Adalimumab (Humira, AbbVie) enhances both health-related quality of life and work productivity in patients with moderate-to-severe hidradenitis suppurativa, according to the results of two phase 3 clinical trials.
Dr. KimballAdalimumab (Humira, AbbVie) enhances both health-related quality of life and work productivity in patients with moderate-to-severe hidradenitis suppurativa (HS), according to the results of two phase 3 clinical trials.
“We increasingly understand that pain is a major debilitating symptom for patients with hidradenitis suppurativa (HS),” says Alexandra Kimball, M.D., M.P.H., president and CEO, Harvard Medical Faculty Physicians, at Beth Israel Deaconess Medical Center in Boston. “We wanted to assess whether pain control, even in the absence of complete disease activity control, had benefits - and it did.”
Dr. Kimball was lead author of a study that combined data from two phase 3 clinical trials (PIONEER 1 and 2); results were presented in March at the annual meeting of the American Academy of Dermatology (AAD) in Orlando, Fla.
Two key indicators
A total of 455 patients (combining both adalimumab-treated patients and placebo-treated patients) were stratified into four groups, based on their status 12 weeks after taking adalimumab therapy, with two indicators: NRS30, a measurement of pain control, defined as at least a 30% reduction and at least one unit reduction from baseline in the numerical rating scale (NRS) for pain (ranging from 0 to 10); and Hidradenitis Suppurativa Clinical Response (HiSCR), a measurement of HS lesion control, defined as at least a 50% reduction in abscesses and inflammatory nodule count, no increase in abscess count and no increase in draining fistula count, relative to baseline.
“The main conclusions of this study indicate that both objective disease control and skin-pain control are associated with improved quality of life and work productivity in patients with HS,” Dr. Kimball tells Dermatology Times. “Furthermore, patients who had good disease control and who achieved skin-pain control reported additional benefits in patient-reported outcomes. However, achieving even just pain control conferred benefits for patients.”
Findings for the four groups demonstrated that 20.0% (91 patients) achieved a significant improvement in both NRS30 and HiSCR; 13.6% (62 patients) attained improvement in NRS30, but not HiSCR; 20.7% (94 patients) achieved improvement in HiSCR, but not NRS30; and 45.7% (208 patients) achieved improvement in neither NRS30 nor HiSCR.
All groups had similar baseline characteristics.
For those who were HiSCR and NRS30 achievers at week 12, the mean score on the self-reported Dermatology Life Quality Index (DLQI) was 6.8 (on a scale of 0 to 30 for maximum impact) compared with 10.0 among the HiSCR positive but NRS30 non-achievers, and with 14.4 among patients who did not achieve in either measure.
Similarly, for the Work Productivity and Activity Impairment (WPAI) Questionnaire, among HiSCR and NRS30 achievers, total work impairment (on a scale of 0% to 100% impairment) decreased from 44.6% to 19.5%, and total activity impairment decreased from 49.5% to 21.0%.
This compared to 23.5% and 36.3% respectively, for HiSCR positive NRS30 non-achievers.
The Short Form Heath Survey (SF-36) (with a population mean score of 50) found that for HiSCR and NRS30 achievers, the mental component summary (MCS) was 44.8 (improved from 41.9) and the physical component summary (PCS) was 49.8 (improved from 39.4), as opposed to 42.5 and 43.5, respectively, for HiSCR positive but NRS30 non-achievers.
The Hospital Anxiety and Depression Scale (HADS) scores (on a scale of 0 to 21 for greatest distress) were 6.7 for anxiety and 4.2 for depression among HiSCR and NRS30 achievers, and 7.6 and 5.6, respectively, for HiSCR positive and NRS30 non-achievers.
For the NRS overall, there was a 66.6% reduction in patients who were both NRS30 and HiSCR positive and a 56.8% reduction in patients who were NRS30 positive and HiSCR non-achievers. However, there was a 7.9% increase in patients who were NRS30 non-achievers and HiSCR positive and a 14.2% increase in patients who were non-achievers on both NRS30 and HiSCR.
Many months of treatment
“In my clinical experience, HS is a disease that takes many months of treatment to control,” Dr. Kimball says. “It is important to see that pain control can occur early in the course of treatment and that it provides real benefit, even before some of the other clinical improvements can be detected.”
Also, because HS does not disappear as quickly as some other diseases, such as psoriasis, setting realistic patient expectations is key. “We need to let them know that pain improvement may be meaningful and earlier, even as the rest of the disease is slowly calming,” Dr. Kimball says.
Because knowledge of HS is rapidly expanding, “I am optimistic that as we learn more about how to manage this disease, we will continue to improve the lives of our patients,” Dr. Kimball says.
Disclosure: Dr. Kimball is a consultant and investigator for AbbVie and Novartis.