International Journal of Dermatology 2010, 49, 950955 2010 The International Society of Dermatology
Amano, Grant, and Kerdel Adalimumab for treating hidradenitis suppurativa Clinical trial 951
2010 The International Society of Dermatology International Journal of Dermatology 2010, 49, 950955
952 Clinical trial Adalimumab for treating hidradenitis suppurativa Amano, Grant, and Kerdel
Results
Ten patients were enrolled in this study. Of these, six
patients completed the 12-week study and four patients
Figure 1 Changes of disease activity (HSSI) score during the
withdrew during the treatment period. Four patients with- 12-week treatment period
drew because of disease worsening and lack of efficacy. Of
the six patients who completed the treatment period, four
completed the post-treatment assessment at 13 weeks.
Two patients were lost to follow-up after the week 12 One patient reported a decrease in the number of daily
visit. Although patients were allowed to use nonsteroidal dressing changes at week 2. Three patients reported a
anti-inflammatory drugs and or low-dose prednisone, none decrease of the number of daily dressing changes at week
of the patients received any concomitant therapy during 4 and two patients reported a decrease of the number of
the trial. The characteristics of patients enrolled in this daily dressing changes at week 8. One patient reported a
study and their affected skin areas are shown in Table 2. decrease of the number of daily dressing changes at week
Changes in disease activity as measured by the HSSI score 12 but the rest of the patients reported no change of the
during the 12-week treatment period for each of the number of daily dressing changes at each week (data not
enrolled patients is shown in Fig. 1. A 50% decrease of shown).
that score was not found in any of the patients at week 2, Changes in pain scales using VAS during therapy and
4, 8, or 12. None of the 10 patients was classified as a at follow-up for each of the enrolled patients are shown
responder at week 12 compared with baseline. A 30% in Fig. 2. The median VAS scores were diminished from
decrease of that score was found in one patient at week 2; 60.0 to 20.0 at week 2 (P = 0.17), and from 60.0 to 20.0
in two patients at week 4; in one patient at week 8; and at week 4 (P = 0.42), from 60.0 to 30.0 at week 8
no patients at week 12. The median baseline HSSI score (P = 0.29), from 60.0 to 57.5 at week 12 (P = 0.55). No
was 17.0 and this score decreased slightly after 12 weeks significant differences were found between baseline and
of treatment to 14.5 (P = 0.40). Statistically significant dif- week 2, 4, 8, and 12.
ference was found between baseline and week 8 (P < 0.05) Changes of the DLQI score over the 12-week treatment
only, but no significant differences were found between period for each of the enrolled patients are shown in
baseline and week 2, 4, and 12. Fig. 3. The median DLQI scores were diminished from
Table 2 Demographic characteristics of ten patients with hidradenitis suppurativa enrolled in the study
Gender HSSI at
Patient Age (M/F) Ethnicity screening Involved skin areas
International Journal of Dermatology 2010, 49, 950955 2010 The International Society of Dermatology
Amano, Grant, and Kerdel Adalimumab for treating hidradenitis suppurativa Clinical trial 953
2010 The International Society of Dermatology International Journal of Dermatology 2010, 49, 950955
954 Clinical trial Adalimumab for treating hidradenitis suppurativa Amano, Grant, and Kerdel
Reference (No. of
patients treated) Medication regimen and dose Outcome
IBD, inflammatory bowel disease; EOW, every other week; HS, hidradenitis suppurativa; E3W, every three weeks.
every 3 weeks if HS was in clinical remission. Significant dose as a favorable trend occurred after the induction
improvements after 1 month of treatment were seen in phase with a high dose. Therefore, in the treatment of HS
the DLQI, in the number of affected regions, nodules, fis- a higher dose may be required, particularly after the
tulas, and in the basic laboratory findings. Improvements induction phase.
were maintained and the medication was well tolerated.15 In regards to effects as pain as measured by VAS, no
The present study is the fifth report of HS cases treated significant differences were found between baseline and
with adalimumab. The results of our study demonstrate week 2, 4, 8, 12. The DLQI score over the 12-week treat-
that adalimumab is well tolerated in patients with HS but ment found a statistically significant difference between
had minimal clinical significant efficacy. baseline and week 2 (P < 0.05), but no significant differ-
The existing prospective studies of TNF-a inhibitors for ences were found between baseline and week 4, 8, 12.
