Table 4.
Case reports, case series and retrospective studies | ||||||
---|---|---|---|---|---|---|
Case reports | ||||||
Study | Subject characteristics | Therapies | Dose | Treatment duration | Efficacy | Complications |
Koilakou S et al106 | One 38-year-old male | ADA | 40 mg EOW | NR | No | None |
Benhadou F et al 201822 | One 55-year-old female | ADA | 160 mg once | 1 week | Yes | Erythroderma |
Van der Zee HH et al 201353 | One 51-year-old female | ADA, GOL, ANK | ADA 40 mg EOW, GOL 50 mg monthly, ANK 100 mg monthly | ADA for 2 years, GOL for 1 year, ANK for 1 year | All ineffective | None |
Moul DK et al 2006107 | One 67-year-old male | ADA | 40 mg EOW | 5 months | Yes | None |
Harde V et al 2008108 | One 32-year-old male | ADA | 80 mg once, then 40 mg weekly | 6 months | Yes | None |
de Wet J et al 201717 | One 42-year-old male | ADA | 160 mg at week 0, 80 mg at week 2, and 40 mg weekly for 5 weeks | 8 weeks | Yes | None |
Samycia M et al109 | One 48-year-old male | ETA, INF, ADA | ETA 50 mg weekly, then twice weekly, INF 5 mg/kg, then 10 mg/kg every 6 weeks, ADA 80 mg at week 0 then 40 mg EOW then weekly |
ETA for 4 months, INF for 1 year 6 months, ADA for 1 year |
No Yes, for 1 year Yes |
Fatigue (from INF) |
Diamantova et al 2014110 | One 50-year-old female | ADA | 80 mg at week 0 then 40 mg EOW | 8 weeks | Yes | None |
Bosnić et al 2016111 | One 39-year-old male | ADA | 40 mg EOW | 1 year | Yes | None |
Saraceno et al 201518 | One 50-year-old male | ADA | 40 mg EOW | 36 weeks | Yes | None |
Bessaleli et al 2018112 | One 33-year-old female | ADA | 40 mg, then increased to 80 mg weekly | 8 months | Yes | Cervical squamous cell carcinoma in situ |
Crowley EL et al 2018113 | One 32-year-old male | ADA | 80 mg at week 0 and then 40 mg weekly | 3 years | Yes | Oral candidiasis |
Molina-Leyva et al 2018114 | One 39-year-old female | ADA | NR | 16 weeks | DLQI reduced from 18 to 0 at week 4 and 16 | None |
Gorovoy et al 2009115 | One 47-year-old female | INF, ADA | INF NR, ADA 40 mg EOW | 15 months for each biologic | Initial response for INF, good response for ADA | Infusion reaction with urticaria (INF) |
Murphy et al 201519 | One 26-year-old female | INF, ADA | INF 5 mg/kg for 2 doses, ADA 160 mg/80 mg then 40 mg EOW | INF NR, ADA for 2 months |
Response to both | Drug hypersensitivity (INF) |
Friedman et al 201813 | One 48-year-old female | ANK | 100 mg/day for 9 months, then 200 mg/day for 15 months | 24 months | Moderate response | Drug-induced sarcoidosis |
Zarchi et al 2013116 | One 37-year-old female | ANK | 200 mg/day | 1 year | Yes | Staphylococcus aureus pustular folliculitis |
Jaeger T et al 201364 | One 27-year-old male | CAN | 150 mg every 3–6 weeks for 8 injections | NR | Yes | NR |
Tekin B et al 201765 | One 27-year-old male | INF, CAN | INF 5 mg/kg for 8 sessions, CAN 150 mg every 4 weeks for 3 doses | NR | Slight improvement with INF, worsening with CAN | Worsening of HS with CAN |
Zangrilli A et al 2008117 | One 32-year-old male | ETA | 50 mg 2x/week for 24 weeks, then 25 mg 2x/week for 24 weeks | 48 weeks | Yes | None |
Tursi A 201654 | One 42-year-old female | GOL | 200 mg once then 100 mg every 4 weeks | NR | Yes | None |
Roussomoustakaki M et al 200338 | One 29-year-old female | INF | 5 mg/kg at 0, 2 and 6 weeks | 6 weeks | Yes | None |
Adams DR et al 2003118 | One 17-year-old male | INF | 5 mg/kg at 0, 2, 6 weeks, and 7 months | 7 months | Yes | None |
