Drugs

Drug Trials Snapshot: ANTHIM

 

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights subjects who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among these subjects when grouped by sex, race, and age. The efficacy of this drug was studied in animal models while the safety was studied in healthy human volunteers. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to ANTHIM Prescribing Information for complete information.

ANTHIM (obiltoxaximab)
(ˈan(t)-thim)
Elusys Therapeutics, Inc
Approval date: March 18, 2016


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ANTHIM is a drug for the treatment of inhalational anthrax. It is meant to be used together with an appropriate antibiotic.

ANTHIM can also be used to prevent inhalational anthrax when there are no other treatment options.

Inhalational anthrax is a rare and serious bacterial disease that can cause massive and irreversible tissue injury, shock and death.

How is this drug used?

ANTHIM is given by a healthcare provider through a vein (IV or intravenous infusion) over about 1 hour and 30 minutes.

What are the benefits of this drug?

ANTHIM improved survival in the studies done on animals with inhalational anthrax. Because inhalational anthrax is very rare, the efficacy of ANTHIM could not be studied in human patients.

What are the benefits of this drug (results of trials used to assess efficacy)?

The efficacy of ANTHIM for the treatment of inhalational anthrax is based on studies in New Zealand White (NZW) rabbits and monkeys (cynomolgus macaques). More animals survived in the group treated with ANTHIM compared to the placebo group. It was not possible to conduct controlled clinical trials in humans with inhalational anthrax, because this infection is very rare.

Table 2. Survival Proportions in Monotherapy Treatment Studies of ANTHIM 16 mg/kg IV in All Randomized Animals Positive for Bacteremia Prior to Treatment

 Proportion of  Survival at Day 281
(# survived/n)
  p-value2  95% CI3
 PlaceboANTHIM 16 mg/kg IV
NZW* Rabbits
Study 10% (0/9)93% (13/14)0.0010(0.59, 1.00)
Study 20 % (0/13)62% (8/13)0.0013(0.29, 0.86)
Cynomolgus Macaques
Study 36 % (1/16)47% (7/15)0.0068(0.09, 0.68)
Study 440 % (0/17)31% (5/16)
35% (6/17)
0.0085
0.0055
(0.08, 0.59)
(0.11, 0.62)
IV: intravenous, CI: Confidence Interval
1Survival assessed 28 days after spore challenge
2p-value is from 1-sided Boschloo Test (with Berger-Boos modification of gamma=0.001) compared to placebo
3Exact 95% confidence interval of difference in survival rates
4ANTHIM products manufactured at two different facilities were tested in two separate treatment arms.
*New Zealand White
ANTHIM Prescribing Information

 

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

The efficacy of ANTHIM has been studied only in animals, so the differences among subjects grouped by sex, race, and age could not be determined.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

Due to ethical considerations, clinical efficacy trials for ANTHIM were not conducted in humans. Therefore, human data on efficacy and subgroup analyses are not available.

What are the possible side effects?

The side effects of ANTHIM have been studied in healthy human volunteers.

ANTHIM may cause serious allergic reactions including a life threatening reaction called anaphylaxis.

Other common side effects of ANTHIM are headache, itching, upper respiratory tract infections, cough, IV site bruising, swelling, and pain, stuffy nose (nasal congestion), rash, and pain in a limb.

What are the possible side effects (results of trials used to assess safety)?

Hypersensitivity reactions were the most common adverse reactions seen in 34 (10%) of the healthy humans who received Anthim; these reactions included pruritus, urticaria, cough and anaphylaxis. The table below summarizes adverse reactions that occurred in ≥ 1.5% of healthy human participants receiving a single dose of ANTHIM (16 mg/kg IV) and more frequently than those receiving placebo.

Table 3. Adverse Reactions Reported in ≥ 1.5% of Healthy Adult Participants Exposed to Single Dose ANTHIM 16 mg/kg IV

Adverse ReactionsPlacebo
N =70 (%)
Single Dose
ANTHIM N = 300* (%)
Headache4 (6%)24 (8%)
Pruritus1 (1%)11 (4%)
Infections of the upper respiratory tract2 (3%)14 (5%)
Cough09 (3%)
Vessel puncture site bruise1 (1%)8 (3%)
Infusion site swelling1 (1%)8 (3%)
Nasal congestion1 (1%)5 (2%)
Infusion site pain07 (2%)
Urticaria05 (2%)
Pain in extremity1 (1%)5 (2%)
*Single-dose population: 210 participants in trial 1 + 70 participants in the first treatment period of trial 2
+ 20 participants in the ANTHIM alone treatment arm of study 3

ANTHIM Prescribing Information

Were there any differences in side effects among sex, race, and age?