HS have varied in their outcome assessment, population The DLQI score was positively correlated with the pain
studied, and dose and type of TNF-a inhibitor used. In scale using VAS.
particular, these studies tended to find higher responses In conclusion, results of the present prospective open-
when using the Sartorius score compared with using glo- label phase II trial showed minimal evidence of clinically
bal assessment tools.16 Our study used the HSSI score significant efficacy of adalimumab in the treatment of HS.
which is a comprehensive instrument that assesses clinical The patients in this study were on the severe spectrum of
severity of HS and takes into account the number of disease and this could have affected the results. Neverthe-
lesions, pain, and impact on daily activities. Other instru- less a trend toward a beneficial response was observed.
ments proposed for the assessment of HS include Hurleys Future studies using higher doses of adalimumab are war-
Clinical Staging18 and the recently validated Sartorius ranted. Ultimately, a double-blind, placebo-controlled
score.17 The former allows for staging of the disease with trial will be necessary to demonstrate the efficacy of ada-
suggestions on treatment for patients at each stage but is limumab in the management of HS.
not suitable to report treatment effects, whereas the latter
fails to evaluate the main features of the disease such as
References
drainage or pain. It is furthermore difficult to use and has
not been used in a clinical trial to report treatment effect. 1 Wiseman MC. Hidradenitis suppurativa: a review.
The need for a reliable tool provided impetus for the Dermatol Ther 2004; 17: 5054.
development of the HSSI to assess disease severity in 2 Yu CC, Cook MG. Hidradenitis suppurativa: a disease of
these patients. follicular epithelium, rather than apocrine glands. Br J
Statistically significant differences in HSSI were found Dermatol 1990; 122: 763769.
3 Rosi YL, Lowe L, Kang S. Treatment of hidradenitis
between baseline and week 8 (P < 0.005) but no signifi-
suppurativa with infliximab in a patient with crohns
cant differences were found between baseline and week 2,
disease. J Dermatolog Treat 2005; 16: 5861.
4, 12. Our results clearly demonstrate a lack of significant 4 Adams DR, Gordon KB, Devenyi AG, et al. Severe
clinical response based on the results of HSSI score. hidradenitis suppurativa treated with infliximab infusion.
The difference in HSSI from baseline to week 2 and 4 Arch Dermatol 2003; 139: 15401542.
reached no statistical differences but a decreasing trend of 5 Sullivan TP, Welsh E, Kerdel FA, et al. Infliximab for
the values was observed in week 2 and 4. Most patients hidradenitis suppurativa. Br J Dermatol 2003; 149:
reported relapse of their disorder within weeks 812. The 10461049.
reasons for relapse after week 8 could be related to the
International Journal of Dermatology 2010, 49, 950955 2010 The International Society of Dermatology
Amano, Grant, and Kerdel Adalimumab for treating hidradenitis suppurativa Clinical trial 955
6 Lebwohl B, Sapadin AN. Infliximab for the treatment of 12 Yamauchi P, Mau N. Hidradenitis suppurativa managed
hidradenitis suppurativa. J Am Acad Dermatol 2003; 49: with adalimumab. J Drugs Dermatol 2009; 8: 181183.
S275S276. 13 Blanco R, Martinez-Taboada VM, Villa I, et al. Long-
7 Martinez F, Nos P, Benlloch S, et al. Hidradenitis term successful adalimumab therapy in severe hidradenitis
suppurativa and Crohns disease: response to suppurativa. Arch Dermatol 2009; 145: 580584.
treatment with infliximab. Inflamm Bowel Dis 2001; 14 Lee AR, Dommasch E, Treat J, et al. A prospective
7: 323326. clinical trial of open-label etanercept for the treatment of
8 Katsanos KH, Christodoulou DK, Tsianos EV. Axillary hidradenitis suppurativa. J Am Acad Dermatol Apr 2009;
hidradenitis suppurativa successfully treated with 60(4): 565573.
infliximab in a Crohns disease patient. Am J 15 Hurley HJ. Axillary hyperhidrosis, apocrine
Gastroenterol 2002; 97: 21552156. bromhidrosis, hidradenitis suppurativa and familial
9 Giamarellos-Bourboulis EJ, Pelekanou E, Antonopoulou bening pemphigus: surgical approach. In: Roenigk RK,
A, et al. An open-label phase II study of the safety and Roenigk HH eds. Dermatologic Surgery. New York:
efficacy of etanercept for the therapy of hidradenitis Marcel Dekker, 1989: 729739.
suppurativa. Br J Dermatol 2008; 158: 567572. 16 Sartorius K, Lapins J, Emtestam L, et al. Suggestions for
10 Moul DK, Korman NJ. Severe hidradenitis suppurativa uniform outcome variables when reporting treatment
treated with adalimumab. Arch Dermatol 2006; 142: effects in hidradenitis suppurativa. Br J Dermatol 2003;
11101112. 149: 211213.
11 Scheinfeld N. Treatment of coincident seronegative
arthritis and hidradenitis suppurativa with adalimumab.
J Am Acad Dermatol 2006; 55: 163164.
2010 The International Society of Dermatology International Journal of Dermatology 2010, 49, 950955