Rosi YL et al 2005119 | One 30-year-old female | INF | 5 mg/kg at 0, 2 and 6 weeks | 6 weeks | Yes | None |
Husein-ElAhmed H et al 2011120 | One 47-year-old male | INF | 4.6 mg/kg at weeks 0, 2, 6, 10 | 10 weeks | Yes, but recurrence in 2 weeks | None |
von Preussen AC et al 2012121 | One 42-year-old female | INF | 5 mg/kg at 0, 2 and 6 weeks and then every 8 weeks | NR | Yes | None |
Montes-Romero JA et al 200837 | One 39-year-old male | INF | 5 mg/kg at weeks 0, 2, 6 and 14 |
NR | Yes | None |
Goertz RS et al 200841 | One 54-year-old male | INF | 5 mg/kg for 7 infusions | 2 years | Yes, but effect plateaued | New superinfection |
Blazquez I et al 201339 | One 50-year-old female | INF | INF 5 mg/kg at 0, 2 and 6 weeks and then every 8 weeks | 6 months | Yes | None |
Groleau PF et al 201540 | One 51-year-old male | INF | I5 mg/kg at 0, 2 and 6 weeks and then 7.5 mg/kg every 8 weeks for 1 year, then 5 mg/kg every 8 weeks twice, then 2.5 mg/kg every 8 weeks twice Stopped for 7 months, then 5 mg/kg every 8 weeks when relapsed |
NR | Yes, relapsed after cessation | None |
Martínez F et al 200142 | One 30-year-old male | INF | 5 mg/kg for 2 doses | NR | Yes | Generalized erythema and dyspnea |
Lebwohl B et al 2003122 | One 21-year-old male | INF | NR | NR | Yes, but recurred on prolonged sitting | None |
Thielen AM et al 2006123 | One 48-year-old male | INF | 5 mg/kg at 0, 2 and 6 weeks then every 8 weeks | 104 weeks | Yes | Limited herpes zoster |
Gori A et al 201244 | One 19-year-old male | INF | 5 mg/kg at 0, 2 and 6 weeks then every 8 weeks | 14 weeks | Yes | Acne |
Alecsandru D et al 2010124 | One 47-year-old male | INF | 5 mg/kg at 0, 2 and 6 weeks then every 8 weeks | NR | Yes, flared upon stopping | None |
Poulin Y et al 2009125 | One 25-year-old female | ETA, INF | ETA 50 mg twice a week, INF 5 mg/kg at 0, 2 and 6 weeks then every 6 weeks | 26 months of ETA, 20 months of INF | Worsened with ETA, improved with INF | ETA caused flare of HS |
Staub J et al 201536 | One 22-year-old female | ETA, ADA, ANK, INF | ETA, ADA and ANK NR, INF 5 mg/kg at 0 and 2 weeks then every 8 weeks | 10 months of ETA, 5 months of ADA, 20 months of INF Not stated for ANK |
Improved with INF in combination with dapsone, steroids and cyclosporine but relapsed on tailing cyclosporine | None |
Ozer I et al 201635 | One 43-year-old male | INF | 5 mg/kg at 0, 2 and 6 weeks then every 8 weeks | 2 years | Yes | None |
Kozub P et al 2012126 | One 53-year-old female | INF | 500 mg at 0, 2 and 6 weeks then every 8 weeks | 43 weeks | Initial improvement but plateaued until addition of dapsone | None |
Vossen MG et al 201143 | One 21-year-old male | ETA, INF | ETA 50 mg/week, INF 5 mg/kg | NR | NR | Gemella morbillorum bacteremia |
Takahashi H et al 201795 | One 19-year-old male | RIT | 200 mg for 2 doses 1 year apart | 1 year | Yes | None |
Thorlacius L et al 201774 | One 47-year-old male | ADA, INF, ANK, SEC | ADA, INF, ANK NR, SEC 300 mg/week for 4 weeks then every 4 weeks after | 7 years | Not improved with ADA, INF, ANK. Responded to SEC | Oral candidiasis (SEC) |
Schuch A et al 201775 | One 24-year-old male | ADA, INF SEC | ADA, INF NR, SEC 300 mg/week for 4 weeks then every 4 weeks after | NR | Not improved with ADA and INF, responded to SEC | None |
Giuseppe P et al 2018127 | One 37-year-old male | INF, SEC | INF 5 mg/kg, SEC 300 mg/week for 4 weeks then every 4 weeks after | NR | Partial improvement with INF, improved with SEC | None |
