverse effects similar to the RA experience and no unusual
micronodular cirrhosis at a cumulative methotrexate dose of
400 mg (with an unchanged biopsy at a cumulative dose of1080 mg). In a 24 month study of 38 patients, patients
treated with methotrexate did not show any improvement in
Both azathioprine and its derivative, 6-mercaptopurine, are
radiographic progression compared with matched controls.24
purine analogues that have been used in the treatment of
Whether the use of methotrexate in psoriasis and PsA results
psoriasis and PsA. Although favourable results have been
in more frequent or severe toxicity compared with RA is
reported, the study populations have been small and no
unknown. A retrospective study of 104 patients followed over
placebo controlled data are available. Eleven of 13 patients
two decades did not suggest increased toxicity.25 No
treated with 6-mercaptopurine (20–50 mg/kg per day)
consensus exists as to the indications for liver biopsy either
showed improvement in both joint and skin disease within
before treatment or at specified intervals during treatment.
three weeks of initiation of therapy and maintenance of thisimprovement on a dose of 1 mg/kg per day with minimal
adverse effects.36 A 12 month double blind crossover study of
A beneficial response in some assessment measures has been
azathioprine (3 mg/kg per day) in six patients reported
demonstrated with both oral and parenteral gold in PsA. In a
moderate or marked joint improvement in all six patients and
six month double blind, placebo controlled study of
cutaneous improvement in four; however, the dose of
auranofin (6 mg/day) involving 238 patients, the auranofin
azathioprine had to be reduced in five patients because of
treated group showed a modest but significant improvement
leucopenia.37 In view of the known toxicity of these agents,
in physician global assessment and occupational/daily func-
appropriate monitoring is mandatory.
tion scores compared with the placebo group, but nosignificant difference was seen in morning stiffness or joint
tenderness/swelling scores.26 The rate of withdrawal from
Ciclosporin A has been used with success in cutaneous
auranofin because of adverse drug reactions was 10%. An
psoriasis and beneficial effect in PsA. Representative of this
uncontrolled study of 14 patients treated with injectable gold
experience is a six month open study of eight patients (seven
showed either remission or improvement (50% reduction in
of whom were refractory to methotrexate) with a starting
number of inflamed joints) in 71% of patients.27 Toxicity was
dose of 3.5 mg/kg per day, which produced marked improve-
similar to that observed with parenteral gold in RA. A double
ment in joint and skin disease in seven of the eight patients
blind comparison of auranofin (6 mg/day), intramuscular
after two months.38 One patient withdrew from the study
gold sodium thiomalate (50 mg/wk), and placebo showed
because of lack of efficacy, and three patients required a 25%
significant improvement in the Ritchie articular index, the
reduction in the dose of ciclosporin A because of a 50%
visual analogue pain score, and the erythrocyte sedimenta-
increase in serum creatinine. A prospective controlled trial
tion rate (ESR) over 24 weeks in the parenteral gold group
comparing ciclosporin A (3 mg/kg per day) with methotrex-
but no significant difference in the auranofin group as
ate (7.5 mg weekly) treated over a one year period suggested
compared with the placebo group.28 Radiographic disease
equivalent efficacy in 35 patients with PsA, although
progression was not prevented in a small controlled two year
combined withdrawals due lack of efficacy and toxicity were
greater in the ciclosporin A group.39 A single six month pilot
in the early withdrawal of three patients receiving colchicine
study has employed ciclosporin A (3–5 mg/kg per day) in
from the trial. Creatine kinase values increased, without
combination with methotrexate (10–15 mg/week) in eight
weakness, during treatment with colchicine (five patients)
patients who had failed prior second line therapy.40
and placebo (four patients). This study did not provide
Significant improvement was described in all patients during
evidence that colchicine is of therapeutic value in the
the first month of treatment, with five patients continuing on
treatment of PsA. Larger studies of longer duration will be
combined therapy at the conclusion of the study period.
necessary to establish any role of colchicine in the manage-
Further studies are needed to define benefit and toxicity
Etretinate, a vitamin A derivative, is the most commonly used
Reports of favourable response to both chloroquine (250 mg/
retinoid in the treatment of psoriasis, and initial experience
day) and hydroxychloroquine (200–400 mg/day) in approxi-
with this agent in PsA suggests a beneficial effect. In one
mately 75% of patients have been offset by concerns that
pilot study, 40 patients treated with etretinate (50 mg/day)
antimalarial drugs may have an adverse effect on the skin
for a mean of 21.9 weeks experienced significant improve-
disease. The spectrum of suspected cutaneous toxicity
ment in the number of tender joints, the duration of morning
includes exacerbation of plaques, photosensitivity, general-
stiffness, and the ESR.46 Maximal improvement for most
ised erythroderma, evolution to pustular psoriasis, and the
efficacy measurements was seen at between 12 and
development of an exfoliative dermatitis. Although the
16 weeks. Mucocutaneous reactions consisting of dried and
reported incidence of these reactions ranges from 0% to
cracked lips, mouth soreness, and nosebleeds were seen in
100%, it is important to note that more frequent reactions
the preponderance of patients (39/40) and required cessation
were observed in early trials that had few patients and
of treatment in nine patients. Other relatively frequent
primarily used regimens with quinacrine; much less toxicity
adverse effects were alopecia, hyperlipidaemia, myalgias,
has been seen in the more recent experience involving larger
and elevated transaminase levels. Etretinate is a teratogen
numbers of patients and using chloroquine or hydroxychlor-
and should not be used in women of childbearing potential.
