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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS - page 5 / 6

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Number of anti-D

Other ITP treatment on

Months of patient follow-up

Total cost of anti-D and splenectomy per group

Cost per patient per month

Outcome group

infusions on study

study*

Cost per patient

Off treatment (n 5 12) On treatment (n 5 7) Splenectomy (n 5 8) Sum

79 54 64 197

16 G, 13 mo P, 28 mo D 22 G, 31 mo P, 3 mo A 8 G, 1 V, 2 M, 18 mo D, 14 P

381 176 116† 673

$87 280 $68 480 $214 640 ($86 640‡) $370 400 ($242 400‡)

$7 273 $9 978 $26 830 ($10 830‡)

$229 $389 $1 850 ($747‡)

1926

COOPER et al

Table 3. Cost comparisons of anti-D and splenectomy

BLOOD, 15 MARCH 2002 VOLUME 99, NUMBER 6

G indicates IVIG; P, prednisone; D, danazol; V, vincristine; M, methylprednisolone; and A, azathio *The number of IVIG, vincristine, or methylprednisolone treatments and the number of months of

  • Follow-up until month of splenectomy.

  • Cost of anti-D alone.

prine. prednisone, danazol, or azathioprine per group.

platelet increment or duration of response to the first infusion on the long-term outcome. There was no significant difference be- tween the outcome groups for either rhesus phenotype (CDE) or ABO blood group.

costs of both anti-D and splenectomy but not treatment after splenectomy, was $214 640, or $1,850 per patient per month. These estimates are an oversimplification because they do not include many other costs, such as the cost of other therapies, blood tests, outpatient visits, nursing time, or the cost of time lost from work.

Bleeding diaries

No patient had a severe bleeding episode throughout the 64 years of patient follow-up following study enrollment. Twenty-four of the patients complained of nonsevere bleeding, including 7 nose bleeds, 7 mouth bleeds, 10 petechiae, and 11 increased bruising. Six of the 15 females described menorrhagia. Bleeding symptoms tended to occur at lower platelet counts; however, occasional patients described petechiae, bruising, and nose bleeds at normal platelet counts.

Discussion

Studies assessing the long-term outcome of adults with ITP (Table 4) suggest that between 9% and 32% of newly identified adults will go into remission either spontaneously or following a short course of steroids.3-8 Those patients who do not go into early remission tend to undergo splenectomy.

Quality of life survey

There was no change from baseline to 6, 12, or 18 months in the scores of questions 3, 4, and 6. There was an increased score (greater well being) for question 5 at 12 months (P , .05) and at 18 months (P , .01) when compared with baseline. There was also an increased score at 6 (P , .05), 12 (P , .01), and 18 (P , .01) months in question 2 when compared with baseline. Question 1 showed a decreased score (decreased feeling of well being) at 6 (P , .05) and 18 (P , .05) months when compared with baseline.

Cost analysis

The cost of treating patients with IV anti-D for each outcome group is estimated in Table 3 using the number of vials of anti-D actually used by each patient and the costs listed in “Patients and methods.” Using these estimates, the cost of the anti-D used in all 28 patients plus the 8 splenectomies would be $370 400. In comparison, the cost of performing splenectomy in all 28 patients would have been $448 000. The cost of treating the 12 patients who were able to discontinue treatment for the study period was $87 280, or $229 per patient per month. The cost of treating those patients still on treatment was $68 480, or $389 per patient per month. The cost of treating the patients who underwent splenectomy, including the

Several studies have reported anecdotal patients who achieve late remission after multiple courses of steroids.3,4,6 In general, however, the natural history of those adults who do not improve after an initial course of steroids and do not undergo splenectomy is unknown. This pilot study was designed to assess the 1- to 5-year outcome of patients with recently diagnosed ITP who did not improve after their initial treatment. The hemorrhagic complica- tions associated with persistently low platelet counts were avoided by using palliative treatment with repeated infusions of IV anti-D.

The results were encouraging. Twelve (43%) of the 28 adults who participated in this study have been off all treatment and have maintained platelet counts above 30 3 109/L (30 000/mL) for more than 6 months. Six (21%) of these continued to improve after discontinuing therapy and now have counts above 100 3 109/L (100 000/mL) with 3 (11%) in complete remission. Furthermore, 71% of the 28 patients have so far avoided splenectomy, and those still receiving IV anti-D are receiving it significantly less fre- quently. Of particular note, those patients with counts above 100 3 109/L (100 000/mL) (Figure 3A) achieved this a median of 22.5 months (range 13-38 months) from diagnosis and received a median of 16 months (range 7-20 months) of treatment. Given that the 28 patients enrolled in this study had completed a median of 2 courses of treatment and were a median 3.5 months from diagnosis at study entry, it was surprising that almost half the patients were

Year

Country

No. of patients treated with steroids

Initial CR, steroids alone (%)

CR maintained after discontinuing treatment (%)

Late CR

Total CR (%)

t al3

Thompson e DiFino et al4 Pizzuto et al5 JiJi et al6 Stasi et al7 Ikkala et al8

1972 1980 1984 1984 1995 1978

US US South America US Italy Finland

57 59 818 91 121 40

13 (23) 25 (43) 386 (47) 22 (24) 52 (39) 16 (40)

13 (23) 13 (22) 262 (32) 21 (23) 11 (9) 10 (25)

3 3 5

16 (28) 16 (27) 262 (32) 26 (29) 11 (9) 10 (25)

Table 4. Summary of studies assessing the long-term outcome of patients with ITP

CR indicates complete response.

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