Jørgensen AR et al 2018128 | One 36-year-old female | INF, ADA, UST, SEC | INF, ADA, UST NR, SEC 300 mg/week for 5 weeks then every month | 1 year | No response to INF, ADA, UST, improved with SEC but small relapse | Throat infections, fever |
Santos-Pérez MI et al 2014129 | One 50-year-old female | ADA, UST | ADA 80 mg, then 40 mg every 2 weeks, UST 45 mg at weeks 0, 4 and then every 12 weeks | 2 years of ADA, 1.5 years of UST | Stable then worsened on ADA, improved with UST but 2 exacerbations reported | None |
Sharon VR et al 2012130 | One 55-year-old male | ADA, UST | ADA NR, UST 45 mg at weeks 0, 4 and 12, then 90 mg every 8 weeks | NR | Did not respond to ADA, improved with UST but flares 2 weeks prior to next dose | None |
Scheinfeld N 201445 | One 47-year-old male | INF | 500 mg for 3 courses | NR | NR | Metastatic cutaneous squamous cell carcinoma |
Case series | ||||||
Study | Subject characteristics | Therapies | Dose | Treatment duration | Efficacy | Complications |
Blanco R et al 2009131 | Six patients, two males and four females | ADA in six, ETA in one | ADA 40 mg EOW, increased to weekly if inadequately controlled, decreased to 3-weekly if in remission | Mean of 21.5 months | ETA ineffective, ADA effective | Pain at injection site, severe facial cellulitis in one patient |
Chinniah N et al 2014132 | Six patients, four males and two females | ADA in three cases, INF in four cases, ETA in one case** | NR | Mean 25.3 months | Significant response to ADA in two, INF in three, ETA in one | Neurological adverse events in one patient on ADA |
Houriet C et al 201763 | Two (One male, one female) | CAN | One given 150 mg monthly, one given 150 mg on day 1 and 15 and then monthly | One for 26 months, one for 12 months | Reduction in Sartorius score and VAS for both patients | None |
Sun NZ et al 201762 | Two females | CAN and ANK in one, ADA, INF and CAN in one | INF 5 mg/kg at week 0, 2 and 6, CAN 150 mg every 8 weeks, ANK 100 mg daily for first patient, ADA 40 mg weekly, INF 6 mg/kg and CAN 150 mg weekly for second patient | NR | INF effective in one patient, ADA partial response in same patient | INF - hypersensitivity reaction in first patient, suspicion of drug-related interstitial nephritis in second patient |
Sand FL et al 201556 | 29 patients | ADA in 22, ETA in five, INF in six, CER in two** | ADA 40 mg once weekly, ETA 50 mg once weekly, INF 5 mg/kg every 8 weeks, ADA 40 mg once weekly | Mean of 13 months (1–50 months) | 12 out of 22 responded to ADA, two of five to ETA, one of six to INF, none of two for CER | ADA – Meningealia, headache, fever in one patient, pneumonia in two patients, visual disturbances and headache in one patient; ETA – urosepticemia in one patient, sebopsoriasis in one patient; INF –sensory and motor polyneuropathy, myalgia and arthralgia in one patient, recurrent tonsillitis in one patient |
Zhao CY et al 201821 | Four males | ADA | NR | 10–60 months | 50–100% improvement | One with development of melanoma in situ, one with worsening of Charcot-Marie-Tooth syndrome, one with drug-induced lupus |
Patil 2018133 | Two males | ADA biosimilar (ZRC-3197) | 40 mg weekly for 3 weeks, then EOW for 3 months | 3 months and 3 weeks | >50% reduction in abscess and inflammatory nodule count in both patients | None |
Menis et al 2014103 | Two males | ANK | 100 mg daily | 12 weeks | No | One with worsening of HS |
