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Limited effects of intravenous IgG in treating systemic lupus erythematosus-associated thrombocytopenia.

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787
LETTERS
Limited effects of intravenous IgG in treating systemic
lupus erythematosus-associated thrombocytopenia
To the Editor:
The treatment of systemic lupus erythematosus
(SLEtassociated thrombocytopenia is at times difficult.
Intravenous (IV) administration of immunoglobulin G (IgG)
has been used with success in idiopathic thrombocytopenic
purpura, and a recent study by Maier et al(1) investigated its
efficacy in a small number of patients with SLE-associated
thrombocytopenia. To help define the role of this form of
therapy, we describe our experience with IV IgG therapy in
SLE-associated thrombocytopenia.
The 3 patients were ethnic southern Chinese who had
clinical manifestations related to the thrombocytopenia (Table 1). They were treated with either Gammagard (Baxter
Healthcare, Glendale, CA) 1 gm/kg/day on 3 alternate days
or Gamimune (Cutter Biologicals, Berkeley, CA) 0.4 gm/kg/
day on 5 successive days, according to the manufacturers'
instructions. Each patient received at least 2 full courses of
IV therapy.
Only patient 1 demonstrated a continued response at
1 month, and that was only after the second course of
therapy. Even in this patient, the response was clearly
inadequate, since the platelet count remained <30 x lo9/
liter. Patient 2 required a cesarean section within 2 weeks of
the second course of IV IgG therapy. Preoperatively, this
patient was given a further infusion of IgG (1 gmlkg of
Gammagard), followed by 8 units of platelets. There was a
resultant increase in the platelet count, to 260 x lO"/Iiter,
and there were no operative complications. Six days postpartum, the patient's platelet count again decreased, to 21 x
109/liter. All 3 patients have subsequently required further
therapy. They have been treated with danazol, and the
results have been good. Patient 3 had to discontinue this
therapy, however, because of hepatitis, presumed to be
related to the danazol.
Bussel and Hilgartner commented in a review article
(2) that intravenous immunoglobulin therapy is useful in the
treatment of SLE-associated thrombocytopenia, but they
did not describe their patients in detail. We, however, do not
consider any of our patients to have had a sufficient response
that would justify the continued use of IV IgG treatments.
Similarly, none of the 4 patients described by Lin and Rack
(3) had more than a brief response to this therapy. Of the 7
patients described by Maier et al ( I ) , only 6 are assessableone patient underwent splenectomy immediately after the
course of IV IgG therapy. Despite the administration of
monthly maintenance therapy, only 2 of their patients had a
response that persisted beyond 6 months. Indeed, 2 patients
who did not respond initially did not appear to derive benefit
from further maintenance therapy. Thus, combining our
experience with that of others (1,3), we see that only 2 of 13
patients who have received IV immunoglobulin therapy have
had prolonged, clinically worthwhile, responses.
Nonetheless, we have found that a single infusion of
high-dose IgG followed by transfusions with allogeneic
platelets is effective when performed preoperatively, as
illustrated in the case of patient 2. This is consistent with a
previous report describing this therapy for patients with
idiopathic thrombocytopenic purpura (4). Whereas a controlled trial is warranted, it appears that the combined
regimen more reliably provides a rapid and clinically useful
elevation in the platelet count than does IV IgG therapy
alone.
In contrast with our experience with IV IgG treatment, and consistent with the experience of others (9,we
have found that danazol is effective in the treatment of
SLE-associated thrombocytopenia. The 4 patients who have
been treated thus far have all had good responses within a
month of commencing treatment (unpublished observations).
In summary, available data suggest that IV treatment
with IgG is only of limited efficacy in the management of
SLE-associated thrombocytopenia. We anticipate that its
Table 1. Clinical features and response to IV treatment with IgG in 3 patients with SLE-associated thrombocytopenia*
Patientlagelsex
1130lF
212SlF
3/19/F
Features of S L E
Duration of SLE/
thrombocvtoDenia
~.
(years)
Prior
immunosuppressants
13/15
Prednisone, vincristine
Arthritis, thrombocytopenia,
pericardial effusion, ANA
Arthritis, thrombocytopenia,
hemolytic anemia,
proteinuria, ANA
Thrombocytopenia,
psychosis, ANA, anti-Sm
antibodies
81 1
1/0.5
Prednisone
Prednisone, vincristine,
azathioprine
Response to 1V IgG, platelet count
( X lO9/liter)
Course no.
Before
After
1 month
1
2
5
1
2
43
23
155
32
69
41
29
23
-
1
2
3
2
6
6
1
13
27
18
1
6
6
-
* Patient 2 was 20 weeks pregnant at the onset of thrombocytopenia. Her I-month platelet count after the first course of therapy was performed
at 2 weeks, and 2 weeks after the second course of therapy, she underwent cesarean section. Patient 3 was started on a regimen of danazol after
the last infusion of the third course of therapy. IV = intravenous; SLE = systemic lupus erythematosus; ANA = antinuclear antibodies.
Arthritis and Rheumatism, Vol. 34, No. 6 (June 1991)
788
LETTERS
greatest role will be in combination with platelet transfusions
preoperatively and in the management of acute bleeding.