  • Sex: The occurrence of side effects was similar in men and women
  • Race: The occurrence of side effects was similar between White and Black participants. Differences among other races could not be determined due to the small number of participants.
  • Age: Most participants in the clinical trials were younger than 65 years of age, so differences in the occurrence of side effects between groups of participants below and above 65 years of age could not be determined.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below shows the incidence of treatment-emergent adverse events (TEAEs) by subgroup.

Table 4. Subgroup Analysis of TEAEs

SubgroupANTHIM single dose (n=300)Placebo (n=70)
n (%)Total
number of patients (n)
  n (%)Total
number of patients (n)
Overall/All participants138 (46%)30027 (40%)70
Sex
   Male72 (44%)16212 (32%)38
   Female66 (48%)13815 (47%)32
Age Group
   18-65 years119 (44%)27025 (38%)66
   65 years and older19 (63%)302 (50%)4
Race
   White104 (50%)21021 (48%)44
   Black or African American29 (36%)805 (22%)23
   Asian1 (33%)31 (50%)2
   American  Indian or Alaska
   Native
2 (67%)300
   Other2 (50%)401
Clinical trial data

 


WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved ANTHIM based on efficacy results from animal studies and safety results from three human clinical trials. The clinical trials enrolled 370 heathy participants and were conducted in the United States.

The figure below summarizes how many men and women were in the clinical trials that evaluated ANTHIM safety.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials of the drug ANTHIM. In total, 200 men (54%) and 170 women (46%) participated in the clinical trials used to evaluate the safety of drug ANTHIM.Clinical trial data

Figure 2 and Table 1 below summarize healthy participants by race were in the clinical trials that evaluated ANTHIM safety.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of participants by race in the ANTHIM clinical trials. In total, 254 Whites (69%), 103 Blacks (28%), 5 Asians (1%), 3 American Indian or Alaska Natives (1%) and 5 Other (1%) participated in the clinical trials.Clinical trial data

Table 1. Baseline Demographics by Race

RaceNumber of ParticipantsPercentage
White25469%
Black or African American10328%
Asian51%
American Indian or Alaska Native31%
Other51%

Clinical trial data

Figure 3 summarizes the percentage of healthy participants by age group who were in the clinical trials that evaluated ANTHIM safety.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were in the ANTHIM clinical trials.  In total, 336 participants were below 65 years old (91%) and 34 participants were 65 and older (91%) and 34 participants were 65 and older (9%). Clinical trial data

Who participated in the trials?

The table below summarizes demographics of participants in the clinical trials.

Table 5. Baseline Demographics of Healthy Participants in the Safety Clinical Trials

Demographic ParametersPlacebo
(N=70)
n (%)
ANTHIM
(N=300)
n (%)
Total
(N=370)

n (%)
Sex
  Male38 (54)162 (54)200 (54)
  Female32 (46)138 (46)170 (46)
Age 
  Mean years41.541.941.7
  Median (years)404241
  Min, Max (years)20,7818,7918,79
Age Group (years)
≥18 - <6566 (94)270 (90)336(91)
≥654 (6)30 (10)34 (9)
Race 
  White44 (63)210 (70)254(69)
  Black or African American23 (33)80 (27)103(28)
  Asian2 (3)3 (1)5 (1)
  American Indian or Alaska Native03 (1)3(1)
 Other1 (1)4 (1)5 (1)
Ethnicity 
  Hispanic or Latino9 (13)26 (8)35(9)
  Not Hispanic or Latino61 (87)274 (91)335 (91)
Clinical trial data

 

How were the trials designed?

The efficacy of ANTHIM was evaluated in rabbits and monkeys. The side effects of ANTHIM were evaluated in the three clinical trials of healthy participants. Most participants received one or more treatments with ANTHIM, while the rest of the participants received placebo. Neither the participant nor the health care providers knew which treatment was given until after the trials were completed.

How were the trials designed?

The efficacy of ANTHIM for the treatment of inhalational anthrax was studied in NZW rabbits and cynomolgus macaques. The animal efficacy studies were conducted under varying conditions and measured survival rates at Day 28 post-exposure.

The safety of ANTHIM was studied in healthy participants who were treated with one or more doses of 16 mg/kg IV ANTHIM in three clinical trials. Trial 1 was a single-dose placebo-controlled trial, Trial 2 was an open label repeat-dose trial, and Trial 3 was an open label, single-dose, drug interaction trial with ciprofloxacin.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

Back to Drug Trials Snapshots

 

Page Last Updated: 04/06/2016
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