Cusack et al 2006134 | Six females | ETA | 25 mg twice weekly | 17–40 weeks | All six improved, between 44% and 73% in DLQI reduction | Increased frequency of upper respiratory tract infections in one patient |
Lasocki et al 2010135 | Four (One male, three female) | INF | 5 mg/kg at week 0, 2 and 6, then 8-weekly maintenance infusions. | 38–54 weeks | Improvement in all patients, but with recurrence in all after cessation of therapy | Headache and vomiting in one patient |
Lozeron et al 200920 | One male | INF | 5 mg/kg at 0, 2, 6, 12 and 18 weeks | 18 weeks | Not effective | Lewis-Summer Syndrome (demyelinating neuropathy) |
Elkjaer et al 2008136 | Two males | INF | 5 mg/kg/day at 0, 2 and 6 weeks and then 5 weekly | NR | Effective | Infusion reactions in one patient |
Antonucci et al 2008137 | Two (one male, one female) | INF | 5 mg/kg on weeks 0, 2 and 6 and then every 8 weeks | 59 weeks | Effective in one, ineffective in one | None |
Delage et al 201132 | Seven (Three males, Four females) | INF | 5 mg/kg on weeks 0, 2 and 6 and then every 8 weeks | 6–110 weeks | Effective in six | One with eczema-like eruption, one with pretragian abscess |
Brunasso et al 2008138 | Seven (Three males, four females) | INF | 5 mg/kg on weeks 0, 2 and 6 and then every 8 weeks | Mean 58.6 weeks (4–72) | Improvements in pain, discharge, area reduction and DLQI. 3 with new lesions during therapy | One with adverse drug reaction, not further specified |
Moschella 2007139 | Three (One male, two females) | INF | 5 mg/kg on weeks 0, 2 and 6 and then varying subsequent dosing | 54–80 weeks | Effective in all | None |
Sullivan et al 2003140 | Five (One male, four females) | INF | 5 mg/kg at week 0 for all five patients, and again at week 4–6 for three patients | 0– 6 weeks | Effective in all | Presumed Mycobacterium tuberculosis lymph node infection in one patient |
Torres et al 2010141 | Two patients | INF | 5 mg/kg on weeks 0, 2 and 6 and then every 8 weeks | 7 months | Ineffective | None |
Usmani et al 2006142 | Four patients (two males, two females) | INF | 5 mg/kg, varying dosing | Up to 11 months | Two with good response, one with mild response, one with poor response | One with INF-induced lupus, one with infusion reaction |
Fernández-Vozmediano et al 2007143 | Six patients (Two males, four females) | INF | 5–10 mg/kg at weeks 0, 2 and 6, then every 4 weeks | 6 months | Improvement to stage I in four cases, stage II in two cases | One with headache |
Moriarty et al 201431 | 11 patients (Eight males, three females) | INF | 5–10 mg/kg at weeks 0, 2 and 6, then every 4 to 8 weeks | Median 49.1 months | All with initial improvement, two with secondary failure | Nine cutaneous infections requiring antibiotics, four respiratory tract infections requiring antibiotics, one episode of tonsillitis requiring antibiotics, one case of Hodgkin lymphoma 36 months after cessation of INF |
Kovacs et al 201884 | Three (Two males, one female) | GUS | 100 mg at weeks 0 and 4, then 8 weekly | At least 12 weeks | Improvements in IHS4, VAS and DLQI at 12 weeks in all patients | None |
Weber et al 201788 | Nine patients (Six males, three females) | APR | 30 mg twice daily | 2 days to 9 months | Improvement in five of six who persisted with therapy | Two with weight loss, one with loose stool, one with dry cough, one with nausea, one with reflux |