Michael G. Cohen, MBBS, PhD, FRACP
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Edmund K. Li, MD, FRCP(C), FACP
Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
1. Maier WP, Gordon DS, Howard RF, Saleh MN, Miller SB,
Lieberman JD, Woodlee PM: Intravenous immunoglobulin therapy in systemic lupus erythematosus-associated thrombocytopenia. Arthritis Rheum 33:1233-1239, 1990
2. Bussel JB, Hilgartner MW: Intravenous immunoglobulin therapy
of idiopathic thrombocytopenic purpura in childhood and adolescence. Hematol Oncol Clin North Am 1:465482, 1987
3. Lin RY, Rack SP: In vivo reduction of circulating C l q binding
immune complexes by intravenous gammaglobulin administration. Int Arch Allergy Appl Immunol 79:28&290, 1986
4. Baumann MA, Menitove JE, Aster RH, Anderson T: Urgent
treatment of idiopathic thrombocytopenic purpura with singledose gammaglobulin infusion followed by platelet transfusion.
Ann Intern Med 104:808-809, 1986
5. West SG, Johnson SC: Danazol for the treatment of refractory
autoimmune thrombocytopenia in systemic lupus erythematosus.
Ann Intern Med 108:703-706, 1988
Transcutaneous electrical nerve stimulation in
ankylosing spondylitis: a double-blind study
To the Editor:
Inflammatory low back pain and stiffness is a characteristic feature of ankylosing spondylitis (AS). Since no
drug has been shown to modify the inflammatory process per
se, the aim of treatment is to ensure analgesia and normal
spine mobility. Transcutaneous electrical nerve stimulation
(TENS) can reduce pain in many musculoskeletal disorders,
and in an open trial (l), it was reportedly effective in the
treatment of unresponsive pain from AS.
We evaluated the efficacy of TENS in the management of AS lumbar pain in a controlled double-blind study of
20 patients with definite AS (New York criteria [2]), who had
lumbar pain and stiffness for at least 1 month, for which
treatment with nonsteroidal antiinflammatory drugs
(NSAIDs) was not sufficient. NSAID therapy was discontinued 1 week before the beginning of the trial; only paracetamol was allowed for severe pain.
TENS was delivered by an Agopik A86 stimulator
(Sanitec, Alessandria, Italy), through 4 electrodes placed on
the skin of the lower back. Standard acupuncture points (3)
were chosen as the sites of stimulation, and a low-frequency
(5-Hz) current was applied to group A patients. The same
stimulator with the current switched off delivered sham
TENS. In order to support the placebo effect, the lights and
the acoustic signal of the apparatus were demonstrated to
the group B patients. Each patient received 10 treatments of
20 minutes each, over a 3-week period. Patients had been
randomly assigned to 1 of the 2 treatment groups at study
entry.
Assessments were performed before and after treat-
Table 1. Changes in pain and stiffness in 20 patients with ankylosing spondylitis after treatment with transcutaneous electrical nerve
stimulation (TENS) or with sham TENS*
Group A
(active TENS)
Pain (100-mm VAS)
Before study
After study
Difference
Stiffness (100-mm VAS)
Before study
After study
Difference
Group B
(sham TENS)
57.1 f 13.7
35.6 +. 20.5t
21.5 2 16.3$
47.6
41.9
5.7
56.1 f 14.4
31.0 f 19.3t
24.3 k 24.41
49.8 f 14.6
43.0 f 14.5
6.2 f 16.1
f
f
f
17.8
16.3
15.4
* Pain and stiffness were scored on a visual analog scale (VAS).
Values are the mean f SD.
t P < 0.025 versus before study value.
I.- P < 0.025 versus group B.
8 P < 0.05 versus group B.
ment by 1 of us (10),who had no knowledge of the study
group to which the patient was assigned. Pain and stiffness
(0-100-mm visual analog scale), Shober’s test, finger-to-floor
distance in anterior and lateral flexion, and pill counts of the
analgesic were performed. At the end of treatment, all
patients and the blinded evaluator were asked independently
to record, on a 7-point scale, their scoring of the treatment
results. Statistical analysis of the data was performed using
the chi-square test, Student’s t-test, Wilcoxon’s test, and the
Mann-Whitney U test, as appropriate.
Significant differences (P < 0.025) in pain and stiffness measurements over the treatment period were found
only in group A patients. There were also statistically
significant differences in pain (P < 0.025) and, to a lesser
extent, stiffness (P < 0.05) between the 2 treatment groups
when the mean differences before and after treatment were
compared (Table 1). There was no statistically significant
improvement in lumbar mobility in either treatment group.
One group A patient and 5 group B patients took
paracetamol; the difference was not statistically significant.
The blinded evaluator scored the treatment results higher in
group A patients than in group B ( P < 0.025); the group A
patients scored the results higher than did the group B
patients, but the difference did not reach statistical significance. Despite the lack of significant differences between the
2 groups, individual responses to both active and placebo
treatments were worthy of note. Nine patients in the active
TENS group and 6 in the sham TENS group stated that their
low back pain had improved mildly or greatly at the end of
treatment.
Our data are consistent with the results of Nienhuis
and Hoekstra’s open study, and show that TENS is significantly more effective than placebo in the treatment of lumbar
pain and stiffness caused by AS. Although the difference is
not statistically significant, the analgesic effect of TENS may
also be suggested by the lower number of analgesic pills
taken by group A compared with group B during treatment.
Nevertheless, the positive trend of the scores of both groups
of patients reveals that the placebo effect plays a prominent
role in the efficacy of TENS, as confirmed by reports in the
literature (4).
These results suggest that TENS may provide a
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lupus, effect, associates, intravenous, treating, limited, systemic, igg, erythematosus, thrombocytopenic
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