oquine.41 A prospective controlled trial is needed to establishthe efficacy and safety of these agents in the treatment of
The most commonly used form of photochemotherapyinvolves the oral administration of 8-methoxypsoralen, a
photosensitising medication, followed by exposure to long
A favourable effect on PsA has been observed with the use of
wave ultraviolet A (PUVA) light, which activates the drug. A
D-penicillamine, but the available information is anecdotal
prospective study of 27 patients treated with PUVA found a
and very limited. Eleven patients (two with spondylitis, four
49% mean improvement in articular index of patients with
with asymmetric oligoarthritis, and five with symmetric
peripheral arthritis, whereas no benefit was seen in patients
polyarthritis) were randomised to an initial phase consisting
with spondylitis.47 In responders, improvement in the
of treatment with either D-penicillamine or placebo for four
peripheral arthritis seemed to correlate with clearing of the
months, followed by four months of treatment with D-
skin disease, whereas no such relationship was observed in
penicillamine for all patients.42 The maximum dose of D-
patients with axial disease. Extracorporeal photochemother-
penicillamine was 750 mg/day, and no unusual toxicity was
apy, also known as photopheresis, has been shown to
observed. Clinical benefit was seen only during D-penicilla-
diminish the in vitro viability, proliferation, and mitogen
mine treatment; however, no efficacy measure attained
response of lymphocytes, but reports of clinical improvement
statistically significant improvement.
in arthritis symptoms are variable and no effect on skinlesions has been observed.48 49
ColchicineColchicine is an alkaloid known to attenuate the inflamma-
tory response by interfering with neutrophil chemotaxis. A
Somatostatin may benefit some patients with PsA but
pilot study showed that 11 of 22 patients treated with
requires prolonged intravenous infusion (48 hours) and is
colchicine (0.02 mg/kg per day) had significant cutaneous
poorly tolerated because of nausea. In one study, patients
clearing, while four of eight patients with arthralgias had
with extensive skin lesions and polyarticular involvement
symptomatic improvement.43 A subsequent 16 week double
blind crossover study of 15 patients compared colchicine(1.5 mg/day) with placebo.44 With the patient global assess-
ment as the primary efficacy measure, colchicine was judged
Other agents that have been reported to have activity in PsA
more effective than placebo by 10/12 patients (83%) who
include bromocriptine, cimetidine, fumaric acid, 2-chloro-
completed the study, and significant improvement was seen
deoxyadenosine, parenteral nitrogen mustard, peptide T,
in grip strength, Ritchie index, joint pain, and joint swelling
radiation synovectomy with yttrium 90, dietary supplements
during treatment with colchicine. Gastrointestinal symptoms
and total lymph node irradiation. Further study is needed to
results in withdrawal of two patients from the study and a
define what role, if any, these regimens might have in patient
temporary dose reduction in five others. No unanticipated
clinical or laboratory toxicity was seen. A 23 week study of 25patients comparing the therapeutic effect of colchicine (0.6–
1.8 mg per day) with placebo was reported in 1993.45 No
For a disease as prevalent as PsA, the evidence base
significant difference was noted between colchicine or
demonstrating efficacy of therapy with traditional DMARDs
is very limited. There are data that demonstrate marginal
(Lansbury joint counts) or any of the seven secondary
efficacy of sulfasalazine and perhaps gold in the treatment of
outcome measures. No change in the psoriasis was noted
during active or placebo treatment. Adverse clinical effects
Methotrexate and ciclosporin are effective for treating the
were reported more often during treatment with colchicine
rash but evidence for improvement of the arthropathy is
(14 patients) than with the placebo (four patients), resulting
empirical; at present these have not been systematically
studied. None of the traditional DMARDs have been shown
20 Clegg DO, Reda DJ, Abdellatif M. Comparison of sulfasalazine and placebo
for the treatment of axial and peripheral articular manifestations of the
to prevent radiological progression nor to impact significantly
seronegative spondylarthropathies: a Department of Veterans Affairs
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21 Black RL, O’Brien WM, VanScott EJ, Aurbach R, Eisen AZ, Bunim JJ.
Methotrexate therapy in psoriatic arthritis; double-blind study on 21 patients.
with definition, standardisation, and validation of outcome
measures. These will result in more rigorous studies with
22 Willkens RF, Williams HJ, Ward JR, Egger MJ, Reading JC, Clements PJ, et al.
agents such as TNF inhibitors and other novel biological
Randomized, double-blind, placebo controlled trial of low-dose pulse
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23 Espinoza LR, Zakraoui L, Espinoza CG, Gutierrez F, Jara LJ, Silveira LH, et al.
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24 Abu-Shakra M, Gladman DD, Thorne JC, Long J, Gough J, Farewell VT.
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