Zhang et al 2014144 | 22 (nine males, 13 females) | 15 on INF, seven on ADA | NR | 1 month to 3 years | 14 with improvement (11 with INF, three with ADA) | Three with infusion reactions, two with fatigue, one with anaphylaxis, one with heart failure, one with dyspnea, one with recurrent HSV. One death from lung malignancy, one death from metastatic perianal squamous cell carcinoma (both on INF) but no direct causal relationship established. |
DeFazio et al 2016145 | 11 patients | Eight on INF, three on UST | Mean 10.5 months (6 to 15 months) | NR | Effective in seven, local recurrence in four, of which one was after 4 months of INF | None |
Monné et al 2014146 | Four patients | Four on ADA, of which one also tried INF and ETA | Varying doses | NR | ADA effective in three of four, ETA and INF ineffective | None |
Gulliver et al 2011147 | Three (one male, two female) | UST | 45 mg at 0, 1 and 4 months | 6 months | One ineffective, one 25–49% disease clearance, one complete clearance | One patient with S. aureus of right axilla, one patient with cystitis, psoriasiform dermatitis and arthritis |
Retrospective analyses | ||||||
Study | Subject characteristics | Therapies | Dose | Treatment duration | Efficacy | Complications |
van Rappard et al 2012148 | 30 patients (17 males and 13 females) | INF | Weeks 0, 2 and 6 and subsequently every 8 weeks. |
Mean 9.3 months | 10 free of lesions, 13 improved, 4 moderately improved, 3 no response | Noted in 12 patients, not further specified |
Martin-Ezquerra G et al 2014149 | 19 patients (ten males, nine females) | ADA in 11 cases, INF in ten cases, UST in two cases, ETA in two cases** | NR | Mean of 12 months | Physician-judged at least partial responses for ADA in eight, INF in seven, UST in three, none for ETA | Severe infusion reaction and hypertriglyceridemia in two patients |
Bettoli, Manfredini et al 2018150 | 34 patients (19 males, 15 females) | ADA | NR | Varying, up to at least 1 year | Among group receiving ADA for >1 year, 60% achieved HiSCR at 3 months and maintained up to 12 months. | NR |
Kyriakou et al 2018151 | 19 (five males, 14 females) | ADA | 160 mg at week 0, 80 mg at week 2, 40 mg at week 4 and 40 mg weekly after | At least 24 weeks | 63.1% achieved clinical response at 24 weeks (defined by HS-PGA score of clear, minimal or mild with at least two-grade improvement from baseline). | None# |
Casseres et al 201885 | Eight (five males, three females) | GUS | 100 mg at week 0, 4 and then 8 weekly | Up to 10 months | Five (63%) with improvement | None |
Cohort studies | ||||||
Study | Subject characteristics | Therapies | Dose | Treatment duration | Efficacy | Complications |
van Rappard et al 2011152 | 19 patients (12 males, seven females) | Ten on INF, nine on ADA | INF 5 mg/kg at weeks 0, 2 and 6. ADA 40 mg EOW. | 6 weeks | 46% reduction in Sartorius score in INF group vs 34% in ADA group | One on INF with acute arthritis and myalgia, three on ADA with fatigue, one with injection site pain |
Sbidian et al 2016153 | 67 patients (30 males, 37 females) | 17 on ADA, 63 on ADA, eight on ETA** | INF 5 mg/kg, ADA 40 mg EOW, ETA 50 mg twice a week | NR | Treatment with ADA associated with at least partial response compared to ETA or INF with hazards ratio of 6.6 (p=0.001) | One each with hepatitis, lupus, repeated urinary tract infection and pulmonary embolism |
Shanmugam et al 2018112 | 68 patients (23 males, 45 females; 31 ever had biologics, 37 never had biologics) | NR | NR | NR | Ever receiving biologics associated with sharper decline in HS activity, biologic use associated with significant reduction in HSS and Hurley stage, effect of biologics greater in patients who received surgery, combination therapy with surgery and biologics associated with higher probability of achieving 75% reduction in active nodule count. | NR |
Clinical trials | |||||||
---|---|---|---|---|---|---|---|
Study | Trial characteristics | Subject characteristics | Therapies | Dose | Treatment duration | Efficacy | Complications |
Kimball et al 2016,12 Zouboulis et al 201815 | Randomized double-blind placebo-controlled Phase III trial, with open-label extension to 168 weeks | 307 for PIONEER I, 326 for PIONEER II | ADA | 40 mg weekly vs 40 mg EOW vs placebo | 36 weeks | More patients in the weekly ADA group achieved HiSCR [41.8% versus 26.0% in PIONEER I (p=0.003) and 58.9% vs 27.6% in PIONEER II (p<0.001)]. Mean duration of infection-free HiSCR was significantly longer in ADA compared to placebo group (p< 0.001).154 More patients on ADA achieved a ≥30% in the Patient’s Global Assessment of Skin Pain, both PIONEER I (ADA [40.3%] vs placebo [24.9%]; OR =2.03, p=0.004) and II (ADA [61.2%] vs placebo [24.8%]; OR=4.78, p<0.001).155 Achievement of HiSCR was maintained through week 168 in 52.3% in weekly ADA group and 57.1% of responders plus partial responders.15 |
Among ADA group, new psoriasiform eruptions and psoriasis in ten patients, one case of squamous cell carcinoma of the nose, and one death from cardiorespiratory arrest 42 days after the last dose of ADA in a 35-year-old man with a history of diabetes mellitus, smoking and a family history of ischemic heart disease. Adverse events observed during open-label extension were similar to safety profiles observed in PIONEER studies.15 Safety analysis of every week and EOW dosing showed similar adverse event rates.16 |
Jiménez-Gallo et al 2018156 | Prospective open label study | 19 (11 males, eight females) | ADA | 40 mg weekly | 36 weeks | HiSCR in 68.42%. | NR |
Kimball et al 201211 | Phase II parallel randomized, placebo-controlled trial with a blinded 16-week period and an open-label 36-week period | 154 | ADA | 40 mg weekly vs 40 mg EOW vs placebo | 52 weeks | 17.6% in weekly ADA vs 9.6% in EOW group vs 3.9% in placebo group achieved HS-PGA score of clear, minimal, or mild with at least a two-grade improvement relative to baseline score at week 16 (EOW vs placebo difference, 5.6% [95% CI, 4.0% to 15.3%]; p 0.25; weekly vs placebo difference, 13.7% [CI, 1.7% to 25.7%]; p 0.025). Proportion with clinical response decreased after change from weekly to EOW dosing. A shorter time to achieving HiSCR in weekly ADA vs EOW group.99 | 24 listed serious adverse events: rectal fissure, inadequately controlled diabetes mellitus, goiter, hidradenitis, interstitial lung disease, pilonidal cyst, viral infection, anemia, bacteremia, vocal cord neoplasm, bacterial genital infection, Escherichia infection, penile swelling, purulent discharge, pustular rash, scrotal swelling, noncardiac chest pain, and cellulitis. |
Arenbergerova et al 2010157 | Open label trial | Eight (three males, five females) | ADA | 80 mg at week 0, 40 mg at week 1, then 40 mg EOW | 12 months | Mean reduction in pain and discharge of 86.5% and 72.8% respectively at 12 months, and 56.6% and 50.1% at 24 months | One case of EBV infection |
Amano et al 2010101 | Open-label Phase II trial | Ten, of which six completed treatment | ADA | 160 mg at week 0, 80 mg at week 1, 40 mg EOW | 12 weeks | None responded, as defined by at least 50% decrease in HSSI score | No serious adverse events |
Leslie et al 201460 | Open-label trial | 6 (Two males, four females), of which five completed the study | ANK | 100 mg daily | 8 weeks | Significant improvement in modified Sartorius score during treatment and rebound during follow-up post-treatment | None |
Tzanetakou et al 201658 | Randomized double-blind placebo-controlled trial | 20 patients (ten in anakinraANK arm, ten in placebo arm), of which 19 completed study | ANK | 100 mg daily | 12 weeks | At week 12, 78% in ANK arm vs 20% in placebo arm had reduction in disease activity score, defined as the sum of scores of all affected areas (two largest diameters in each affected areas multiplied by degree of inflammation at each lesion), and 78% vs 30% achieved HiSCR. At week 24, 10% vs 33% achieved HiSCR. | No serious adverse events |
Vossen et al 201889 | Randomized double-blind placebo-controlled trial | 20 (15 given apremilastAPR and five given placebo) of which 18 completed the study | APR | 30 mg BD | 16 weeks | Eight of 15 achieved HiSCR in APR arm compared to none in placebo arm (p=0.055) at week 16. | 38 adverse events in APR arm vs 11 in placebo arm, none categorized as severe. |
Cusack et al 2006134 | Open-label trial | Six | ETA | 25 mg twice weekly | 17 to 40 weeks | 44 to 73% reduction in DLQI 12 to 24 weeks after starting treatment | Increased incidence of URTIs in one patient |
Giamarellos-Bourboulis et al 200747 | Open-label Phase II trial | Ten three males, seven females) | ETA | 50 mg weekly | 12 weeks | >50% decrease in disease activity (defined as sum of lesions with each lesion evaluated with the formula: lesion diameters multiplied by severity) in six patients at week 12 and seven patients at week 24. | No serious adverse events: three patients with self-limited injection site erythema, one patient with right gluteal abscess |
Sotiriou et al 200850 | Open- label trial | Four (one male and three females) | ETA | 25 mg twice a week | 6 months | 54–73% reduction in DLQI | One case of mild injection site reaction |
Lee et al 200949 | Open-label trial | 15, of which ten completed treatment | ETA | 50 mg weekly for 12 weeks, then 25 mg weekly for 2 weeks | 14 weeks | Only three (20%) of patients achieved 20% reduction in PGA, based on intention to treat analysis. | No serious adverse events reported |
Pelekanou et al 201048 | Open-label Phase II trial | Ten | ETA | 50 mg weekly | Initial 12-week duration, then subsequent 0 to 96-week course depending on recurrence | Three who improved in mSS with no recurrence and 7 who improved and then recurred after stopping treatment, of which five had a positive response to repeat treatment | None |
Adams et al 201051 | Randomized trial with 12-week double-blind placebo-controlled phase followed by 12-week open-label phase | 20 patients (ten in etanerceptETA arm and ten in placebo arm), of which 14 completed entire study | ETA | 50 mg twice weekly | 24 weeks | No statistically significant difference in physician global assessment between treatment and placebo arms | No serious adverse events |
Paradela et al 201233 | Open-label trial | Ten (four males, six females) | INF | 5 mg/kg at week 0, 2, 6 and then 8-weekly | 29 to 181 weeks | Eight with response (defined as 50% reduction in hidradenitis severity score), of which four relapsed (defined as 40% increase in score of initial response) | One case of mycobacterial folliculitis, one case of scrotal abscess, two cases of psoriasis, five cases of positive anti-nuclear antibodies, two cases of transient hyperlipidemia |
Grant et al 20109 | Clinical trial with 8-week double-blind placebo-controlled phase followed by 14- to 22-week open label phase | 38 patients (15 in infliximabINF arm and 23 in placebo arm) | INF | 5 mg/kg at week 0, 2 and 6 and then 8 weekly | 22 weeks | At week 8, 60% of patients in INF arm vs 5.6% of patients in placebo arm had 25% to less than 50% reduction in HSSI, and 13.3% of patients in INF arm vs 88.9% in placebo arm had less than 25% decrease in HSSI (p<0.001). | Serious adverse events: one pregnancy, one case of hypertension, one infusion reaction requiring hospitalization. |
Mekkes et al 200734 | Open-label trial | 11, of which ten (four males, six females) completed the study | INF | 5 mg/kg at week 0, 2 and 6 | 6 weeks | Improvements in all patients within 2–6 weeks, as defined by reduction in mSS. At one year, improvements in 6 patients, but recurrences in 4. | One with numbness and pain in both legs, one with anaphylactic shock, and one with myalgia and fever |
Kanni et al 201866 | Randomized double-blind placebo-controlled trial | 20 patients (10 in bermekimabBER arm and 10 in placebo arm) | BER | 7.5 mg/kg every 14 days | 12 weeks | 60% in BER arm vs 10% in placebo arm achieved HiSCR at week 12, and 40% vs 0% at week 24. | 19 HS exacerbations in BER group, of which 2 required hospitalization |
Blok et al 201672 | Open-label trial | 17 (four males, 13 females) | UST | Week 0, 4, 16 and 28–45 mg per dose for participants weighing <100 kg and 90 mg per dose for those >100 kg | 28 weeks | Marked improvement of mSS in six (35%), moderate in eight (47%), mild in one (6%), no change/worsening in two (12%) at 40 weeks. Mean mSS of intention-to-treat population decreased from 112.12 to 60.18 at week 40 (46.33% improvement, p<0.01). Eight (47%) achieved HiSCR at week 40. | Headache, fatigue, URTI |
Guo et al 201791 | Open-label phase II trial | 12 | IFX-1 | 800 mg on days 1, 4, 8, 15, 22, 29, 36, 43 and 50 | 50 days | 83% achieved HiSCR at Day 134 (95% CI: 0.52–0.98). | NR |
Notes: **Overlapping due to switches in therapy. #Study excluded patients who discontinued treatment due to adverse event or had to receive another therapeutic modality.
Abbreviations: ADA, adalimumab; GOL, golimumab; ANK, anakinra; ETA, etanercept; INF, infliximab; CAN, canakinumab; RIT, rituximab; SEC, secukinumab; UST, ustekinumab; CER, certolizumab; GUS, guselkumab; APR, apremilast; BER, bermekimab; EOW, every other week; NR, not reported; PASH, pyoderma gangrenosum, acne and suppurative hidradenitis; NSAID, non-steroidal anti-inflammatory drug; HPV, human papillomavirus; SAPHO, synovitis, acne, pustulosis, hyperostosis and osteitis; HCV, hepatitis C virus; Nd-YAG, neodymium-doped yttrium aluminum garnet; CO2, carbon dioxide; IHS4, international HS severity score system; HSV, herpes simplex virus; HSS, HS score; HiSCR, HS clinical response; URTI, upper respiratory tract infection; PGA, physician global assessment; mSS, modified sartorius score; EBV, Epstein-Barr virus, HSSI, HS severity index.